The rejection rate of the phase 3 trial is much higher than that of the phase 1 and phase 2 trials, said Dr. Sanjay Rai.
New Delhi:
Although the phase 1 trial of its Covaxin vaccine obtained “encouraging” results, Hyderabad-based Bharat Biotech faces challenges in phase 3 trials of its vaccine in India, a senior official associated with the Covaxin told NDTV. draft.
The drugmaker has seen a 70% -80% reduction in participation in the Covaxin trial, according to Dr. Sanjay Rai, principal investigator of the phase 3 Covaxin trial at AIIMS.
“People are not willing to participate in the trial because they believe a vaccine for everyone will come soon. AIIMS Delhi needs 1,500-2,000 participants for the phase 3 trial of Covaxin, but only 200 have signed up so far,” said the Dr. Rai to NDTV.
The rejection rate of the phase 3 trial is much higher than that of the phase 1 and 2 trials, which was less than 10 percent, he said.
“For phase 1, we were inundated with applications, 100 participants were needed and 4,500 had submitted. The authorities must clearly inform the volunteers who come for phase 3, as part of the protocol, that it is only a test and is they deny. under the assumption that a vaccine will arrive in India for everyone within a week or 15 days anyway, and therefore they don’t want to be part of a trial, “he said.
Bharat Biotech’s Covaxin is among three companies that have applied for emergency use authorization from the Indian drug regulator. The ICMR (Indian Council for Medical Research), which is a partner in Covaxin clinical trials, announced today that the results of the phase 1 trial are “encouraging.”
The Phase 1 results, Dr. Rai said, reflect that the vaccine is “safe and has negligible side effects.” “Covaxin also induced an immune response. The phase 1 results have addressed immediate safety concerns,” he added.
Although there was a serious adverse event with one trial participant, it was later found not to be associated with the vaccine, he said.
Although India’s drug regulator has sought data from the phase 3 trial, approval, according to Dr. Rai, can come only if the drug regulator is satisfied with the phase 1 and phase 2 trial data and how. Similar vaccines are being used in China.
When asked if the challenges with phase 3 will affect the emergency use authorization for Covaxin, Dr. Rai said: “There are similar vaccines that are based on the ‘whole virion’ concept and have been approved in China. Yes If they are satisfied with the results of Covaxin phase 1 and phase 2, as well as what is happening in China, drug regulators can give the thumbs up. If they think it is safe enough and generates an immune response. But it is entirely the prerogative of the subject matter of the Indian drug regulator’s expert committee. “
Posters are also being distributed to people to raise awareness and seek volunteers for the trial. AIIMS and Sir Gangaram Hospital in Delhi are putting up posters, which are among the locations for the phase 3 trials.
The Phase 3 trials of Covaxin are intended to be conducted with a total of 25,800 participants at 25 different sites in India.
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