Although the Phase 1 trial of its Covaxin vaccine has seen “encouraging” results, Hyderabad-based Bharat Biotech is facing challenges in Phase 3 trials of its vaccine in India, a senior project associate told NDTV. .
The drug manufacturer saw a 70% -80% reduction in participation in the Covaxin study, according to Dr Sanjay Rai who is the principal investigator of the Covaxin phase 3 study at AIIMS.
“People are unwilling to participate in the trial because they think a vaccine will come soon for everyone. AIIMS Delhi needs 1,500-2,000 participants for Covaxin’s Phase 3 trial, but only 200 have enrolled so far,” the said. Dr. Rai at NDTV.
The rejection rate of the phase 3 study is much higher than the phase 1 and phase 2 studies, which was less than 10 percent, he said.
“For phase 1 we were inundated with applications, 100 participants were needed and 4,500 had applied. Volunteers who are arriving for phase 3 must be clearly informed by the authorities as part of the protocol that it is only a process and they refuse. Many are assuming that a vaccine will still arrive in India for everyone within a week or 15 days and therefore do not want to be part of a trial, “he said.
Covaxin of Bharat Biotech is among three companies that have applied for emergency use authorization from the Indian drug regulator. Covaxin’s clinical trial partner ICMR (Indian Council of Medical Research) announced today that the Phase 1 trial results are “encouraging.”
The Phase 1 results, Dr. Rai said, reflect that the vaccine is “safe and has negligible side effects.” “Covaxin also induced the immune response. The immediate safety concerns were addressed by the Phase 1 results,” he added.
Although a serious adverse event occurred with 1 study participant, it was later found that it was not associated with the vaccine, he said.
Although the Indian drug regulator has looked for data from the phase 3 trial, approval, according to Dr. Rai, could only come if the drug regulator is satisfied with the data from the phase 1 and phase 2 trials and how they are made. similar vaccines used in China.
Asked whether the challenges with phase 3 will affect Covaxin’s emergency use authorization, Dr Rai said: “There are similar vaccines that are based on the ‘whole virion’ concept and have been approved in China. Drug regulators are satisfied based on Covaxin’s Phase 1 and 2 results and what is happening in China, they can give the green light. If they think it’s safe enough and generates an immune response. But that’s entirely the prerogative of the committee. subject matter experts of the Indian drug regulator “.
Posters are also distributed to people to create awareness and to seek volunteers for the process. The posters were posted by the AIIMS and Sir Gangaram Hospital in Delhi, which are among the sites for the phase 3 trials.
Covaxin’s Phase 3 studies are expected to be conducted on a total of 25,800 participants at 25 different sites in India.