Keeping in mind the rapid spread of the Delta variant of coronavirus, Israel’s government has decided to offer a third shot of the <a href="https://www.wionews.com/topics/coronavirus-vaccine">COVID-19 vaccine</a> to all adults.

Israel has taken this decision after the new infections of coronavirus increased from single-digit to nearly 450 cases per day. The country has also moved to fast-track its next shipment of Pfizer’s vaccine doses.

Also read |&nbsp;<a href="https://www.wionews.com/world/covid-19-who-chief-scientist-lists-four-reasons-for-pandemic-not-slowing-down-397170" hreflang="en">COVID-19: WHO chief scientist lists four reasons for pandemic not slowing down</a>

All adults with ‘impaired immune systems’ who had already received the first two shots of the Pfizer vaccine are now eligible for a third shot of the vaccine, declared Health Minister Nitzan Horowitz.

Pfizer-BioNTech, the suppliers, has assured that the authorities are in contact with the US and European regulators to authorise the third shot, acting as a booster shot against the new 'variant of concern'.

The third shot has faced criticism from some scientists. "We are examining this issue and we still do not have a final answer," Horowitz said. "In any case, we are administering as of now a third shot to people suffering from immunodeficiency … These are for instance people who have undergone organ transplants or suffer from a medical condition which causes a drop in immunity."

Also read |&nbsp;<a href="https://www.wionews.com/world/covid-19-95-may-need-to-be-vaccinated-to-stop-delta-variant-warns-french-scientists-397151" hreflang="en">COVID-19: 95% may need to be vaccinated to stop Delta variant, warn French scientists</a>

This decision has also been taken keeping in mind that nearly half of the 46 patients currently admitted in Israel’s hospitals due to coronavirus are vaccinated, as per data provided to the public by the health ministry. Out of these half, majority are patients from the vulnerable groups who had prior health issues or are aged 60 and above.

Meanwhile, the health minister has also assured that the officials are working on filling in the supply gap between the first two shots of the ongoing inoculation programmes for the general adult population by using Moderna vaccine doses,&nbsp;available in stock.

Keeping in mind the rapid spread of the Delta variant of coronavirus, Israel’s government has decided to offer a third shot of the COVID-19 vaccine to all adults.

Keeping in mind the rapid spread of the Delta variant of coronavirus, Israel’s government has decided to offer a third shot of the COVID-19 vaccine to all adults. Israel has taken this decision after the new infections of coronavirus increased from single-digit to nearly 450 cases per day. The country has also moved to fast-track its next shipment of Pfizer’s vaccine doses. Also read | COVID-19: WHO chief scientist lists four reasons for pandemic not slowing down All adults with ‘impaired immune systems’ who had already received the first two shots of the Pfizer vaccine are now eligible for a third shot of the vaccine, declared Health Minister Nitzan Horowitz. Pfizer-BioNTech, the suppliers, has assured that the authorities are in contact with the US and European regulators to authorise the third shot, acting as a booster shot against the new 'variant of concern'. The third shot has faced criticism from some scientists. "We are examining this issue and we still do not have a final answer," Horowitz said. "In any case, we are administering as of now a third shot to people suffering from immunodeficiency … These are for instance people who have undergone organ transplants or suffer from a medical condition which causes a drop in immunity." Also read | COVID-19: 95% may need to be vaccinated to stop Delta variant, warn French scientists This decision has also been taken keeping in mind that nearly half of the 46 patients currently admitted in Israel’s hospitals due to coronavirus are vaccinated, as per data provided to the public by the health ministry. Out of these half, majority are patients from the vulnerable groups who had prior health issues or are aged 60 and above. Meanwhile, the health minister has also assured that the officials are working on filling in the supply gap between the first two shots of the ongoing inoculation programmes for the general adult population by using Moderna vaccine doses, available in stock.

COVID-19: Israel set to offer booster shot of Pfizer vaccine against Delta variant

Pfizer&nbsp;and BioNTech announced Thursday they would seek regulatory authorization for a third dose of their Covid-19 vaccine.

It comes after initial data from an ongoing trial showed a third shot pushed antibody levels five to 10 times higher against the original coronavirus strain and the Beta variant, first found in South Africa, compared to the first two doses alone, according to a statement.

"The companies expect to publish more definitive data soon as well as in a peer-reviewed journal and plan to submit the data to the FDA (Food and Drug Administration), EMA (European Medicines Agency) and other regulatory authorities in the coming weeks," the statement said.

In addition, the companies expect that a third dose will perform similarly well against the highly transmissible Delta strain, which is quickly becoming globally dominant.

<a href="https://www.wionews.com/world/israel-sees-steep-drop-in-pfizer-vaccine-efficacy-rate-396119">Also read | Israel sees steep drop in Pfizer vaccine efficacy rate</a>

Out of caution, the companies are also developing a Delta-specific vaccine, the first batch of which has been manufactured at BioNTech's facility in Mainz, Germany.&nbsp;

The companies anticipate the clinical studies will begin in August, subject to regulatory approvals.

Based on drop-offs in efficacy seen in Israel after six months, the companies said they believe a third dose may be needed within six to 12 months after full vaccination

"While protection against severe disease remained high across the full 6 months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected," the statement said.

The FDA and US Centers for Disease Control and Prevention released a joint statement late Thursday saying authorities were studying "whether or when a booster might be necessary."

"Americans who have been fully vaccinated do not need a booster shot at this time," the agencies said. "We are prepared for booster doses if and when the science demonstrates that they are needed."

Pfizer and BioNTech announced Thursday they would seek regulatory authorization for a third dose of their Covid-19 vaccine. It comes after initial data from an ongoing trial showed a third shot pushed antibody levels five to 10 times higher against the original coronavirus strain and the Beta variant, first found in South Africa, compared to the first two doses alone, according to a statement.

Pfizer and BioNTech announced Thursday they would seek regulatory authorization for a third dose of their Covid-19 vaccine. It comes after initial data from an ongoing trial showed a third shot pushed antibody levels five to 10 times higher against the original coronavirus strain and the Beta variant, first found in South Africa, compared to the first two doses alone, according to a statement. "The companies expect to publish more definitive data soon as well as in a peer-reviewed journal and plan to submit the data to the FDA (Food and Drug Administration), EMA (European Medicines Agency) and other regulatory authorities in the coming weeks," the statement said. In addition, the companies expect that a third dose will perform similarly well against the highly transmissible Delta strain, which is quickly becoming globally dominant. Also read | Israel sees steep drop in Pfizer vaccine efficacy rate Out of caution, the companies are also developing a Delta-specific vaccine, the first batch of which has been manufactured at BioNTech's facility in Mainz, Germany. The companies anticipate the clinical studies will begin in August, subject to regulatory approvals. Based on drop-offs in efficacy seen in Israel after six months, the companies said they believe a third dose may be needed within six to 12 months after full vaccination "While protection against severe disease remained high across the full 6 months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected," the statement said. The FDA and US Centers for Disease Control and Prevention released a joint statement late Thursday saying authorities were studying "whether or when a booster might be necessary." "Americans who have been fully vaccinated do not need a booster shot at this time," the agencies said. "We are prepared for booster doses if and when the science demonstrates that they are needed."

Pfizer-BioNTech to seek authorization for 3rd Covid shot: statement

Pfizer and BioNTech have announced that they would seek the FDA's approval for the third dose of their COVID-19 vaccine to boost its efficacy, as the Delta variant is increasingly becoming a global dominant.

Pfizer-BioNTech to seek FDA approval for third dose of COVID-19 vaccine

Health authorities in Israel have claimed that the Pfizer vaccines are reportedly less effective in checking the spread of Coronavirus in the country. However, they say that inoculation is still highly effective in keeping serious illness at bay.

Israel sees decline in Pfizer's efficacy rate amid spread of Delta variant

Israel has recorded a drop in the efficacy rate of the Pfizer Inc.-BioNTech SE in preventing the deadly coronavirus infections, reveals Health Ministry data. Also, a decline in protection against serious cases and hospitalization is considerably milder.

Israel has recorded a drop in the efficacy rate of the Pfizer Inc.-BioNTech SE in preventing the deadly coronavirus infections, reveals Health Ministry data. Also, a decline in protection against serious cases and hospitalization is considerably milder. However, there was no immediate comment from the ministry. As per the figures, between May 2 and June 5, the vaccine had a 94.3 per cent efficacy rate. From June 6, which is five days after the government cancelled coronavirus restrictions, the rate dropped to 64 per cent. Also read | Israel sees probable link between Pfizer vaccine and myocarditis cases These figures are in line with ministry data that show that many of the new cases are among people who have been vaccinated. Also, the number of 'serious' cases is rising much more slowly. Last Friday, 55 per cent of the newly infected had been vaccinated. As of July 4, there were 35 serious cases of coronavirus in Israel, compared with 21 on June 19. Pfizer CEO Albert Bourla has said people will “likely” need a third dose of a COVID-19 vaccine within 12 months of getting fully vaccinated. To cope up with a rise in cases, the government is considering reinstating additional coronavirus-related restrictions. The government will also mandate to wear masks indoors in public spaces. Officials are also discussing whether to recommend a third dose of vaccine.

Israel sees steep drop in Pfizer vaccine efficacy rate

Europe's drug regulator has said&nbsp;the COVID-19 vaccines approved in the&nbsp;European Union offered protection against all coronavirus variants, including Delta, but called for active monitoring by vaccine manufacturers to stay alert.

"It seems that the four vaccines that are approved in the&nbsp;European Union are protective against all strains that are circulating in&nbsp;Europe, including the Delta variant," said Marco Cavaleri,&nbsp;European Medicines Agency's (EMA) head of vaccine strategy, during a news briefing.

The upbeat assessment came as the World Health Organization warned that the coronavirus variant first detected&nbsp;in India could fuel a new wave of cases in Europe.

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The EMA's head of vaccine strategy, Marco Cavaleri, said the Amsterdam-based watchdog was "aware of concerns caused by the rapid spread of the Delta variant.

"Right now it seems that the four vaccines approved in the European Union are protecting against all the strains circulating in Europe, including the Delta variant," he said.

"Emerging data from real world evidence are showing that two doses of vaccines are protective against the Delta variant."

Lab tests also showed that antibodies from the vaccines were able to neutralise Delta "so these are very reassuring news."

Four vaccines are currently approved for use in the EU: Pfizer/BioNTech, Moderna, AstraZeneca and&nbsp;Johnson&nbsp;&amp;&nbsp;Johnson.&nbsp;

But while the EU has been stepping up its vaccination programme, the WHO warned that cases are on the rise again after two months of decline.

The WHO said the reversal came as the Delta variant was overtaking the original Alpha variant that emerged in Britain "very quickly".

The EMA's Cavaleri said the regulator urged manufacturers to keep checking that their jabs were effective against all new variants of the disease including the so-called 'Delta Plus'.

"There are a number of variants that have been emerging over the last months, and we expect more to come over," Cavaleri said.

"Now there is the so-called Delta Plus variant, which is the Delta variant with an additional mutation in the spike protein, that is also important and we need to check that as well."

(With inputs from agencies)

Europe's drug regulator has said the COVID-19 vaccines approved in the European Union offered protection against all coronavirus variants, including Delta, but called for active monitoring by vaccine manufacturers to stay alert.

Europe's drug regulator has said the COVID-19 vaccines approved in the European Union offered protection against all coronavirus variants, including Delta, but called for active monitoring by vaccine manufacturers to stay alert. "It seems that the four vaccines that are approved in the European Union are protective against all strains that are circulating in Europe, including the Delta variant," said Marco Cavaleri, European Medicines Agency's (EMA) head of vaccine strategy, during a news briefing. The upbeat assessment came as the World Health Organization warned that the coronavirus variant first detected in India could fuel a new wave of cases in Europe. The EMA's head of vaccine strategy, Marco Cavaleri, said the Amsterdam-based watchdog was "aware of concerns caused by the rapid spread of the Delta variant. "Right now it seems that the four vaccines approved in the European Union are protecting against all the strains circulating in Europe, including the Delta variant," he said. "Emerging data from real world evidence are showing that two doses of vaccines are protective against the Delta variant." Lab tests also showed that antibodies from the vaccines were able to neutralise Delta "so these are very reassuring news." Four vaccines are currently approved for use in the EU: Pfizer/BioNTech, Moderna, AstraZeneca and Johnson & Johnson. But while the EU has been stepping up its vaccination programme, the WHO warned that cases are on the rise again after two months of decline. The WHO said the reversal came as the Delta variant was overtaking the original Alpha variant that emerged in Britain "very quickly". The EMA's Cavaleri said the regulator urged manufacturers to keep checking that their jabs were effective against all new variants of the disease including the so-called 'Delta Plus'. "There are a number of variants that have been emerging over the last months, and we expect more to come over," Cavaleri said. "Now there is the so-called Delta Plus variant, which is the Delta variant with an additional mutation in the spike protein, that is also important and we need to check that as well." (With inputs from agencies)

EU-approved vaccines effective against Delta variant in bloc, says EMA

German biotech company&nbsp;CureVac&nbsp;said on Wednesday its COVID-19 vaccine was only 48&nbsp;per cent&nbsp;effective in the final trial,&nbsp; missing the study's main goal and throwing in doubt the potential delivery of hundreds of millions of doses to the European Union.

The company in part blamed "the unprecedented context of 15 strains circulating" among the trial volunteers, as well as varying responses across age groups.

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/germanys-biontech-curevac-joins-coronavirus-vaccine-race-314191/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

The stakes for&nbsp;CureVac&nbsp;and prospective buyers of its vaccine in Europe had risen after age limits were imposed on the use of the Johnson &amp; Johnson and AstraZeneca vaccines due to a link to extremely rare but potentially fatal clotting disorders.

CureVac's shot was also expected to help in low and middle-income countries that have lagged far behind richer nations in the global immunisation drive.

As&nbsp;CureVac's only major supply deals, the European Union in November secured up to 405 million doses of the vaccine, of which 180 million are optional. That was followed by a memorandum of understanding with Germany for another 20 million doses.

The Covid vaccines developed by Germany's BioNTech in partnership with US giant Pfizer and by US firm Moderna -- based on the same novel messenger RNA technology -- were approved earlier on in the pandemic after showing around 95 percent efficacy.

Their trials only had to contend with the original strain of the virus. But recent studies indicate that both vaccines also offer strong protection against the newer, more contagious variants.

CureVac&nbsp;said its jab, known as CVnCoV, did slightly better among people aged 18 to 60 than among older ages, with efficacy climbing to 53 percent.&nbsp;

Among that same 18-60 age group, the vaccine offered 100-percent protection against hospitalisation and death.

In a statement, chief executive officer Franz-Werner Haas said "CVnCoV demonstrates a strong public health value" for people aged 18 to 60 "which we believe will be an important contribution to help manage the Covid-19 pandemic and the dynamic variant spread".

The Tuebingen-based company has shared its data with the European Medicines Agency (EMA), which will now decide if the vaccine is good enough to be greenlit.

The European Union has secured up to 405 million doses of the&nbsp;CureVac&nbsp;vaccine should it receive regulatory approval.

Despite being a laggard in the vaccine race,&nbsp;CureVac&nbsp;believes it has advantages over mRNA competitors.

CureVac's product can be stored at standard refrigerator temperature, unlike the first-generation Pfizer and Moderna vaccines which require super-cold freezers.

CureVac's vaccine also requires a lower dosage of just 12 microgrammes, compared to 30 microgrammes for BioNTech and 100 for Moderna, allowing for faster and cheaper mass production.

These factors could possibly give&nbsp;CureVac&nbsp;an edge in poorer or warmer countries.

Scientists have said the weaker-than-hoped results may be down to the lower dosage, or even&nbsp;CureVac's recipe, which unlike its rivals uses an unmodified form of messenger RNA.

The company is already working on a second-generation Covid vaccine for which it has teamed up with pharma giant GSK.

Early results on rats have been promising, it said.&nbsp;Clinical testing on humans is set to begin in the third quarter of 2021.

CureVac&nbsp;was founded in 2000 by mRNA pioneer Ingmar Hoerr and is backed by Dietmar Hopp, the German billionaire behind software behemoth SAP.

The German government last year took a 23-percent stake in&nbsp;CureVac&nbsp;for 300 million euros.

The move came shortly after media reports said then President Donald Trump had sought exclusive US access to any&nbsp;CureVac&nbsp;vaccine, a claim both sides strenuously denied.

(With inputs from agencies)

German biotech company CureVac said on Wednesday its COVID-19 vaccine was only 48 per cent effective in the final trial, missing the study's main goal and throwing in doubt the potential delivery of hundreds of millions of doses to the European Union.

German biotech company CureVac said on Wednesday its COVID-19 vaccine was only 48 per cent effective in the final trial, missing the study's main goal and throwing in doubt the potential delivery of hundreds of millions of doses to the European Union. The company in part blamed "the unprecedented context of 15 strains circulating" among the trial volunteers, as well as varying responses across age groups. The stakes for CureVac and prospective buyers of its vaccine in Europe had risen after age limits were imposed on the use of the Johnson & Johnson and AstraZeneca vaccines due to a link to extremely rare but potentially fatal clotting disorders. CureVac's shot was also expected to help in low and middle-income countries that have lagged far behind richer nations in the global immunisation drive. As CureVac's only major supply deals, the European Union in November secured up to 405 million doses of the vaccine, of which 180 million are optional. That was followed by a memorandum of understanding with Germany for another 20 million doses. The Covid vaccines developed by Germany's BioNTech in partnership with US giant Pfizer and by US firm Moderna -- based on the same novel messenger RNA technology -- were approved earlier on in the pandemic after showing around 95 percent efficacy. Their trials only had to contend with the original strain of the virus. But recent studies indicate that both vaccines also offer strong protection against the newer, more contagious variants. CureVac said its jab, known as CVnCoV, did slightly better among people aged 18 to 60 than among older ages, with efficacy climbing to 53 percent. Among that same 18-60 age group, the vaccine offered 100-percent protection against hospitalisation and death. In a statement, chief executive officer Franz-Werner Haas said "CVnCoV demonstrates a strong public health value" for people aged 18 to 60 "which we believe will be an important contribution to help manage the Covid-19 pandemic and the dynamic variant spread". The Tuebingen-based company has shared its data with the European Medicines Agency (EMA), which will now decide if the vaccine is good enough to be greenlit. The European Union has secured up to 405 million doses of the CureVac vaccine should it receive regulatory approval. Despite being a laggard in the vaccine race, CureVac believes it has advantages over mRNA competitors. CureVac's product can be stored at standard refrigerator temperature, unlike the first-generation Pfizer and Moderna vaccines which require super-cold freezers. CureVac's vaccine also requires a lower dosage of just 12 microgrammes, compared to 30 microgrammes for BioNTech and 100 for Moderna, allowing for faster and cheaper mass production. These factors could possibly give CureVac an edge in poorer or warmer countries. Scientists have said the weaker-than-hoped results may be down to the lower dosage, or even CureVac's recipe, which unlike its rivals uses an unmodified form of messenger RNA. The company is already working on a second-generation Covid vaccine for which it has teamed up with pharma giant GSK. Early results on rats have been promising, it said. Clinical testing on humans is set to begin in the third quarter of 2021. CureVac was founded in 2000 by mRNA pioneer Ingmar Hoerr and is backed by Dietmar Hopp, the German billionaire behind software behemoth SAP. The German government last year took a 23-percent stake in CureVac for 300 million euros. The move came shortly after media reports said then President Donald Trump had sought exclusive US access to any CureVac vaccine, a claim both sides strenuously denied. (With inputs from agencies)

Germany's COVID-19 vaccine CureVac disappoints in pivotal final trial, with only 48 per cent efficacy

Top infectious disease expert Dr. Anthony&nbsp;Fauci announced that the US&nbsp;is devoting $3.2 billion to advance the development of antiviral pills for COVID-19 and other dangerous viruses that could turn into pandemics.

The pills for COVID-19, which would be used to minimise symptoms after infection, are in development and could begin arriving by year’s end, pending the completion of clinical trials. The funding will speed those clinical trials and provide additional support to private sector research, development, and manufacturing.

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/study-covid-19-found-in-5-states-of-us-before-first-confirmed-case-reported-391960/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

Fauci said the new program would invest in “accelerating things that are already in progress” for COVID-19 but also would work to innovate new therapies for other viruses.

“There are few treatments that exist for many of the viruses that have pandemic potential,” he said.

But he added, “vaccines clearly remain the centerpiece of our arsenal.”

Also read:&nbsp;<a href="https://www.wionews.com/world/regeneron-covid-19-therapy-cuts-deaths-among-hospitalised-patients-who-lack-antibodies-study-391885" hreflang="en">Regeneron COVID-19 therapy cuts deaths among hospitalised patients who lack antibodies: Study</a>

The US&nbsp;has approved one antiviral drug, Remdesivir, against COVID-19 and allowed emergency use of three antibody combinations that help the immune system fight the virus. But all the drugs have to be infused at hospitals or medical clinics, and demand has been low due to these logistical hurdles.

The US&nbsp;government has been trying to raise awareness of the treatments, connecting people who test positive for COVID-19 with information about nearby providers.

Health experts, including Fauci, have increasingly called for simpler pill-based drugs that patients could take themselves. Some drugmakers are testing such medications, but initial results aren’t expected for several more months.

The currently available drugs have mostly been shown to help patients avoid hospitalisation or shorten their recovery time by several days.

Under President Donald Trump, the US&nbsp;poured more than $19 billion into rapidly developing multiple vaccines. But less than half that amount went toward developing new treatments. That shortfall has become increasingly concerning as the vaccination campaign slows and experts emphasize the need to manage the disease in millions of Americans who may never get inoculated.

The biggest need is for a convenient pill that can help keep patients with early symptoms of COVID-19 from developing severe disease and needing hospitalization.

Several companies, including Pfizer, Roche, and AstraZeneca, are testing antivirals in pill form.

Until this week, the only medicines shown to boost survival were steroids given to patients sick enough to need extra oxygen and intensive care. But on Wednesday, UK&nbsp;researchers reported that one of the antibody combinations successfully reduced deaths in a large study of hospitalized COVID-19 patients.

(With inputs from agencies)

Top infectious disease expert Dr. Anthony Fauci announced that the US is devoting $3.2 billion to advance the development of antiviral pills for COVID-19 and other dangerous viruses that could turn into pandemics.

Top infectious disease expert Dr. Anthony Fauci announced that the US is devoting $3.2 billion to advance the development of antiviral pills for COVID-19 and other dangerous viruses that could turn into pandemics. The pills for COVID-19, which would be used to minimise symptoms after infection, are in development and could begin arriving by year’s end, pending the completion of clinical trials. The funding will speed those clinical trials and provide additional support to private sector research, development, and manufacturing. Fauci said the new program would invest in “accelerating things that are already in progress” for COVID-19 but also would work to innovate new therapies for other viruses. “There are few treatments that exist for many of the viruses that have pandemic potential,” he said. But he added, “vaccines clearly remain the centerpiece of our arsenal.” Also read: Regeneron COVID-19 therapy cuts deaths among hospitalised patients who lack antibodies: Study The US has approved one antiviral drug, Remdesivir, against COVID-19 and allowed emergency use of three antibody combinations that help the immune system fight the virus. But all the drugs have to be infused at hospitals or medical clinics, and demand has been low due to these logistical hurdles. The US government has been trying to raise awareness of the treatments, connecting people who test positive for COVID-19 with information about nearby providers. Health experts, including Fauci, have increasingly called for simpler pill-based drugs that patients could take themselves. Some drugmakers are testing such medications, but initial results aren’t expected for several more months. The currently available drugs have mostly been shown to help patients avoid hospitalisation or shorten their recovery time by several days. Under President Donald Trump, the US poured more than $19 billion into rapidly developing multiple vaccines. But less than half that amount went toward developing new treatments. That shortfall has become increasingly concerning as the vaccination campaign slows and experts emphasize the need to manage the disease in millions of Americans who may never get inoculated. The biggest need is for a convenient pill that can help keep patients with early symptoms of COVID-19 from developing severe disease and needing hospitalization. Several companies, including Pfizer, Roche, and AstraZeneca, are testing antivirals in pill form. Until this week, the only medicines shown to boost survival were steroids given to patients sick enough to need extra oxygen and intensive care. But on Wednesday, UK researchers reported that one of the antibody combinations successfully reduced deaths in a large study of hospitalized COVID-19 patients. (With inputs from agencies)

US allocates $3.2 billion to advance development of antiviral pills for COVID-19

Brazilian President Jair Bolsonaro on Monday asked Pfizer Inc to bring forward planned delivery of COVID-19 vaccines, a government source said, aiming to speed up a slow national inoculation programme. 
 
The request is a turnaround for Bolsonaro, who last year ignored offers of vaccines from Pfizer, according to testimony to a Senate commission investigating delays in vaccinating the country with the world's second-deadliest outbreak. 
 
Bolsonaro, his chief of staff and ministers of health and foreign affairs, held a conference call with Pfizer Brasil Chief Executive Marta Diez and Pfizer Latin America Chief Executive Carlos Murillo, the president's office said on social media. 
 
Bolsonaro asked the Pfizer executives if deliveries for later this year could be brought forward to June, from the fourth quarter, a government official with knowledge of the matter said. 
 
Pfizer Brasil declined to comment on the meeting. 
 
Almost half a million Brazilians have died from COVID-19, yet only 10.3% of the country's 210 million people have received a first vaccine dose, and just 25% have been fully vaccinated, mainly with vaccines developed by China's Sinovac Biotech Ltd and AstraZeneca Plc. 
 
Bolsonaro, a vaccine skeptic, who opposed lockdown and social distancing, has advocated the use of anti-malaria drug hydroxychloroquine for treating COVID-19 patients, even though there is no evidence that it is effective. 
 
The far-right leader's government is being investigated by a Senate commission for delays in a vaccination plan that lags behind many other countries. The commission heard testimony that the government never replied to letters from Pfizer last year offering to sell vaccines. 
 
Brazil signed a deal with Pfizer in March to purchase 100 million doses, and the first doses arrived in late April. A second contract in May provided for another 100 million doses to be delivered in the fourth quarter. 
 
(With inputs from agencies)

Brazilian President Jair Bolsonaro on Monday asked Pfizer Inc to bring forward planned delivery of COVID-19 vaccines, a government source said, aiming to speed up a slow national inoculation programme.

Brazilian President Jair Bolsonaro on Monday asked Pfizer Inc to bring forward planned delivery of COVID-19 vaccines, a government source said, aiming to speed up a slow national inoculation programme. The request is a turnaround for Bolsonaro, who last year ignored offers of vaccines from Pfizer, according to testimony to a Senate commission investigating delays in vaccinating the country with the world's second-deadliest outbreak. Bolsonaro, his chief of staff and ministers of health and foreign affairs, held a conference call with Pfizer Brasil Chief Executive Marta Diez and Pfizer Latin America Chief Executive Carlos Murillo, the president's office said on social media. Bolsonaro asked the Pfizer executives if deliveries for later this year could be brought forward to June, from the fourth quarter, a government official with knowledge of the matter said. Pfizer Brasil declined to comment on the meeting. Almost half a million Brazilians have died from COVID-19, yet only 10.3% of the country's 210 million people have received a first vaccine dose, and just 25% have been fully vaccinated, mainly with vaccines developed by China's Sinovac Biotech Ltd and AstraZeneca Plc. Bolsonaro, a vaccine skeptic, who opposed lockdown and social distancing, has advocated the use of anti-malaria drug hydroxychloroquine for treating COVID-19 patients, even though there is no evidence that it is effective. The far-right leader's government is being investigated by a Senate commission for delays in a vaccination plan that lags behind many other countries. The commission heard testimony that the government never replied to letters from Pfizer last year offering to sell vaccines. Brazil signed a deal with Pfizer in March to purchase 100 million doses, and the first doses arrived in late April. A second contract in May provided for another 100 million doses to be delivered in the fourth quarter. (With inputs from agencies)

Brazilian President asks Pfizer to speed up COVID-19 vaccine delivery

While the people of Trinidad and Tobago (T&amp;T) welcomed the arrival of a batch of 200,000 doses of COVID-19 vaccine made by China's Sinopharm on Monday, the US Embassy faced a barrage of criticism and mockery after announcing the donation of 80 vials of vaccine to the nation of 1.4 million people.

The US embassy in Port of Spain, the country's capital, announced the contribution in a tweet sent late Sunday local time, stating that "every vaccine matters."

"The government of the United States of America has made a donation of COVID-19 vaccines to the government of Trinidad and Tobago. The donation includes 80 vials of Pfizer vaccines. The United States is committed to assisting the Government of Trinidad and Tobago with its vaccination efforts. We believe that every vaccine counts," the tweet read.

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USA Donates Vaccines to Trinidad and Tobago <a href="https://t.co/5S0OTQfJU5">pic.twitter.com/5S0OTQfJU5</a>
— U.S. Embassy POS (@USinTT) <a href="https://twitter.com/USinTT/status/1404227576789454849?ref_src=twsrc%5Etfw">June 14, 2021</a></blockquote>
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A single vial of the Pfizer vaccine generates five doses, which are given in two injections 21 days apart. As a result, America's vaccine gift is anticipated to yield 400 shots, enough to inoculate 200 people. 
 
Social media users mocked the gift by sharing memes about the donation. 
&nbsp;

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Imagine bragging about sending 80 vaccines to a country with a population of 1,267,145 <a href="https://t.co/HmtRxGcZxJ">https://t.co/HmtRxGcZxJ</a>
— Left Flank Veterans (@LeftFlankVets) <a href="https://twitter.com/LeftFlankVets/status/1404468226944167939?ref_src=twsrc%5Etfw">June 14, 2021</a></blockquote>
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I really really hope they just forgot some zeroes <a href="https://t.co/CzhERkfjyH">https://t.co/CzhERkfjyH</a>
— shahenshah🌞pilsudski (सामाजिक फासीवाद युग) (@misandrogynist) <a href="https://twitter.com/misandrogynist/status/1404343151897112578?ref_src=twsrc%5Etfw">June 14, 2021</a></blockquote>
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USA Donates Vaccines to Trinidad and Tobago <a href="https://t.co/5S0OTQfJU5">pic.twitter.com/5S0OTQfJU5</a>
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While the people of Trinidad and Tobago (T&T) welcomed the arrival of a batch of 200,000 doses of COVID-19 vaccine made by China's Sinopharm on Monday, the US Embassy faced a barrage of criticism and mockery after announcing the donation of 80 vials of vaccine to the nation of 1.

While the people of Trinidad and Tobago (T&T) welcomed the arrival of a batch of 200,000 doses of COVID-19 vaccine made by China's Sinopharm on Monday, the US Embassy faced a barrage of criticism and mockery after announcing the donation of 80 vials of vaccine to the nation of 1.4 million people. The US embassy in Port of Spain, the country's capital, announced the contribution in a tweet sent late Sunday local time, stating that "every vaccine matters." "The government of the United States of America has made a donation of COVID-19 vaccines to the government of Trinidad and Tobago. The donation includes 80 vials of Pfizer vaccines. The United States is committed to assisting the Government of Trinidad and Tobago with its vaccination efforts. We believe that every vaccine counts," the tweet read. USA Donates Vaccines to Trinidad and Tobago pic.twitter.com/5S0OTQfJU5 — U.S. Embassy POS (@USinTT) June 14, 2021 × A single vial of the Pfizer vaccine generates five doses, which are given in two injections 21 days apart. As a result, America's vaccine gift is anticipated to yield 400 shots, enough to inoculate 200 people. Social media users mocked the gift by sharing memes about the donation. Imagine bragging about sending 80 vaccines to a country with a population of 1,267,145 https://t.co/HmtRxGcZxJ — Left Flank Veterans (@LeftFlankVets) June 14, 2021 × I really really hope they just forgot some zeroes https://t.co/CzhERkfjyH — shahenshah🌞pilsudski (सामाजिक फासीवाद युग) (@misandrogynist) June 14, 2021 × USA Donates Vaccines to Trinidad and Tobago pic.twitter.com/5S0OTQfJU5 — U.S. Embassy POS (@USinTT) June 14, 2021 ×

US donates 80 vials of COVID-19 vaccine to a nation of 1.4 million, trolled for online post

The Pfizer-BioNTech coronavirus vaccine can 'effectively neutralize' the Beta and Gamma variant of the deadly virus, according to a new study led by researchers from the New York University.

The Pfizer-BioNTech coronavirus vaccine can 'effectively neutralize' the Beta and Gamma variant of the deadly virus, according to a new study led by researchers from the New York University. As per the study, the Pfizer BNT162b2 vaccination worked well against the majority of variants. However, the vaccine neutralized the South African variant and the Brazil variant with a 3-fold decrease in titer. Published in the journal mBio, the study revealed that a monoclonal antibody cocktail, which consists of casirivamab and imdevimab might be less effective against SARS-CoV-2 variants in laboratory experiments. This was after lab experiments on Regeneron pharmaceuticals' REGN-COV2, which is a 2 recombinant monoclonal antibody cocktail, showed that casirivamab had lost some of its neutralizing activity against the South African and Brazilian variants. It also showed that the cocktail was 9- to 15- fold decreased in titer. Also Read | Pfizer less effective, AstraZeneca even worse against variant first detected in India: Study As a part of the research, the team created a panel of pseudotyped viruses. This was done using the spike proteins from 6 different variants of SARS-CoV-2. These included the B117 lineage variant identified in the UK, the B1351 lineage variant identified in South Africa, the B11248 lineage variant identified in Brazil, the COH.20G/677H lineage variant identified in Columbus Ohio, the 20 EUs variant identified in Spain, and later found elsewhere in Europe, and the Mink cluster five spike proteins located in minks in Denmark. Nathaniel "Ned" Landau, Professor in the Department of Microbiology at the NYU Grossman School of Medicine said, "Our interpretation of the results is that the vaccine antibodies are very powerful, and even if you lose 3-fold of the titer, there is still plenty of antibody there to neutralize the virus. We believe the findings demonstrate that the vaccines will remain protective against the variants that we tested". Landau noted, "The question with this work is 'how do the laboratory findings translate into clinical effects, that is what will happen when you treat a patient infected with one of the variants?' We cannot say for sure. We will only know when the clinical data comes in". As per Landau, similar experiments in Moderna's Covid vaccine also showed the same results.

Pfizer's vaccine protective against Beta, Gamma variant of Coronavirus: Study

US President Joe Biden plans to buy and donate 500 million doses of the Pfizer coronavirus vaccine to more than 90 countries while calling on the world's democracies to do their part to help end the deadly pandemic, the White House said.

The announcement of the vaccine donation - the largest ever by a single country - comes ahead of Biden's meeting with leaders of the other Group of Seven advanced economies - Britain, Canada, France, Germany, Italy, and Japan - in Cornwall, England. 
"The goal of today's donation is to save lives and end the pandemic and will provide the foundation for additional actions to be announced in the coming days," the White House said.

<a href="https://www.wionews.com/world/eu-us-to-end-trade-tariffs-call-for-new-study-into-covid-19-origins-says-summit-draft-390485">Also Read|&nbsp;EU, US to end trade tariffs, call for new study into COVID-19 origins, says summit draft</a>

U.S. drugmaker Pfizer and its German partner BioNTech confirmed they will provide 200 million doses in 2021 and 300 million doses in the first half of 2022, which the United States will then distribute to 92 lower-income countries and the African Union. 
The shots, which will be produced at Pfizer's U.S. production sites, will be provided at a not-for-profit price.

"Our partnership with the U.S. government will help bring hundreds of millions of doses of our vaccine to the poorest countries around the world as quickly as possible," said Pfizer Chief Executive Albert Bourla.

 
"SUPERCHARGE THE GLOBAL FIGHT" 
The donation, first reported on Wednesday, was negotiated over the past four weeks by White House COVID-19 response coordinator Jeff Zients and the coronavirus task force team, a source familiar with the matter said.

It is meant to "supercharge the global fight against the pandemic," the White House said. 
The pandemic has killed about 3.9 million people around the world, with the infection reported in more than 210 countries and territories since the first cases were identified in China in December 2019.

The new donations come on top of some 80 million doses Washington has already pledged to donate by the end of June, and $2 billion in funding earmarked for the COVAX program led by the World Health Organization and the Global Alliance for Vaccines and Immunization, the White House said.

They will be part of the total U.S. commitment of $4 billion to COVAX announced earlier this year, a White House official said.&nbsp;Washington is also taking steps to support local production of COVID-19 vaccines in other countries, including through its Quad initiative with Japan, India, and Australia.

"President Biden has been clear that borders cannot keep this pandemic at bay and has vowed that our nation will be the arsenal of vaccines," the White House said.

Pfizer plans to produce the half a billion doses at its facilities in Kalamazoo, Michigan; McPherson, Kansas; Chesterfield, Missouri; and Andover, Massachusetts, the White House said.

CNBC reported on Wednesday that the United States is also talking with Moderna Inc about buying some of its shots to donate to other countries.

A Moderna spokesperson said the company is interested in providing the U.S. government with COVID-19 shots for low- and middle-income countries but declined to comment on any talks.

Biden's announcement comes amid mounting pressure for the United States, which has now given at least one shot to around 64% of its adult population, to boost donations of COVID-19 shots to other countries that are desperately seeking doses.

US President Joe Biden plans to buy and donate 500 million doses of the Pfizer coronavirus vaccine to more than 90 countries while calling on the world's democracies to do their part to help end the deadly pandemic, the White House said.

US President Joe Biden plans to buy and donate 500 million doses of the Pfizer coronavirus vaccine to more than 90 countries while calling on the world's democracies to do their part to help end the deadly pandemic, the White House said. The announcement of the vaccine donation - the largest ever by a single country - comes ahead of Biden's meeting with leaders of the other Group of Seven advanced economies - Britain, Canada, France, Germany, Italy, and Japan - in Cornwall, England. "The goal of today's donation is to save lives and end the pandemic and will provide the foundation for additional actions to be announced in the coming days," the White House said. Also Read| EU, US to end trade tariffs, call for new study into COVID-19 origins, says summit draft U.S. drugmaker Pfizer and its German partner BioNTech confirmed they will provide 200 million doses in 2021 and 300 million doses in the first half of 2022, which the United States will then distribute to 92 lower-income countries and the African Union. The shots, which will be produced at Pfizer's U.S. production sites, will be provided at a not-for-profit price. "Our partnership with the U.S. government will help bring hundreds of millions of doses of our vaccine to the poorest countries around the world as quickly as possible," said Pfizer Chief Executive Albert Bourla. "SUPERCHARGE THE GLOBAL FIGHT" The donation, first reported on Wednesday, was negotiated over the past four weeks by White House COVID-19 response coordinator Jeff Zients and the coronavirus task force team, a source familiar with the matter said. It is meant to "supercharge the global fight against the pandemic," the White House said. The pandemic has killed about 3.9 million people around the world, with the infection reported in more than 210 countries and territories since the first cases were identified in China in December 2019. The new donations come on top of some 80 million doses Washington has already pledged to donate by the end of June, and $2 billion in funding earmarked for the COVAX program led by the World Health Organization and the Global Alliance for Vaccines and Immunization, the White House said. They will be part of the total U.S. commitment of $4 billion to COVAX announced earlier this year, a White House official said. Washington is also taking steps to support local production of COVID-19 vaccines in other countries, including through its Quad initiative with Japan, India, and Australia. "President Biden has been clear that borders cannot keep this pandemic at bay and has vowed that our nation will be the arsenal of vaccines," the White House said. Pfizer plans to produce the half a billion doses at its facilities in Kalamazoo, Michigan; McPherson, Kansas; Chesterfield, Missouri; and Andover, Massachusetts, the White House said. CNBC reported on Wednesday that the United States is also talking with Moderna Inc about buying some of its shots to donate to other countries. A Moderna spokesperson said the company is interested in providing the U.S. government with COVID-19 shots for low- and middle-income countries but declined to comment on any talks. Biden's announcement comes amid mounting pressure for the United States, which has now given at least one shot to around 64% of its adult population, to boost donations of COVID-19 shots to other countries that are desperately seeking doses.

COVID-19: US to donate 500 million Pfizer doses, urge others to join in

As the world struggles to procure <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine</a>, a South Korean mayor made a public announcement that Pfizer will be sending 30 million doses within three weeks.

However, his announcement fell short as he soon realised he was being scammed and had to issue a public apology.

Kwon Young-jin, who is critical of the government’s vaccine distribution, took some time to realise that Pfizer does not distribute vaccines through third parties.

<a href="https://www.wionews.com/videos/meet-grace-the-healthcare-robot-covid-19-created-390437">WATCH |</a>

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/meet-grace-the-healthcare-robot-covid-19-created-390437/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

"It was my mistake that this case regarded as one of the simple cases of a failed vaccine import has escalated into a fake vaccine fraud case," the Mayor said. "The image of Daegu was tarnished due to my careless words. I also caused deep wounds and disappointment to the citizens suffering from COVID-19."

Kwon had informed the national media that his team has held negotiations with a foreign trading company in Daegu who have assured supply of 30 million doses of the Pfizer vaccine.

The Medi-City Daegu Council and the trading company had exchanged several documents, but it was the Ministry of Health and Welfare who spotted the leak in the deal after they claimed it had "reliability issues".

As the world struggles to procure coronavirus vaccine, a South Korean mayor made a public announcement that Pfizer will be sending 30 million doses within three weeks.

As the world struggles to procure coronavirus vaccine, a South Korean mayor made a public announcement that Pfizer will be sending 30 million doses within three weeks. However, his announcement fell short as he soon realised he was being scammed and had to issue a public apology. Kwon Young-jin, who is critical of the government’s vaccine distribution, took some time to realise that Pfizer does not distribute vaccines through third parties. WATCH | "It was my mistake that this case regarded as one of the simple cases of a failed vaccine import has escalated into a fake vaccine fraud case," the Mayor said. "The image of Daegu was tarnished due to my careless words. I also caused deep wounds and disappointment to the citizens suffering from COVID-19." Kwon had informed the national media that his team has held negotiations with a foreign trading company in Daegu who have assured supply of 30 million doses of the Pfizer vaccine. The Medi-City Daegu Council and the trading company had exchanged several documents, but it was the Ministry of Health and Welfare who spotted the leak in the deal after they claimed it had "reliability issues".

South Korea: Mayor apologises for falling prey to vaccine scam

Pfizer vaccine trials on children aged 5 through 11 are underway in the United States. The children underwent temperature and blood pressure checks before getting a shot of either the vaccine or a placebo.

United States: Pfizer vaccine trials underway for kids aged 5 to 11 years

Will India get vaccines from Pfizer and Moderna this year? Reports say the Indian government could make major concessions to get these shots. The vaccine makers may get indemnity.

Gravitas: India makes concessions to Pfizer

Foreign secretary Harsh V Shringla has said that India is in talks with global <a href="https://www.wionews.com/topics/coronavirus-vaccine">vaccine</a> manufacturers such as Pfizer, Johnson &amp; Johnson, and Moderna for local manufacturing of <a href="https://www.wionews.com/topics/coronavirus">coronavirus</a> vaccines.

This&nbsp;development has come even as India has been trying to increase the production of vaccines for its population and for export.

Also read |&nbsp;<a href="https://www.wionews.com/india-news/covid-19-serum-institute-of-india-seeks-approval-to-make-russias-sputnik-v-vaccine-389175" hreflang="en">COVID-19: Serum Institute of India seeks approval to make Russia's Sputnik V vaccine</a>

"We are also part of the discussions with major vaccine manufacturers like Pfizer, Johnson &amp; Johnson, and Moderna about sourcing and possible local manufacturing of their vaccines in India. We have also helped to expedite the introduction of Sputnik-V vaccines," Shringla said while&nbsp;speaking at World Health Organization's "South-East Asia Regional Health Partners' Forum on COVID-19".

As of now only three vaccines have been given authorisation in India, namely Covishield (produced by Serum Institute of India), Covaxin&nbsp;(produced by Bharat Biotech) and Russia's Sputnik V. Last month, India received the first few batches of Suptink V vaccines — which will be also produced by Indian companies.&nbsp;

Also read |&nbsp;<a href="https://www.wionews.com/india-news/explainer-inside-pfizers-demands-for-vaccine-indemnity-and-indian-governments-next-move-389072" hreflang="en">Explainer: Inside Pfizer's demands for vaccine 'indemnity' and Indian government's next move</a>

He also mentioned that India is "working with several other countries in the WTO on a targeted and temporary waiver under TRIPS to ensure timely and secure access to vaccines for all".

India and South Africa had given a proposal for wavier on Covid vaccine patent at the WTO which will help in mass production of the vaccines for the world. After the US extended its support to the vaccine waiver, the West has been able to fight its hesitations against this. Earlier in the week, BRICS became the first multilateral block to extend support to the proposal.

Also read |&nbsp;<a href="https://www.wionews.com/india-news/no-vaccination-no-salary-for-government-employees-in-this-indian-state-388942" hreflang="en">'No vaccination, no salary' for government employees in this Indian state</a>

Shringla also said that New Delhi looks forward to the World Health Organization (WHO) giving approval to India's indigenous vaccine manufactured by Bharat Biotech, Covaxin. Hyderabad-based Bharat Biotech submitted an application to the WHO for Emergency Use Listing (EUL) on April 19 and a pre-submission meeting will take place in June.

He highlighted how amid the pandemic, which he termed as a "Black Swan event", the ministry of external affairs "had to innovate, to repurpose and to re-engineer and create an entirely new vertical for pandemic diplomacy." He explained that the "Ministry and our network of diplomatic posts played a key role in organising the 'Vande Bharat Mission' — the largest logistical exercise of its kind ever undertaken." The Vande Bharat Mission facilitated the movement of seven million people through lockdown and post-lockdown periods.&nbsp;

The ministry as the "global arm of the Government of India’s Empowered Group" procured raw materials during the crisis. During the April to August 2020 period, 91 cargo flights brought in ventilators, PPE kits, test kits, etc. from across the globe to meet the domestic demand.

Foreign secretary Harsh V Shringla has said that India is in talks with global vaccine manufacturers such as Pfizer, Johnson & Johnson, and Moderna for local manufacturing of coronavirus vaccines.

Foreign secretary Harsh V Shringla has said that India is in talks with global vaccine manufacturers such as Pfizer, Johnson & Johnson, and Moderna for local manufacturing of coronavirus vaccines. This development has come even as India has been trying to increase the production of vaccines for its population and for export. Also read | COVID-19: Serum Institute of India seeks approval to make Russia's Sputnik V vaccine "We are also part of the discussions with major vaccine manufacturers like Pfizer, Johnson & Johnson, and Moderna about sourcing and possible local manufacturing of their vaccines in India. We have also helped to expedite the introduction of Sputnik-V vaccines," Shringla said while speaking at World Health Organization's "South-East Asia Regional Health Partners' Forum on COVID-19". As of now only three vaccines have been given authorisation in India, namely Covishield (produced by Serum Institute of India), Covaxin (produced by Bharat Biotech) and Russia's Sputnik V. Last month, India received the first few batches of Suptink V vaccines — which will be also produced by Indian companies. Also read | Explainer: Inside Pfizer's demands for vaccine 'indemnity' and Indian government's next move He also mentioned that India is "working with several other countries in the WTO on a targeted and temporary waiver under TRIPS to ensure timely and secure access to vaccines for all". India and South Africa had given a proposal for wavier on Covid vaccine patent at the WTO which will help in mass production of the vaccines for the world. After the US extended its support to the vaccine waiver, the West has been able to fight its hesitations against this. Earlier in the week, BRICS became the first multilateral block to extend support to the proposal. Also read | 'No vaccination, no salary' for government employees in this Indian state Shringla also said that New Delhi looks forward to the World Health Organization (WHO) giving approval to India's indigenous vaccine manufactured by Bharat Biotech, Covaxin. Hyderabad-based Bharat Biotech submitted an application to the WHO for Emergency Use Listing (EUL) on April 19 and a pre-submission meeting will take place in June. He highlighted how amid the pandemic, which he termed as a "Black Swan event", the ministry of external affairs "had to innovate, to repurpose and to re-engineer and create an entirely new vertical for pandemic diplomacy." He explained that the "Ministry and our network of diplomatic posts played a key role in organising the 'Vande Bharat Mission' — the largest logistical exercise of its kind ever undertaken." The Vande Bharat Mission facilitated the movement of seven million people through lockdown and post-lockdown periods. The ministry as the "global arm of the Government of India’s Empowered Group" procured raw materials during the crisis. During the April to August 2020 period, 91 cargo flights brought in ventilators, PPE kits, test kits, etc. from across the globe to meet the domestic demand.

India in talks with Pfizer, J&J, Moderna for local manufacturing of covid vaccines: FS Harsh Shringla

Drugs Controller General of India recently did away with specific trials of <a href="https://www.wionews.com/topics/coronavirus">COVID-19</a> vaccines to improve the pace of vaccinations in the country and to invite more players to the country.

This waiver will be applicable for <a href="https://www.wionews.com/topics/coronavirus-vaccine">vaccines</a> that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for "Emergency Use" by the World Health Organization.

Also Read |&nbsp;<a href="https://www.wionews.com/india-news/over-50-million-pfizer-vaccines-ready-to-be-delivered-to-india-talks-ongoing-for-partial-indemnity-388951">Over 50 million Pfizer vaccines ready to be delivered to India; talks ongoing for 'partial indemnity'</a>

For the vaccines that are well established from the standpoint that millions have already been vaccinated with the said vaccines, the requirement for conduction post-approval bridging clinical trials and&nbsp;testing of every batch of the vaccine by the Central Drugs Laboratory (CDL) in&nbsp;Kasauli can be exempted&nbsp;if the vaccine batch/lot has been certified and released by the National Control Laboratory of the country of origin.

While this move is likely to clear the way for foreign vaccines like Pfizer and Moderna for the country’s urgent requirement, pharma company Pfizer wants more. The company is demanding indemnity and according to reports, the Indian government just might grant it.

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/indian-govt-pfizer-at-loggerheads-over-covid-19-vaccine-indemnity-demand-386752/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

But what exactly is ‘Indemnity’?

Indemnity is a legal exemption from future lawsuits over their vaccines. It basically means that if the vaccine maker is sued in India, it will be the government's problem, and not the company's.

India has not given such indemnity to any vaccine producer, why should Pfizer be the first?

Pfizer and Moderna are among the best shots on the international market. Both vaccines work on the same technology. They are more than 90 per cent effective. Together, they have been approved by more than 40 countries. India wants them too. Countries like the US and Britain have already signed such indemnity clauses.

Also Read |&nbsp;<a href="https://www.wionews.com/india-news/pfizer-and-moderna-dont-want-to-deal-with-indian-states-for-vaccines-387168">Pfizer and Moderna don't want to deal with Indian states for vaccines</a>

Can the Government of India grant indemnity to Pfizer?

To date, no vaccine maker in India has this immunity. Granting such immunity to one company may solicit similar demands from other pharma companies. But according to reports, Pfizer has indemnity in all the countries it has exported its vaccines. So the government can extend indemnity on the lines of what other importer countries did.

As per Niti Ayog member VK Paul, "They have requested indemnity to all the nations, including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now,".

Will the company have&nbsp;indemnity in severe cases?

As of now, a "complete waiver" won't be given on the Pfizer vaccine by India. As per sources,&nbsp;"reactions to the vaccine are indemnified" but the "reaction amounting to death or serious ailment like paralysis can't be given waiver and will carry liability".

The final decision on the matter is yet to be taken.

A Pfizer spokesperson on Wednesday said that the company continues to remain engaged with the Indian government towards making its coronavirus vaccine available for use in the government immunisation programme, adding that "as these discussions are ongoing, we are unable to share any additional details at this time,".

(With inputs from agencies)

Drugs Controller General of India recently did away with specific trials of COVID-19 vaccines to improve the pace of vaccinations in the country and to invite more players to the country.

Drugs Controller General of India recently did away with specific trials of COVID-19 vaccines to improve the pace of vaccinations in the country and to invite more players to the country. This waiver will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for "Emergency Use" by the World Health Organization. Also Read | Over 50 million Pfizer vaccines ready to be delivered to India; talks ongoing for 'partial indemnity' For the vaccines that are well established from the standpoint that millions have already been vaccinated with the said vaccines, the requirement for conduction post-approval bridging clinical trials and testing of every batch of the vaccine by the Central Drugs Laboratory (CDL) in Kasauli can be exempted if the vaccine batch/lot has been certified and released by the National Control Laboratory of the country of origin. While this move is likely to clear the way for foreign vaccines like Pfizer and Moderna for the country’s urgent requirement, pharma company Pfizer wants more. The company is demanding indemnity and according to reports, the Indian government just might grant it. But what exactly is ‘Indemnity’? Indemnity is a legal exemption from future lawsuits over their vaccines. It basically means that if the vaccine maker is sued in India, it will be the government's problem, and not the company's. India has not given such indemnity to any vaccine producer, why should Pfizer be the first? Pfizer and Moderna are among the best shots on the international market. Both vaccines work on the same technology. They are more than 90 per cent effective. Together, they have been approved by more than 40 countries. India wants them too. Countries like the US and Britain have already signed such indemnity clauses. Also Read | Pfizer and Moderna don't want to deal with Indian states for vaccines Can the Government of India grant indemnity to Pfizer? To date, no vaccine maker in India has this immunity. Granting such immunity to one company may solicit similar demands from other pharma companies. But according to reports, Pfizer has indemnity in all the countries it has exported its vaccines. So the government can extend indemnity on the lines of what other importer countries did. As per Niti Ayog member VK Paul, "They have requested indemnity to all the nations, including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now,". Will the company have indemnity in severe cases? As of now, a "complete waiver" won't be given on the Pfizer vaccine by India. As per sources, "reactions to the vaccine are indemnified" but the "reaction amounting to death or serious ailment like paralysis can't be given waiver and will carry liability". The final decision on the matter is yet to be taken. A Pfizer spokesperson on Wednesday said that the company continues to remain engaged with the Indian government towards making its coronavirus vaccine available for use in the government immunisation programme, adding that "as these discussions are ongoing, we are unable to share any additional details at this time,". (With inputs from agencies)

Explainer: Inside Pfizer's demands for vaccine 'indemnity' and Indian government's next move

Israel's Health Ministry said on Tuesday, it found the small number of heart inflammation cases observed mainly in young men, who received Pfizer's COVID-19 vaccine in Israel,&nbsp;were likely linked to their vaccination. 
 
Pfizer has said it has not observed a higher rate of the condition, known as myocarditis, than would normally be expected in the general population. 
 
In Israel, 275 cases of myocarditis were reported between December 2020 and May 2021 among more than five million vaccinated people, the ministry said in disclosing the findings of a study it commissioned to examine the matter. 
 
Most patients, who experienced heart inflammation spent no more than four days in hospital and 95% of the cases were classified as mild, according to the study, which the ministry said was conducted by three teams of experts. 
 
The study found "there is a probable link between receiving the second dose (of Pfizer) vaccine and the appearance of myocarditis among men aged 16 to 30," it said in a statement. 
 
According to the findings, such a link was observed more among men aged 16 to 19 than in other age groups. 
 
Pfizer said in a statement that it is aware of the Israeli observations of myocarditis, noting that no causal link to its vaccine has been established. 
 
Adverse events are thoroughly reviewed and Pfizer meets regularly with the Vaccine Safety Department of the Israeli Ministry of Health to review data, it said. 
 
A US&nbsp;Centers for Disease Control and Prevention advisory group last month recommended further study of the possibility of a link between myocarditis and mRNA vaccines, which include those from Pfizer and Moderna Inc. 
 
CDC monitoring systems had not found more cases than would be expected in the population, but the advisory group said in a statement that members felt healthcare providers should be made aware of reports of a "potential adverse event." 
 
The Israeli ministry released the statement, which contained no recommendations, ahead of a widely expected decision on whether to begin vaccinating youngsters aged 12 to 15 in Israel. 
 
It said a team examining that issue would make its recommendation to the ministry's director-general, but gave no date. 
 
Israeli media reports said a decision on including the 12-15 age group in the country's vaccination programme could come as early as Sunday. 
 
Israel has been a world leader in its vaccination rollout. 
 
With COVID-19 infections down to just a handful a day and total active cases at just 340 across the country, the economy has fully opened, though restrictions remain on incoming tourism. 
 
Some 55% of Israel's population has already been vaccinated. As of Tuesday, restrictions on social distancing and the need for special green vaccination passes to enter certain restaurants and venues were scrapped. 
 
(With inputs from agencies)

Israel's Health Ministry said on Tuesday, it found the small number of heart inflammation cases observed mainly in young men, who received Pfizer's COVID-19 vaccine in Israel, were likely linked to their vaccination.

Israel's Health Ministry said on Tuesday, it found the small number of heart inflammation cases observed mainly in young men, who received Pfizer's COVID-19 vaccine in Israel, were likely linked to their vaccination. Pfizer has said it has not observed a higher rate of the condition, known as myocarditis, than would normally be expected in the general population. In Israel, 275 cases of myocarditis were reported between December 2020 and May 2021 among more than five million vaccinated people, the ministry said in disclosing the findings of a study it commissioned to examine the matter. Most patients, who experienced heart inflammation spent no more than four days in hospital and 95% of the cases were classified as mild, according to the study, which the ministry said was conducted by three teams of experts. The study found "there is a probable link between receiving the second dose (of Pfizer) vaccine and the appearance of myocarditis among men aged 16 to 30," it said in a statement. According to the findings, such a link was observed more among men aged 16 to 19 than in other age groups. Pfizer said in a statement that it is aware of the Israeli observations of myocarditis, noting that no causal link to its vaccine has been established. Adverse events are thoroughly reviewed and Pfizer meets regularly with the Vaccine Safety Department of the Israeli Ministry of Health to review data, it said. A US Centers for Disease Control and Prevention advisory group last month recommended further study of the possibility of a link between myocarditis and mRNA vaccines, which include those from Pfizer and Moderna Inc. CDC monitoring systems had not found more cases than would be expected in the population, but the advisory group said in a statement that members felt healthcare providers should be made aware of reports of a "potential adverse event." The Israeli ministry released the statement, which contained no recommendations, ahead of a widely expected decision on whether to begin vaccinating youngsters aged 12 to 15 in Israel. It said a team examining that issue would make its recommendation to the ministry's director-general, but gave no date. Israeli media reports said a decision on including the 12-15 age group in the country's vaccination programme could come as early as Sunday. Israel has been a world leader in its vaccination rollout. With COVID-19 infections down to just a handful a day and total active cases at just 340 across the country, the economy has fully opened, though restrictions remain on incoming tourism. Some 55% of Israel's population has already been vaccinated. As of Tuesday, restrictions on social distancing and the need for special green vaccination passes to enter certain restaurants and venues were scrapped. (With inputs from agencies)

Israel sees probable link between Pfizer vaccine and myocarditis cases

Nearly&nbsp;50-60 million doses of Pfizer's <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine</a> are ready to be delivered to India even as talks continue for a "partial indemnity" on the impact of the vaccine with New Delhi. &nbsp;

As of now, a "complete waiver" won't be given on the Pfizer vaccine by India. As per sources,&nbsp;"reactions to the vaccine are indemnified" but the "reaction amounting to death or serious ailment like paralysis can't be given waiver and will carry liability".

Also read |&nbsp;<a href="https://www.wionews.com/india-news/covid-19-vaccination-tips-to-follow-before-and-after-taking-the-jab-388927" hreflang="en">COVID-19 vaccination: Tips to follow before and after taking the jab</a>

However, the talks are ongoing on priority, and are expected to conclude by the end of this month.&nbsp;

Pfizer-BioNTech's COVID-19 vaccine is an mRNA vaccine that instructs the cells to generate the spike protein found on the surface of the novel <a href="https://www.wionews.com/topics/coronavirus">coronavirus</a>. This, in turn, generates an immune response. mRNA vaccines do not contain any virus particles — weakened or dead parts of a virus. Like other vaccines, Pfizer can also&nbsp;cause&nbsp;allergic reactions such as breathing difficulty, fast heartbeat, dizziness, and weakness.

ALso read |&nbsp;<a href="https://www.wionews.com/india-news/indian-drugs-regulator-dcgi-eases-norms-for-clearing-foreign-made-covid-19-vaccines-388931" hreflang="en">Indian drugs regulator DCGI eases norms for clearing foreign-made COVID-19 vaccines</a>

The other key question with the Pfizer vaccine is logistics, considering it requires cold temperature. For that, logistics control infrastructure is needed to create a temperature-controlled vaccine. The developed countries, today, have excess supply and don't need reserves of this vaccine, leading to&nbsp;spare capacity for India.&nbsp;

These important issues were also discussed during India's External Affairs Minister Dr&nbsp;S Jaishankar's US visit. The visit, from May 24-28, focused on Covid-related cooperations between India and the US.

Nearly 50-60 million doses of Pfizer's coronavirus vaccine are ready to be delivered to India even as talks continue for a "partial indemnity" on the impact of the vaccine with New Delhi.

Nearly 50-60 million doses of Pfizer's coronavirus vaccine are ready to be delivered to India even as talks continue for a "partial indemnity" on the impact of the vaccine with New Delhi. As of now, a "complete waiver" won't be given on the Pfizer vaccine by India. As per sources, "reactions to the vaccine are indemnified" but the "reaction amounting to death or serious ailment like paralysis can't be given waiver and will carry liability". Also read | COVID-19 vaccination: Tips to follow before and after taking the jab However, the talks are ongoing on priority, and are expected to conclude by the end of this month. Pfizer-BioNTech's COVID-19 vaccine is an mRNA vaccine that instructs the cells to generate the spike protein found on the surface of the novel coronavirus. This, in turn, generates an immune response. mRNA vaccines do not contain any virus particles — weakened or dead parts of a virus. Like other vaccines, Pfizer can also cause allergic reactions such as breathing difficulty, fast heartbeat, dizziness, and weakness. ALso read | Indian drugs regulator DCGI eases norms for clearing foreign-made COVID-19 vaccines The other key question with the Pfizer vaccine is logistics, considering it requires cold temperature. For that, logistics control infrastructure is needed to create a temperature-controlled vaccine. The developed countries, today, have excess supply and don't need reserves of this vaccine, leading to spare capacity for India. These important issues were also discussed during India's External Affairs Minister Dr S Jaishankar's US visit. The visit, from May 24-28, focused on Covid-related cooperations between India and the US.

Over 50 million Pfizer vaccines ready to be delivered to India; talks ongoing for 'partial indemnity'

India’s apex drug regulator has announced that foreign vaccines like Pfizer and Moderna will no longer have to clear India-specific trials. The Drug Controller General of India (DCGI) has done away with such requirements in order to speed up vaccine imports.

DCGI relaxes norms for clearing foreign vaccines, no local trials for Pfizer and Moderna

US drugmaker Pfizer on Monday formally authorized the use of its COVID-19 vaccine for around 4 million children age 12 to 15 in Japan, following similar moves overseas to allow adolescents to be vaccinated.

Japan green lights Pfizer COVID-19 vaccines for 12 to 15-year-olds

The Pfizer-BioNTech <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine </a>is slightly less effective but still appears to offer protection against variant first detected in India, according to a study by France's Pasteur Institute.&nbsp;

"Despite slightly diminished efficacy, the Pfizer vaccine probably protects" against the strain first discovered in India, Olivier Schwartz, the institute's director and co-author of the study was quoted as saying by news agency AFP.&nbsp;

Watch |&nbsp;

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="http://wionews.com/videos/coronavirus-update-european-union-backs-pfizer-jab-for-12-15-year-old-388175/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

However, the study published on the BioRxiv website is still to be peer-reviewed.&nbsp;

Twenty-eight healthcare workers in the city of Orleans were part of the study, out of which 16 received two doses of the Pfizer-BioNTech vaccine, while 12 were given one dose of AstraZeneca-Oxford University vaccine.&nbsp;

There was a three-fold decrease in the number of antibodies of people who had taken the Pfizer-BioNTech vaccine against the B.1.617 variant, but still, there was protection.&nbsp;

Also read |&nbsp;<a href="http://wionews.com/world/european-regulator-approves-pfizer-biontech-vaccine-for-12-to15-year-olds-388097">European regulator approves Pfizer-BioNTech vaccine for 12 to15-year old</a>

"The situation was different with the AstraZeneca vaccine, which induced particularly low levels of antibodies neutralising" the variant first found in India, the study noted.&nbsp;

Schwartz said that people who got infected with COVID-19 within the last one year and people vaccinated with two jabs of Pfizer-BioNTech vaccine have enough antibodies to counter the B.1.617 variant.&nbsp;

The Pfizer-BioNTech coronavirus vaccine is slightly less effective but still appears to offer protection against variant first detected in India, according to a study by France's Pasteur Institute.

The Pfizer-BioNTech coronavirus vaccine is slightly less effective but still appears to offer protection against variant first detected in India, according to a study by France's Pasteur Institute. "Despite slightly diminished efficacy, the Pfizer vaccine probably protects" against the strain first discovered in India, Olivier Schwartz, the institute's director and co-author of the study was quoted as saying by news agency AFP. Watch | However, the study published on the BioRxiv website is still to be peer-reviewed. Twenty-eight healthcare workers in the city of Orleans were part of the study, out of which 16 received two doses of the Pfizer-BioNTech vaccine, while 12 were given one dose of AstraZeneca-Oxford University vaccine. There was a three-fold decrease in the number of antibodies of people who had taken the Pfizer-BioNTech vaccine against the B.1.617 variant, but still, there was protection. Also read | European regulator approves Pfizer-BioNTech vaccine for 12 to15-year old "The situation was different with the AstraZeneca vaccine, which induced particularly low levels of antibodies neutralising" the variant first found in India, the study noted. Schwartz said that people who got infected with COVID-19 within the last one year and people vaccinated with two jabs of Pfizer-BioNTech vaccine have enough antibodies to counter the B.1.617 variant.

Pfizer less effective, AstraZeneca even worse against variant first detected in India: Study

Europe's drug regulator has approved the Pfizer vaccine for children aged between 12 to 15 years old. Now this is a significant step in protecting children from future waves of COVID.

Coronavirus Update: European Union backs Pfizer jab for 12-15-year-old

The government is examining Pfizer's request for indemnity and will take a decision in the larger interest of people and on merit, NITI Aayog Member (Health) V K Paul said on Thursday.

At a press conference, Paul said, "Yes we are engaged with Pfizer and they have indicated the availability of a certain amount of vaccine in the coming months, possibly starting in July."

"We are looking at what their expectations are from the government and they are looking at what our expectations are from them. That's the process in which this will move. Because they will have to come to India and apply for licensure in India, that's one path and there are imperatives of cold chain and supply.

"They have requested indemnity to all the nations, including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now," Paul said.

Seeking a fast-track approval for its COVID-19 vaccine, US major Pfizer has told Indian authorities that its jab has shown "high effectiveness" against the SARS-CoV-2 variant prevalent in India and on people of Indian ethnicity or nationality, besides it is suitable for everyone aged 12 years or above and can be stored for a month at 2-8 degrees, sources said on Wednesday.

Pfizer, which is ready to offer 5 crore doses to India between July and October this year and has sought certain relaxations including indemnification, has held a series of interactions with the Indian government authorities recently including one this week, during which it shared the most recent data points regarding efficacy trials and approvals for its vaccine in various countries and by the World Health Organisation (WHO).

Another source privy to the discussions said that following recent meetings between the Indian government and Pfizer's Chairman and CEO Albert Bourla, they have agreed to jointly work on three key issues to accelerate approval for the company's COVID-19 vaccine in India, namely procurement through a central government pathway; indemnity and liability; and the regulatory requirement for post-approval bridging studies.

While India has administered over 20 crore doses so far since the launch of its vaccination drive in mid-January, it is still a long way to reach the vaccination for the entire population, more so in the backdrop of many states having flagged shortage of vaccines and the gap between supply and requirement widening amid the deadly second wave.

India is currently using mainly two 'Made in India' jabs -- Covishield manufactured by the Serum Institute and Covaxin of Bharat Biotech -- and Russian-made Sputnik V at a smaller scale to inoculate its population, all of which are approved only for those aged 18 years and above.

In its latest communication to the government, Pfizer has also thanked Government of India to have agreed to its request for procurement through a central government pathway and to discuss "the indemnity and liability protection".

"The timely alignment and execution of the draft heads of terms will enable Pfizer to reserve the allocation of doses and pave the pathway for executing the distribution and supply agreement," the company told the government while seeking fast-tracking of the regulatory pathway to help it supply "Pfizer's COVID-19 vaccine as expeditiously as possible to India".

Pfizer has said India should "rely on the 44 authorizations, including WHO approval, facilitate a EUA (Emergency Use Authorisation)/Restricted Use pathway for the Pfizer vaccine in India, and not seek a local PSA (Post Approval Commitment) study."

The company is, however, open to considering safety surveillance of the first 100 subjects after understanding the process to be followed. "Recent data points confirm the high effectiveness of BNT612b2 2-dose regimen against SARS-CoV-2 variants, and among individuals of Indian ethnicity," Pfizer has said.

The government is examining Pfizer's request for indemnity and will take a decision in the larger interest of people and on merit, NITI Aayog Member (Health) V K Paul said on Thursday.

The government is examining Pfizer's request for indemnity and will take a decision in the larger interest of people and on merit, NITI Aayog Member (Health) V K Paul said on Thursday. At a press conference, Paul said, "Yes we are engaged with Pfizer and they have indicated the availability of a certain amount of vaccine in the coming months, possibly starting in July." "We are looking at what their expectations are from the government and they are looking at what our expectations are from them. That's the process in which this will move. Because they will have to come to India and apply for licensure in India, that's one path and there are imperatives of cold chain and supply. "They have requested indemnity to all the nations, including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now," Paul said. Seeking a fast-track approval for its COVID-19 vaccine, US major Pfizer has told Indian authorities that its jab has shown "high effectiveness" against the SARS-CoV-2 variant prevalent in India and on people of Indian ethnicity or nationality, besides it is suitable for everyone aged 12 years or above and can be stored for a month at 2-8 degrees, sources said on Wednesday. Pfizer, which is ready to offer 5 crore doses to India between July and October this year and has sought certain relaxations including indemnification, has held a series of interactions with the Indian government authorities recently including one this week, during which it shared the most recent data points regarding efficacy trials and approvals for its vaccine in various countries and by the World Health Organisation (WHO). Another source privy to the discussions said that following recent meetings between the Indian government and Pfizer's Chairman and CEO Albert Bourla, they have agreed to jointly work on three key issues to accelerate approval for the company's COVID-19 vaccine in India, namely procurement through a central government pathway; indemnity and liability; and the regulatory requirement for post-approval bridging studies. While India has administered over 20 crore doses so far since the launch of its vaccination drive in mid-January, it is still a long way to reach the vaccination for the entire population, more so in the backdrop of many states having flagged shortage of vaccines and the gap between supply and requirement widening amid the deadly second wave. India is currently using mainly two 'Made in India' jabs -- Covishield manufactured by the Serum Institute and Covaxin of Bharat Biotech -- and Russian-made Sputnik V at a smaller scale to inoculate its population, all of which are approved only for those aged 18 years and above. In its latest communication to the government, Pfizer has also thanked Government of India to have agreed to its request for procurement through a central government pathway and to discuss "the indemnity and liability protection". "The timely alignment and execution of the draft heads of terms will enable Pfizer to reserve the allocation of doses and pave the pathway for executing the distribution and supply agreement," the company told the government while seeking fast-tracking of the regulatory pathway to help it supply "Pfizer's COVID-19 vaccine as expeditiously as possible to India". Pfizer has said India should "rely on the 44 authorizations, including WHO approval, facilitate a EUA (Emergency Use Authorisation)/Restricted Use pathway for the Pfizer vaccine in India, and not seek a local PSA (Post Approval Commitment) study." The company is, however, open to considering safety surveillance of the first 100 subjects after understanding the process to be followed. "Recent data points confirm the high effectiveness of BNT612b2 2-dose regimen against SARS-CoV-2 variants, and among individuals of Indian ethnicity," Pfizer has said.

Central government examining Pfizer's request for indemnity, will take decision on merit: VK Paul

Pfizer is ready to send 50 million doses to India by July this year. But, it wants significant regulatory relaxations from India. What are Pfizer's demands? Palki Sharma brings you a report.

Gravitas: What Pfizer wants from India

Seeking a fast-track approval for its <a href="https://www.wionews.com/topics/coronavirus">COVID-19</a> vaccine, US major <a href="https://www.wionews.com/topics/pfizer">Pfizer</a> has told Indian authorities that its jab has shown "high effectiveness" against the SARS-CoV-2 variant found in India and on people of Indian ethnicity or nationality, while it is suitable for everyone aged 12 years or above and can be stored for a month at 2-8 degrees, sources said on Wednesday.

Also Read |&nbsp;<a href="https://www.wionews.com/india-news/modernas-single-dose-vaccine-in-india-likely-next-year-pfizer-ready-with-50-mn-doses-for-2021-387438">Moderna's single-dose vaccine in India likely next year; Pfizer ready with 50 mn doses for 2021</a>

Pfizer, which is ready to offer 50 million doses to India between July and October this year and has sought certain relaxations including indemnification, has held a series of interactions with the Indian government authorities recently including one this week, during which it shared the most recent data points regarding efficacy trials and approvals for its vaccine in various countries and by the World Health Organisation (WHO).

"The current situation in India, and across the world, is not 'business as usual'&nbsp;and we must not respond to it with processes as usual too," a source quoted <a href="https://www.wionews.com/topics/pfizer">Pfizer</a> as having communicated to the Indian government.

Also Read |&nbsp;<a href="https://www.wionews.com/india-news/pfizer-and-moderna-dont-want-to-deal-with-indian-states-for-vaccines-387168">Pfizer and Moderna don't want to deal with Indian states for vaccines</a>

Another source privy to the discussions said that following recent meetings between the Indian government and Pfizer's Chairman and CEO Albert Bourla, they have agreed to jointly work on three key issues to accelerate approval for the company's COVID-19 vaccine in India, namely procurement through a central government pathway; indemnity and liability; and the regulatory requirement for post-approval bridging studies.

While India has administered over 20 crore doses so far since the launch of its vaccination drive in mid-January, it is still a long way to reach the vaccination for the entire population, more so in the backdrop of many states having flagged shortage of vaccines and the gap between supply and requirement widening amid the deadly second wave.

India is currently using mainly two 'made-in India' jabs,&nbsp;Covishield manufactured by the Serum Institute and Covaxin of Bharat Biotech,&nbsp;and Russian-made Sputnik V at a smaller scale to inoculate its population, all of which are approved only for those aged 18 years and above.

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/gravitas-why-cant-india-get-covid-vaccines-from-pfizer-and-moderna-387165/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

In its latest communication to the government, Pfizer has also thanked the Government of India to have agreed to its request for procurement through a central government pathway and to discuss "the Indemnity and Liability protection".

"The timely alignment and execution of the draft Heads of Terms will enable Pfizer to reserve the allocation of doses and pave the pathway for executing the Distribution and Supply Agreement," the company told the government while seeking fast-tracking the regulatory pathway to help it supply "Pfizer's COVID-19 vaccine as expeditiously as possible to India".

Pfizer has said India should "rely on the 44 authorizations, including WHO approval, facilitate a EUA (Emergency Use Authorisation)/Restricted Use pathway for the Pfizer vaccine in India, and not seek a local PSA (Post Approval Commitment) study."

Also Read |&nbsp;<a href="https://www.wionews.com/world/us-approves-pfizer-biontechs-covid-vaccine-for-children-aged-12-15-384195">US approves Pfizer-BioNTech's Covid vaccine for children aged 12-15</a>

The company is, however, open to considering safety surveillance of the first 100 subjects after understanding the process to be followed.

It has also stated that the Pfizer vaccine has undergone significant development over the last six months which includes improvement in storage conditions at 208 degrees for over one month (31 days) at the site of vaccination.

"Recent data points confirm the high effectiveness of BNT612b2 2-dose regimen against SARS-CoV-2 variants, and among individuals of Indian ethnicity," Pfizer has said.

Also Read |&nbsp;<a href="https://www.wionews.com/science/two-doses-of-covid-vaccines-offer-significant-protection-against-b16172-variant-study-finds-386812">Two doses of Covid vaccines offer significant protection against B.1.617.2 variant, study finds</a>

Providing data, it said UK's Public Health England (PHE) has reported high vaccine effectiveness (87.9 per cent) against the B.1.617.2 variant, most reported in India, in an observational study (concluded on May 22, 2021).

It further said 26 per cent of study participants overall were of "Indian or British Indian" ethnicity, and also included Bangladeshi (1.4 per cent), Pakistani (5.9 per cent) and any other Asian background (5.7 per cent), indicating that the observed vaccine effectiveness applies to these groups as well.

Also, the data from Qatar's nationwide immunization program demonstrated high vaccine effectiveness - 89 per cent against B.1.1.7 variant (first detected in the UK) and 75 per cent against B.1.351 variant (first detected in South Africa).

Also Read |&nbsp;<a href="https://www.wionews.com/world/pfizer-ceo-says-oral-drug-to-treat-coronavirus-could-be-ready-by-end-of-2021-381159" hreflang="en">Pfizer CEO says oral drug to treat coronavirus could be ready by end of 2021</a>

It said 24 per cent of study participants were of Indian nationality (more than 6,000), and others included Nepalese (6-12 per cent), Bangladeshi (4-11 per cent), Sri Lankan (3-4 per cent), Pakistani (4-6 per cent), indicating that the observed vaccine effectiveness applies to these groups as well.

Pfizer has urged the Government of India to rely upon WHO's testing pathways of reliance on testing certificates from country of origin instead of mandating local testing and batch release stating will also help fast track vaccine introduction and prevent vaccine wastage.

Pfizer has also shared the most recent data on the BNT162b2 mRNA vaccine, the phase 3 clinical trial showing vaccine efficacy six months after the second dose from the pivotal registration trial, as also for variants in vitro neutralization, clinically efficacy data and real-world vaccine effectiveness against emerging variants of SARS-CoV-2. The data shared with Indian authorities also include "real-world evidence of BNT162b2 vaccine effectiveness and safety from national immunization programmes".

Also Read |&nbsp;<a href="https://www.wionews.com/world/canada-becomes-first-country-to-authorise-pfizer-covid-vaccine-for-kids-age-12-and-up-383033" hreflang="en">Canada becomes first country to authorise Pfizer Covid vaccine for kids age 12 and up</a>

The shared data points include trials showing nearly 95 per cent effectiveness against COVID-19, 100 per cent efficacy against severe disease and also 100 per cent vaccine efficacy in 12-15-year-old adolescents.

Seeking a fast-track approval for its COVID-19 vaccine, US major Pfizer has told Indian authorities that its jab has shown "high effectiveness" against the SARS-CoV-2 variant found in India and on people of Indian ethnicity or nationality, while it is suitable for everyone aged 12 years or above and can be stored for a month at 2-8 degrees, sources said on Wednesday.

Seeking a fast-track approval for its COVID-19 vaccine, US major Pfizer has told Indian authorities that its jab has shown "high effectiveness" against the SARS-CoV-2 variant found in India and on people of Indian ethnicity or nationality, while it is suitable for everyone aged 12 years or above and can be stored for a month at 2-8 degrees, sources said on Wednesday. Also Read | Moderna's single-dose vaccine in India likely next year; Pfizer ready with 50 mn doses for 2021 Pfizer, which is ready to offer 50 million doses to India between July and October this year and has sought certain relaxations including indemnification, has held a series of interactions with the Indian government authorities recently including one this week, during which it shared the most recent data points regarding efficacy trials and approvals for its vaccine in various countries and by the World Health Organisation (WHO). "The current situation in India, and across the world, is not 'business as usual' and we must not respond to it with processes as usual too," a source quoted Pfizer as having communicated to the Indian government. Also Read | Pfizer and Moderna don't want to deal with Indian states for vaccines Another source privy to the discussions said that following recent meetings between the Indian government and Pfizer's Chairman and CEO Albert Bourla, they have agreed to jointly work on three key issues to accelerate approval for the company's COVID-19 vaccine in India, namely procurement through a central government pathway; indemnity and liability; and the regulatory requirement for post-approval bridging studies. While India has administered over 20 crore doses so far since the launch of its vaccination drive in mid-January, it is still a long way to reach the vaccination for the entire population, more so in the backdrop of many states having flagged shortage of vaccines and the gap between supply and requirement widening amid the deadly second wave. India is currently using mainly two 'made-in India' jabs, Covishield manufactured by the Serum Institute and Covaxin of Bharat Biotech, and Russian-made Sputnik V at a smaller scale to inoculate its population, all of which are approved only for those aged 18 years and above. In its latest communication to the government, Pfizer has also thanked the Government of India to have agreed to its request for procurement through a central government pathway and to discuss "the Indemnity and Liability protection". "The timely alignment and execution of the draft Heads of Terms will enable Pfizer to reserve the allocation of doses and pave the pathway for executing the Distribution and Supply Agreement," the company told the government while seeking fast-tracking the regulatory pathway to help it supply "Pfizer's COVID-19 vaccine as expeditiously as possible to India". Pfizer has said India should "rely on the 44 authorizations, including WHO approval, facilitate a EUA (Emergency Use Authorisation)/Restricted Use pathway for the Pfizer vaccine in India, and not seek a local PSA (Post Approval Commitment) study." Also Read | US approves Pfizer-BioNTech's Covid vaccine for children aged 12-15 The company is, however, open to considering safety surveillance of the first 100 subjects after understanding the process to be followed. It has also stated that the Pfizer vaccine has undergone significant development over the last six months which includes improvement in storage conditions at 208 degrees for over one month (31 days) at the site of vaccination. "Recent data points confirm the high effectiveness of BNT612b2 2-dose regimen against SARS-CoV-2 variants, and among individuals of Indian ethnicity," Pfizer has said. Also Read | Two doses of Covid vaccines offer significant protection against B.1.617.2 variant, study finds Providing data, it said UK's Public Health England (PHE) has reported high vaccine effectiveness (87.9 per cent) against the B.1.617.2 variant, most reported in India, in an observational study (concluded on May 22, 2021). It further said 26 per cent of study participants overall were of "Indian or British Indian" ethnicity, and also included Bangladeshi (1.4 per cent), Pakistani (5.9 per cent) and any other Asian background (5.7 per cent), indicating that the observed vaccine effectiveness applies to these groups as well. Also, the data from Qatar's nationwide immunization program demonstrated high vaccine effectiveness - 89 per cent against B.1.1.7 variant (first detected in the UK) and 75 per cent against B.1.351 variant (first detected in South Africa). Also Read | Pfizer CEO says oral drug to treat coronavirus could be ready by end of 2021 It said 24 per cent of study participants were of Indian nationality (more than 6,000), and others included Nepalese (6-12 per cent), Bangladeshi (4-11 per cent), Sri Lankan (3-4 per cent), Pakistani (4-6 per cent), indicating that the observed vaccine effectiveness applies to these groups as well. Pfizer has urged the Government of India to rely upon WHO's testing pathways of reliance on testing certificates from country of origin instead of mandating local testing and batch release stating will also help fast track vaccine introduction and prevent vaccine wastage. Pfizer has also shared the most recent data on the BNT162b2 mRNA vaccine, the phase 3 clinical trial showing vaccine efficacy six months after the second dose from the pivotal registration trial, as also for variants in vitro neutralization, clinically efficacy data and real-world vaccine effectiveness against emerging variants of SARS-CoV-2. The data shared with Indian authorities also include "real-world evidence of BNT162b2 vaccine effectiveness and safety from national immunization programmes". Also Read | Canada becomes first country to authorise Pfizer Covid vaccine for kids age 12 and up The shared data points include trials showing nearly 95 per cent effectiveness against COVID-19, 100 per cent efficacy against severe disease and also 100 per cent vaccine efficacy in 12-15-year-old adolescents.

Our vaccine highly effective on COVID-19 variant found in India, suitable for 12 yrs and above: Pfizer to Govt

Moderna is in talks with Cipla and other Indian pharma firms to launch its single-dose COVID-19 vaccine in India by the year 2022. Meanwhile, Pfizer has reportedly indicated that it can provide 5 crore doses of its vaccine this year.

Report: India may get single-dose Moderna COVID-19 vaccine by 2022

Moderna is expecting to launch a single-dose COVID-19 vaccine in India next year and is in talks with Cipla among other Indian firms, while another US giant Pfizer is ready to offer 50 million shots in 2021 itself but it wants significant regulatory relaxations including indemnification, sources said on Tuesday.&nbsp;

While Moderna has conveyed to Indian authorities that it does not have surplus vaccines to share in 2021, there are limited prospects of Johnson &amp; Johnson exporting its jabs from the US to other countries in the near future, the sources privy to discussions added.&nbsp;

Two rounds of high-level meetings chaired by the Cabinet Secretary were held last week on the availability of vaccines in the global as well as domestic markets as it was felt that there is an urgent need to procure the jabs at a time the country is reeling under an unprecedented second wave of COVID-19 and a widening gap between supply and requirement.&nbsp;

Currently, the country is using two 'Made in India' jabs, Covishield and Covaxin, to inoculate its billion-plus population and has administered numerous doses since launching the world's largest vaccination drive in mid-January. A third vaccine, Russian-made Sputnik V, has been approved by the government and is being used on a smaller scale at present.&nbsp;

In the high-level meeting officials from the Ministry of External Affairs, NITI Aayog, Department of Biotechnology, Law Ministry and Health Ministry were present.&nbsp;

It was discussed that Moderna doesn't have surplus vaccines to share in 2021 and that it plans to launch its single-dose vaccine for the Indian market only in 2022, for which, they are in discussion with Cipla and other Indian companies, a source said.&nbsp;

It is learnt that Cipla has already evinced interest in procuring 50 million doses from Moderna for 2022 and has requested confirmation from the central government in respect of stability in regulatory requirements/policy regime. The Health Ministry has also been asked to take an early decision on Cipla's request regarding support required by them for procurement of Moderna vaccines.&nbsp;

In the case of Pfizer, the US pharma giant has indicated availability of 50 million vaccine doses, 10 million in July, 10 million in August, 20 million in September and 10 million in October, for supply to India in 2021 and that it will deal only with Government of India and payment for vaccines will have to be made by GOI to Pfizer India.&nbsp;

The central government will make its own arrangement for further channelization of procured vaccines in the domestic market.&nbsp;

According to another source, for the supply of vaccines to India, Pfizer has asked for indemnification from the Government of India and a document in this regard has been received from Pfizer Inc.&nbsp;

Further, Pfizer has also sought certain relaxations in the regulatory regime, including relaxation in the requirement of post-approval bridging trials and dispensing the requirement of testing their vaccines in CDL (Central Drugs Laboratory).&nbsp;

Taking into consideration the track record of the company, similar arrangements done with other countries in the world and the current pandemic situation, an overall view may be taken to indemnify the company by the government, officials said but flagged that in case a view is taken to indemnify the company, similar demands may be made by other companies.&nbsp;

As per the information furnished by Pfizer, around 116 countries in the world including the USA have signed the indemnification document.&nbsp;

Further, considering that over 14.7 crore doses of Pfizer had been administered worldwide without any significant reports of adverse effects, a view needs to be taken to indemnify the company in order to supplement the availability of vaccines in India, officials discussed at one recent meeting.&nbsp;

It was suggested that a decision on the issue of Pfizer Inc may be taken at the earliest and that NEGVAC (National Expert Group on Vaccine Administration for COVID-19) may hold a meeting immediately on these issues.&nbsp;

At a press conference on Monday, in response to a question on states being unable to procure vaccines directly from Moderna and Pfizer, Health Ministry Joint Secretary Lav Agarwal had said, "Whether it is Pfizer or Moderna, at the Centre-level, we have been coordinating with them."&nbsp;

"Also, the order book of both Pfizer and Moderna is full so it depends on their surplus that how much they can provide in India... They will come back to the Centre and we will help in facilitation to states," he said. &nbsp;&nbsp;

Moderna is expecting to launch a single-dose COVID-19 vaccine in India next year and is in talks with Cipla among other Indian firms, while another US giant Pfizer is ready to offer 50 million shots in 2021 itself but it wants significant regulatory relaxations including indemnification, sources said on Tuesday.

Moderna is expecting to launch a single-dose COVID-19 vaccine in India next year and is in talks with Cipla among other Indian firms, while another US giant Pfizer is ready to offer 50 million shots in 2021 itself but it wants significant regulatory relaxations including indemnification, sources said on Tuesday. While Moderna has conveyed to Indian authorities that it does not have surplus vaccines to share in 2021, there are limited prospects of Johnson & Johnson exporting its jabs from the US to other countries in the near future, the sources privy to discussions added. Two rounds of high-level meetings chaired by the Cabinet Secretary were held last week on the availability of vaccines in the global as well as domestic markets as it was felt that there is an urgent need to procure the jabs at a time the country is reeling under an unprecedented second wave of COVID-19 and a widening gap between supply and requirement. Currently, the country is using two 'Made in India' jabs, Covishield and Covaxin, to inoculate its billion-plus population and has administered numerous doses since launching the world's largest vaccination drive in mid-January. A third vaccine, Russian-made Sputnik V, has been approved by the government and is being used on a smaller scale at present. In the high-level meeting officials from the Ministry of External Affairs, NITI Aayog, Department of Biotechnology, Law Ministry and Health Ministry were present. It was discussed that Moderna doesn't have surplus vaccines to share in 2021 and that it plans to launch its single-dose vaccine for the Indian market only in 2022, for which, they are in discussion with Cipla and other Indian companies, a source said. It is learnt that Cipla has already evinced interest in procuring 50 million doses from Moderna for 2022 and has requested confirmation from the central government in respect of stability in regulatory requirements/policy regime. The Health Ministry has also been asked to take an early decision on Cipla's request regarding support required by them for procurement of Moderna vaccines. In the case of Pfizer, the US pharma giant has indicated availability of 50 million vaccine doses, 10 million in July, 10 million in August, 20 million in September and 10 million in October, for supply to India in 2021 and that it will deal only with Government of India and payment for vaccines will have to be made by GOI to Pfizer India. The central government will make its own arrangement for further channelization of procured vaccines in the domestic market. According to another source, for the supply of vaccines to India, Pfizer has asked for indemnification from the Government of India and a document in this regard has been received from Pfizer Inc. Further, Pfizer has also sought certain relaxations in the regulatory regime, including relaxation in the requirement of post-approval bridging trials and dispensing the requirement of testing their vaccines in CDL (Central Drugs Laboratory). Taking into consideration the track record of the company, similar arrangements done with other countries in the world and the current pandemic situation, an overall view may be taken to indemnify the company by the government, officials said but flagged that in case a view is taken to indemnify the company, similar demands may be made by other companies. As per the information furnished by Pfizer, around 116 countries in the world including the USA have signed the indemnification document. Further, considering that over 14.7 crore doses of Pfizer had been administered worldwide without any significant reports of adverse effects, a view needs to be taken to indemnify the company in order to supplement the availability of vaccines in India, officials discussed at one recent meeting. It was suggested that a decision on the issue of Pfizer Inc may be taken at the earliest and that NEGVAC (National Expert Group on Vaccine Administration for COVID-19) may hold a meeting immediately on these issues. At a press conference on Monday, in response to a question on states being unable to procure vaccines directly from Moderna and Pfizer, Health Ministry Joint Secretary Lav Agarwal had said, "Whether it is Pfizer or Moderna, at the Centre-level, we have been coordinating with them." "Also, the order book of both Pfizer and Moderna is full so it depends on their surplus that how much they can provide in India... They will come back to the Centre and we will help in facilitation to states," he said.

Moderna's single-dose vaccine in India likely next year; Pfizer ready with 50 mn doses for 2021

Why can't India get vaccines from Pfizer and Moderna? Big Pharma firms say they want to negotiate directly with the Central government and set the terms. Some demands go beyond money. Palki Sharma tells you more.

Gravitas: Why can't India get COVID vaccines from Pfizer and Moderna?

When the Indian government allowed states to pursue their own vaccine procurement, the idea was welcomed.

States governments were quick to seize the moment. Some chief ministers announced global tenders to buy shots from the international market. Weeks later, they are complaining again.

Because companies like Pfizer and Moderna don't want to deal with them. They want to negotiate directly with the centre and set the terms.&nbsp;

So what do these vaccine majors need from India?

It's not just about the money. They want the kind of guarantees that India hasn't given any vaccine maker.

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Pfizer and Moderna are among the best shots on the international market. Both vaccines work on the same technology. They are more than 90 per cent effective. Together, they have been approved by more than 40 countries. India wants them too. But on its own terms.

The government has authorised states to negotiate for themselves. Global tenders were announced. But it proved to be a damp squib as vaccine makers refused to deal with state governments.

Punjab made request to Moderna, it was denied. Moderna says it will only deal with the central government.

The Delhi state government wrote to Moderna, Pfizer and Johnson and Johnson. It got the same reply. They will only deal with the Government of India.&nbsp;

Beyond the obvious need of approvals and clearances, these vaccine companies have their own demands.

For instance, Pfizer CEO claims that they have been trying to get Pfizer vaccines to India for months. But Pfizer wants indemnity, a legal exemption from future lawsuits over their vaccines. Countries like the US and Britain have signed such clauses.

It basically means that if the vaccine maker is sued in India, it will be the government's problem, not the company's. India has not given such indemnity to any vaccine producer. Why should Pfizer be the exception?

The discussion is still on between the company and the government. In the past, Pfizer has been accused of bullying Latin American countries. They demanded embassy buildings and military bases as guarantee against the cost of any future legal cases.

The other problem is supply. Rich countries have already taken most of the shots off the shelves. Reports say, Moderna has its hands full with the existing orders. It might not have more doses for India. According to a report in April, Moderna already had orders to supply more than 1,000 million doses. These are for countries like the US, the EU, Canada, Japan, Switzerland and others.

Moderna is planning a major expansion in manufacturing. But even with a global tender, India may have to wait in line for its deliveries.

States like, Maharashtra, Uttar Pradesh, Tamil Nadu, Kerala and Karnataka have issued global tenders. But all of them are waiting for a bid.

When the Indian government allowed states to pursue their own vaccine procurement, the idea was welcomed. States governments were quick to seize the moment. Some chief ministers announced global tenders to buy shots from the international market.

When the Indian government allowed states to pursue their own vaccine procurement, the idea was welcomed. States governments were quick to seize the moment. Some chief ministers announced global tenders to buy shots from the international market. Weeks later, they are complaining again. Because companies like Pfizer and Moderna don't want to deal with them. They want to negotiate directly with the centre and set the terms. So what do these vaccine majors need from India? It's not just about the money. They want the kind of guarantees that India hasn't given any vaccine maker. × Pfizer and Moderna are among the best shots on the international market. Both vaccines work on the same technology. They are more than 90 per cent effective. Together, they have been approved by more than 40 countries. India wants them too. But on its own terms. The government has authorised states to negotiate for themselves. Global tenders were announced. But it proved to be a damp squib as vaccine makers refused to deal with state governments. Punjab made request to Moderna, it was denied. Moderna says it will only deal with the central government. The Delhi state government wrote to Moderna, Pfizer and Johnson and Johnson. It got the same reply. They will only deal with the Government of India. Beyond the obvious need of approvals and clearances, these vaccine companies have their own demands. For instance, Pfizer CEO claims that they have been trying to get Pfizer vaccines to India for months. But Pfizer wants indemnity, a legal exemption from future lawsuits over their vaccines. Countries like the US and Britain have signed such clauses. It basically means that if the vaccine maker is sued in India, it will be the government's problem, not the company's. India has not given such indemnity to any vaccine producer. Why should Pfizer be the exception? The discussion is still on between the company and the government. In the past, Pfizer has been accused of bullying Latin American countries. They demanded embassy buildings and military bases as guarantee against the cost of any future legal cases. The other problem is supply. Rich countries have already taken most of the shots off the shelves. Reports say, Moderna has its hands full with the existing orders. It might not have more doses for India. According to a report in April, Moderna already had orders to supply more than 1,000 million doses. These are for countries like the US, the EU, Canada, Japan, Switzerland and others. Moderna is planning a major expansion in manufacturing. But even with a global tender, India may have to wait in line for its deliveries. States like, Maharashtra, Uttar Pradesh, Tamil Nadu, Kerala and Karnataka have issued global tenders. But all of them are waiting for a bid.

Pfizer and Moderna don't want to deal with Indian states for vaccines

Indian government and Pfizer are at loggerheads over a demand by the US drug maker for legal protection from any claims linked to the use of its COVID-19 vaccine in one of the world's biggest markets.

Indian Govt & Pfizer at loggerheads over COVID-19 vaccine indemnity demand

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