NEW DELHI: The Hyderabad-based Bharat Biotech’s coronavirus vaccine has been recommended by a government-appointed group to “prohibit emergency use in the public interest”, which was handed over to the Drugs Controller General of India on Saturday night.
DCGI makes the final call for vaccine approval. The national regulator will address the media at 11 a.m. Sunday.
The recommendation came at a time when there was no effective data. Covaxin completed only two of the three trials. Third, the effectiveness test began in November.
Vaccine efficacy data are the result of an analysis that combines all three phases.
However, Dr. Savita Verma, a pharmaceutical professor at PGIMS in Haryana, who is part of the vaccine team, told NDTV that “good results” have been shown in previous trials.
“Our results in the first and second rounds are very strong and have shown good results. We are currently conducting a third phase test … we need to recruit around 25,800 participants. There are about 22,000 people in India so far … We expect a temporary result by March, ”said Dr. Verma.
Dr. Verma also said that about 10 million Covaxin drugs were ready at this time.
The provisional results of the first phase of the trial showed that Covaxin provoked an immune response and did not register severe side effects. The second phase of the test data showed “tolerable safety results” and suggested that antibodies could last from six to 12 months.
Approval of the prohibited use is usually provided only when there is sufficient evidence to prove that the drug is safe and effective.
The recommendation came a day after the group approved AstraZeneca and another drug from Covishield, manufactured by the University of Oxford and produced by the Puna Serum Institute. AstraZeneca CEO Pascal Soryot said last week that the vaccine “protects 95% of patients.”
“Most of the top 50 million drugs will go to India,” said Adar Ponavalla, chief executive of the Serum Institute.
U.S. pharmaceutical giant Pfizer has also applied for a third-party emergency vaccination license developed by Pfizer, and the group is currently under investigation. Sources close to the situation said the company had not yet submitted the data to the board.
The Pfizer vaccine has already been released in the UK, the United States, and some other countries.
The government tested the vaccine delivery system for a day on Saturday to investigate potential problems after the vaccine was vaccinated. According to the Ministry of Health, dry running activities have been carried out in 116 districts, with nearly one million employees participating in the necessary training.
Health Minister Dr. Harsh Vardan said there should be no misconceptions about the safety of the coronavirus vaccine, which India plans to use this morning. He reiterated that there was no evidence that the vaccine could prevent the virus from spreading.
Dr. Vardan also said that about three million front lines, including important services such as doctors, nurses, and police, will be vaccinated first.