South Africa will be receiving 1.5 million doses of vaccine from Serum Institute of India (SII), country’s health minister, Dr Zweli Mkhize said in a statement.&nbsp;

“Today, I am pleased to announce that the Serum Institute of India (SII) has given us permission to make a public announcement and start engaging with all relevant stakeholders in preparation for the roll out,” he said.&nbsp;

Watch |&nbsp;

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The country will be receiving 1 million doses in January and 500,000 doses in February from the SII.

The minister reiterated that an estimated 1.25 million health care workers from both public and private hospitals will be the first in line to get access to the vaccine.&nbsp;

In order to strengthen the credibility of the process, the acquisition has been done directly by the Department of Health, Mkhize said.

“We will now be engaging all relevant stakeholders in order to ensure the efficient and effective roll out of the vaccine for our health workers,” he added.

According to the latest government statistics, South Africa witnessed a record 21, 832 new cases and 844 new deaths in the last 24 hours, taking the total number of positive cases to around 1.15 million and 31,368 deaths.&nbsp;

 
&nbsp;

South Africa will be receiving 1.5 million doses of vaccine from Serum Institute of India (SII), country’s health minister, Dr Zweli Mkhize said in a statement. “Today, I am pleased to announce that the Serum Institute of India (SII) has given us permission to make a public announcement and start engaging with all relevant stakeholders in preparation for the roll out,” he said.

South Africa will be receiving 1.5 million doses of vaccine from Serum Institute of India (SII), country’s health minister, Dr Zweli Mkhize said in a statement. “Today, I am pleased to announce that the Serum Institute of India (SII) has given us permission to make a public announcement and start engaging with all relevant stakeholders in preparation for the roll out,” he said. Watch | The country will be receiving 1 million doses in January and 500,000 doses in February from the SII. The minister reiterated that an estimated 1.25 million health care workers from both public and private hospitals will be the first in line to get access to the vaccine. In order to strengthen the credibility of the process, the acquisition has been done directly by the Department of Health, Mkhize said. “We will now be engaging all relevant stakeholders in order to ensure the efficient and effective roll out of the vaccine for our health workers,” he added. According to the latest government statistics, South Africa witnessed a record 21, 832 new cases and 844 new deaths in the last 24 hours, taking the total number of positive cases to around 1.15 million and 31,368 deaths.

South Africa to receive 1.5 million vaccines doses from India's Serum Institute

India approved two Wuhan virus vaccines over the weekend. The emergency-use approvals were given to the Oxford-Astrazeneca shot - Covishield and the Bharat Biotech vaccine - Covaxin.

Both are two-shot vaccines and both are easy to store and distribute. The vaccines have been approved and administering shots is the next step. As India's Prime Minister Narendra Modi described it - India will be starting the largest vaccination programme in the world.

The task is to vaccinate over 1.3 billion people. However, no timeline has been announced so far but mass vaccination is expected to start soon. Reports claim it can be as early as this week.

Healthcare workers and frontline workers are set to get vaccinated first. They make up the first priority group and they will be administered the vaccine for free. The second group includes persons above the age of 50 and persons with co-morbidities.

The Wuhan virus vaccination is being called India's most ambitious vaccination drive ever. Mock drills have already been held in 125 districts and across all states with at least 96,000 vaccinators trained.

Cold chain infrastructure has been upgraded. India has secured enough shots to vaccinate its priority group. Those eligible for the vaccine in the first phase will be notified through a text message. They will be informed about the health facility they need to go to for the shot. They will also be provided a date and time.

India has kept the vaccination voluntary, however, that's not the government's biggest challenge since as with most things in India, politics is the biggest hurdle.

Despite all the checks, India has not been able to immunise itself from vaccine politics. India's vaccination programme has come under criticism. Most of it has been directed towards the approval of Covaxin - the home-grown vaccine developed by Bharat Biotech and ICMR the Indian Council of Medical Research(ICMR).

Critics say it has not been vetted properly and was approved prematurely.

The director of India's premier medical institute AIIMS suggested that Covaxin be kept as a backup vaccine. India's opposition leaders have questioned the lack of efficacy data for Covaxin. They also raised questions around the safety of the shot as some called it a "BJP vaccine" tagging it to the ruling party at the Centre in India.

As for the questions about the efficacy &amp; trail data, the managing director of Bharat Biotech Krishna Ella opened Pandora's box. He named a vaccine company and said that it was giving paracetamol to its volunteers suppressing adverse reactions.

He also said that while most vaccine makers have data of around 1,000 volunteers. Bharat Biotech is the only company with data of 25,000 people and that the company has carried out "200 per cent honest clinical trials".

He said that most vaccines will not be effective in the second year. None of the vaccine makers have said if their shots will be effective in case of transmission of the virus. WION has not been able to independently verify any of it.

These are desperate times call for desperate measures. Vaccine makers want to sell their shots, politicians want to play politics over vaccines and governments want to roll out vaccines as soon as possible. Accusations and mudslinging don't help anyone, avoiding transparency however is even worse.

India approved two Wuhan virus vaccines over the weekend. The emergency-use approvals were given to the Oxford-Astrazeneca shot - Covishield and the Bharat Biotech vaccine - Covaxin.

India approved two Wuhan virus vaccines over the weekend. The emergency-use approvals were given to the Oxford-Astrazeneca shot - Covishield and the Bharat Biotech vaccine - Covaxin. Both are two-shot vaccines and both are easy to store and distribute. The vaccines have been approved and administering shots is the next step. As India's Prime Minister Narendra Modi described it - India will be starting the largest vaccination programme in the world. The task is to vaccinate over 1.3 billion people. However, no timeline has been announced so far but mass vaccination is expected to start soon. Reports claim it can be as early as this week. Healthcare workers and frontline workers are set to get vaccinated first. They make up the first priority group and they will be administered the vaccine for free. The second group includes persons above the age of 50 and persons with co-morbidities. The Wuhan virus vaccination is being called India's most ambitious vaccination drive ever. Mock drills have already been held in 125 districts and across all states with at least 96,000 vaccinators trained. Cold chain infrastructure has been upgraded. India has secured enough shots to vaccinate its priority group. Those eligible for the vaccine in the first phase will be notified through a text message. They will be informed about the health facility they need to go to for the shot. They will also be provided a date and time. India has kept the vaccination voluntary, however, that's not the government's biggest challenge since as with most things in India, politics is the biggest hurdle. Despite all the checks, India has not been able to immunise itself from vaccine politics. India's vaccination programme has come under criticism. Most of it has been directed towards the approval of Covaxin - the home-grown vaccine developed by Bharat Biotech and ICMR the Indian Council of Medical Research(ICMR). Critics say it has not been vetted properly and was approved prematurely. The director of India's premier medical institute AIIMS suggested that Covaxin be kept as a backup vaccine. India's opposition leaders have questioned the lack of efficacy data for Covaxin. They also raised questions around the safety of the shot as some called it a "BJP vaccine" tagging it to the ruling party at the Centre in India. As for the questions about the efficacy & trail data, the managing director of Bharat Biotech Krishna Ella opened Pandora's box. He named a vaccine company and said that it was giving paracetamol to its volunteers suppressing adverse reactions. He also said that while most vaccine makers have data of around 1,000 volunteers. Bharat Biotech is the only company with data of 25,000 people and that the company has carried out "200 per cent honest clinical trials". He said that most vaccines will not be effective in the second year. None of the vaccine makers have said if their shots will be effective in case of transmission of the virus. WION has not been able to independently verify any of it. These are desperate times call for desperate measures. Vaccine makers want to sell their shots, politicians want to play politics over vaccines and governments want to roll out vaccines as soon as possible. Accusations and mudslinging don't help anyone, avoiding transparency however is even worse.

Politics overtakes COVID-19 vaccination programme in India

India's Central Drugs Standard Control Organization (CDSCO) expert panel on Saturday recommended approving restricted emergency use of Bharat Biotech's indigenous COVID vaccine Covaxin in India, said officials. 
 
<a href="https://www.wionews.com/india-news/indian-government-okays-emergency-use-of-astrazeneca-covid-vaccine-354050">Also read | Indian government okays emergency use of AstraZeneca COVID vaccine</a>

Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

This is the second Covid-19 vaccine which has been recommended for emergency use approval to DCGI after Serum's locally produced Oxford Covid-19 vaccine 'Covishield'

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Saturday again deliberated on the emergency use authorisation (EUA) application of the Hyderabad-based pharmaceutical firm after it submitted additional data, facts and analysis subsequent to Friday’s review meeting, a source said.

(With inputs from agencies)

India's Central Drugs Standard Control Organization (CDSCO) expert panel on Saturday recommended approving restricted emergency use of Bharat Biotech's indigenous COVID vaccine Covaxin in India, said officials.

India's Central Drugs Standard Control Organization (CDSCO) expert panel on Saturday recommended approving restricted emergency use of Bharat Biotech's indigenous COVID vaccine Covaxin in India, said officials. Also read | Indian government okays emergency use of AstraZeneca COVID vaccine Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). This is the second Covid-19 vaccine which has been recommended for emergency use approval to DCGI after Serum's locally produced Oxford Covid-19 vaccine 'Covishield' The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Saturday again deliberated on the emergency use authorisation (EUA) application of the Hyderabad-based pharmaceutical firm after it submitted additional data, facts and analysis subsequent to Friday’s review meeting, a source said. (With inputs from agencies)

Expert panel recommends India's indigenously developed Covid-19 vaccine Covaxin for restricted emergency use

VG Somani, the Drug Controller General of India said on Monday that Covishield and&nbsp;Covaxin are ''safe and provide a robust immune response.''

India's drugs regulator has given final emergency-use approval for two coronavirus vaccines, Serum Institute of India's Covishield, developed by Oxford University and pharma major AstraZeneca, and Bharat Biotech's Covaxin.

Also read:&nbsp;<a href="https://www.wionews.com/india-news/india-approves-sii-and-bharat-biotechs-covid-19-vaccines-for-restricted-emergency-use-354141" hreflang="en">India approves SII and Bharat Biotech's Covid-19 vaccines for restricted emergency use</a>

During an interview, Somani said&nbsp;"We'll never approve anything if there is slightest of safety concern. The vaccines are 110 per cent safe."&nbsp;

The country&nbsp;is now expected to start a massive immunisation programme within weeks.

Drug Controller General of India (DGCI) chief VG Somani said both firms submitted data on their trial runs and both have been granted permission for "restricted use".

"Safety immunogenicity data submitted by SII found efficacy was 70.42 per cent. Restricted use in emergency conditions allowed. The clinical trials will continue. Covaxin has been developed in collaboration with ICMR and NIV," he said in a press briefing on Sunday.

Indian Prime Minister Narendra Modi called the approval a decisive turning point to strengthen a spirited fight and congratulated&nbsp;scientists and&nbsp;innovators.

<div class="ui-state-default" contenteditable="false">
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A decisive turning point to strengthen a spirited fight! 
 
DCGI granting approval to vaccines of <a href="https://twitter.com/SerumInstIndia?ref_src=twsrc%5Etfw">@SerumInstIndia</a> and <a href="https://twitter.com/BharatBiotech?ref_src=twsrc%5Etfw">@BharatBiotech</a> accelerates the road to a healthier and COVID-free nation. 
 
Congratulations India. 
 
Congratulations to our hardworking scientists and innovators.
— Narendra Modi (@narendramodi) <a href="https://twitter.com/narendramodi/status/1345607618191007747?ref_src=twsrc%5Etfw">January 3, 2021</a></blockquote>
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He said, "The DCGI granting approval to vaccines of Serum Institute of India and Bharat Biotech accelerates the road to COVID-free nation."

VG Somani, the Drug Controller General of India said on Monday that Covishield and Covaxin are ''safe and provide a robust immune response.'' India's drugs regulator has given final emergency-use approval for two coronavirus vaccines, Serum Institute of India's Covishield, developed by Oxford University and pharma major AstraZeneca, and Bharat Biotech's Covaxin.

VG Somani, the Drug Controller General of India said on Monday that Covishield and Covaxin are ''safe and provide a robust immune response.'' India's drugs regulator has given final emergency-use approval for two coronavirus vaccines, Serum Institute of India's Covishield, developed by Oxford University and pharma major AstraZeneca, and Bharat Biotech's Covaxin. Also read: India approves SII and Bharat Biotech's Covid-19 vaccines for restricted emergency use During an interview, Somani said "We'll never approve anything if there is slightest of safety concern. The vaccines are 110 per cent safe." The country is now expected to start a massive immunisation programme within weeks. Drug Controller General of India (DGCI) chief VG Somani said both firms submitted data on their trial runs and both have been granted permission for "restricted use". "Safety immunogenicity data submitted by SII found efficacy was 70.42 per cent. Restricted use in emergency conditions allowed. The clinical trials will continue. Covaxin has been developed in collaboration with ICMR and NIV," he said in a press briefing on Sunday. Indian Prime Minister Narendra Modi called the approval a decisive turning point to strengthen a spirited fight and congratulated scientists and innovators. A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators. — Narendra Modi (@narendramodi) January 3, 2021 × He said, "The DCGI granting approval to vaccines of Serum Institute of India and Bharat Biotech accelerates the road to COVID-free nation."

Covishield, Covaxin are safe and provide robust immune response, says Drug Controller General of India VG Somani

Expert panel at&nbsp;Central Drugs Standard Control Organization&nbsp;has recommended emergency use of Covishield (AstraZeneca) vaccine for coronavirus vaccination in India. The panel has recommended AstraZeneca vaccine with certain conditions. The vaccine is being developed by AstraZeneca and Oxford University. Serum Institute of India (SII) will manufacture the vaccine.

A decision on coronavirus vaccine made by Bharat Biotech is also likely.

As per reports, Serum Institute of India has already stored more than 50 million&nbsp;doses of Astrazeneca vaccine. SII had said several months ago that half of the vaccines it manufactures will be for vaccination purpose in India.&nbsp;

<a href="https://www.wionews.com/videos/gravitas-oxford-vaccine-one-step-away-from-approval-in-india-353934">WATCH|</a>

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Indian&nbsp;government said on Wednesday that Pfizer Inc had sought more time to present data for emergency authorisation of a vaccine it has developed with Germany's BioNTech.

AstraZeneca/ Oxford University coronavirus vaccine has already got approval in Britain and Argentina for urgent public use. USA, which has approved Pfizer vaccine is likely to approve use of Astrazeneca vaccine in April. as per reports received on Thursday.

Moncef Slaoui, the chief advisor to Operation Warp Speed, the military-led US effort for vaccines, told reporters that US trials and assessments would be complete for approval "sometime in early April."

"Several tens of millions of doses will have been manufactured... and therefore will be available for use if the data supports its approval," he said.

(With agency inputs)

Expert panel at Central Drugs Standard Control Organization has recommended emergency use of Covishield (AstraZeneca) vaccine for coronavirus vaccination in India.

Expert panel at Central Drugs Standard Control Organization has recommended emergency use of Covishield (AstraZeneca) vaccine for coronavirus vaccination in India. The panel has recommended AstraZeneca vaccine with certain conditions. The vaccine is being developed by AstraZeneca and Oxford University. Serum Institute of India (SII) will manufacture the vaccine. A decision on coronavirus vaccine made by Bharat Biotech is also likely. As per reports, Serum Institute of India has already stored more than 50 million doses of Astrazeneca vaccine. SII had said several months ago that half of the vaccines it manufactures will be for vaccination purpose in India. WATCH| × Indian government said on Wednesday that Pfizer Inc had sought more time to present data for emergency authorisation of a vaccine it has developed with Germany's BioNTech. AstraZeneca/ Oxford University coronavirus vaccine has already got approval in Britain and Argentina for urgent public use. USA, which has approved Pfizer vaccine is likely to approve use of Astrazeneca vaccine in April. as per reports received on Thursday. Moncef Slaoui, the chief advisor to Operation Warp Speed, the military-led US effort for vaccines, told reporters that US trials and assessments would be complete for approval "sometime in early April." "Several tens of millions of doses will have been manufactured... and therefore will be available for use if the data supports its approval," he said. (With agency inputs)

Indian panel recommends emergency use of AstraZeneca COVID vaccine with conditions

India's Subject Expert Committee (SEC) in Central Drugs Standard Control Organisation (CDSCO) met on Wednesday to consider coronavirus vaccines for emergency use authorisation (EUA) requested by Pfizer-BioNTech, Bharat Biotech and <a href="https://www.wionews.com/india-news/indias-sec-to-decide-on-approving-serum-institute-of-indias-covishield-vaccine-for-emergency-use-authorisation-353405">Serum Institute of India(SII)</a>.

The government said Pfizer-BioNTech requested more time as the SEC analysed additional data and&nbsp;information presented by SII &amp; Bharat Biotech.

The SEC said it was persuing additional data&nbsp;and will meet again on January 1, 2021.

The UK had earlier in the day approved the&nbsp;Oxford-AstraZeneca COVID-19 vaccine. SII CEO Adar Poonawalla said: "This is great and encouraging news. We will wait for the final approval from Indian regulators."

The SII has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine. The Pune-based company has already stocked nearly 50 million dosages of the vaccine and aims to produce up to 100 million dosages per month by March, 2021.

India has the second-largest cases<a href="https://www.wionews.com/india-news/uk-virus-strain-detected-in-two-people-in-uttar-pradeshs-meerut-noida-353422"> coronavirus </a>cases in the world with over 10.2 million cases and over 148, 439 deaths.

Amid the rising number of cases, Tamil Nadu today reported 945 new coronavirus cases with 17 deaths in the last 24 hours with the total death toll rising to 12,109 and the number of active cases rising to 8,615.

In Karnataka, there were 973 new coronavirus cases including 7 deaths in the past 24 hours with the number of active cases rising to 11,610. The total number of COVID-19 cases stands at 9,18,544 in the state.

Maharashtra which is one of the hardest-hit states with the virus recorded &nbsp;3,537 new coronavirus cases and 70 fatalities on Wednesday with the total death toll rising to 49,463 and the number of cases rising to 19,28,603.

India's Subject Expert Committee (SEC) in Central Drugs Standard Control Organisation (CDSCO) met on Wednesday to consider coronavirus vaccines for emergency use authorisation (EUA) requested by Pfizer-BioNTech, Bharat Biotech and Serum Institute of India(SII).

India's Subject Expert Committee (SEC) in Central Drugs Standard Control Organisation (CDSCO) met on Wednesday to consider coronavirus vaccines for emergency use authorisation (EUA) requested by Pfizer-BioNTech, Bharat Biotech and Serum Institute of India(SII). The government said Pfizer-BioNTech requested more time as the SEC analysed additional data and information presented by SII & Bharat Biotech. The SEC said it was persuing additional data and will meet again on January 1, 2021. The UK had earlier in the day approved the Oxford-AstraZeneca COVID-19 vaccine. SII CEO Adar Poonawalla said: "This is great and encouraging news. We will wait for the final approval from Indian regulators." The SII has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine. The Pune-based company has already stocked nearly 50 million dosages of the vaccine and aims to produce up to 100 million dosages per month by March, 2021. India has the second-largest cases coronavirus cases in the world with over 10.2 million cases and over 148, 439 deaths. Amid the rising number of cases, Tamil Nadu today reported 945 new coronavirus cases with 17 deaths in the last 24 hours with the total death toll rising to 12,109 and the number of active cases rising to 8,615. In Karnataka, there were 973 new coronavirus cases including 7 deaths in the past 24 hours with the number of active cases rising to 11,610. The total number of COVID-19 cases stands at 9,18,544 in the state. Maharashtra which is one of the hardest-hit states with the virus recorded 3,537 new coronavirus cases and 70 fatalities on Wednesday with the total death toll rising to 49,463 and the number of cases rising to 19,28,603.

Pfizer-BioNTech requests more time, India's SEC to meet on January 1 to authorise SII, Bharat Biotech vaccines

India's Central Drugs Standard Control Organisation's Subject Expert Committee(SEC) is set to hold a meeting today to decide on approving the Covishield vaccine developed by Serum Institute of India (SII) and AstraZeneca-Oxford University.

Watch:

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The SEC will decide on whether to allow Covishield vaccine emergency use authorisation to combat COVID-19.

The SII had earlier submitted additional data to the Drug Controller General of India (DCGI).

Pfizer-BioNTech, Bharat Biotech and Serum Institute of India had earlier applied to the DCGI for the emergency use vaccine. 
&nbsp;&nbsp; 
SII chief Adar Poonawalla had earlier claimed that his company has already produced 40 million doses of the Oxford vaccine and was aiming to ramp up production to at least 100 million doses a month by March.

"We have 40-50 million doses of Covishield stockpiled. Once we get regulatory approvals in a few days, it'll be down to the government to decide how much they can take and how fast," Poonawalla said.&nbsp;

"All data on Oxford-AstraZeneca COVID19 vaccine submitted in India and UK. There are no concerns, regulators are closely reviewing documents and data," the SII chief executive added.

Poonawala said that although there could be a shortage of vaccine in the first half of the year, there could be an easing off later in 2021 around August September as other vaccine makers will be able to supply it.

India's Central Drugs Standard Control Organisation's Subject Expert Committee(SEC) is set to hold a meeting today to decide on approving the Covishield vaccine developed by Serum Institute of India (SII) and AstraZeneca-Oxford University.

India's Central Drugs Standard Control Organisation's Subject Expert Committee(SEC) is set to hold a meeting today to decide on approving the Covishield vaccine developed by Serum Institute of India (SII) and AstraZeneca-Oxford University. Watch: The SEC will decide on whether to allow Covishield vaccine emergency use authorisation to combat COVID-19. The SII had earlier submitted additional data to the Drug Controller General of India (DCGI). Pfizer-BioNTech, Bharat Biotech and Serum Institute of India had earlier applied to the DCGI for the emergency use vaccine. SII chief Adar Poonawalla had earlier claimed that his company has already produced 40 million doses of the Oxford vaccine and was aiming to ramp up production to at least 100 million doses a month by March. "We have 40-50 million doses of Covishield stockpiled. Once we get regulatory approvals in a few days, it'll be down to the government to decide how much they can take and how fast," Poonawalla said. "All data on Oxford-AstraZeneca COVID19 vaccine submitted in India and UK. There are no concerns, regulators are closely reviewing documents and data," the SII chief executive added. Poonawala said that although there could be a shortage of vaccine in the first half of the year, there could be an easing off later in 2021 around August September as other vaccine makers will be able to supply it.

India's SEC to decide on approving Serum Institute of India's Covishield vaccine for emergency use authorisation

India's ministry of health and family welfare dismissed a media report about the rejection of vaccines developed by Serum Institute of India(SII) and Bharat Biotech as "fake".

Watch:

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India's government had said earlier that emergency use authorisation&nbsp;(EUA) for&nbsp;<a href="https://www.wionews.com/world/countries-like-china-and-saudi-arabia-used-covid-19-to-curtail-civil-liberties-finds-study-348604">coronavirus</a> vaccines developed by Hyderabad-based Bharat Biotech, Pune's Serum Institute of India and Pfizer were under consideration.

All three vaccine makers have applied to the Drugs Controller General of India (DCGI).

In India at least eight vaccines are in different stages of development in phase two and three clinical trials.

Covishield, manufactured by SII in collaboration with AstraZeneca, also Covaxin developed by Bharat Biotech in collaboration with the ICMR is in phase-3 of trials, according to the government.

Also in the running is ZyCOV-D developed by Cadila Healthcare in Ahmedabad which is in phase-2 of the trials.

Russia's Sputnik V is being manufactured by Dr Reddy's Lab, Hyderabad in collaboration with Gamaleya National Centre. The phase-2&nbsp;trial in India of Sputnik V is over and phase-3&nbsp;will begin next week, the government informed.

Russia has already started mass vaccination campaign of the Sputnik V even as testing is underway in India. Biological E Ltd Hyderabad's Recombinant Protein antigen-based vaccine is also undergoing tests in collaboration with MIT, USA.

HGCO 19 manufactured by Genova in Pune in collaboration with HDT, USA is set to begin phase-1 and 2 clinical trials and Bharat Biotech International Ltd's vaccine developed in collaboration with Thomas Jefferson University, USA is in pre-clinical stage.

India's ministry of health and family welfare dismissed a media report about the rejection of vaccines developed by Serum Institute of India(SII) and Bharat Biotech as "fake".

India's ministry of health and family welfare dismissed a media report about the rejection of vaccines developed by Serum Institute of India(SII) and Bharat Biotech as "fake". Watch: India's government had said earlier that emergency use authorisation (EUA) for coronavirus vaccines developed by Hyderabad-based Bharat Biotech, Pune's Serum Institute of India and Pfizer were under consideration. All three vaccine makers have applied to the Drugs Controller General of India (DCGI). In India at least eight vaccines are in different stages of development in phase two and three clinical trials. Covishield, manufactured by SII in collaboration with AstraZeneca, also Covaxin developed by Bharat Biotech in collaboration with the ICMR is in phase-3 of trials, according to the government. Also in the running is ZyCOV-D developed by Cadila Healthcare in Ahmedabad which is in phase-2 of the trials. Russia's Sputnik V is being manufactured by Dr Reddy's Lab, Hyderabad in collaboration with Gamaleya National Centre. The phase-2 trial in India of Sputnik V is over and phase-3 will begin next week, the government informed. Russia has already started mass vaccination campaign of the Sputnik V even as testing is underway in India. Biological E Ltd Hyderabad's Recombinant Protein antigen-based vaccine is also undergoing tests in collaboration with MIT, USA. HGCO 19 manufactured by Genova in Pune in collaboration with HDT, USA is set to begin phase-1 and 2 clinical trials and Bharat Biotech International Ltd's vaccine developed in collaboration with Thomas Jefferson University, USA is in pre-clinical stage.

Fake report on rejection of vaccines by Serum Institute, Bharat Biotech: Government

The Hyderabad-based pharmaceutical firm Bharat Biotech applied to the Drugs Controller General of India (DCGI) on Monday for granting emergency use authorisation for its COVID-19 vaccine Covaxin, becoming the third company after American pharma giant Pfizer and Pune-based Serum Institute of India (SII) to seek emergency use authorisation for its Covid-19 vaccine candidate. 
 
Also read | <a href="https://www.wionews.com/science/is-natural-immunity-from-covid-better-than-a-vaccine-347985">Is ‘natural immunity’ from COVID better than a vaccine?</a>

In its application for emergency use approval, Hyderabad-headquartered Bharat Biotech has included interim data from early- to mid-stage human trials of its vaccine candidate Covaxin. 
 
<a href="https://www.wionews.com/india-news/serum-institute-of-india-applies-for-emergency-use-authorisation-for-oxford-vaccine-348006">Also read: Serum Institute of India applies for emergency use authorisation for Oxford vaccine</a> 
 
The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting a phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials. 
 
Also read | <a href="https://www.wionews.com/world/chinas-sinovac-secures-515-million-to-boost-covid-vaccine-production-347999">China's Sinovac secures $515 million to boost covid vaccine production</a>&nbsp;

An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.

At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks. That evening, the Indian arm of US pharmaceutical giant Pfizer had sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain.

The Serum Institute sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6.

"DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said.

(With inputs from agencies)

The Hyderabad-based pharmaceutical firm Bharat Biotech applied to the Drugs Controller General of India (DCGI) on Monday for granting emergency use authorisation for its COVID-19 vaccine Covaxin, becoming the third company after American pharma giant Pfizer and Pune-based Serum Institute of India (SII) to seek emergency use authorisation for its Covid-19 vaccine candidate.

The Hyderabad-based pharmaceutical firm Bharat Biotech applied to the Drugs Controller General of India (DCGI) on Monday for granting emergency use authorisation for its COVID-19 vaccine Covaxin, becoming the third company after American pharma giant Pfizer and Pune-based Serum Institute of India (SII) to seek emergency use authorisation for its Covid-19 vaccine candidate. Also read | Is ‘natural immunity’ from COVID better than a vaccine? In its application for emergency use approval, Hyderabad-headquartered Bharat Biotech has included interim data from early- to mid-stage human trials of its vaccine candidate Covaxin. Also read: Serum Institute of India applies for emergency use authorisation for Oxford vaccine The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting a phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials. Also read | China's Sinovac secures $515 million to boost covid vaccine production An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates. At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks. That evening, the Indian arm of US pharmaceutical giant Pfizer had sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain. The Serum Institute sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6. "DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said. (With inputs from agencies)

Bharat Biotech seeks emergency use authorisation for Indian Covid-19 vaccine; expert panel to review

Serum&nbsp;Institute of India, the world's largest <a href="https://www.wionews.com/topics/coronavirus-vaccine">vaccine</a>&nbsp;producer by volume, is close to signing a supply contract with the country's central government and likely to fix prices at 250 rupees ($3.39) per dose of the vaccine, Business Standard reported on Tuesday, citing people familiar with the matter.

The government is pinning its hopes for mass supply on&nbsp;Serum&nbsp;Institute, which lodged the first formal application for emergency-use approval of AstraZeneca's shot on Monday.

Also read:&nbsp;<a href="https://www.wionews.com/india-news/bharat-biotech-seeks-emergency-use-authorisation-for-indian-covid-19-vaccine-expert-panel-to-review-348232" hreflang="en">Bharat Biotech seeks emergency use authorisation for Indian Covid-19 vaccine</a>

Chief Executive Officer Adar Poonawalla had earlier said the vaccine would be priced at 1,000 rupees ($13.55) per dose in India's private market, but governments signing large supply deals would likely buy it at lower prices.

Poonawalla had said&nbsp;Serum&nbsp;will first focus on supplying the vaccine to Indians before distributing it to other countries.

With 9.70 million COVID-19 cases recorded so far, India is second only to the United States and is accelerating its review of vaccines developed by Pfizer Inc and AstraZeneca to authorize for emergency use, a senior official said on Monday.

While the state-run Indian Council of Medical Research and Ministry of Health did not respond to Reuters request for comments,&nbsp;Serum&nbsp;Institute declined to offer one.

Serum Institute of India, the world's largest vaccine producer by volume, is close to signing a supply contract with the country's central government and likely to fix prices at 250 rupees ($3.

Serum Institute of India, the world's largest vaccine producer by volume, is close to signing a supply contract with the country's central government and likely to fix prices at 250 rupees ($3.39) per dose of the vaccine, Business Standard reported on Tuesday, citing people familiar with the matter. The government is pinning its hopes for mass supply on Serum Institute, which lodged the first formal application for emergency-use approval of AstraZeneca's shot on Monday. Also read: Bharat Biotech seeks emergency use authorisation for Indian Covid-19 vaccine Chief Executive Officer Adar Poonawalla had earlier said the vaccine would be priced at 1,000 rupees ($13.55) per dose in India's private market, but governments signing large supply deals would likely buy it at lower prices. Poonawalla had said Serum will first focus on supplying the vaccine to Indians before distributing it to other countries. With 9.70 million COVID-19 cases recorded so far, India is second only to the United States and is accelerating its review of vaccines developed by Pfizer Inc and AstraZeneca to authorize for emergency use, a senior official said on Monday. While the state-run Indian Council of Medical Research and Ministry of Health did not respond to Reuters request for comments, Serum Institute declined to offer one.

Serum likely to supply COVID-19 vaccine at over $3 a dose to Indian government

The Serum Institute of India (SII) applied to the Drugs Controller General of India (DCGI) on Sunday for granting emergency use authorisation for the Oxford-AstraZeneca <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine</a>.

The CEO and owner of the institute confirmed the news via a tweet and thanked the Indian Prime Minister Narendra Modi and government for their "invaluable support".

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<blockquote class="twitter-tweet">
As promised, before the end of 2020, <a href="https://twitter.com/SerumInstIndia?ref_src=twsrc%5Etfw">@SerumInstIndia</a> has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri <a href="https://twitter.com/narendramodi?ref_src=twsrc%5Etfw">@narendramodi</a> ji for their invaluable support.
— Adar Poonawalla (@adarpoonawalla) <a href="https://twitter.com/adarpoonawalla/status/1335810817841717249?ref_src=twsrc%5Etfw">December 7, 2020</a></blockquote>
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The phase-three clinical trial of the vaccine, named as Covishield in India, is being carried out by SII in various parts of the country.&nbsp;

Also read | <a href="https://www.wionews.com/science/is-natural-immunity-from-covid-better-than-a-vaccine-347985">Is ‘natural immunity’ from COVID better than a vaccine?</a>

The official sources told news agency PTI, SII's application mentioned data from four clinical studies, two in the UK and one each in Brazil and India, and said that Covishield is highly efficacious against symptomatic and most importantly against severe Covid-19 cases.&nbsp;

Also read | <a href="https://www.wionews.com/world/chinas-sinovac-secures-515-million-to-boost-covid-vaccine-production-347999">China's Sinovac secures $515 million to boost covid vaccine production</a>&nbsp;

"In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae," said a source.&nbsp;

"Therefore, Covishield is safe and well-tolerated and can be used effectively for prevention of Covid-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield."&nbsp;

For a quick roll out of the vaccine, SII, world's largest vaccine manufacturer, entered into a collaboration with the University of Oxford and AstraZeneca to produce the drug and has already produced 40 million doses of the drug.&nbsp;

 
&nbsp;

The Serum Institute of India (SII) applied to the Drugs Controller General of India (DCGI) on Sunday for granting emergency use authorisation for the Oxford-AstraZeneca coronavirus vaccine.

The Serum Institute of India (SII) applied to the Drugs Controller General of India (DCGI) on Sunday for granting emergency use authorisation for the Oxford-AstraZeneca coronavirus vaccine. The CEO and owner of the institute confirmed the news via a tweet and thanked the Indian Prime Minister Narendra Modi and government for their "invaluable support". As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support. — Adar Poonawalla (@adarpoonawalla) December 7, 2020 × The phase-three clinical trial of the vaccine, named as Covishield in India, is being carried out by SII in various parts of the country. Also read | Is ‘natural immunity’ from COVID better than a vaccine? The official sources told news agency PTI, SII's application mentioned data from four clinical studies, two in the UK and one each in Brazil and India, and said that Covishield is highly efficacious against symptomatic and most importantly against severe Covid-19 cases. Also read | China's Sinovac secures $515 million to boost covid vaccine production "In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae," said a source. "Therefore, Covishield is safe and well-tolerated and can be used effectively for prevention of Covid-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield." For a quick roll out of the vaccine, SII, world's largest vaccine manufacturer, entered into a collaboration with the University of Oxford and AstraZeneca to produce the drug and has already produced 40 million doses of the drug.

Serum Institute of India applies for emergency use authorisation for Oxford vaccine

The Serum Institute of India, world's largest vaccine manufacturer, reiterated that the vaccine developed by AstraZeneca and Oxford university was safe and immunogenic.

India's Serum institute reiterates safety of AstraZeneca vaccine for COVID-19

Prime Minister Narendra Modi will visit the Pune-based Serum Institute of India on November 28,&nbsp;a senior official said on Thursday.

The&nbsp;Serum&nbsp;Institute of India, the world's largest manufacturer of vaccines by volume,&nbsp;has partnered with global pharma giant AstraZeneca and Oxford University for the <a href="https://www.wionews.com/topics/coronavirus-vaccine">COVID-19 vaccine</a>.

According to&nbsp;Serum's Chief Executive Adar Poonawalla, it will&nbsp;first focus on supplying AstraZeneca Plc's COVID-19 vaccine to Indians before distributing it to other countries.

Also read:&nbsp;<a href="https://www.wionews.com/world/90-efficacy-of-oxfords-coronavirus-vaccine-came-from-younger-group-345535" hreflang="en">90% efficacy of Oxford's coronavirus vaccine came from younger group</a>

The Central Drug Standard Control Organisation has granted permission for the manufacture of the COVID-19 vaccine for the pre-clinical test, examination, and analysis to seven firms, two of which are the Serum Institute of India (SII) and the Gennova Biopharmaceuticals.

"We have received a confirmation about PM Modi's visit to the Serum Institute of India on Saturday, but his minute-to-minute program is yet to be received," Pune Divisional Commissioner Saurabh Rao said.

Also read:&nbsp;<a href="https://www.wionews.com/india-news/serum-institute-to-focus-on-supplying-covid-19-vaccine-to-india-first-344956">Serum Institute to focus on supplying COVID-19 vaccine to India first</a>

On Tuesday, Rao said there was a possibility of the PM's visit to Pune, and if that happens, it would be aimed at reviewing the status of the vaccine candidate for coronavirus infection and to know about its launch, production and distribution mechanisms.

Rao had also informed that ambassadors and envoys from 100 countries will visit the Serum Institute of India and the Gennova Biopharmaceuticals Ltd here on December 4.

Meanwhile,&nbsp;AstraZeneca&nbsp;and Oxford University have acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine.

AstraZeneca is likely to run an additional global trial to assess the efficacy of its COVID-19 vaccine, its chief executive Pascal Soriot was quoted as saying on Thursday after questions over the results from its late-stage study.

Instead of adding the trial arm to an ongoing US&nbsp;process, a new study would be run to evaluate a lower dosage that performed better than a full amount in AstraZeneca's studies, Soriot said.

On November 23, British-Swedish drug maker AstraZeneca and the University of Oxford had said that the Coronavirus vaccine they are developing is 70.4 per cent effective, on an average, in preventing COVID-19, as per the interim analysis of its late-stage clinical trials conducted in the UK and Brazil.

A statement describing the error made no mention of why some study participants didn't receive as much vaccine in the first of two shots as expected.

In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses.

In the low-dose group, AstraZeneca said, the vaccine appeared to be 90 per cent effective.

In the group that got two full doses, the vaccine appeared to be 62 per cent effective.

But the way in which the results were arrived at and reported by the companies has led to pointed questions from experts.

The partial results announced on Monday are from large ongoing studies in the UK and Brazil designed to determine the optimal dose of vaccine, as well as examine safety and effectiveness.

Multiple combinations and doses were tried in the volunteers.

They were compared to others who were given a meningitis vaccine or a saline shot.

The dose of AstraZeneca Plc's Covid antibody that demonstrated the most significant level of adequacy was tried in a more youthful populace than a greater portion that indicated less viability, as per the top of the US&nbsp;Activity Warp Speed program.&nbsp;

The vaccine being&nbsp;developed by&nbsp;Oxford University was 90 per cent&nbsp;viable when a half-portion was given before a full-portion booster, the partners said&nbsp;on Monday.

However, that system was controlled to members in a gathering whose age was covered at 55, Warp Speed's Moncef Slaoui said Tuesday in a call with columnists.&nbsp;

Prime Minister Narendra Modi will visit the Pune-based Serum Institute of India on November 28, a senior official said on Thursday. The Serum Institute of India, the world's largest manufacturer of vaccines by volume, has partnered with global pharma giant AstraZeneca and Oxford University for the COVID-19 vaccine.

Prime Minister Narendra Modi will visit the Pune-based Serum Institute of India on November 28, a senior official said on Thursday. The Serum Institute of India, the world's largest manufacturer of vaccines by volume, has partnered with global pharma giant AstraZeneca and Oxford University for the COVID-19 vaccine. According to Serum's Chief Executive Adar Poonawalla, it will first focus on supplying AstraZeneca Plc's COVID-19 vaccine to Indians before distributing it to other countries. Also read: 90% efficacy of Oxford's coronavirus vaccine came from younger group The Central Drug Standard Control Organisation has granted permission for the manufacture of the COVID-19 vaccine for the pre-clinical test, examination, and analysis to seven firms, two of which are the Serum Institute of India (SII) and the Gennova Biopharmaceuticals. "We have received a confirmation about PM Modi's visit to the Serum Institute of India on Saturday, but his minute-to-minute program is yet to be received," Pune Divisional Commissioner Saurabh Rao said. Also read: Serum Institute to focus on supplying COVID-19 vaccine to India first On Tuesday, Rao said there was a possibility of the PM's visit to Pune, and if that happens, it would be aimed at reviewing the status of the vaccine candidate for coronavirus infection and to know about its launch, production and distribution mechanisms. Rao had also informed that ambassadors and envoys from 100 countries will visit the Serum Institute of India and the Gennova Biopharmaceuticals Ltd here on December 4. Meanwhile, AstraZeneca and Oxford University have acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine. AstraZeneca is likely to run an additional global trial to assess the efficacy of its COVID-19 vaccine, its chief executive Pascal Soriot was quoted as saying on Thursday after questions over the results from its late-stage study. Instead of adding the trial arm to an ongoing US process, a new study would be run to evaluate a lower dosage that performed better than a full amount in AstraZeneca's studies, Soriot said. On November 23, British-Swedish drug maker AstraZeneca and the University of Oxford had said that the Coronavirus vaccine they are developing is 70.4 per cent effective, on an average, in preventing COVID-19, as per the interim analysis of its late-stage clinical trials conducted in the UK and Brazil. A statement describing the error made no mention of why some study participants didn't receive as much vaccine in the first of two shots as expected. In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses. In the low-dose group, AstraZeneca said, the vaccine appeared to be 90 per cent effective. In the group that got two full doses, the vaccine appeared to be 62 per cent effective. But the way in which the results were arrived at and reported by the companies has led to pointed questions from experts. The partial results announced on Monday are from large ongoing studies in the UK and Brazil designed to determine the optimal dose of vaccine, as well as examine safety and effectiveness. Multiple combinations and doses were tried in the volunteers. They were compared to others who were given a meningitis vaccine or a saline shot. The dose of AstraZeneca Plc's Covid antibody that demonstrated the most significant level of adequacy was tried in a more youthful populace than a greater portion that indicated less viability, as per the top of the US Activity Warp Speed program. The vaccine being developed by Oxford University was 90 per cent viable when a half-portion was given before a full-portion booster, the partners said on Monday. However, that system was controlled to members in a gathering whose age was covered at 55, Warp Speed's Moncef Slaoui said Tuesday in a call with columnists.

Coronavirus vaccine tracker: PM Modi to visit Serum Institute of India on November 28

Several foreign envoys will be visiting Pune on December 4 to see India's covid vaccine development programme. The visit, organized by India's Ministry of External Affairs will be a one-day visit. The envoys will visit 2 institutes--Serum institute of India and Gennova Biopharmaceuticals.

The visit was one of the key outcomes of Foreign Secretary Harsh Shringla's meet with the envoys earlier this month in Delhi. On 6th November, India's Foreign Secretary along with Principal Scientific Advisor to the Government of India, Prof K Vijay Raghavan, Health Secretary Rajesh Bhushan, Secretary of Department of Biotechnology, Dr. Renu Swarup and Secretary of Department of Science &amp; Technology Ashutosh Sharma briefed More than 190 heads of diplomatic missions on India's action on COVID-19 pandemic.

Serum Institute is involved in the AstraZeneca/Oxford vaccine against COVID while Gennova is working on mRNA based vaccine.

Indian PM Narendra Modi during his virtual meet with Chief Minister earlier this week said, "Work on vaccine research is almost at the last stage both in the country as well as in the world" and the "Indian government is keeping a close eye on each and every development and we are in touch with everybody", pointing out, "it is not yet decided whether there will be one, two or three doses of vaccine or what will be its price."

India is expected to be a major centre of the global covid vaccine manufacturing and supply. Amidst the COVID-19 pandemic, India has emerged as the pharma capital of the world supplying medicines such as HCQ, Paracetamol to more than 150 countries.&nbsp;

On vaccine development programme, New Delhi has organized training programmes on clinical trials for neighbouring countries in which nearly 90 experts from 8 countries participated.&nbsp;

It has sent aid, in terms of food and medicines to 5 Indian ocean countries--Maldives, Mauritius, Madagascar, Comoros and Seychelles and 4 African countries--Sudan, South Sudan, Djibouti and Eritrea.

Several foreign envoys will be visiting Pune on December 4 to see India's covid vaccine development programme. The visit, organized by India's Ministry of External Affairs will be a one-day visit.

Several foreign envoys will be visiting Pune on December 4 to see India's covid vaccine development programme. The visit, organized by India's Ministry of External Affairs will be a one-day visit. The envoys will visit 2 institutes--Serum institute of India and Gennova Biopharmaceuticals. The visit was one of the key outcomes of Foreign Secretary Harsh Shringla's meet with the envoys earlier this month in Delhi. On 6th November, India's Foreign Secretary along with Principal Scientific Advisor to the Government of India, Prof K Vijay Raghavan, Health Secretary Rajesh Bhushan, Secretary of Department of Biotechnology, Dr. Renu Swarup and Secretary of Department of Science & Technology Ashutosh Sharma briefed More than 190 heads of diplomatic missions on India's action on COVID-19 pandemic. Serum Institute is involved in the AstraZeneca/Oxford vaccine against COVID while Gennova is working on mRNA based vaccine. Indian PM Narendra Modi during his virtual meet with Chief Minister earlier this week said, "Work on vaccine research is almost at the last stage both in the country as well as in the world" and the "Indian government is keeping a close eye on each and every development and we are in touch with everybody", pointing out, "it is not yet decided whether there will be one, two or three doses of vaccine or what will be its price." India is expected to be a major centre of the global covid vaccine manufacturing and supply. Amidst the COVID-19 pandemic, India has emerged as the pharma capital of the world supplying medicines such as HCQ, Paracetamol to more than 150 countries. On vaccine development programme, New Delhi has organized training programmes on clinical trials for neighbouring countries in which nearly 90 experts from 8 countries participated. It has sent aid, in terms of food and medicines to 5 Indian ocean countries--Maldives, Mauritius, Madagascar, Comoros and Seychelles and 4 African countries--Sudan, South Sudan, Djibouti and Eritrea.

Foreign envoys to visit Pune on Dec 4 to see India's COVID-19 vaccine programme

As countries compete to grab doses of the <a href="https://www.wionews.com/india-news/vaccine-to-lowest-levels-pm-modi-speaks-on-covid-19-vaccine-cost-distribution-strategy-during-chief-ministers-meeting-345108">vaccines</a>, the world is turning to India for vaccine supplies.

India's plays a vital role in the vaccine chain. India is the world's vaccine manufacturing hub and is known for its pharmacy in vaccine production.

India supplies over 60 per cent of the vaccines for the developing world and the Wuhan virus pandemic will be no different. In July, the government had organised an online vaccine symposium with Peter Piot as one of the attendees. Piot is the director of the London School of Hygiene and Tropical Medicine.

Piot said without India there won't be enough <a href="https://www.wionews.com/india-news/russias-sputnik-v-vaccine-to-be-manufactured-in-india-345136">vaccines</a> to save the world. The Serum Institute in Pune is manufacturing one billion doses of the Wuhan virus vaccine being developed by the University of Oxford and AstraZeneca.

India's Serum Institute also happens to be the world's largest vaccine maker and at its full capacity, the company can make 60 to 70 million doses a month. The Serum Institute is also developing and testing four other Wuhan virus vaccines including the Novavax and Codagenix candidates.

There are other Indian firms that have entered into partnerships for manufacturing potential Wuhan virus vaccines. Hyderabad-based biological e has struck a deal for the shot being developed by Johnson and Johnson's subsidiary Belgium's Janssen Pharamaceutica.

Reports say biological e may also manufacture a candidate being developed by Houston's Baylor college of medicine. Indian immunologicals, a firm based out of Hyderabad has entered into a partnership with Australia's Griffith University.

The Indian firm will be testing and manufacturing the university's vaccine candidate. Bharat Biotech has a deal to manufacture 1 billion doses of Washington University's intranasal vaccine.

It also has a partnership with the University of Wisconsin Madison and US-based firm Flugen to make almost 300 million doses of a vaccine for global distribution.

Dr. Reddy's has a deal to produce 100 million doses of the Sputnik V. Ahmedabad-based Zydus Cadila is also working on a shot which is undergoing clinical trials.&nbsp;

Earlier this month, India's foreign secretary Harsh Vardhan Shringla said: "Several countries have been approaching us for receiving vaccine supply. I reiterate the prime minister’s commitment that India’s vaccine production and delivery capacity will be used to help all humanity in fighting this crisis."

Shringla added that India also help "interested countries in enhancing their cold chain and storage capacities for the delivery of the vaccines."

There is a difference between India's approach to the Wuhan virus vaccine, and how the world is looking at the vaccine race while there are countries looking at hoarding vaccines, pre-ordering at least a billin doses for a population of just 330 million.&nbsp;

India is not just manufacturing vaccines for its citizens, but also for the world and in doing so, India is not looking to discriminate on the basis on global economic rankings.

India exported its vaccine stock to other nations when the pandemic struck. In a visit to Dhaka in August this year, Harsh Vardhn Shringla promised that India would supply vaccines to Bangladesh on a priority basis. Dhaka signed a deal with the Serum Insitute for 30 million doses of the AstraZeneca vaccine.

India has stated that its closest neighbours, friends, partners and other countries will receive privileged access. On August, 7, the global vaccine alliance announced a collaboration with India's Serum Institute and the Bill &amp; Melinda Gates Foundation.

The deal gave the Indian company financial support of $150 million dollars in order to supply 100 million doses of vaccines for distribution in low and middle-income countries in 2021.

India's biologicals e has promised to push for equal procurement and distribution of the vaccine and stay committed to the COVAX vaccine alliance.&nbsp;

According to CEPI or coalition for epidemic preparedness innovations survey, India has the largest production capacity for drug substance and as the world battles a deadly Wuhan virus, India is not prioritising profit over the health of billions.

As countries compete to grab doses of the vaccines, the world is turning to India for vaccine supplies. India's plays a vital role in the vaccine chain. India is the world's vaccine manufacturing hub and is known for its pharmacy in vaccine production.

As countries compete to grab doses of the vaccines, the world is turning to India for vaccine supplies. India's plays a vital role in the vaccine chain. India is the world's vaccine manufacturing hub and is known for its pharmacy in vaccine production. India supplies over 60 per cent of the vaccines for the developing world and the Wuhan virus pandemic will be no different. In July, the government had organised an online vaccine symposium with Peter Piot as one of the attendees. Piot is the director of the London School of Hygiene and Tropical Medicine. Piot said without India there won't be enough vaccines to save the world. The Serum Institute in Pune is manufacturing one billion doses of the Wuhan virus vaccine being developed by the University of Oxford and AstraZeneca. India's Serum Institute also happens to be the world's largest vaccine maker and at its full capacity, the company can make 60 to 70 million doses a month. The Serum Institute is also developing and testing four other Wuhan virus vaccines including the Novavax and Codagenix candidates. There are other Indian firms that have entered into partnerships for manufacturing potential Wuhan virus vaccines. Hyderabad-based biological e has struck a deal for the shot being developed by Johnson and Johnson's subsidiary Belgium's Janssen Pharamaceutica. Reports say biological e may also manufacture a candidate being developed by Houston's Baylor college of medicine. Indian immunologicals, a firm based out of Hyderabad has entered into a partnership with Australia's Griffith University. The Indian firm will be testing and manufacturing the university's vaccine candidate. Bharat Biotech has a deal to manufacture 1 billion doses of Washington University's intranasal vaccine. It also has a partnership with the University of Wisconsin Madison and US-based firm Flugen to make almost 300 million doses of a vaccine for global distribution. Dr. Reddy's has a deal to produce 100 million doses of the Sputnik V. Ahmedabad-based Zydus Cadila is also working on a shot which is undergoing clinical trials. Earlier this month, India's foreign secretary Harsh Vardhan Shringla said: "Several countries have been approaching us for receiving vaccine supply. I reiterate the prime minister’s commitment that India’s vaccine production and delivery capacity will be used to help all humanity in fighting this crisis." Shringla added that India also help "interested countries in enhancing their cold chain and storage capacities for the delivery of the vaccines." There is a difference between India's approach to the Wuhan virus vaccine, and how the world is looking at the vaccine race while there are countries looking at hoarding vaccines, pre-ordering at least a billin doses for a population of just 330 million. India is not just manufacturing vaccines for its citizens, but also for the world and in doing so, India is not looking to discriminate on the basis on global economic rankings. India exported its vaccine stock to other nations when the pandemic struck. In a visit to Dhaka in August this year, Harsh Vardhn Shringla promised that India would supply vaccines to Bangladesh on a priority basis. Dhaka signed a deal with the Serum Insitute for 30 million doses of the AstraZeneca vaccine. India has stated that its closest neighbours, friends, partners and other countries will receive privileged access. On August, 7, the global vaccine alliance announced a collaboration with India's Serum Institute and the Bill & Melinda Gates Foundation. The deal gave the Indian company financial support of $150 million dollars in order to supply 100 million doses of vaccines for distribution in low and middle-income countries in 2021. India's biologicals e has promised to push for equal procurement and distribution of the vaccine and stay committed to the COVAX vaccine alliance. According to CEPI or coalition for epidemic preparedness innovations survey, India has the largest production capacity for drug substance and as the world battles a deadly Wuhan virus, India is not prioritising profit over the health of billions.

Amid race for vaccine, world turns to India for vaccine supply

India is racing ahead with work on its coronavirus vaccine as countries around the world sought to conquer the pandemic and rescue their economies. 
 
<a href="https://www.wionews.com/india-news/these-three-indian-companies-are-ready-to-produce-covid-19-vaccine-342884">Also read: These three Indian companies are ready to produce Covid-19 vaccine</a> 
 
Companies like Zydus Cadila, Serum Institute and Bharat Biotech are at the forefront of research on covid vaccines and are likely to be among the leading manufacturers as and when their commercial application is permitted. 
 
Also read |&nbsp;<a href="https://www.wionews.com/india-news/confident-that-covid-19-vaccine-will-be-ready-in-3-4-months-indias-health-minister-344051">Confident that Covid-19 vaccine will be ready in 3-4 months: India's health minister</a>

Serum Institute of India's CEO Adar Poonawalla on Thursday said the Oxford COVID-19 vaccine should be available for healthcare workers and elderly people by around February 2021 and by April for the general public and will be priced at a maximum of ₹ 1,000 for two necessary doses for the public, depending on the final trial results and regulatory approvals.

Probably by 2024, every Indian will get vaccinated, he said at a media event.

"It will probably take two or three years for every Indian to get inoculated, not just because of the supply constraints but because you need the budget, the vaccine, logistics, infrastructure and then, people should be willing to take the vaccine. So these are the factors that lead up to being able to vaccinate 80-90 per cent of the population.

"It will be 2024 for everybody, if willing to take a two-dose vaccine, to be vaccinated," Mr Poonawalla said.

Asked at what price the public will get it, he said it will be around USD 5-6 per dose with an MRP of around ₹ 1,000 for the two necessary doses.

"The government of India will be getting it at a far cheaper price at around USD 3-4, because it will be buying in a large volume and get access to the price that is similar to what COVAX has got. We are still pricing it far cheaper and more affordable than other vaccines we have in the market today," Mr Poonawalla said.

Asked about the efficacy of the vaccine, he said the Oxford-Astrazeneca vaccine is so far proving to work very well even in elderly people, which was a concern earlier.

"It has induced a good T-cell response, which is an indicator for your long-term immunity and antibody response but then again, time will only tell if these vaccines are going to protect you in the long term. Nobody can answer that for any of the vaccines today," Mr Poonawalla said.

Responding to a question on the safety aspect, he said there has been no major complaints, reactions or adverse events, adding, "We would need to wait and see. The efficacy and immunogenicity results from the Indian trials will come out in about a month-and-a-half."

(With inputs from agencies)

India is racing ahead with work on its coronavirus vaccine as countries around the world sought to conquer the pandemic and rescue their economies. Also read: These three Indian companies are ready to produce Covid-19 vaccine Companies like Zydus Cadila, Serum Institute and Bharat Biotech are at the forefront of research on covid vaccines and are likely to be among the leading manufacturers as and when their commercial application is permitted.

India is racing ahead with work on its coronavirus vaccine as countries around the world sought to conquer the pandemic and rescue their economies. Also read: These three Indian companies are ready to produce Covid-19 vaccine Companies like Zydus Cadila, Serum Institute and Bharat Biotech are at the forefront of research on covid vaccines and are likely to be among the leading manufacturers as and when their commercial application is permitted. Also read | Confident that Covid-19 vaccine will be ready in 3-4 months: India's health minister Serum Institute of India's CEO Adar Poonawalla on Thursday said the Oxford COVID-19 vaccine should be available for healthcare workers and elderly people by around February 2021 and by April for the general public and will be priced at a maximum of ₹ 1,000 for two necessary doses for the public, depending on the final trial results and regulatory approvals. Probably by 2024, every Indian will get vaccinated, he said at a media event. "It will probably take two or three years for every Indian to get inoculated, not just because of the supply constraints but because you need the budget, the vaccine, logistics, infrastructure and then, people should be willing to take the vaccine. So these are the factors that lead up to being able to vaccinate 80-90 per cent of the population. "It will be 2024 for everybody, if willing to take a two-dose vaccine, to be vaccinated," Mr Poonawalla said. Asked at what price the public will get it, he said it will be around USD 5-6 per dose with an MRP of around ₹ 1,000 for the two necessary doses. "The government of India will be getting it at a far cheaper price at around USD 3-4, because it will be buying in a large volume and get access to the price that is similar to what COVAX has got. We are still pricing it far cheaper and more affordable than other vaccines we have in the market today," Mr Poonawalla said. Asked about the efficacy of the vaccine, he said the Oxford-Astrazeneca vaccine is so far proving to work very well even in elderly people, which was a concern earlier. "It has induced a good T-cell response, which is an indicator for your long-term immunity and antibody response but then again, time will only tell if these vaccines are going to protect you in the long term. Nobody can answer that for any of the vaccines today," Mr Poonawalla said. Responding to a question on the safety aspect, he said there has been no major complaints, reactions or adverse events, adding, "We would need to wait and see. The efficacy and immunogenicity results from the Indian trials will come out in about a month-and-a-half." (With inputs from agencies)

Oxford COVID-19 vaccine to be available for Indians by April 2021: Serum Institute Chief 

India is racing ahead with work on its coronavirus vaccine as countries around the world sought to conquer the pandemic and rescue their economies. 
 
<a href="https://www.wionews.com/world/volunteers-face-severe-hangover-headache-and-pain-after-getting-pfizer-vaccine-shot-342518">Also read | Volunteers face 'severe hangover', headache and pain after getting Pfizer vaccine shot</a>

Companies like Zydus Cadila, Serum Institute and Bharat Biotech are at the forefront of research on covid vaccines and are likely to be among the leading manufacturers as and when their commercial application is permitted.

Ahmedabad-based pharmaceutical major Zydus Cadila's COVID-19 candidate vaccine ZyCov-D is likely to enter Phase III final stage of clinical trials by December. If all goes well, the vaccine should be ready for launch by March, next year. Further, Zydus is working on a second vaccine for COVID-19 and its pre-clinical data will be ready by January.

Hyderabad based Bharat Biotech is also reached to the third phase of clinical trials for 'Covaxin', in collaboration with the Indian Council of Medical Research (ICMR). Phase 3 trials of Covaxin will take place at 25 centres across India with a total of 26,000 participants. India's drug regulator, the Drug Controller General of India (DCGI), granted approval for the third phase after successful completion of the first two phases of trials.&nbsp;

Serum Insitute of India, the world's largest maker of vaccines, has also said that it has already produced 40 million doses of AstraZeneca's potential COVID-19 vaccine.

The vaccine is named Covishield by the institute and is jointly developed by pharma giant AstraZeneca and the University of Oxford. It is originally named ChAdOx1 nCoV-19 and is one of the top contenders in the race to develop vaccines to treat Covid-19.&nbsp;

Covishield has been developed at SII Pune laboratory with a master seed from Oxford University/AstraZeneca.

Serum refused to confirm whether the 40 million doses of vaccine will be supplied globally or only distributed in India, news agency Reuters reported.&nbsp;

The vaccine maker also said doses of Novavax vaccine, another top candidate, will be produced soon, adding that the bulk of the drug has been received from the US Company.&nbsp;

(With inputs from agencies)

India is racing ahead with work on its coronavirus vaccine as countries around the world sought to conquer the pandemic and rescue their economies. Also read | Volunteers face 'severe hangover', headache and pain after getting Pfizer vaccine shot Companies like Zydus Cadila, Serum Institute and Bharat Biotech are at the forefront of research on covid vaccines and are likely to be among the leading manufacturers as and when their commercial application is permitted.

India is racing ahead with work on its coronavirus vaccine as countries around the world sought to conquer the pandemic and rescue their economies. Also read | Volunteers face 'severe hangover', headache and pain after getting Pfizer vaccine shot Companies like Zydus Cadila, Serum Institute and Bharat Biotech are at the forefront of research on covid vaccines and are likely to be among the leading manufacturers as and when their commercial application is permitted. Ahmedabad-based pharmaceutical major Zydus Cadila's COVID-19 candidate vaccine ZyCov-D is likely to enter Phase III final stage of clinical trials by December. If all goes well, the vaccine should be ready for launch by March, next year. Further, Zydus is working on a second vaccine for COVID-19 and its pre-clinical data will be ready by January. Hyderabad based Bharat Biotech is also reached to the third phase of clinical trials for 'Covaxin', in collaboration with the Indian Council of Medical Research (ICMR). Phase 3 trials of Covaxin will take place at 25 centres across India with a total of 26,000 participants. India's drug regulator, the Drug Controller General of India (DCGI), granted approval for the third phase after successful completion of the first two phases of trials. Serum Insitute of India, the world's largest maker of vaccines, has also said that it has already produced 40 million doses of AstraZeneca's potential COVID-19 vaccine. The vaccine is named Covishield by the institute and is jointly developed by pharma giant AstraZeneca and the University of Oxford. It is originally named ChAdOx1 nCoV-19 and is one of the top contenders in the race to develop vaccines to treat Covid-19. Covishield has been developed at SII Pune laboratory with a master seed from Oxford University/AstraZeneca. Serum refused to confirm whether the 40 million doses of vaccine will be supplied globally or only distributed in India, news agency Reuters reported. The vaccine maker also said doses of Novavax vaccine, another top candidate, will be produced soon, adding that the bulk of the drug has been received from the US Company. (With inputs from agencies)

These three Indian companies are ready to produce Covid-19 vaccine

Serum Insitute of India, the world's largest maker of vaccines, on Thursday said it has already produced 40 million doses of AstraZeneca's potential COVID-19 vaccine.

The vaccine is named Covishield by the institute and is jointly developed by pharma giant AstraZeneca and the University of Oxford.&nbsp;

Also read | <a href="https://www.wionews.com/world/volunteers-face-severe-hangover-headache-and-pain-after-getting-pfizer-vaccine-shot-342518">Volunteers face 'severe hangover', headache and pain after getting Pfizer vaccine shot</a>

It is originally named ChAdOx1 nCoV-19 and is one of the top contenders in the race to develop vaccines to treat Covid-19.&nbsp;

Also read |&nbsp;<a href="https://www.wionews.com/world/eu-president-warns-recurring-cycles-viral-spread-despite-vaccine-342445">EU president warns 'recurring cycles' viral spread despite vaccine</a>

Serum refused to confirm whether the 40 million doses of vaccine will be supplied globally or only distributed in India, news agency Reuters reported.&nbsp;

The vaccine maker also said doses of Novavax vaccine, another top candidate, will be produced soon, adding that the bulk of the drug has been received from the US company.&nbsp;

It also said the AstraZeneca vaccine is in the most advanced stage of human testing in India, adding that the company along with the Indian Council of Medical Research (ICMR) will pursue "early availability" of the doses in India.

India also has at least two indigenously developed vaccine candidates, while Dr Reddy's Labs is conducting a trial for Russia's vaccine candidate.

The development came as coronavirus infections in India, the world's second-worst, reached 8.68 million on Thursday and the death toll rose over 128,000.

 
&nbsp;

Serum Insitute of India, the world's largest maker of vaccines, on Thursday said it has already produced 40 million doses of AstraZeneca's potential COVID-19 vaccine.

Serum Insitute of India, the world's largest maker of vaccines, on Thursday said it has already produced 40 million doses of AstraZeneca's potential COVID-19 vaccine. The vaccine is named Covishield by the institute and is jointly developed by pharma giant AstraZeneca and the University of Oxford. Also read | Volunteers face 'severe hangover', headache and pain after getting Pfizer vaccine shot It is originally named ChAdOx1 nCoV-19 and is one of the top contenders in the race to develop vaccines to treat Covid-19. Also read | EU president warns 'recurring cycles' viral spread despite vaccine Serum refused to confirm whether the 40 million doses of vaccine will be supplied globally or only distributed in India, news agency Reuters reported. The vaccine maker also said doses of Novavax vaccine, another top candidate, will be produced soon, adding that the bulk of the drug has been received from the US company. It also said the AstraZeneca vaccine is in the most advanced stage of human testing in India, adding that the company along with the Indian Council of Medical Research (ICMR) will pursue "early availability" of the doses in India. India also has at least two indigenously developed vaccine candidates, while Dr Reddy's Labs is conducting a trial for Russia's vaccine candidate. The development came as coronavirus infections in India, the world's second-worst, reached 8.68 million on Thursday and the death toll rose over 128,000.

India's Serum Institute, world's largest vaccine maker says 40 million doses of AstraZeneca drug produced

Serum Institute of India and Bharat Biotech are expected to pursue late stage clinical trials of intranasal COVID-19 vaccines in the coming months once they receive regulatory approval, India`s health minister said on Sunday.

Dr Harsh Vardhan said the late stage trial generally involves thousands of participants, sometimes 30,000 to 40,000.

Of the vaccines currently in Phase 3 trials, all are administered by injection, according to the World Health Organization (WHO).

On Saturday, India`s Dr Reddy`s Laboratories Ltd and the Russian Direct Investment Fund (RDIF) said they have received renewed approval to conduct late-stage clinical trials in India of the Russian COVID-19 vaccine.

India`s coronavirus infections rose by another 61,871 over the past 24 hours, data released on Sunday showed, although the health ministry said it is seeing a trend of steadily declining active cases.

The Indian Council of Medical Research (ICMR) said it will revisit its protocol for COVID-19 treatment after the WHO found some of the commonly used drugs, including remdesivir, had little or no impact on a patient`s chances of surviving, local media reported earlier on Sunday.

Serum Institute of India and Bharat Biotech are expected to pursue late stage clinical trials of intranasal COVID-19 vaccines in the coming months once they receive regulatory approval, India`s health minister said on Sunday.

Serum Institute of India and Bharat Biotech are expected to pursue late stage clinical trials of intranasal COVID-19 vaccines in the coming months once they receive regulatory approval, India`s health minister said on Sunday. Dr Harsh Vardhan said the late stage trial generally involves thousands of participants, sometimes 30,000 to 40,000. Of the vaccines currently in Phase 3 trials, all are administered by injection, according to the World Health Organization (WHO). On Saturday, India`s Dr Reddy`s Laboratories Ltd and the Russian Direct Investment Fund (RDIF) said they have received renewed approval to conduct late-stage clinical trials in India of the Russian COVID-19 vaccine. India`s coronavirus infections rose by another 61,871 over the past 24 hours, data released on Sunday showed, although the health ministry said it is seeing a trend of steadily declining active cases. The Indian Council of Medical Research (ICMR) said it will revisit its protocol for COVID-19 treatment after the WHO found some of the commonly used drugs, including remdesivir, had little or no impact on a patient`s chances of surviving, local media reported earlier on Sunday.

Serum Institute, Bharat Biotech to begin trial of intranasal COVID-19 vaccine soon

The Drugs Controller General of India (DCGI) has allowed Serum Institute of India (SII) to restart its phase two and three clinical trials for COVID-19 vaccine after the pharma major submitted the recommendations of the Data Safety Monitoring Board (DSMB), UK and DSMB India and requested permission to restart enrolment in the subject clinical trial of the vaccine being developed by AstraZeneca and Oxford University.

DCGI VG Somani, in a letter to SII, has said that the institute's reply has been "carefully examined" as also the recommendations of the DSMB in India and in UK.

"You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the DSMB, India as per already approved protocol and the provisions laid down under New Drugs and Clinical Trials Rules, 2019 subject to the conditions mentioned which are to be scrupulously followed such as extra care during screening, additional information in the informed consent and close monitoring for similar events during the study follow-up," the letter said.

The DCGI has also asked SII to submit the details of the medication used as per protocol for the management of the adverse events.

AstraZeneca had earlier paused the ongoing trial of nCoV19 coronavirus vaccine (recombinant) as a volunteer developed an unexplained illness. It was reported that the clinical trial had been put on hold in the US, UK, Brazil and South Africa.

Following this, the country's top drugs regulator had September 11 ordered the SII to suspend any new recruitment in phase 2 and 3 clinical trials for vaccine"&gt;COVID-19 vaccine till further orders.

AstraZeneca has already resumed trials in the UK for the vaccine.

A government official said that Serum Institute of India submitted the recommendations of the DSMB, UK and DSMB India on September 15 and requested permission to restart enrolment in the subject clinical trial.

"The DSMB, UK recommended that investigators recommend all immunizations in their clinical trials subject to certain conditions. The DSMB, India recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol subject to three conditions to the scrupulously followed," the official said.

These recommendations include revised participant information sheet, revised informed consent form (ICF) and additional safety monitory plans for the enrolled participants incorporating the latest SUSAR and indicating the specific contact numbers for participants for seeking assistants in case of any problem or question.

India's top drugs regulator had in August granted permission to SII to conduct a phase II/III clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in the country to determine its safety and immunogenicity.

The Drugs Controller General of India (DCGI) has allowed Serum Institute of India (SII) to restart its phase two and three clinical trials for COVID-19 vaccine after the pharma major submitted the recommendations of the Data Safety Monitoring Board (DSMB), UK and DSMB India and requested permission to restart enrolment in the subject clinical trial of the vaccine being developed by AstraZeneca and Oxford University.

The Drugs Controller General of India (DCGI) has allowed Serum Institute of India (SII) to restart its phase two and three clinical trials for COVID-19 vaccine after the pharma major submitted the recommendations of the Data Safety Monitoring Board (DSMB), UK and DSMB India and requested permission to restart enrolment in the subject clinical trial of the vaccine being developed by AstraZeneca and Oxford University. DCGI VG Somani, in a letter to SII, has said that the institute's reply has been "carefully examined" as also the recommendations of the DSMB in India and in UK. "You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the DSMB, India as per already approved protocol and the provisions laid down under New Drugs and Clinical Trials Rules, 2019 subject to the conditions mentioned which are to be scrupulously followed such as extra care during screening, additional information in the informed consent and close monitoring for similar events during the study follow-up," the letter said. The DCGI has also asked SII to submit the details of the medication used as per protocol for the management of the adverse events. AstraZeneca had earlier paused the ongoing trial of nCoV19 coronavirus vaccine (recombinant) as a volunteer developed an unexplained illness. It was reported that the clinical trial had been put on hold in the US, UK, Brazil and South Africa. Following this, the country's top drugs regulator had September 11 ordered the SII to suspend any new recruitment in phase 2 and 3 clinical trials for vaccine">COVID-19 vaccine till further orders. AstraZeneca has already resumed trials in the UK for the vaccine. A government official said that Serum Institute of India submitted the recommendations of the DSMB, UK and DSMB India on September 15 and requested permission to restart enrolment in the subject clinical trial. "The DSMB, UK recommended that investigators recommend all immunizations in their clinical trials subject to certain conditions. The DSMB, India recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol subject to three conditions to the scrupulously followed," the official said. These recommendations include revised participant information sheet, revised informed consent form (ICF) and additional safety monitory plans for the enrolled participants incorporating the latest SUSAR and indicating the specific contact numbers for participants for seeking assistants in case of any problem or question. India's top drugs regulator had in August granted permission to SII to conduct a phase II/III clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in the country to determine its safety and immunogenicity.

DCGI gives go-ahead to Serum Institute for Covid-19 vaccine trials in India

In a big blow to the expectations regarding the covid-19&nbsp;vaccine, the Serum Institute of India has said adequate coronavirus vaccine will not be available for everybody in the world to be immunised until the end of 2024.

The chief executive of the world’s largest manufacturer of vaccines, Adar Poonawalla, has said dampened the hopes of a COVID-19 vaccine by year-end in an interview with the Financial Times. He said that pharma firms were not ramping up production capacity swiftly to be able to innoculate the world population in less duration.

“It’s going to take four to five years until everyone gets the vaccine on this planet,” Poonawalla was quoted as saying. He had earlier predicted that if the coronavirus shot is a two-dose vaccine, as is the case with measles or rotavirus, then the world would require 15 billion doses.

The Serum Institute has partnered with five international pharmaceutical companies, including AstraZeneca and Novavax, to develop a coronavirus vaccine. The firm may also tie-up with Russia’s Gamaleya Research Institute to produce the Sputnik vaccine.

The institute has pledged to manufacture one billion doses, out of which it has promised 50% to India.

The firm will, as part of its agreement with AstraZeneca, seek to produce Covid-19 vaccine doses that cost closed $3 for 68 countries and under its deal with Novavax, for 92 countries.

Poonawalla had in April ordered 600m glass vials and other particulars to gear up for the mass manufacturing of the vaccine.

Meanwhile, as of Tuesday morning, the total number of coronavirus cases stood at 29,281,638 and the fatalities rose to 928,423, the University's Center for Systems Science and Engineering (CSSE) revealed in its latest update.

In a big blow to the expectations regarding the covid-19 vaccine, the Serum Institute of India has said adequate coronavirus vaccine will not be available for everybody in the world to be immunised until the end of 2024.

In a big blow to the expectations regarding the covid-19 vaccine, the Serum Institute of India has said adequate coronavirus vaccine will not be available for everybody in the world to be immunised until the end of 2024. The chief executive of the world’s largest manufacturer of vaccines, Adar Poonawalla, has said dampened the hopes of a COVID-19 vaccine by year-end in an interview with the Financial Times. He said that pharma firms were not ramping up production capacity swiftly to be able to innoculate the world population in less duration. “It’s going to take four to five years until everyone gets the vaccine on this planet,” Poonawalla was quoted as saying. He had earlier predicted that if the coronavirus shot is a two-dose vaccine, as is the case with measles or rotavirus, then the world would require 15 billion doses. The Serum Institute has partnered with five international pharmaceutical companies, including AstraZeneca and Novavax, to develop a coronavirus vaccine. The firm may also tie-up with Russia’s Gamaleya Research Institute to produce the Sputnik vaccine. The institute has pledged to manufacture one billion doses, out of which it has promised 50% to India. The firm will, as part of its agreement with AstraZeneca, seek to produce Covid-19 vaccine doses that cost closed $3 for 68 countries and under its deal with Novavax, for 92 countries. Poonawalla had in April ordered 600m glass vials and other particulars to gear up for the mass manufacturing of the vaccine. Meanwhile, as of Tuesday morning, the total number of coronavirus cases stood at 29,281,638 and the fatalities rose to 928,423, the University's Center for Systems Science and Engineering (CSSE) revealed in its latest update.

Coronavirus vaccine won’t be available to everyone before 2024 end: India's Serum Institute chief

Bangladesh`s Beximco Pharmaceuticals is investing in the Serum Institute of India (SII) to ensure Dhaka gets priority access to COVID-19 vaccines being developed by the Indian drug manufacturer, the company said on Friday.

The deal announced by the Bangladeshi generic drugmaker comes after Dhaka said this month it was ready to hold trials of candidate vaccines being developed by India as both countries seek to curb the spread of the virus.

SII has partnered with AstraZeneca, the Gates Foundation and the Gavi vaccine alliance to produce more than a billion doses of a COVID-19 vaccine for global supply.

<a href="https://www.wionews.com/india-news/covid-19-delhi-records-highest-single-day-cases-in-august-death-toll-rises-to-over-4400-323981">Also read|&nbsp;COVID-19: Delhi records highest single-day cases in August; death toll rises to over 4,400</a>

"The investment amount will be treated as an advance and once the vaccine receives regulatory approvals, SII will include Bangladesh among the countries who will be the first to receive an agreed quantity of this vaccine from SII on a priority basis," Beximco said in a statement.

It did not give details about the size of the investment in SII nor how many vaccines Beximco might receive.

"This landmark agreement reflects the deep-rooted desire for collaboration between the two countries and as representatives of the two nations, between us we can go a long way towards helping to mitigate the health crisis caused by the COVID-19 pandemic," the heads of both companies said in the statement.

<a href="https://www.wionews.com/india-news/india-has-one-of-lowest-global-covid-19-fatality-rates-029-cases-on-ventilators-harsh-vardhan-323962">Also read|&nbsp;India has one of lowest global COVID-19 fatality rates, 0.29% cases on ventilators: Harsh Vardhan</a>

It said Beximco would be the exclusive supplier in Bangladesh for the vaccine being developed by SII and that the Bangladeshi company would discuss with the government the number of doses it wants. Beximco will also secure additional doses to be distributed to the private pay market in Bangladesh.

The Serum Institute is the world`s largest manufacturer of vaccines by volume. It is holding trials for three potential coronavirus vaccines, including one licensed to AstraZeneca by Oxford University.

Bangladesh has also approved a late-stage trial of a potential coronavirus vaccine developed by China`s Sinovac Biotech Ltd in the hope of being a priority recipient for the jab.

Bangladesh confirmed 47 more deaths and reported 2,211 new cases on Friday, taking the total number of cases in the country to 306,794 with 4,174 deaths.

India reported a record daily jump of 77,266 coronavirus infections on Friday, taking its total number of cases to 3.39 million with 61,529 deaths.

Bangladesh`s Beximco Pharmaceuticals is investing in the Serum Institute of India (SII) to ensure Dhaka gets priority access to COVID-19 vaccines being developed by the Indian drug manufacturer, the company said on Friday.

Bangladesh`s Beximco Pharmaceuticals is investing in the Serum Institute of India (SII) to ensure Dhaka gets priority access to COVID-19 vaccines being developed by the Indian drug manufacturer, the company said on Friday. The deal announced by the Bangladeshi generic drugmaker comes after Dhaka said this month it was ready to hold trials of candidate vaccines being developed by India as both countries seek to curb the spread of the virus. SII has partnered with AstraZeneca, the Gates Foundation and the Gavi vaccine alliance to produce more than a billion doses of a COVID-19 vaccine for global supply. Also read| COVID-19: Delhi records highest single-day cases in August; death toll rises to over 4,400 "The investment amount will be treated as an advance and once the vaccine receives regulatory approvals, SII will include Bangladesh among the countries who will be the first to receive an agreed quantity of this vaccine from SII on a priority basis," Beximco said in a statement. It did not give details about the size of the investment in SII nor how many vaccines Beximco might receive. "This landmark agreement reflects the deep-rooted desire for collaboration between the two countries and as representatives of the two nations, between us we can go a long way towards helping to mitigate the health crisis caused by the COVID-19 pandemic," the heads of both companies said in the statement. Also read| India has one of lowest global COVID-19 fatality rates, 0.29% cases on ventilators: Harsh Vardhan It said Beximco would be the exclusive supplier in Bangladesh for the vaccine being developed by SII and that the Bangladeshi company would discuss with the government the number of doses it wants. Beximco will also secure additional doses to be distributed to the private pay market in Bangladesh. The Serum Institute is the world`s largest manufacturer of vaccines by volume. It is holding trials for three potential coronavirus vaccines, including one licensed to AstraZeneca by Oxford University. Bangladesh has also approved a late-stage trial of a potential coronavirus vaccine developed by China`s Sinovac Biotech Ltd in the hope of being a priority recipient for the jab. Bangladesh confirmed 47 more deaths and reported 2,211 new cases on Friday, taking the total number of cases in the country to 306,794 with 4,174 deaths. India reported a record daily jump of 77,266 coronavirus infections on Friday, taking its total number of cases to 3.39 million with 61,529 deaths.

Bangladesh's Beximco signs COVID-19 vaccine deal with India's Serum Institute

Serum Institute of India said on Friday it would receive $150 million in funding from the Bill &amp; Melinda Gates Foundation and the GAVI vaccines alliance to make 100 million COVID-19 vaccine doses for India and other emerging economies as early as 2021.

The candidate vaccines, including those from AstraZeneca and Novavax, will be priced at $3 per dose and will be made available in 92 countries in GAVI's COVAX Advance Market Commitment (AMC), the company said in a statement.

Also read |&nbsp;<a href="https://www.wionews.com/india-news/indias-covid-19-tally-crosses-20-lakh-with-highest-single-day-spike-of-62538-318766">India's COVID-19 tally crosses 20 lakh with highest single-day spike of 62,538</a>

The Gates Foundation will provide the funds to GAVI, which will be used to support Serum Institute.

GAVI, backed by the Gates Foundation, is a public–private global health partnership with the goal of increasing access to immunization in poor countries.

It co-leads COVAX - a scheme designed to guarantee fast and equitable access globally to COVID-19 vaccines - along with the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI).

COVAX aims to deliver 2 billion doses of approved and effective COVID-19 vaccines by the end of 2021.

India reported a record jump in daily coronavirus infections on Friday and became the third country in the world to surpass 2 million cases. It lags only the United States and Brazil in the number of infections.

Serum Institute of India said on Friday it would receive $150 million in funding from the Bill & Melinda Gates Foundation and the GAVI vaccines alliance to make 100 million COVID-19 vaccine doses for India and other emerging economies as early as 2021.

Serum Institute of India said on Friday it would receive $150 million in funding from the Bill & Melinda Gates Foundation and the GAVI vaccines alliance to make 100 million COVID-19 vaccine doses for India and other emerging economies as early as 2021. The candidate vaccines, including those from AstraZeneca and Novavax, will be priced at $3 per dose and will be made available in 92 countries in GAVI's COVAX Advance Market Commitment (AMC), the company said in a statement. Also read | India's COVID-19 tally crosses 20 lakh with highest single-day spike of 62,538 The Gates Foundation will provide the funds to GAVI, which will be used to support Serum Institute. GAVI, backed by the Gates Foundation, is a public–private global health partnership with the goal of increasing access to immunization in poor countries. It co-leads COVAX - a scheme designed to guarantee fast and equitable access globally to COVID-19 vaccines - along with the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI). COVAX aims to deliver 2 billion doses of approved and effective COVID-19 vaccines by the end of 2021. India reported a record jump in daily coronavirus infections on Friday and became the third country in the world to surpass 2 million cases. It lags only the United States and Brazil in the number of infections.

Serum Institute to get $150 million from Gates Foundation for COVID-19 vaccine

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