Decision to Use Covaxin was Scientific, Say Govt Sources After it Shows 81% Efficacy as India Wins Global Applause

After facing questions for providing emergency approval to Bharat Biotech’s Covaxin without vaccinating enough participants in its phase 3 trial, top officials in the government have cleared that the decision was backed by a ‘sound scientific process and logic’.

Bharat Biotech in a statement on Wednesday said Covaxin vaccine demonstrated 81 per cent interim efficacy in preventing Covid-19 after a third round of clinical trials.

“The 81 per cent efficacy data of Covaxin is a big validation for India’a scientific community and the stringency of our processes. It shows how the decision to grant emergency use authorisation to Covaxin was backed by sound scientific process and logic,” said a source in the government.

On January 3, the Drugs Controller General of India (DCGI) had approved Covaxin for ‘emergency use’ under ‘clinical trial mode’. The approval was criticised for not having enough data.

“The regulator and the government has been proved right in rolling out Covaxin. It has given India an almost additional 2 months to vaccinate its people. Otherwise it would have taken around mid March for the roll out,” added the source.

Data from 25,800 participants received a vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well tolerated. The first interim analysis is based on 43 cases, of which 36 cases of Covid-19 were observed in the placebo group versus 7 cases observed in the Covaxin group, resulting in a point estimate of vaccine efficacy of 80.6 percent.

“Covaxin is also the world’s highest efficacy vaccine based on the ‘whole inactivated virus’ platform. It is also the only vaccine in India where full stage 3 trails have been held in India,” said the government official who did not want to be named.

Regarding costs, the official said, “India is providing vaccines to its citizens (who want to pay) at Rs 150 only. An additional Rs 100 are to cover other overheads like logistics, hospital costs, etc. This is the cheapest in the world by a big margin. This cost is as high as Rs 2000 in other countries. We have already seen stories how vaccine companies are gunning for sovereign assets in Latin America.”

Meanwhile, India has been winning global accolades for its provision of vaccines.

Prime Minister of Barbados Mia Amor Mottley, tweeted, ” PM Modi made it possible for more than 40K persons in Barbados and tens of thousands elsewhere, to receive their 1st dose of COVISHIELD via #VaccineMaitri before receiving his. A genuine demonstration of generosity. Thank you and we wish you continued good health.”

Antigua and Barbuda Prime Minister Barbuda Gaston Browne also appreciated Indian PM Modi’s ‘s assistance in providing doses of Covid vaccines to Caribbean nations.

US-based author Shirish Thorat tweeted, ” Just saw pictures of my friends in India recieving their vaccination shots and here I am in the great United states of America with an immunocompromised Son and Daughter and the vaccine is nowhere in sight. America’s population is lessthan 1/4th population of India.”

So far, India has exported the Oxford-AstraZeneca Covid-19 vaccine manufactured by the Serum Institute of India (SII) and Bharat Biotech’s indigenous vaccine to more than 15 countries while another 25 countries are queued at different levels to receive supplies. These include Brazil, Afghanistan, Bangladesh, Myanmar, Bhutan, Nepal, and Sri Lanka. Both the vaccines are already in circulation in India with senior citizens receiving the jabs in the second phase of the immunization drive.

Canada also received 500,000 doses of coronavirus vaccine from India on Thursday.

“The AZ/CoviShield vaccine is now in Canada. The first tranche of 500,000 doses arrived this morning from Serum Institute of India with 1.5 million more doses to follow. Thank you to all whose hard work made this happen. We look forward to future collaboration,” said Anita Anand, Canadian minister of public services and procurement, in a tweet.

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