How Expert Panel Gave Nod to Bharat Biotech's Covaxin: What Minutes of Meetings Revealed
Covaxin has been developed by Hyderabad-based Bharat Biotech. (File photo)
Even as Bharat Biotech last week called the restricted emergency use of its Covid-19 vaccine Covaxin ‘a great milestone for India's scientific capability’, minutes from a meeting of the subject expert committee set up by the India’s drug regulator Central Drugs Standard Control Organization show that the panel wasn’t sure of the “efficacy” of the vaccine but changed its mind within a day.
Reports suggest that the expert panel changed its mind about the vaccine in 24 hours last week. While experts had expressed apprehension, the makers of Covaxin had it out at critics calling it "200% safe".
Bharat Biotech chairperson Krishna Ella had told the media, “It is easy to target Indian scientists. I had to tell this because some other company has branded my product as ‘safe like water’. Some local company in press yesterday said that safety is like water of other companies. Only three companies have done efficacy, and other vaccine is like water. I want to deny that. It hurts us as scientists; we work 24 hours and don’t deserve this type of bashing from people.”
Reports on the u-turn made by the expert panel is likely to raise further questions on the effectiveness of the vaccine.
Details from the meeting
According to reports the expert panel has said during a meeting on January 1 that while the vaccine demonstrated a strong immune response, data provided by Bharat Biotech wasn’t enough.
The Indian Express reported the panel as saying “efficacy is yet to be demonstrated” for the vaccine and asked Bharat biotech to expedite getting volunteers for human trials in phase three.
The apprehensions expressed by the committee, the minutes of the meeting show, disappeared by January 2.
The Indian Express report says that in a day, the panel said “firm has presented the safety and efficacy data from non-human primate challenge study where the vaccine has been found to be safe and effective.”
While questions were raised on the way in which this u-turn was made, Indian Council of Medical Research Balram Bhargava said that under the Clinical Trial Rules of 2019 there were provisions for emergency approval of vaccines.
Hindustan Times quoted him as saying, “In a pandemic situation, restricted use is considered based on safety and immunogenicity data while phase three clinical trail is still ongoing. The immunogenicity data generated through phase two clinical trial serves as a surrogate for efficacy. The Clinical Trial Rule, 2019, provides for considering phase two results to guide approval. Now the SEC guides the DCGI in the process of decision making for restricted use under emergency situation. Now we have two vaccines.”
Critics have, however, questioned this sudden change of decision by the expert panel. Deccan Herald quoted Malini Aisola from the All India Drug Action Network as saying, “We are perplexed at the abrupt change in thinking of the SEC from the first two meetings to the third day on which the approval was recommended while apparently discounting the need for efficacy data as the condition of the approval.”
Experts had questioned Covaxin
Even as Covaxin was touted safe, experts had questioned the government's claims that Covaxin could target mutated coronavirus strains.
Virologist Shahid Jameel had told PTI, “If approval requires both safety and efficacy data for a representative population, phase 2 safety and immunogenicity do not fulfill that criteria… that is why we conduct a phase 3. It is the closest you get to a population. Where is that data? Vaccines are not drugs. They are given to healthy people. They are prevention not a treatment. Both safety and efficacy is required," he said.
Jameel had questioned the use of the vaccine as a backup, saying, “Does this mean that if needed, a vaccine of unproven efficacy would be used?"