The WHO's technical advisory group will meet on October 26 to consider the emergency use listing of India's Covaxin which is being used in the country's nationwide anti-COVID-19 vaccination programme, according to the global health agency's chief scientist Soumya Swaminathan.

Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the World Health Organisation on April 19 for its vaccine.

Also Read |&nbsp;<a href="https://www.wionews.com/world/us-development-finance-corporation-chief-to-visit-india-to-boost-vaccine-manufacturing-421167">US Development Finance Corporation chief to visit India to boost vaccine manufacturing</a>

Swaminathan, the WHO's Chief Scientist, said on Twitter on Sunday that the technical advisory group will meet on October 26 to consider the Emergency Use Listing (EUL) for Covaxin. @WHO has been working closely with @BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere," she said in the tweet.

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The technical advisory group will meet on Oct 26th to consider EUL for <a href="https://twitter.com/hashtag/Covaxin?src=hash&amp;ref_src=twsrc%5Etfw">#Covaxin</a>. <a href="https://twitter.com/WHO?ref_src=twsrc%5Etfw">@WHO</a> has been working closely with <a href="https://twitter.com/BharatBiotech?ref_src=twsrc%5Etfw">@BharatBiotech</a> to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use &amp; to expand access to populations everywhere <a href="https://t.co/lqQIyqItF9">https://t.co/lqQIyqItF9</a>
— Soumya Swaminathan (@doctorsoumya) <a href="https://twitter.com/doctorsoumya/status/1449756927496495112?ref_src=twsrc%5Etfw">October 17, 2021</a></blockquote>
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Earlier this month, the WHO said that Bharat Biotech has been submitting data to WHO on a rolling basis and submitted additional information at the WHO's request on September 27.

The WHO experts are currently reviewing this information and if it addresses all questions raised, the WHO assessment will be finalised next week."

The Geneva-based WHO said it began rolling data of the vaccine on July 6. Rolling data allows the WHO to start its review right away, as information continues to come in to accelerate the overall review process.

According to the WHO, submissions for pre-qualification or listing under the emergency use procedure are confidential.

Also Read |<a href="https://www.wionews.com/world/uk-lab-suspended-after-false-negative-covid-tests-420952">&nbsp;UK lab suspended after false negative Covid tests</a>

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If a product submitted for assessment is found to meet the criteria for listing, the WHO will publish the results widely.

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Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on the data meeting the WHO's criteria, according to the agency.

The indigenously-developed Bharat Biotech's Covaxin is one of the six vaccines that have received emergency use authorisation from India's drug regulator Drugs Controller General of India (DGCI) and is being used in the nationwide anti-COVID-19 inoculation programme along with Covishield and Sputnik V.

Bharat Biotech recently said it has submitted all data pertaining to Covaxin to the WHO for the EUL and is awaiting feedback from the global health watchdog.

"#COVAXIN clinical trial data was fully compiled and available in June 2021. All Data

submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July. We have responded to any clarifications sought by #WHO and are awaiting further feedback," Bharat Biotech had tweeted last month.

Also Read |&nbsp;<a href="https://www.wionews.com/world/moderna-racing-for-profits-keeps-covid-vaccine-out-of-reach-of-poor-419518">Moderna, racing for profits, keeps Covid vaccine out of reach of poor</a>

"We are diligently working with the WHO to obtain EUL at the earliest,&nbsp;the company had said on Tuesday.

India, the world's largest producer of vaccines overall, suspended exports of COVID-19 vaccines in April to focus on inoculating its own population following a sudden spike in infections.

Last month, Union Health Minister Mansukh Mandaviya announced that India will resume the supplies abroad.

According to Johns Hopkins University, the coronavirus has claimed 4,897,386 lives along with 240,559,605 confirmed cases across the world so far.

The WHO's technical advisory group will meet on October 26 to consider the emergency use listing of India's Covaxin which is being used in the country's nationwide anti-COVID-19 vaccination programme, according to the global health agency's chief scientist Soumya Swaminathan.

The WHO's technical advisory group will meet on October 26 to consider the emergency use listing of India's Covaxin which is being used in the country's nationwide anti-COVID-19 vaccination programme, according to the global health agency's chief scientist Soumya Swaminathan. Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the World Health Organisation on April 19 for its vaccine. Also Read | US Development Finance Corporation chief to visit India to boost vaccine manufacturing Swaminathan, the WHO's Chief Scientist, said on Twitter on Sunday that the technical advisory group will meet on October 26 to consider the Emergency Use Listing (EUL) for Covaxin. @WHO has been working closely with @BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere," she said in the tweet. The technical advisory group will meet on Oct 26th to consider EUL for #Covaxin. @WHO has been working closely with @BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use & to expand access to populations everywhere https://t.co/lqQIyqItF9 — Soumya Swaminathan (@doctorsoumya) October 17, 2021 × Earlier this month, the WHO said that Bharat Biotech has been submitting data to WHO on a rolling basis and submitted additional information at the WHO's request on September 27. The WHO experts are currently reviewing this information and if it addresses all questions raised, the WHO assessment will be finalised next week." The Geneva-based WHO said it began rolling data of the vaccine on July 6. Rolling data allows the WHO to start its review right away, as information continues to come in to accelerate the overall review process. According to the WHO, submissions for pre-qualification or listing under the emergency use procedure are confidential. Also Read | UK lab suspended after false negative Covid tests If a product submitted for assessment is found to meet the criteria for listing, the WHO will publish the results widely. Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on the data meeting the WHO's criteria, according to the agency. The indigenously-developed Bharat Biotech's Covaxin is one of the six vaccines that have received emergency use authorisation from India's drug regulator Drugs Controller General of India (DGCI) and is being used in the nationwide anti-COVID-19 inoculation programme along with Covishield and Sputnik V. Bharat Biotech recently said it has submitted all data pertaining to Covaxin to the WHO for the EUL and is awaiting feedback from the global health watchdog. "#COVAXIN clinical trial data was fully compiled and available in June 2021. All Data submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July. We have responded to any clarifications sought by #WHO and are awaiting further feedback," Bharat Biotech had tweeted last month. Also Read | Moderna, racing for profits, keeps Covid vaccine out of reach of poor "We are diligently working with the WHO to obtain EUL at the earliest, the company had said on Tuesday. India, the world's largest producer of vaccines overall, suspended exports of COVID-19 vaccines in April to focus on inoculating its own population following a sudden spike in infections. Last month, Union Health Minister Mansukh Mandaviya announced that India will resume the supplies abroad. According to Johns Hopkins University, the coronavirus has claimed 4,897,386 lives along with 240,559,605 confirmed cases across the world so far.

WHO to meet next week to consider emergency use listing of India's Covaxin

The World Health Organisation is scheduled to meet on october 26 to consider listing India's indegeneous COVID vaccine for emergency use.

World Health Organisation scheduled to meet on October 26

The technical advisory group of the World Health Organisation will meet on October 26 to consider the Emergency use listing for Covaxin, Chief Scientist at the WHO Soumya Swaminathan said on Sunday.

The approval for Bharat Biotech’s made-in-India vaccine is much awaited.&nbsp;

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The technical advisory group will meet on Oct 26th to consider EUL for <a href="https://twitter.com/hashtag/Covaxin?src=hash&amp;ref_src=twsrc%5Etfw">#Covaxin</a>. <a href="https://twitter.com/WHO?ref_src=twsrc%5Etfw">@WHO</a> has been working closely with <a href="https://twitter.com/BharatBiotech?ref_src=twsrc%5Etfw">@BharatBiotech</a> to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use &amp; to expand access to populations everywhere <a href="https://t.co/lqQIyqItF9">https://t.co/lqQIyqItF9</a>
— Soumya Swaminathan (@doctorsoumya) <a href="https://twitter.com/doctorsoumya/status/1449756927496495112?ref_src=twsrc%5Etfw">October 17, 2021</a></blockquote>
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Bharat Biotech had submitted all the necessary documents required for the EUL on July 9.&nbsp;

“We have responded to any clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines,” said Bharat Biotech in a statement.

Suchitra Ella, the company’s co-founder and joint managing director said that the approval is not expected to be a “long-drawn process”.

<a href="https://www.wionews.com/india-news/covaxins-wait-continues-as-who-delays-emergency-use-again-413949">Also read |&nbsp;Covaxin's wait continues as WHO delays emergency use again</a>

“We are working closely with the World Health Organisation for the inclusion of Covaxin in its Emergency Use Listing. Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past,” she said in a tweet.

Meanwhile, the pharma regulator's Subject Expert Committee (SEC) has recommended that Bharat Biotech's Covaxin be approved for emergency use in children aged 2 to 18.

The SEC has submitted its proposal for final clearance to the Drugs Controller General of India (DCGI).

"After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation," the expert panel said in a statement.

The technical advisory group of the World Health Organisation will meet on October 26 to consider the Emergency use listing for Covaxin, Chief Scientist at the WHO Soumya Swaminathan said on Sunday.

The technical advisory group of the World Health Organisation will meet on October 26 to consider the Emergency use listing for Covaxin, Chief Scientist at the WHO Soumya Swaminathan said on Sunday. The approval for Bharat Biotech’s made-in-India vaccine is much awaited. The technical advisory group will meet on Oct 26th to consider EUL for #Covaxin. @WHO has been working closely with @BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use & to expand access to populations everywhere https://t.co/lqQIyqItF9 — Soumya Swaminathan (@doctorsoumya) October 17, 2021 × Bharat Biotech had submitted all the necessary documents required for the EUL on July 9. “We have responded to any clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines,” said Bharat Biotech in a statement. Suchitra Ella, the company’s co-founder and joint managing director said that the approval is not expected to be a “long-drawn process”. Also read | Covaxin's wait continues as WHO delays emergency use again “We are working closely with the World Health Organisation for the inclusion of Covaxin in its Emergency Use Listing. Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past,” she said in a tweet. Meanwhile, the pharma regulator's Subject Expert Committee (SEC) has recommended that Bharat Biotech's Covaxin be approved for emergency use in children aged 2 to 18. The SEC has submitted its proposal for final clearance to the Drugs Controller General of India (DCGI). "After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation," the expert panel said in a statement.

WHO team to meet on October 26 to consider EUL for Covaxin

The pharma regulator's Subject Expert Committee (SEC) has recommended that Bharat Biotech's Covaxin be approved for emergency use in children aged 2 to 18.

The SEC has submitted its proposal for final clearance to the Drugs Controller General of India (DCGI).

"After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation," the expert panel said in a statement. 
 
Also Read |<a href="https://www.wionews.com/world/who-covid-19-update-high-infection-rate-in-0-19-age-group-in-india-globally-new-cases-fall-by-9-419214">&nbsp;WHO COVID-19 Update: High infection rate in 0-19 age group in India, globally new cases fall by 9%</a>

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<h5>Covaxin is the second Covid-19 vaccine to be authorised for emergency use in children in India, following Zydus Healthcare's ZyCoV-D, which is intended for children over the age of 12.</h5>
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It said that the emergency use authorisation, however, is subject to four conditions.

"The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol," SEC added. 
 
Watch: India administers over 900 million jabs of COVID vaccines

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The expert panel also mentioned the following conditions:&nbsp; 
 
The company should provide updated Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC), and Factsheet; the company should submit safety data, including AEFI and AESI data, with due analysis, every 15 days for the first two months and monthly thereafter, as required by the New Drugs and Clinical Trials Rules, 2019; and the company should submit risk management plan.&nbsp;

(With inputs from agencies)

The pharma regulator's Subject Expert Committee (SEC) has recommended that Bharat Biotech's Covaxin be approved for emergency use in children aged 2 to 18. The SEC has submitted its proposal for final clearance to the Drugs Controller General of India (DCGI).

The pharma regulator's Subject Expert Committee (SEC) has recommended that Bharat Biotech's Covaxin be approved for emergency use in children aged 2 to 18. The SEC has submitted its proposal for final clearance to the Drugs Controller General of India (DCGI). "After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation," the expert panel said in a statement. Also Read | WHO COVID-19 Update: High infection rate in 0-19 age group in India, globally new cases fall by 9% Covaxin is the second Covid-19 vaccine to be authorised for emergency use in children in India, following Zydus Healthcare's ZyCoV-D, which is intended for children over the age of 12. × It said that the emergency use authorisation, however, is subject to four conditions. "The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol," SEC added. Watch: India administers over 900 million jabs of COVID vaccines The expert panel also mentioned the following conditions: The company should provide updated Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC), and Factsheet; the company should submit safety data, including AEFI and AESI data, with due analysis, every 15 days for the first two months and monthly thereafter, as required by the New Drugs and Clinical Trials Rules, 2019; and the company should submit risk management plan. (With inputs from agencies)

COVID-19: Covaxin gets emergency use nod for children aged 2-18 years

The subject expert committee of India's drug regulator is all set to take a call on Bharat Biotech’s pediatric COVID vaccine. Bharat biotech, which completed its phase-ii and iii trials of Covaxin's pediatric jab has submitted the data to the central drugs standard control organization for its verification and subsequent approval.

India's drug regulator all set to take call on Bharat Biotech’s pediatric COVID vaccine

The World Health Organization is likely to delay its approval for the Covaxin shot, once again, till October 5 this time. According to a report by the ANI news agency, the Strategic Advisory Group of Experts on Immunisation (SAGE) will be meeting on October 5 to decide on granting the EUA to Covaxin.

The SAGE session of the specialised agency of the United Nations will recommend EUA based on the clinical on Covaxin from Phase 1, 2, and 3 trials.

The session will also consider the post-marketing studies on safety, immunogenicity, efficacy, and effectiveness. Also, it will review updates on global, regional, and country-level plans for vaccine safety monitoring.

<a href="https://www.wionews.com/world/deepening-partnership-with-india-eu-steps-up-engagement-in-indo-pacific-with-new-plan-413844">Also read |&nbsp;Deepening partnership with India: EU steps up engagement in Indo Pacific with new plan</a>

Based on the assessment, the WHO will then consider the available pieces of evidence to determine EUA.

The Phase-3 clinical trials of Covaxin demonstrated an efficacy rate of 77.8 per cent.

All the relevant trial data has been submitted to WHO for EUL.

“We have responded to any clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines,” said Bharat Biotech in a statement.

The World Health Organization is likely to delay its approval for the Covaxin shot, once again, till October 5 this time. According to a report by the ANI news agency, the Strategic Advisory Group of Experts on Immunisation (SAGE) will be meeting on October 5 to decide on granting the EUA to Covaxin.

The World Health Organization is likely to delay its approval for the Covaxin shot, once again, till October 5 this time. According to a report by the ANI news agency, the Strategic Advisory Group of Experts on Immunisation (SAGE) will be meeting on October 5 to decide on granting the EUA to Covaxin. The SAGE session of the specialised agency of the United Nations will recommend EUA based on the clinical on Covaxin from Phase 1, 2, and 3 trials. The session will also consider the post-marketing studies on safety, immunogenicity, efficacy, and effectiveness. Also, it will review updates on global, regional, and country-level plans for vaccine safety monitoring. Also read | Deepening partnership with India: EU steps up engagement in Indo Pacific with new plan Based on the assessment, the WHO will then consider the available pieces of evidence to determine EUA. The Phase-3 clinical trials of Covaxin demonstrated an efficacy rate of 77.8 per cent. All the relevant trial data has been submitted to WHO for EUL. “We have responded to any clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines,” said Bharat Biotech in a statement.

Covaxin's wait continues as WHO delays emergency use again

World Health Organisation (WHO) chief scientist Dr Soumya Swaminathan on Wednesday said the COVID-19 infection in India will likely enter “some kind of stage of endemicity” marked by low or moderate levels of transmission.

The endemic stage is when the infection is present in a certain population or region and the people have learnt to live with it.

On clearance of the Indian-made COVID vaccine Covaxin, Swaminathan said she is “fairly confident” that the WHO's technical group will be satisfied to give the vaccine clearance for one of its authorised vaccines, adding “it could happen by mid-September”.

"We may be entering some kind of stage of endemicity where there is low-level transmission or moderate level transmission going on but we are not seeing the kinds of exponential growth and peaks that we saw a few months ago," Swaminathan was quoted by local media.

“As far as India is concerned that seems to be what is happening and because of size of India and heterogeneity of population and immunity status in different parts of the country in different pockets, it is very very feasible that the situation may continue like this with ups and downs in different parts of the country, particularly where there are more susceptible population, so those groups who were perhaps less affected by first and second waves or those areas with low levels of vaccine coverage we could see peaks and troughs for the next several months," she said.

She also expressed hope of India achieving the targeted vaccine coverage of 70% of the population by the end of 2022.

While speaking on the prevalence of Covid among children, Swaminathan asked parents to remain calm.

“We can take from the serosurvey and what we learnt from other countries also that while it is possible that children could get infected and transmit, children luckily have very mild illness most of the time and there is a small percentage that gets sick and get inflammatory complications and few will die but much much less than the adult population...But it is good to prepare... Preparing hospitals for paediatric admissions, paediatric intensive care is going to serve our health system in many ways for other illnesses children have but we should not panic about thousands of children crowding into ICUs," she said.

On the use of drugs like Remdesivir, Ivermectin or HCQ for treatment of COVID systems, she said there is no evidence of these drugs playing a role in reducing mortality or morbidity in people infected with the virus.

On the third wave, she said no one has a "crystal ball" and it's impossible to predict a third wave.

Meanwhile, India logged 37,593 new coronavirus infections, while the active cases increased marginally to 3,22,327, according to the Union Health Ministry data updated on Wednesday.

The total tally of COVID-19 cases increased to 3,25,12,366 and the number of deaths climbed to 4,35,758 with 648 fresh fatalities, according to the data.

(With inputs from agencies)

World Health Organisation (WHO) chief scientist Dr Soumya Swaminathan on Wednesday said the COVID-19 infection in India will likely enter “some kind of stage of endemicity” marked by low or moderate levels of transmission.

World Health Organisation (WHO) chief scientist Dr Soumya Swaminathan on Wednesday said the COVID-19 infection in India will likely enter “some kind of stage of endemicity” marked by low or moderate levels of transmission. The endemic stage is when the infection is present in a certain population or region and the people have learnt to live with it. On clearance of the Indian-made COVID vaccine Covaxin, Swaminathan said she is “fairly confident” that the WHO's technical group will be satisfied to give the vaccine clearance for one of its authorised vaccines, adding “it could happen by mid-September”. "We may be entering some kind of stage of endemicity where there is low-level transmission or moderate level transmission going on but we are not seeing the kinds of exponential growth and peaks that we saw a few months ago," Swaminathan was quoted by local media. “As far as India is concerned that seems to be what is happening and because of size of India and heterogeneity of population and immunity status in different parts of the country in different pockets, it is very very feasible that the situation may continue like this with ups and downs in different parts of the country, particularly where there are more susceptible population, so those groups who were perhaps less affected by first and second waves or those areas with low levels of vaccine coverage we could see peaks and troughs for the next several months," she said. She also expressed hope of India achieving the targeted vaccine coverage of 70% of the population by the end of 2022. While speaking on the prevalence of Covid among children, Swaminathan asked parents to remain calm. “We can take from the serosurvey and what we learnt from other countries also that while it is possible that children could get infected and transmit, children luckily have very mild illness most of the time and there is a small percentage that gets sick and get inflammatory complications and few will die but much much less than the adult population...But it is good to prepare... Preparing hospitals for paediatric admissions, paediatric intensive care is going to serve our health system in many ways for other illnesses children have but we should not panic about thousands of children crowding into ICUs," she said. On the use of drugs like Remdesivir, Ivermectin or HCQ for treatment of COVID systems, she said there is no evidence of these drugs playing a role in reducing mortality or morbidity in people infected with the virus. On the third wave, she said no one has a "crystal ball" and it's impossible to predict a third wave. Meanwhile, India logged 37,593 new coronavirus infections, while the active cases increased marginally to 3,22,327, according to the Union Health Ministry data updated on Wednesday. The total tally of COVID-19 cases increased to 3,25,12,366 and the number of deaths climbed to 4,35,758 with 648 fresh fatalities, according to the data. (With inputs from agencies)

India might be entering endemic stage of COVID-19: WHO chief scientist Swaminathan

US pharma giant Johnson &amp; Johnson has moved an application before the Central Drugs Standard Control Organisation (CDSCO) in India, seeking permission to conduct clinical trials of its single-dose Janssen vaccine against COVID-19 on adolescents (children of age group 12-17 years).

Earlier in August, Johnson &amp; Johnson&nbsp;was given emergency use approval in India for its single-dose COVID-19 vaccine.

A statement by Johnson &amp; Johnson read, "On August 17, 2021, we submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of the Johnson &amp; Johnson COVID-19 vaccine in India in adolescents aged 12 - 17 years."

"To ultimately achieve herd immunity, it is imperative that COVID-19 vaccine clinical trials continue to move forward in this population, and we remain deeply committed to the critical work needed to make our COVID-19 vaccine equitably accessible for all age groups," the company`s spokesperson said.

The five vaccines which were granted emergency use authorisation in India are Serum Institute`s Covishield, Bharat Biotech`s Covaxin, Russia`s Sputnik V m, Moderna and Now Johnson &amp; Johnson (J&amp;J).

US pharma giant Johnson & Johnson has moved an application before the Central Drugs Standard Control Organisation (CDSCO) in India, seeking permission to conduct clinical trials of its single-dose Janssen vaccine against COVID-19 on adolescents (children of age group 12-17 years).

US pharma giant Johnson & Johnson has moved an application before the Central Drugs Standard Control Organisation (CDSCO) in India, seeking permission to conduct clinical trials of its single-dose Janssen vaccine against COVID-19 on adolescents (children of age group 12-17 years). Earlier in August, Johnson & Johnson was given emergency use approval in India for its single-dose COVID-19 vaccine. A statement by Johnson & Johnson read, "On August 17, 2021, we submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of the Johnson & Johnson COVID-19 vaccine in India in adolescents aged 12 - 17 years." "To ultimately achieve herd immunity, it is imperative that COVID-19 vaccine clinical trials continue to move forward in this population, and we remain deeply committed to the critical work needed to make our COVID-19 vaccine equitably accessible for all age groups," the company`s spokesperson said. The five vaccines which were granted emergency use authorisation in India are Serum Institute`s Covishield, Bharat Biotech`s Covaxin, Russia`s Sputnik V m, Moderna and Now Johnson & Johnson (J&J).

COVID-19: J&J applies for approval to conduct clinical trials on adolescents in India for single-dose vaccine

After an expert panel of the Central Drugs Standard Control Organisation (CDSCO) last month recommended granting permission to mix Covaxin and Covishield vaccine doses, India's Drugs Controller General of India (DCGI) has given its approval, reports said.

Reports say the study will be conducted by the Christian Medical College (CMC) in Vellore involving 300 healthy volunteers.

A study in the UK had recently revealed that one dosage of the AstraZeneca vaccine with a dose of the Pfizer-BioNTech vaccine produces strong immunological responses.

The Oxford study said mixed does of produced high concentrations of antibodies against the SARS-CoV2 spike IgG protein.

The study said although two doses of Pfizer were effective but one dose of Pfizer and Oxford's AstraZeneca in "mix and match"&nbsp;combination&nbsp;was equally effective.&nbsp;

India's health ministry had said earlier that mixing vaccines hadn't become the protocol yet with harmful effects not ruled out due to lack of research.

However, VK Paul, Niti Ayog member, had informed&nbsp;there were moves to test mixing of vaccines in the future.&nbsp;

The Indian government last week had given emergency use authorisation to Johnson and Johnson’s single-dose COVID-19 vaccine. The vaccine joined Covishield, Covaxin, Moderna and Sputnik V which were earlier approved in the country.

India on Tuesday had reported 38,353 in 24 hours on Tuesday a rise of over 10,000 from Monday as the country continues to grapple with the virus even as the country's health minister said Russia's Sputnik V shot was 83 per cent effective against the hightly transferable Delta variant.

(With inputs from Agencies) 
&nbsp;

After an expert panel of the Central Drugs Standard Control Organisation (CDSCO) last month recommended granting permission to mix Covaxin and Covishield vaccine doses, India's Drugs Controller General of India (DCGI) has given its approval, reports said.

After an expert panel of the Central Drugs Standard Control Organisation (CDSCO) last month recommended granting permission to mix Covaxin and Covishield vaccine doses, India's Drugs Controller General of India (DCGI) has given its approval, reports said. Reports say the study will be conducted by the Christian Medical College (CMC) in Vellore involving 300 healthy volunteers. A study in the UK had recently revealed that one dosage of the AstraZeneca vaccine with a dose of the Pfizer-BioNTech vaccine produces strong immunological responses. The Oxford study said mixed does of produced high concentrations of antibodies against the SARS-CoV2 spike IgG protein. The study said although two doses of Pfizer were effective but one dose of Pfizer and Oxford's AstraZeneca in "mix and match" combination was equally effective. India's health ministry had said earlier that mixing vaccines hadn't become the protocol yet with harmful effects not ruled out due to lack of research. However, VK Paul, Niti Ayog member, had informed there were moves to test mixing of vaccines in the future. The Indian government last week had given emergency use authorisation to Johnson and Johnson’s single-dose COVID-19 vaccine. The vaccine joined Covishield, Covaxin, Moderna and Sputnik V which were earlier approved in the country. India on Tuesday had reported 38,353 in 24 hours on Tuesday a rise of over 10,000 from Monday as the country continues to grapple with the virus even as the country's health minister said Russia's Sputnik V shot was 83 per cent effective against the hightly transferable Delta variant. (With inputs from Agencies)

India's drug regulator DCGI allows study on mixing Covaxin, Covishield vaccines

Bharat&nbsp;Biotech&nbsp;has terminated a memorandum of understanding to sell its COVID-19 vaccine Covaxin to Brazil's Precisa Medicamentos, the Indian company said on Friday without disclosing the reason.

Bharat's statement said it will continue to work with Brazilian healthcare regulator Anvisa to obtain all required approvals for the use of Covaxin in the country.

The termination of the MoU came after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country.

Precisa Medicamentos is Bharat Biotech's partner in Brazil, providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance and conduct of phase III clinical trials, among others.

Bharat Biotech is pursuing approvals in various countries as per legal requirements applicable in each country, it said.

The company had signed a MoU with Precisa Medicamentos and Envixia Pharmaceuticals LL.C on November 20 for the purpose of introducing Covaxin in the territory of Brazil.

The global pricing of the vaccine has been set between $15-20 and accordingly, the jab was offered to the Government of Brazil at the rate of $15 per dose, Bharat Biotech said.

It is further stated that the company has not received any advance payments from, nor has it supplied any vaccines to the Ministry of Health in Brazil, the company said.

The vaccine maker stressed that all its actions, including its global dealings, are done in accordance with local laws and the company employs and follows the highest standards of ethics, integrity and compliance at all times

Bharat Biotech has terminated a memorandum of understanding to sell its COVID-19 vaccine Covaxin to Brazil's Precisa Medicamentos, the Indian company said on Friday without disclosing the reason.

Bharat Biotech has terminated a memorandum of understanding to sell its COVID-19 vaccine Covaxin to Brazil's Precisa Medicamentos, the Indian company said on Friday without disclosing the reason. Bharat's statement said it will continue to work with Brazilian healthcare regulator Anvisa to obtain all required approvals for the use of Covaxin in the country. The termination of the MoU came after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country. Precisa Medicamentos is Bharat Biotech's partner in Brazil, providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance and conduct of phase III clinical trials, among others. Bharat Biotech is pursuing approvals in various countries as per legal requirements applicable in each country, it said. The company had signed a MoU with Precisa Medicamentos and Envixia Pharmaceuticals LL.C on November 20 for the purpose of introducing Covaxin in the territory of Brazil. The global pricing of the vaccine has been set between $15-20 and accordingly, the jab was offered to the Government of Brazil at the rate of $15 per dose, Bharat Biotech said. It is further stated that the company has not received any advance payments from, nor has it supplied any vaccines to the Ministry of Health in Brazil, the company said. The vaccine maker stressed that all its actions, including its global dealings, are done in accordance with local laws and the company employs and follows the highest standards of ethics, integrity and compliance at all times

Bharat Biotech terminates Covaxin deal with Brazil after graft allegations

Ocugen Inc., Bharat Biotech's partner for the USA and Canada for <a href="https://www.wionews.com/topics/coronavirus-vaccine">COVID-19 vaccine</a> Covaxin has initiated a rolling submission to Health Canada for the jab, the US company said in a regulatory filing.

The move follows the release by Bharat Biotech of Phase 3 clinical trial results, which demonstrated efficacy and safety in nearly 25,800 adults, it said on Thursday.

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/bharat-biotech-announces-covaxins-efficacy-rate-after-final-stage-trials-395623/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process.

Ocugen initiated the rolling submission through its affiliate, Vaccigen, Ltd.

Health Canada will make a decision upon review of the evidence submitted that supports its safety, efficacy and quality.

The rolling submission process was recommended and accepted under the Minister of Health's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and transitioned to a new drug, Ocugen said.

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/estonia-becomes-first-eu-nation-to-approve-both-indian-vaccines-395244/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

"We thank Health Canada for their upcoming review of Covaxin and look forward to working with them so that we can offer the possibility of another safe and effective option to be used in their fight against COVID-19 and its Delta variant," Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen said.

Covaxin was developed in collaboration with the Indian Council of Medical Research (ICMR) National Institute of Virology (NIV)

Ocugen Inc., Bharat Biotech's partner for the USA and Canada for COVID-19 vaccine Covaxin has initiated a rolling submission to Health Canada for the jab, the US company said in a regulatory filing.

Ocugen Inc., Bharat Biotech's partner for the USA and Canada for COVID-19 vaccine Covaxin has initiated a rolling submission to Health Canada for the jab, the US company said in a regulatory filing. The move follows the release by Bharat Biotech of Phase 3 clinical trial results, which demonstrated efficacy and safety in nearly 25,800 adults, it said on Thursday. Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process. Ocugen initiated the rolling submission through its affiliate, Vaccigen, Ltd. Health Canada will make a decision upon review of the evidence submitted that supports its safety, efficacy and quality. The rolling submission process was recommended and accepted under the Minister of Health's Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and transitioned to a new drug, Ocugen said. "We thank Health Canada for their upcoming review of Covaxin and look forward to working with them so that we can offer the possibility of another safe and effective option to be used in their fight against COVID-19 and its Delta variant," Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen said. Covaxin was developed in collaboration with the Indian Council of Medical Research (ICMR) National Institute of Virology (NIV)

Bharat Biotech's partner seeks approval for India-made Covaxin in Canada

Brazilian President Jair&nbsp;Bolsonaro&nbsp;used foul language Thursday as he said he would refuse to answer corruption charges that a Senate committee is investigating involving government vaccine purchases.

The senate's Parliamentary Commission of Inquiry, known in Portuguese by its acronym CPI, has been for weeks investigating&nbsp;Bolsonaro's handling of the coronavirus pandemic.

"Do you know what my answer is?"&nbsp;Bolsonaro&nbsp;said in his weekly broadcast on social media.

"I crap on the CPI. I will answer nothing."

Senators on the commission have asked&nbsp;Bolsonaro&nbsp;to answer charges that a deal to purchase the Indian-made Covaxin vaccine was a front to embezzle millions of dollars, that a&nbsp;Bolsonaro&nbsp;ally masterminded the plan, and that the president knew about it.

"I'm not going to answer any kind of hypothetical situation to that kind of people,"&nbsp;Bolsonaro&nbsp;snapped, claiming that the senators "are not concerned about the truth but instead are interested in wearing down the government."

In a letter, the three senators heading the commission,&nbsp;Omar Aziz, Randolfe Rodrigues, and Renan Calheiros, said that after 13 days of accusations&nbsp;Bolsonaro&nbsp;has yet to clearly and "categorically" reject "the serious statements attributed to him."

A health ministry official earlier told the senators that his superiors had exerted "atypical, excessive" pressure on him to approve payment for the Indian vaccine deal, which he suspected was over-billed.

The official said he informed&nbsp;Bolsonaro&nbsp;in March, but the president apparently failed to pass the information to the police.&nbsp;

This resulted in Brazil's attorney general looking into whether&nbsp;Bolsonaro&nbsp;participated in a coverup.

On Wednesday Aziz ordered the arrest of a former director of Brazil's health ministry on charges of perjury in connection with the case.

Brazilian President Jair Bolsonaro used foul language Thursday as he said he would refuse to answer corruption charges that a Senate committee is investigating involving government vaccine purchases.

Brazilian President Jair Bolsonaro used foul language Thursday as he said he would refuse to answer corruption charges that a Senate committee is investigating involving government vaccine purchases. The senate's Parliamentary Commission of Inquiry, known in Portuguese by its acronym CPI, has been for weeks investigating Bolsonaro's handling of the coronavirus pandemic. "Do you know what my answer is?" Bolsonaro said in his weekly broadcast on social media. "I crap on the CPI. I will answer nothing." Senators on the commission have asked Bolsonaro to answer charges that a deal to purchase the Indian-made Covaxin vaccine was a front to embezzle millions of dollars, that a Bolsonaro ally masterminded the plan, and that the president knew about it. "I'm not going to answer any kind of hypothetical situation to that kind of people," Bolsonaro snapped, claiming that the senators "are not concerned about the truth but instead are interested in wearing down the government." In a letter, the three senators heading the commission, Omar Aziz, Randolfe Rodrigues, and Renan Calheiros, said that after 13 days of accusations Bolsonaro has yet to clearly and "categorically" reject "the serious statements attributed to him." A health ministry official earlier told the senators that his superiors had exerted "atypical, excessive" pressure on him to approve payment for the Indian vaccine deal, which he suspected was over-billed. The official said he informed Bolsonaro in March, but the president apparently failed to pass the information to the police. This resulted in Brazil's attorney general looking into whether Bolsonaro participated in a coverup. On Wednesday Aziz ordered the arrest of a former director of Brazil's health ministry on charges of perjury in connection with the case.

Brazilian President Jair Bolsonaro slams corruption probe with foul language

Bharat Biotech said that it has concluded the final analysis for its COVID-19 vaccine Covaxin as part of phase-3 clinical trials. The Hyderabad-based pharma company claimed that its indigenous jab demonstrates an overall efficacy of 77.8% against symptomatic infection.

Bharat Biotech announces Covaxin's efficacy rate after final stage trials

Estonia's envoy&nbsp;Katrin Kivi has said, "any vaccine is better than no vaccine" after&nbsp;the European Union&nbsp;launched&nbsp;a digital COVID certificate system&nbsp;designed to help citizens travel more freely across the 27-nation bloc and open up summer tourism.

The EU digital COVID certificate, which can be on a smartphone or printed out, takes the form of a QR-code, which indicates if a traveller has been fully vaccinated against COVID-19, has received a recent negative test result, or has immunity due to recent recovery from a COVID-19 infection.

The certificate is designed to be free of charge, issued and valid in all EU countries, and set out in the national language and in English. It also extends to non-EU countries of the border-free Schengen zone - Iceland, Liechtenstein, Norway, and Switzerland.

While the bloc&nbsp;uses the European Medicines Agency's (EMA) list that has listed four, each member country is free to put any vaccine on the national list.&nbsp;

Speaking to our diplomatic correspondent Sidhant Sibal,&nbsp;envoy&nbsp;Katrin Kivi&nbsp;said, "India has been giving so many vaccines to Indians and under&nbsp;COVAX&nbsp;scheme. It would be absolutely natural that Covishield will get recognition by WHO and EMA".&nbsp;

Estonia is the first country in Europe that has approved&nbsp;India-made Covishield and Covaxin on its national travel list. That means, any Indian vaccinated with these two&nbsp;vaccines will be allowed in the country subjected to other conditions in the Schengen rules.&nbsp;

WION: India-made vaccine Covishield and Covaxin have been approved by your country for Covid vaccine certificates. If you can give us the details?

Katrin Kivi:&nbsp;Thank you for inviting me, namaste. Indeed, the Estonia government had decided already on June 21 to acknowledge the vaccine certificates of countries like India. If travellers from these countries are able to present on the border covid vaccination certificate which has been approved officially by their governments and vaccines which are administered in this country. India is vaccinating Indians with Covishield and Covaxin, the citizens can get certificates concerning both vaccines.

The vaccine certificate only helps people to escape the mandatory quarantine at the border, it is not like a new sort of visa and it will not open automatically issuing or resuming third country person Schengen visas as of tourist. It is related with those Indian citizens already have a valid visa, who may be even are Estonian temporary or permanent resident. They can travel easily if they can present at the border the certificate. Other issue is EU green pass, it was meant to ease travel inside and in between EU member states.

Like in India you have different rules and restrictions between various states and territories, EU member states also had issued restrictions and travel was not so easy. Now with member states have decided to take these vaccines that are acknowledged by European medicine agencies into EU green pass, but it is not way a precondition or required by Indian citizens on the border. This is just for all EU members vaccinated with 4 vaccines. Until now we have only Pfizer, Moderna, AstraZeneca, and J&amp;J on the green pass.

In order for India to get Covishield on the green pass approved vaccines, the Indian government should request a European medicines agency to add Covishield into this list, to do that particular file should be handed over. I really encourage India to do it, because India has been giving so many vaccines to Indians and to Covax. It would be absolutely natural that Covishield will get recognition by WHO and EMA.&nbsp; &nbsp;

WION: What was the thought process in allowing all nationally recognised vaccines?

Katrin Kivi:&nbsp;This is mainly aimed to protect the help of Estonians, and other citizens who are travelling to Estonia because it is very sure any vaccine is better than not being vaccinated. Estonian govt has just decided to acknowledge it and even we have a lot of border movement with Russia and they have sputnik which is administered. If Russians are travelling to Estonia, and they have a valid reason, relatives living in Estonia, they can present this certificate and escape the quarantine. Otherwise, they must be&nbsp;quarantined or isolated or not having any contact. If they are fully vaccinated and having negative PCR tests, why should they be isolated, that was the reason.&nbsp;

WION: what do you have to say about the EU Green pass. The pass could have used WHO list, instead of EMA list?

Katrin Kivi:&nbsp;This decision has been made together conjointly with all EU member states especially Schengen states. According to our commonly agreed rules, the European medicines agency or EMA has a say here, which vaccines are included in the green pass. This agency is not a political agency, it is a purely medical scientific agency and it works for the benefit of all people who are travelling inside the European Union. If Indian residents in Estonia, would be vaccinated , they could also get this green pass. In Estonia, we are vaccinating only with 4 vaccines. The main goal was to ease travel against the member states, so it not against the third country and not required or a pre-requisite or a must on the border.&nbsp;

WION: Are Indians allowed in Estonia?

Katrin Kivi:&nbsp;It is of course still a tricky question and fully related to the situation of pandemic. It means Indians who already have a valid Schengen visa or who are Estonian resident, who need to go to Estonia for work or meet relatives or health issue of close people, they are allowed to enter Estonia. As for new visas, Estonia embassy consular section has not yet resumed, issuing C visas, visas for touristic or non-essential travel. This may need some time, it may happen but we look at covid numbers and stick to the exiting Schengen rules, under which tourism is not open.

WION: What kind of cooperation between India, and Estonia? Both countries are non-permanent members of the UNSC, in fact, Estonia was the president just last month.

Katrin Kivi:&nbsp;You mention the good cooperation in the United Nations Security council, indeed, our second chairmanship just finished and one of the two&nbsp;most important debates in June, one on Afghanistan in which EAM Jaishankar took the floor, and the second was just two&nbsp;days ago on cybersecurity. These topics, Estonia and India understand are crucial in keeping the world safe and be virtual or physical space --we need rules and good state behaviour inside cyberspace.

Estonian and Indian relations in the current year will be marked by few other happy moments, namely, India is preparing to open its embassy in our capital, we welcome the Indian minister of external affairs. This year we also celebrate the 30 years of establishing diplomatic relations and last but not least we are waiting to unveil the statue of Mahatma Gandhi and our two&nbsp;nations have a link and understanding that struggle, the battle for the restoration of Independence should be non-violent and fully peacefully.&nbsp; &nbsp;

Estonia's envoy Katrin Kivi has said, "any vaccine is better than no vaccine" after the European Union launched a digital COVID certificate system designed to help citizens travel more freely across the 27-nation bloc and open up summer tourism.

Estonia's envoy Katrin Kivi has said, "any vaccine is better than no vaccine" after the European Union launched a digital COVID certificate system designed to help citizens travel more freely across the 27-nation bloc and open up summer tourism. The EU digital COVID certificate, which can be on a smartphone or printed out, takes the form of a QR-code, which indicates if a traveller has been fully vaccinated against COVID-19, has received a recent negative test result, or has immunity due to recent recovery from a COVID-19 infection. The certificate is designed to be free of charge, issued and valid in all EU countries, and set out in the national language and in English. It also extends to non-EU countries of the border-free Schengen zone - Iceland, Liechtenstein, Norway, and Switzerland. While the bloc uses the European Medicines Agency's (EMA) list that has listed four, each member country is free to put any vaccine on the national list. Speaking to our diplomatic correspondent Sidhant Sibal, envoy Katrin Kivi said, "India has been giving so many vaccines to Indians and under COVAX scheme. It would be absolutely natural that Covishield will get recognition by WHO and EMA". Estonia is the first country in Europe that has approved India-made Covishield and Covaxin on its national travel list. That means, any Indian vaccinated with these two vaccines will be allowed in the country subjected to other conditions in the Schengen rules. WION: India-made vaccine Covishield and Covaxin have been approved by your country for Covid vaccine certificates. If you can give us the details? Katrin Kivi: Thank you for inviting me, namaste. Indeed, the Estonia government had decided already on June 21 to acknowledge the vaccine certificates of countries like India. If travellers from these countries are able to present on the border covid vaccination certificate which has been approved officially by their governments and vaccines which are administered in this country. India is vaccinating Indians with Covishield and Covaxin, the citizens can get certificates concerning both vaccines. The vaccine certificate only helps people to escape the mandatory quarantine at the border, it is not like a new sort of visa and it will not open automatically issuing or resuming third country person Schengen visas as of tourist. It is related with those Indian citizens already have a valid visa, who may be even are Estonian temporary or permanent resident. They can travel easily if they can present at the border the certificate. Other issue is EU green pass, it was meant to ease travel inside and in between EU member states. Like in India you have different rules and restrictions between various states and territories, EU member states also had issued restrictions and travel was not so easy. Now with member states have decided to take these vaccines that are acknowledged by European medicine agencies into EU green pass, but it is not way a precondition or required by Indian citizens on the border. This is just for all EU members vaccinated with 4 vaccines. Until now we have only Pfizer, Moderna, AstraZeneca, and J&J on the green pass. In order for India to get Covishield on the green pass approved vaccines, the Indian government should request a European medicines agency to add Covishield into this list, to do that particular file should be handed over. I really encourage India to do it, because India has been giving so many vaccines to Indians and to Covax. It would be absolutely natural that Covishield will get recognition by WHO and EMA. WION: What was the thought process in allowing all nationally recognised vaccines? Katrin Kivi: This is mainly aimed to protect the help of Estonians, and other citizens who are travelling to Estonia because it is very sure any vaccine is better than not being vaccinated. Estonian govt has just decided to acknowledge it and even we have a lot of border movement with Russia and they have sputnik which is administered. If Russians are travelling to Estonia, and they have a valid reason, relatives living in Estonia, they can present this certificate and escape the quarantine. Otherwise, they must be quarantined or isolated or not having any contact. If they are fully vaccinated and having negative PCR tests, why should they be isolated, that was the reason. WION: what do you have to say about the EU Green pass. The pass could have used WHO list, instead of EMA list? Katrin Kivi: This decision has been made together conjointly with all EU member states especially Schengen states. According to our commonly agreed rules, the European medicines agency or EMA has a say here, which vaccines are included in the green pass. This agency is not a political agency, it is a purely medical scientific agency and it works for the benefit of all people who are travelling inside the European Union. If Indian residents in Estonia, would be vaccinated , they could also get this green pass. In Estonia, we are vaccinating only with 4 vaccines. The main goal was to ease travel against the member states, so it not against the third country and not required or a pre-requisite or a must on the border. WION: Are Indians allowed in Estonia? Katrin Kivi: It is of course still a tricky question and fully related to the situation of pandemic. It means Indians who already have a valid Schengen visa or who are Estonian resident, who need to go to Estonia for work or meet relatives or health issue of close people, they are allowed to enter Estonia. As for new visas, Estonia embassy consular section has not yet resumed, issuing C visas, visas for touristic or non-essential travel. This may need some time, it may happen but we look at covid numbers and stick to the exiting Schengen rules, under which tourism is not open. WION: What kind of cooperation between India, and Estonia? Both countries are non-permanent members of the UNSC, in fact, Estonia was the president just last month. Katrin Kivi: You mention the good cooperation in the United Nations Security council, indeed, our second chairmanship just finished and one of the two most important debates in June, one on Afghanistan in which EAM Jaishankar took the floor, and the second was just two days ago on cybersecurity. These topics, Estonia and India understand are crucial in keeping the world safe and be virtual or physical space --we need rules and good state behaviour inside cyberspace. Estonian and Indian relations in the current year will be marked by few other happy moments, namely, India is preparing to open its embassy in our capital, we welcome the Indian minister of external affairs. This year we also celebrate the 30 years of establishing diplomatic relations and last but not least we are waiting to unveil the statue of Mahatma Gandhi and our two nations have a link and understanding that struggle, the battle for the restoration of Independence should be non-violent and fully peacefully.

Exclusive: Any vaccine is better than no vaccine, says Estonia Envoy

Estonia has become the first European Union country to recognise both the COVID-19 vaccines authorised by India-Covisheild and Covaxin. Seven other EU nations have also given nod to Covishield.

Estonia becomes first EU nation to approve both Indian vaccines

Estonia's envoy Katrin Kivi has said, "any vaccine is better than no vaccine" even as the European Union has come with new certificates for travel inside the block. While the block uses the European Medicines Agency's (EMA) list that has 4 vaccines listed, each member country is free to put any vaccine on the national list.

Any vaccine is better than no vaccine, says Estonia Envoy Katrin Kivi

India has reached out to member countries of the European Union, urging to list domestically-made coronavirus&nbsp;vaccines--Covaxin and&nbsp;Covishield on the national travel lists formed in the backdrop of the Covid crisis.

Listing of these two&nbsp;vaccines ensures that anyone who is inoculated by them can be exempted under the EU green pass, also known as European Union (EU) Digital Covid Certificate that comes into effect from today.&nbsp;

New Delhi has also urged the EU member counties to accept the&nbsp;vaccination certificate issued through India's CoWIN portal. The CoWIN portal is a digital platform India is using as part of its vaccination drive against the Covid.

In a quid pro quo gesture, the offer includes "reciprocal&nbsp;recognition" of EU green pass if EU states agree with the above two proposals. This, in effect, means that travelers from the EU countries carrying the EU&nbsp;Digital Covid Certificate will be exempted from&nbsp;mandatory quarantine.&nbsp;&nbsp;Many EU Member states like Ireland have given approval to Covishield for its national travel list.

The EU green pass uses the&nbsp;&nbsp;European Medicines Agency (EMA) list of approved vaccines.&nbsp;EMA, which gives commercial authorisation lists only 4 vaccines, none of them are India-made vaccines. But each member state has been given the&nbsp;flexibility to also accept vaccines that have been authorized at the national level or by the World Health Organization. WHO has given approval to 8 vaccines, which include Covishield manufactured by Serum Institute of India.

"The EU Digital covid certificate is meant to facilitate safe movement during the COVID-19 pandemic within the European Union. It will serve as proof that the person was vaccinated against covid 19 or received a negative result or recovered from COVID",&nbsp;European Union's envoy to India Ugo Astuto told WION earlier this week.&nbsp;

External Affairs Minister Dr S Jaishankar had met his European counterpart Josep Borrell on the sidelines of the G20 Foreign Ministers' meet in Italy had raised the matter of Covishield's authorization. Earlier the matter has been raised with the&nbsp;EMA as well.

&nbsp;

India has reached out to member countries of the European Union, urging to list domestically-made coronavirus vaccines--Covaxin and Covishield on the national travel lists formed in the backdrop of the Covid crisis.

India has reached out to member countries of the European Union, urging to list domestically-made coronavirus vaccines--Covaxin and Covishield on the national travel lists formed in the backdrop of the Covid crisis. Listing of these two vaccines ensures that anyone who is inoculated by them can be exempted under the EU green pass, also known as European Union (EU) Digital Covid Certificate that comes into effect from today. New Delhi has also urged the EU member counties to accept the vaccination certificate issued through India's CoWIN portal. The CoWIN portal is a digital platform India is using as part of its vaccination drive against the Covid. In a quid pro quo gesture, the offer includes "reciprocal recognition" of EU green pass if EU states agree with the above two proposals. This, in effect, means that travelers from the EU countries carrying the EU Digital Covid Certificate will be exempted from mandatory quarantine. Many EU Member states like Ireland have given approval to Covishield for its national travel list. The EU green pass uses the European Medicines Agency (EMA) list of approved vaccines. EMA, which gives commercial authorisation lists only 4 vaccines, none of them are India-made vaccines. But each member state has been given the flexibility to also accept vaccines that have been authorized at the national level or by the World Health Organization. WHO has given approval to 8 vaccines, which include Covishield manufactured by Serum Institute of India. "The EU Digital covid certificate is meant to facilitate safe movement during the COVID-19 pandemic within the European Union. It will serve as proof that the person was vaccinated against covid 19 or received a negative result or recovered from COVID", European Union's envoy to India Ugo Astuto told WION earlier this week. External Affairs Minister Dr S Jaishankar had met his European counterpart Josep Borrell on the sidelines of the G20 Foreign Ministers' meet in Italy had raised the matter of Covishield's authorization. Earlier the matter has been raised with the EMA as well.

India reaches out to EU member countries for exemption on India-made vaccines

The Indian government has reportedly told the EU that it should either accept the two vaccines manufactured in India, Covaxin and Covishield, or face mandatory quarantine upon arrival in India.

India asks EU to accept Covaxin, Covishield or to face quarantine

The COVID-19 vaccine Covaxin, produced by Bharat Biotech, is highly efficient in neutralising both Alpha and Delta strains of coronavirus, according to the US National Institute of Health (NIH).

"Results of two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the UK and India," the NIH said. 
 
<a href="https://www.wionews.com/india-news/covishield-becomes-collateral-damage-in-the-inter-eu-tussle-over-chinese-vaccines-394744">Also read | Covishield becomes collateral damage in the inter EU tussle over Chinese vaccines</a> 
 
Covaxin comprises a disabled form of SARS-CoV-2 that can not replicate but still stimulates the immune system to make antibodies against the virus. Published results from a phase 2 trial of the vaccine indicate that it is safe and well tolerated, the NIH said, adding that safety data from a phase 3 trial of Covaxin will become available later this year. 
 
Also read |&nbsp;<a href="https://www.wionews.com/science/delhi-new-virus-cytomegalovirus-found-in-covid-patients-394725" hreflang="en">Delhi: New virus, Cytomegalovirus, found in Covid patients</a>

Covaxin is a non-replicating version of SARS-CoV-2 that induces the immune system to produce antibodies against the virus.

The vaccine is safe and well tolerated, according to published results from a phase 2 trial. Safety data from a phase 3 trial of Covaxin will be available later this year.

"Meanwhile, unpublished interim results from the phase 3 trial indicate that the vaccine has 78 per cent efficacy against symptomatic disease, 100 per cent efficacy against severe COVID-19, including hospitalisation, and 70 per cent efficacy against asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19," it said. 
 
Also read |&nbsp;<a href="https://www.wionews.com/india-news/cipla-gets-dcgi-nod-to-import-modernas-covid-vaccine-for-restricted-emergency-use-in-india-sources-394590" hreflang="en">Cipla gets DCGI nod to import Moderna's Covid vaccine for restricted emergency use in India: Sources</a>

"The results from two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the UK and India, respectively," the NIH said.

Earlier, the Centre had stated that Covishield and Covaxin work against SARS-CoV-2 variants Alpha, Beta, Gamma and Delta, while effectiveness tests against the Delta Plus variant is ongoing, the government said on Friday. There are four variants of concern of the coronavirus disease, Alpha, Beta, Gamma and Delta, with Delta Plus being a sub-lineage of the Delta variant which is also a variant of concern.

Addressing a press conference, ICMR Director General Balram Bhargava said reduction of neutralisation capabilities of vaccine with different variants, which is based on global literature, shows that Covaxin does not change with the Alpha variant at all and so it is same as it is with the standard strain. "Covishield reduces slightly with Alpha, by 2.5 times. "Covaxin is effective for the Delta variant, but antibody response is slightly reduced to a three-fold reduction for Covishield, a two-fold reduction for Pfizer and Moderna, and a seven-fold reduction for Pfizer and Moderna," he said.

"However, Covishield and Covaxin work against the variants of SARS-CoV-2- Alpha, Beta, Gamma and Delta. That is well established for these two vaccines," Bhargava said.

(With inputs from agencies)

The COVID-19 vaccine Covaxin, produced by Bharat Biotech, is highly efficient in neutralising both Alpha and Delta strains of coronavirus, according to the US National Institute of Health (NIH).

The COVID-19 vaccine Covaxin, produced by Bharat Biotech, is highly efficient in neutralising both Alpha and Delta strains of coronavirus, according to the US National Institute of Health (NIH). "Results of two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the UK and India," the NIH said. Also read | Covishield becomes collateral damage in the inter EU tussle over Chinese vaccines Covaxin comprises a disabled form of SARS-CoV-2 that can not replicate but still stimulates the immune system to make antibodies against the virus. Published results from a phase 2 trial of the vaccine indicate that it is safe and well tolerated, the NIH said, adding that safety data from a phase 3 trial of Covaxin will become available later this year. Also read | Delhi: New virus, Cytomegalovirus, found in Covid patients Covaxin is a non-replicating version of SARS-CoV-2 that induces the immune system to produce antibodies against the virus. The vaccine is safe and well tolerated, according to published results from a phase 2 trial. Safety data from a phase 3 trial of Covaxin will be available later this year. "Meanwhile, unpublished interim results from the phase 3 trial indicate that the vaccine has 78 per cent efficacy against symptomatic disease, 100 per cent efficacy against severe COVID-19, including hospitalisation, and 70 per cent efficacy against asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19," it said. Also read | Cipla gets DCGI nod to import Moderna's Covid vaccine for restricted emergency use in India: Sources "The results from two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the UK and India, respectively," the NIH said. Earlier, the Centre had stated that Covishield and Covaxin work against SARS-CoV-2 variants Alpha, Beta, Gamma and Delta, while effectiveness tests against the Delta Plus variant is ongoing, the government said on Friday. There are four variants of concern of the coronavirus disease, Alpha, Beta, Gamma and Delta, with Delta Plus being a sub-lineage of the Delta variant which is also a variant of concern. Addressing a press conference, ICMR Director General Balram Bhargava said reduction of neutralisation capabilities of vaccine with different variants, which is based on global literature, shows that Covaxin does not change with the Alpha variant at all and so it is same as it is with the standard strain. "Covishield reduces slightly with Alpha, by 2.5 times. "Covaxin is effective for the Delta variant, but antibody response is slightly reduced to a three-fold reduction for Covishield, a two-fold reduction for Pfizer and Moderna, and a seven-fold reduction for Pfizer and Moderna," he said. "However, Covishield and Covaxin work against the variants of SARS-CoV-2- Alpha, Beta, Gamma and Delta. That is well established for these two vaccines," Bhargava said. (With inputs from agencies)

COVID-19: US NIH says Covaxin very effective against Delta variant

India's home-made shot Covaxin is at the centre of a storm in Brazil. Federal prosecutors in Brazil suspect corruption in the way Bharat Biotech's representative reached an agreement with the government. Palki Sharma tells you more.

Gravitas: Covaxin at the centre of a storm in Brazil

India's Covaxin&nbsp;has shown 77.8 per cent efficacy against coronavirus in phase 3 trial data in review by the subject expert committee, news agency ANI quoting sources reported on Tuesday.

According to ANI sources, Covaxin is likely to get clearance from the Drugs Controller General of India (DCGI) today.

Watch:

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/biden-administration-announces-allocation-plan-for-55-mn-covid-19-vaccine-doses-393157/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

The development comes as the health ministry said on Tuesday that the average daily <a href="https://www.wionews.com/world/abdala-vaccine-9228-effective-against-covid-19-says-cuba-393134">vaccination</a> was 34,62,841 in the country, therefore 88 lakh vaccines and capacity is possible.

India on Monday administered 88.09 lakh <a href="https://www.wionews.com/india-news/over-82-million-vaccine-doses-administered-across-india-health-ministry-393026">vaccine</a> jabs in a single day reaching a historic milestone with Madhya Pradesh inoculating the highest number of doses numbering over 17 lakh followed by Karnataka with 11 lakh doses, Uttar Pradesh with 7 lakh jabs and Bihar with 5.75 lakh doses

The health ministry informed that Indian vaccines Covishield and Covaxin are effective against the Delta variant.

Niti Aayog's&nbsp;VK Paul informed that more than half of the doses administered over the last few weeks were inoculated in rural areas.

Union health secretary Rajesh Bhushan informed that the new Delta Plus variant has been found in 16 of the 22 cases including Ratnagiri and Jalgaon in Maharashtra including Kerala and Madhya Pradesh.

As India continues to battle the virus, the health ministry announced that in 553 districts in the country the coronavirus positivity rate has dipped to less than 5 per cent.

The ministry said that over 2.14 crore coronavirus vaccine doses were still available with the states and Union Territories and over 33,80,590 vaccine doses are in the pipeline.

On Monday, the Indian government had started the "Free Vaccination For All campaign".

According to the revised guidelines, vaccine doses will be provided free of cost by the Centre based on criteria such as state's population, disease burden and vaccination progress. All adults above 18 years will be eligible for the free jabs.

India's Covaxin has shown 77.8 per cent efficacy against coronavirus in phase 3 trial data in review by the subject expert committee, news agency ANI quoting sources reported on Tuesday.

India's Covaxin has shown 77.8 per cent efficacy against coronavirus in phase 3 trial data in review by the subject expert committee, news agency ANI quoting sources reported on Tuesday. According to ANI sources, Covaxin is likely to get clearance from the Drugs Controller General of India (DCGI) today. Watch: The development comes as the health ministry said on Tuesday that the average daily vaccination was 34,62,841 in the country, therefore 88 lakh vaccines and capacity is possible. India on Monday administered 88.09 lakh vaccine jabs in a single day reaching a historic milestone with Madhya Pradesh inoculating the highest number of doses numbering over 17 lakh followed by Karnataka with 11 lakh doses, Uttar Pradesh with 7 lakh jabs and Bihar with 5.75 lakh doses The health ministry informed that Indian vaccines Covishield and Covaxin are effective against the Delta variant. Niti Aayog's VK Paul informed that more than half of the doses administered over the last few weeks were inoculated in rural areas. Union health secretary Rajesh Bhushan informed that the new Delta Plus variant has been found in 16 of the 22 cases including Ratnagiri and Jalgaon in Maharashtra including Kerala and Madhya Pradesh. As India continues to battle the virus, the health ministry announced that in 553 districts in the country the coronavirus positivity rate has dipped to less than 5 per cent. The ministry said that over 2.14 crore coronavirus vaccine doses were still available with the states and Union Territories and over 33,80,590 vaccine doses are in the pipeline. On Monday, the Indian government had started the "Free Vaccination For All campaign". According to the revised guidelines, vaccine doses will be provided free of cost by the Centre based on criteria such as state's population, disease burden and vaccination progress. All adults above 18 years will be eligible for the free jabs.

Covaxin has shown 77.8 per cent efficacy against virus: Report

The Indian government has denied reports that the homegrown jab Covaxin contains calf serum. Why do fake reports gain so much traction on social media? What is the cost of such misinformation? Palki Sharma explains.

Gravitas: Covaxin has calf serum? Government says no

Bringing the Indian Covid vaccine Covaxin&nbsp;a step closer to World Health Organization's approval, the pre-submission meeting will be taking place on&nbsp;June 23. WHO documents show the Expression of Interest (EOI) has been accepted by the Geneva-based body.

Hyderabad-based&nbsp;Bharat Biotech, which manufactures the vaccine, had submitted its Expression of Interest (EOI) on April 19. Once the dossier is accepted for review and the status of assessment finalised, a decision will be taken.

Covaxin&nbsp;is the second made-in-India vaccine to apply at the global body for Emergency Use Listing (EUL). Covishield, made by the Serum Institute of India,&nbsp; got WHO EUL on 15th February.

WHO listing will allow Covaxin to get global approval for use, something that has other benefits like the easy movement of Indians who have been vaccinated by it.

May saw an important meeting of Bharat Biotech officials and senior officers of the Ministry of Health, Department of Biotechnology, and Ministry of External Affairs to chalk out a strategy for early approval of the vaccine.

Covaxin has received emergency use authorisation from 14 countries, with more than 50 other countries in the pipeline. When it comes to the US, Bharat Biotech's US partner Ocugen has been asked by FDA to pursue Biologics License Applications (BLA) path for Covaxin's full approval.

So far, eight vaccines globally have been approved by WHO for EUL, including those made by Pfizer, AstraZeneca, Janssen, Moderna, Sinovac and Sinopharm.

Russia's Sputnik vaccine is expected to get approval soon "once all the data is submitted", said WHO documents. A total of 22 vaccines have applied for WHO approval globally, with 14 in various stages of negotiations.

Bringing the Indian Covid vaccine Covaxin a step closer to World Health Organization's approval, the pre-submission meeting will be taking place on June 23. WHO documents show the Expression of Interest (EOI) has been accepted by the Geneva-based body.

Bringing the Indian Covid vaccine Covaxin a step closer to World Health Organization's approval, the pre-submission meeting will be taking place on June 23. WHO documents show the Expression of Interest (EOI) has been accepted by the Geneva-based body. Hyderabad-based Bharat Biotech, which manufactures the vaccine, had submitted its Expression of Interest (EOI) on April 19. Once the dossier is accepted for review and the status of assessment finalised, a decision will be taken. Covaxin is the second made-in-India vaccine to apply at the global body for Emergency Use Listing (EUL). Covishield, made by the Serum Institute of India, got WHO EUL on 15th February. WHO listing will allow Covaxin to get global approval for use, something that has other benefits like the easy movement of Indians who have been vaccinated by it. May saw an important meeting of Bharat Biotech officials and senior officers of the Ministry of Health, Department of Biotechnology, and Ministry of External Affairs to chalk out a strategy for early approval of the vaccine. Covaxin has received emergency use authorisation from 14 countries, with more than 50 other countries in the pipeline. When it comes to the US, Bharat Biotech's US partner Ocugen has been asked by FDA to pursue Biologics License Applications (BLA) path for Covaxin's full approval. So far, eight vaccines globally have been approved by WHO for EUL, including those made by Pfizer, AstraZeneca, Janssen, Moderna, Sinovac and Sinopharm. Russia's Sputnik vaccine is expected to get approval soon "once all the data is submitted", said WHO documents. A total of 22 vaccines have applied for WHO approval globally, with 14 in various stages of negotiations.

COVID-19: Bharat Biotech's pre-submission meeting for Covaxin's WHO approval on June 23

The Indian government clarified that the indigenously developed Covaxin does not contain newborn calf serum. The clarification came in response to some social media posts where it has been suggested that the Covaxin vaccine contains the newborn calf serum.

Covaxin vaccine does not contain newborn calf serum: Indian govt busts myths

The recruitment for the clinical trial of the country's first indigenously-developed COVID-19 vaccine, Covaxin, among children in the age group of 6-12 years will begin at the AIIMS here from Tuesday. This will be followed by the clinical trial of children in the age group of 2-6 years.

The enrolment of children volunteers aged 12-18 years at the All India Institute of Medical Sciences (AIIMS) has been completed and they have been given the first dose of Covaxin.

"The recruitment process for the clinical trial of Covaxin among children in the age group of 6-12 years will begin from Tuesday," Dr Sanjay Rai, Professor at the Centre for Community Medicine at the AIIMS, told PTI.

The Drugs Controller General of India (DCGI) had granted permission for conducting the Phase 2/3 clinical trial of Bharat Biotech's Covaxin among children aged two to 18 years on May 12.

The trial is to be conducted in three parts -- 175 volunteers each in the groups aged 12-18, 6-12 and 2-6 years. In the trial, the vaccine will be given by the intramuscular route in two doses on day 0 and day 28.

Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in the country's ongoing COVID-19 vaccination drive. The clinical trials will evaluate the safety, reactogenicity and immunogenicity of the vaccine in children.

The government recently cautioned that even though COVID-19 has not taken a serious shape among children till now, its impact can increase among them if there is a change in the virus behaviour or epidemiology dynamics and said preparations are being strengthened to deal with any such situation.

A national expert group has been formed to review COVID-19 cases in children and approach the pandemic in a renewed way to strengthen the country's preparedness, NITI Aayog Member (Health) V K Paul had told a press conference. The group has examined signs that were not available four-five months before, he had said.

The recruitment for the clinical trial of the country's first indigenously-developed COVID-19 vaccine, Covaxin, among children in the age group of 6-12 years will begin at the AIIMS here from Tuesday.

The recruitment for the clinical trial of the country's first indigenously-developed COVID-19 vaccine, Covaxin, among children in the age group of 6-12 years will begin at the AIIMS here from Tuesday. This will be followed by the clinical trial of children in the age group of 2-6 years. The enrolment of children volunteers aged 12-18 years at the All India Institute of Medical Sciences (AIIMS) has been completed and they have been given the first dose of Covaxin. "The recruitment process for the clinical trial of Covaxin among children in the age group of 6-12 years will begin from Tuesday," Dr Sanjay Rai, Professor at the Centre for Community Medicine at the AIIMS, told PTI. The Drugs Controller General of India (DCGI) had granted permission for conducting the Phase 2/3 clinical trial of Bharat Biotech's Covaxin among children aged two to 18 years on May 12. The trial is to be conducted in three parts -- 175 volunteers each in the groups aged 12-18, 6-12 and 2-6 years. In the trial, the vaccine will be given by the intramuscular route in two doses on day 0 and day 28. Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in the country's ongoing COVID-19 vaccination drive. The clinical trials will evaluate the safety, reactogenicity and immunogenicity of the vaccine in children. The government recently cautioned that even though COVID-19 has not taken a serious shape among children till now, its impact can increase among them if there is a change in the virus behaviour or epidemiology dynamics and said preparations are being strengthened to deal with any such situation. A national expert group has been formed to review COVID-19 cases in children and approach the pandemic in a renewed way to strengthen the country's preparedness, NITI Aayog Member (Health) V K Paul had told a press conference. The group has examined signs that were not available four-five months before, he had said.

Recruitment for clinical trial of Covaxin in 6-12 age group to start at AIIMS from Tuesday

Covaxin has been denied emergency use authorisation in the US. The vaccine is yet to be listed on the WHO's list of approved vaccines. The lack of global approvals has put a question mark on travel, work & study plans of millions of Indians.

Gravitas: Why did America deny approval to Covaxin?

India: No American approval for Covaxin

India's apex drug regulator has waived the requirement of testing every batch of foreign-made COVID-19 vaccines by the Central Drugs Laboratory, Kasauli and post-launch bridging trials for such firms, a move that will bolster the availability of vaccines.

The decision by the Drugs Controller General of India (DCGI) comes in the backdrop of Pfizer and Cipla putting forth similar demands during negotiations to supply imported vaccines to India.

These exemptions have been made in light of the huge vaccination requirements in India in the wake of the recent surge of COVID-19 cases and the need for increased availability of imported vaccines to meet national requirements, according to DCGI.

"It has been decided that for approval of COVID-19 vaccines in India for restricted use in an emergency situation which is already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing and which are well-established vaccines from the standpoint that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post-approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of the country of origin," it said.

However, scrutiny of their summary lot protocol and certificate of analysis of batch or lot shall be undertaken by CDL, Kasauli for release as per standard procedures and requirement of assessment on the first 100 beneficiaries for seven days for safety outcomes before the vaccine is rolled out for further immunization programme, the DCGI said in a notice issued on June 1.

India's apex drug regulator has waived the requirement of testing every batch of foreign-made COVID-19 vaccines by the Central Drugs Laboratory, Kasauli and post-launch bridging trials for such firms, a move that will bolster the availability of vaccines.

India's apex drug regulator has waived the requirement of testing every batch of foreign-made COVID-19 vaccines by the Central Drugs Laboratory, Kasauli and post-launch bridging trials for such firms, a move that will bolster the availability of vaccines. The decision by the Drugs Controller General of India (DCGI) comes in the backdrop of Pfizer and Cipla putting forth similar demands during negotiations to supply imported vaccines to India. These exemptions have been made in light of the huge vaccination requirements in India in the wake of the recent surge of COVID-19 cases and the need for increased availability of imported vaccines to meet national requirements, according to DCGI. "It has been decided that for approval of COVID-19 vaccines in India for restricted use in an emergency situation which is already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing and which are well-established vaccines from the standpoint that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post-approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of the country of origin," it said. However, scrutiny of their summary lot protocol and certificate of analysis of batch or lot shall be undertaken by CDL, Kasauli for release as per standard procedures and requirement of assessment on the first 100 beneficiaries for seven days for safety outcomes before the vaccine is rolled out for further immunization programme, the DCGI said in a notice issued on June 1.

Indian drugs regulator DCGI eases norms for clearing foreign-made COVID-19 vaccines

People all over the world are still learning how effective vaccinations are at preventing the deadly virus that causes COVID-19 from spreading to others, even if you don't have symptoms.&nbsp;

Early evidence suggests that vaccinations can help prevent COVID-19 from spreading among people who have no symptoms.&nbsp;

Vaccines are effective and safe. You may experience side effects as a result of the vaccine, but these are common and will pass in a few days.

Here are some of the tips from health experts about what to do before, during and after getting vaccinated for COVID-19:&nbsp;

Which one is the best vaccine among all 3 available in India?

Covisheild, Covaxin and the recently added Sputnik V&nbsp;are the vaccines available to Indians. All three are effective in both avoiding infection and preventing the disease from progressing to a severe stage. They avoid fatality in the long run for the elderly and those with comorbidities.&nbsp;

Who should not get the Covid vaccine?

According to the UNICEF, at present, people with the following health conditions should not receive a COVID-19 vaccine to avoid any possible adverse effects:

If you have a history of severe allergic reactions to any ingredients of a COVID-19 vaccine.

If you are currently sick or experiencing symptoms of COVID-19 (although you can get vaccinated once you have recovered and your doctor has approved). 
 
Before getting vaccinated, here are some tips to keep in mind

1: Register yourself for the jab on the Co-WIN portal and Aarogya Setu app

2: The vaccine should not be taken on an empty stomach. As you prepare for your immunisation, eat healthily.

3: Stay hydrated by drinking plenty of water.

4: Alcohol use should be avoided because it can dehydrate you.

5: To feel your best on the day of your vaccination, get a good night's sleep.&nbsp;

Valuable tips that will help you after vaccination

Stay for monitoring:&nbsp;

Stay seated at the health centre for 15-30 minutes after your vaccination. Doctors will keep an eye on you for any immediate reactions. If you feel dizzy, nauseated, vomiting, or have an allergic response, please report it to the health workers.&nbsp;

Common side effects&nbsp;

As your body develops immunological defence, expect some side effects. These may go away in 1-2 days.&nbsp;

These side effects are:

Arm soreness at the injection site 
Mild fever 
Fatigue 
Headaches 
Muscle or joint aches&nbsp; 
Chills 
Diarrhoea 
Sleeplessness 
 
Which drug should be taken to minimise the adverse effects of this vaccine?

According to the Ministry of Health and Family Welfare website, in case of minor adverse effects such as injection site pain, tenderness, malaise, pyrexia, etc., paracetamol may be used to alleviate the symptoms.

People all over the world are still learning how effective vaccinations are at preventing the deadly virus that causes COVID-19 from spreading to others, even if you don't have symptoms.

People all over the world are still learning how effective vaccinations are at preventing the deadly virus that causes COVID-19 from spreading to others, even if you don't have symptoms. Early evidence suggests that vaccinations can help prevent COVID-19 from spreading among people who have no symptoms. Vaccines are effective and safe. You may experience side effects as a result of the vaccine, but these are common and will pass in a few days. Here are some of the tips from health experts about what to do before, during and after getting vaccinated for COVID-19: Which one is the best vaccine among all 3 available in India? Covisheild, Covaxin and the recently added Sputnik V are the vaccines available to Indians. All three are effective in both avoiding infection and preventing the disease from progressing to a severe stage. They avoid fatality in the long run for the elderly and those with comorbidities. Who should not get the Covid vaccine? According to the UNICEF, at present, people with the following health conditions should not receive a COVID-19 vaccine to avoid any possible adverse effects: If you have a history of severe allergic reactions to any ingredients of a COVID-19 vaccine. If you are currently sick or experiencing symptoms of COVID-19 (although you can get vaccinated once you have recovered and your doctor has approved). Before getting vaccinated, here are some tips to keep in mind 1: Register yourself for the jab on the Co-WIN portal and Aarogya Setu app 2: The vaccine should not be taken on an empty stomach. As you prepare for your immunisation, eat healthily. 3: Stay hydrated by drinking plenty of water. 4: Alcohol use should be avoided because it can dehydrate you. 5: To feel your best on the day of your vaccination, get a good night's sleep. Valuable tips that will help you after vaccination Stay for monitoring: Stay seated at the health centre for 15-30 minutes after your vaccination. Doctors will keep an eye on you for any immediate reactions. If you feel dizzy, nauseated, vomiting, or have an allergic response, please report it to the health workers. Common side effects As your body develops immunological defence, expect some side effects. These may go away in 1-2 days. These side effects are: Arm soreness at the injection site Mild fever Fatigue Headaches Muscle or joint aches Chills Diarrhoea Sleeplessness Which drug should be taken to minimise the adverse effects of this vaccine? According to the Ministry of Health and Family Welfare website, in case of minor adverse effects such as injection site pain, tenderness, malaise, pyrexia, etc., paracetamol may be used to alleviate the symptoms.

COVID-19 vaccination: Tips to follow before and after taking the jab

Vietnam's envoy to India Pham Sanh Chau has said that his country is waiting for World Health Organization (WHO) to give approval to the Indian <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine</a> Covaxin, even as they are sourcing more vaccines globally.

Speaking to WION's Sidhant Sibal, Pham Sanh Chau said, "Covaxin is not yet approved by WHO for emergency use, that is why we are waiting for this approval by WHO and then we will intensify the discussion".

Also read |&nbsp;<a href="https://www.wionews.com/india-news/over-50-million-pfizer-vaccines-ready-to-be-delivered-to-india-talks-ongoing-for-partial-indemnity-388951" hreflang="en">Over 50 million Pfizer vaccines ready to be delivered to India; talks ongoing for 'partial indemnity'</a>

Covaxin is an Indian vaccine made by Bharat Biotech, headquartered in the southern Indian city of Hyderabad. Bharat Biotech submitted its application to the WHO for Emergency Use Listing (EUL) on April 19 and a pre-submission meeting will happen later this month.

Chau, himself, has been recently got Covaxin jab at Delhi's Dr Ram Manohar Lohia hospital.

Also read |&nbsp;<a data-ctorig="https://www.wionews.com/world/spreads-through-air-vietnam-reports-new-variant-of-coronavirus-388243" data-cturl="https://www.google.com/url?client=internal-element-cse&amp;cx=006054055338965708568:09spwrlibei&amp;q=https://www.wionews.com/world/spreads-through-air-vietnam-reports-new-variant-of-coronavirus-388243&amp;sa=U&amp;ved=2ahUKEwibud7W1vjwAhXjILcAHaImD4MQFjACegQIARAC&amp;usg=AOvVaw14bcGnXoshT20jfqSvPX_Q" dir="ltr" href="https://www.wionews.com/world/spreads-through-air-vietnam-reports-new-variant-of-coronavirus-388243" target="_blank">'Spreads through air': Vietnam reports new&nbsp;variant&nbsp;of coronavirus</a>

Vietnam also sent assistance to India amid the second wave of&nbsp;<a href="https://www.wionews.com/topics/coronavirus">coronavirus</a> pandemic in the country. The first batch of aid consisted 109 ventilators and 50 oxygen cylinders. The next batch had&nbsp;100 ventilators, 275 concentrators, 1300 oxygen cylinders, and 50,000 masks.

WION: How is Vietnam assisting India when it comes to the coronavirus crisis in the country? 
Pham Sanh Chau: I think one of the most salient features of the relief that Vietnam provided to India is that most of the relief comes from people, from individuals and organisations which are not state agencies. So, there is a big campaign at the national level of collecting relief to provide to Indian friends. From children to the elderly, to the religious people, everyone is trying to contribute small things in order to support India. So, this is the solidarity, sentiment and love that Vietnamese people give to Indian friends at this difficult moment.&nbsp;

WION:&nbsp;Vietnam has recently reported a new hybrid variant&nbsp;found in the <a href="https://www.wionews.com/world/kappa-delta-who-releases-greek-nomenclature-for-covid-variants-including-ones-found-in-india-388657">UK (Alpha) and India (delta)</a>. How is the country dealing with the pandemic? 
Pham Sanh Chau: We have just been hit by the fourth wave as it has been identified since April 27. This has increased the cases&nbsp;from 1600 to more than 6000. It means over the past one month, the number of infections has doubled the total infection that Vietnam has incurred over the past one and half years. This mutant is spreading very fast. So, we are still analysing the sources of that and are waiting for the final certification of health authorities.

WION: What kind of global cooperation is underway when it comes to Vietnam, especially on vaccines? 
Pham Sanh Chau: Like other Asian countries,&nbsp;Vietnam badly needs vaccines. Recently, we placed an&nbsp;order recently with Pfizer and are in the process of negotiating with Moderna. We have also signed an agreement with AstraZeneca. Vietnam also has the opportunity to purchase Covaxin, but it is not yet approved by WHO for emergency use. We&nbsp;are waiting for this approval by WHO and then we will intensify the discussion and drafting of the contract for the purchase of this Covaxin for Vietnamese people.

Vietnam's envoy to India Pham Sanh Chau has said that his country is waiting for World Health Organization (WHO) to give approval to the Indian coronavirus vaccine Covaxin, even as they are sourcing more vaccines globally.

Vietnam's envoy to India Pham Sanh Chau has said that his country is waiting for World Health Organization (WHO) to give approval to the Indian coronavirus vaccine Covaxin, even as they are sourcing more vaccines globally. Speaking to WION's Sidhant Sibal, Pham Sanh Chau said, "Covaxin is not yet approved by WHO for emergency use, that is why we are waiting for this approval by WHO and then we will intensify the discussion". Also read | Over 50 million Pfizer vaccines ready to be delivered to India; talks ongoing for 'partial indemnity' Covaxin is an Indian vaccine made by Bharat Biotech, headquartered in the southern Indian city of Hyderabad. Bharat Biotech submitted its application to the WHO for Emergency Use Listing (EUL) on April 19 and a pre-submission meeting will happen later this month. Chau, himself, has been recently got Covaxin jab at Delhi's Dr Ram Manohar Lohia hospital. Also read | 'Spreads through air': Vietnam reports new variant of coronavirus Vietnam also sent assistance to India amid the second wave of coronavirus pandemic in the country. The first batch of aid consisted 109 ventilators and 50 oxygen cylinders. The next batch had 100 ventilators, 275 concentrators, 1300 oxygen cylinders, and 50,000 masks. WION: How is Vietnam assisting India when it comes to the coronavirus crisis in the country? Pham Sanh Chau: I think one of the most salient features of the relief that Vietnam provided to India is that most of the relief comes from people, from individuals and organisations which are not state agencies. So, there is a big campaign at the national level of collecting relief to provide to Indian friends. From children to the elderly, to the religious people, everyone is trying to contribute small things in order to support India. So, this is the solidarity, sentiment and love that Vietnamese people give to Indian friends at this difficult moment. WION: Vietnam has recently reported a new hybrid variant found in the UK (Alpha) and India (delta). How is the country dealing with the pandemic? Pham Sanh Chau: We have just been hit by the fourth wave as it has been identified since April 27. This has increased the cases from 1600 to more than 6000. It means over the past one month, the number of infections has doubled the total infection that Vietnam has incurred over the past one and half years. This mutant is spreading very fast. So, we are still analysing the sources of that and are waiting for the final certification of health authorities. WION: What kind of global cooperation is underway when it comes to Vietnam, especially on vaccines? Pham Sanh Chau: Like other Asian countries, Vietnam badly needs vaccines. Recently, we placed an order recently with Pfizer and are in the process of negotiating with Moderna. We have also signed an agreement with AstraZeneca. Vietnam also has the opportunity to purchase Covaxin, but it is not yet approved by WHO for emergency use. We are waiting for this approval by WHO and then we will intensify the discussion and drafting of the contract for the purchase of this Covaxin for Vietnamese people.

Waiting for Covaxin's approval by WHO, says Vietnam envoy to WION

As <a href="https://www.wionews.com/india-news/indias-active-covid-19-caseload-below-2-million-mark-127510-new-cases-reported-388727">India</a> continues to grapple with the pandemic, the health ministry said mixing of vaccines has not become the protocol yet with Covishield and Covaxin vaccines to be administered separately for both doses.

Watch:

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/india-reports-127510-new-covid-19-cases-2795-deaths-in-last-24-hours-388781/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

"There's international research underway on the mixing of <a href="https://www.wionews.com/india-news/covid-19-tamil-nadu-govt-to-receive-4-20000-doses-of-vaccines-as-stocks-went-empty-had-to-stop-vaccination-388765">vaccines</a> as the possibility of a positive effect is also plausible but a harmful reaction cannot be ruled out either," the health ministry said.

The ministry added that it is an "unresolved" scientific question and that "science will settle it."

"There is absolutely no change in the schedule of Covishield doses,&nbsp;it will be two doses only," it said, adding, "after the first Covishield dose is administered, the second dose will be given after 12 weeks."

According to the health ministry, a total 21.60 crore vaccine doses have been administered in India with 1.67 crore doses to health workers and 15.48 crore to people in 45+ age group.

The health ministry informed that 1,27,000 cases have been reported in the last 24 hours with the country reporting less than 2 lakh cases since May 28.

The number of active COVID-19 cases are down 50 per cent with 1.3 lakh decrease in active cases in a day, the health ministry said.

Meanwhile, India's capital reported 623 new coronavirus cases and 62 fatalities with the number of active cases at over 10,000.

As cases in India show&nbsp;a steep decline, NITI Aayog's Dr VK Paul said that the government's focus has now turned to coronavirus disease among children.

"The pediatric population is generally asymptomatic. They often get infections but their symptoms are minimal," VK Paul said.

"The infection has not taken serious shape in children but the virus may change its behaviour in the pediatric population. The impact of coronavirus may increase in children."

"The data has shown that a low number of children are being admitted to hospitals. We are pushing for preparedness," the Niti Ayog official added.

(With inputs from agencies)

As India continues to grapple with the pandemic, the health ministry said mixing of vaccines has not become the protocol yet with Covishield and Covaxin vaccines to be administered separately for both doses.

As India continues to grapple with the pandemic, the health ministry said mixing of vaccines has not become the protocol yet with Covishield and Covaxin vaccines to be administered separately for both doses. Watch: "There's international research underway on the mixing of vaccines as the possibility of a positive effect is also plausible but a harmful reaction cannot be ruled out either," the health ministry said. The ministry added that it is an "unresolved" scientific question and that "science will settle it." "There is absolutely no change in the schedule of Covishield doses, it will be two doses only," it said, adding, "after the first Covishield dose is administered, the second dose will be given after 12 weeks." According to the health ministry, a total 21.60 crore vaccine doses have been administered in India with 1.67 crore doses to health workers and 15.48 crore to people in 45+ age group. The health ministry informed that 1,27,000 cases have been reported in the last 24 hours with the country reporting less than 2 lakh cases since May 28. The number of active COVID-19 cases are down 50 per cent with 1.3 lakh decrease in active cases in a day, the health ministry said. Meanwhile, India's capital reported 623 new coronavirus cases and 62 fatalities with the number of active cases at over 10,000. As cases in India show a steep decline, NITI Aayog's Dr VK Paul said that the government's focus has now turned to coronavirus disease among children. "The pediatric population is generally asymptomatic. They often get infections but their symptoms are minimal," VK Paul said. "The infection has not taken serious shape in children but the virus may change its behaviour in the pediatric population. The impact of coronavirus may increase in children." "The data has shown that a low number of children are being admitted to hospitals. We are pushing for preparedness," the Niti Ayog official added. (With inputs from agencies)

Mixing vaccines has not become the protocol: India health ministry

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