Members of the national Covid-19 working group clarified that Covaxin, the vaccine being developed by Bharat Biotech, would be used in a “clinical trial” mode and Union Health Minister Harsh Vardhan said his approval of use emergency was “a strategic decision for our vaccine.” security.”
But some independent scientists said that while the data from the Phase 1 and Phase 2 trials of the vaccine are very encouraging, they questioned the approval process when efficacy data from the Phase 3 trials of the vaccine, which began in November. , they had not arrived. Efficacy data is an indication of the efficacy of the vaccine in preventing virus attack.
“If you take a look at what the DCGI (Controller General of Drugs of India) proposed as a suitable data package in September when they published their preliminary guidance (for the approval of Covid-19 vaccines), it was very clear that they wanted safety and efficacy data and it was hoped that for safety data there would be at least two months of follow-up, “said Dr. Gagandeep Kang, vaccine scientist and professor at Christian Medical College.
“In the case of Covaxin… he hasn’t finished enrolling. So where is your security data as requested by DCGI? Obviously, there is no efficacy data either, ”he said.
Shahid Jameel, virologist and director of the Trivedi School of Biosciences at Ashoka University, said Shahid Jameel: “Even emergency use authorization requires efficacy data … These Indian vaccines would eventually also enter the international market. It is very important that there is trust in our regulatory institutions. Otherwise, these same companies would suffer. “
Randeep Guleria, director of AIIMS and a member of the national Covid-19 task force, told The Indian Express that Covaxin’s approval was given to ensure that, in the event of a sudden increase in cases, the availability of the vaccine from Oxford University was insufficient. , it could be implemented “in clinical trial mode.”
Jameel said this was one more reason why Covaxin’s approval need not have been rushed.
“The Serum Institute has already said that it is ready with at least 50 million doses. And the Bharat Biotech vaccine is not rolling out right away. So the right thing to do would have been to wait for the preliminary data from the phase III trials to come in and then grant approval. Trials are already underway and preliminary data will be available in a few weeks, ”he said.
Satyajit Rath, an immunologist who previously worked at the National Institute of Immunology in New Delhi, said the scientists did not question the safety or efficacy of the vaccine itself, but rather expressed concern about the institutional process.
“The problem is not in the form of an increased risk for the person who is receiving the vaccine. The problem is at the policy level, at the regulatory level. There are several problems with the way approval has been granted, which can lead to people losing confidence in the regulatory system, ”he said.
L Shashidhara, biologist and professor at IISER, Pune suggested a way forward that was in accordance with what Guleria described.
“The use of Covaxin and other vaccines for which efficacy data is limited should be treated as expanded clinical trials. While they are produced in large quantities and undergoing batch testing, the government must develop capacities across the country to monitor the immune response to different vaccines and assess the efficacy in populations. This helps to design a better vaccination program strategy before a larger scale implementation, ”he said.
.
