Hurried approval of COVID-19 vaccines raises eyebrows; experts raise questions

A number of experts have expressed doubts over the “hasty approval” given to COVID-19 vaccine in spite of the lack of data regarding the efficacy of the vaccine.

On Sunday, Central Drugs Standard Control Organisation gave approval for restricted emergency use of the Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute of India, and Covaxin of Bharat Biotech.

But this approval in India has made many experts of the field uncomfortable because the vaccines are still in the trial stage.

In an interview to CNBC-TV18, Dr Gagandeep Kang, Professor, Christian Medical College, Vellore and Vice Chairman of the board of Coalition for Epidemic said, “I’m completely unaware of any data that suggests that Covaxin has any efficacy against any SARS-CoV-2 strain, let alone the U.K. strain.”

“I am completely confused. I read the SEC document yesterday, the approval, the SEC recommendations. I can understand what they are saying about the Covishield vaccine and then they have this very complicated language for the Covaxin vaccine. The DCGI has actually quoted that language, but its approval for both of the vaccines is identical,” Kang was quoted as saying by the TOI.

Kang further highlighted the lack of data available for the vaccine. Had the data been made public, people could have trusted the vaccine more.

“At this point, I wouldn’t advise Covaxin. All we seem to know is that it’s safe and so may not be harmful but efficacy is a different matter and needs to be proved,” an expert said requesting anonymity.

“In the interest of transparency, we ask that the regulator share detailed rationale or the decision along with disclosure of data... We are baffled to understand what scientific logic has motivated top experts in the SEC (Subject Expert Committee) to approve this vaccine (Covaxin) post haste,” Malini Aisola, of the All India Drug Action Network, said in a statement.

However, Randeep Guleria, Director, All India Institute of Medical Sciences, said that Covaxin could be a “backup vaccine” and added that it is to be used if it was not clear how efficacious the SII vaccine would be.