Covaxin has completed only two of the three required testing phases (file)
New Delhi:
Results from the phase 3 clinical trial for Bharat Biotech’s coronavirus vaccine, Covaxin, were released Wednesday afternoon, and the drug demonstrated “an interim 81 percent efficacy in preventing COVID-19 in those without previous infection after the second dose, “the company said.
The trial involved 25,800 participants at 25 sites, who were randomly divided into two groups.
One group received the vaccine and the other received a placebo. 43 people (seven from the group that received the vaccine) were found to be infected with the coronavirus.
Interim analysis also showed that medically assisted, serious and serious adverse events occurred at low levels and balanced between the vaccine and placebo groups, Bharat Biotech said.
The company also said that “National Institute of Virology analysis indicates that vaccine-induced antibodies can neutralize UK variant strains and other heterologous strains.”
However, these data have not yet been peer reviewed.
Trials will continue until final analysis of 130 confirmed cases to collect more data and evaluate the efficacy of the vaccine, the company added.
“Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today’s results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1 trials. , 2 and 3 involving around 27,000 participants, “said Dr. Krishna Ella, President and Managing Director of Bharat Biotech.
Data from the third stage of the trials, which measures the vaccine’s success in protecting against coronavirus, has been widely anticipated amid concerns about the safety and efficacy of Covaxin.
Covaxin is one of two Covid vaccines that have been approved by the government for emergency use; the other is Covishield, which was developed by AstraZeneca and the University of Oxford and produced by the Pune-based Serum Institute.
Covishield has a 70 percent efficacy rate after the second dose.
Both vaccines were approved by the Comptroller General of Medicines of India (DCGI) in early January, at a time when no data was available from the later stages of the Covaxin trial; it was approved on the basis of Phase I and II data confirming its “safety and immunogenicity”.
Covaxin was given “restricted use in emergency situations of public interest,” meaning that everyone who received the drug as part of the vaccination campaign was enrolled as part of the study.
The criticism provoked an emotional rejection from Dr. Ella, who told critics “… do not accuse us of inexperience. We are a global company … we have manufactured 16 vaccines …”
When the government launched the national vaccination campaign on January 16, many expressed reservations about the administration of Covaxin, mostly because a selection of vaccines was not offered.
On Monday, when the second phase of the vaccination campaign began, Prime Minister Narendra Modi rolled up his sleeves and received an injection of Covaxin at the AIIMS in Delhi to allay any fears.
This morning, the center reported nearly 15,000 new Covid cases in the past 24 hours, and the number of active cases increased by around 1,700.
As of March 1, of these, the number of strain cases in the UK is 187.
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