Bharat Biotech’s coronavirus vaccine, which is still undergoing clinical trial, is likely to be the “back-up” vaccine in the coming days, Dr Randeep Guleria, the chief of Delhi’s All-India Institute of Medical Sciences said today as two vaccines got emergency approval from the country’s drug regulator. Politics has started over the approval to Covaxin, with several opposition parties pointing out that the vaccine was approved without the full process.
Congress’s Shashi Tharoor tweeted, “The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. @drharshvardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime”.
“I feel that in the coming days it is the Serum Institute vaccine that will be the main vaccine, Bharat Biotech only a backup for emergency use in case of reinfection,” Dr Randeep Guleria told NDTV in an exclusive interview.
“By that their time they will get their dosage ready and by the time they will get the data which will be able to show that the phase 3 data is robust and they have enough events to show that it is efficacious and it is safe, we will be able to have that vaccine available. But the first few weeks, it will be the serum institute vaccine which will be rolled out. It has 50 million doses available,” Dr Guleria told NDTV.
The health ministry said the expert committee appointed by the government has reviewed all data on its “safety and immunogenicity” and gave permission for “restricted use in emergency situation in public interest”.
The idea was to have “more options for vaccinations, especially in case of infection by mutant strains,” the ministry said, adding that the clinical trials of the vaccine will continue.
Covaxin, the clinical trial of which is being conducted in collaboration with the Indian Council of Medical Research, has completed its Phase I and Phase II trials.
While announcing that the vaccine is being given “restricted” approval, Drug Controller General VG Somani said the results showed it is “safe and provides a robust immune response”.
The Phase III trial is on and 22,500 of the 25,800 participants have been vaccinated,” he added.