COVAXIN 81% effective, offers protection against UK variant: Bharat Biotech
COVAXIN, the COVID-19 vaccine developed by Hyderabad-based Bharat Biotech, has been found to have 81% interim efficacy against preventing infections, the company said on Wednesday. Further, the company said that antibodies induced by COVAXIN can neutralize the UK variant strains of the coronavirus along with other heterologous strains. The vaccine is already being used in India's nationwide vaccination drive. Here are more details.
Trial involved 25,800 participants across 25 sites
The Phase III trial of COVAXIN involved 25,800 participants across 25 sites. Among the participants, 43 were found to have been infected with the coronavirus. Seven among them had received the vaccine shot, while the others were administered a placebo. The trial will continue until 130 infections are confirmed among participants. The findings of the interim analysis are yet to be peer-reviewed.
Adverse events occurred at low levels
Bharat Biotech said COVAXIN has 81% interim efficacy in preventing COVID-19 in those without prior infection after the second dose. Severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups, the company said. Further, it said the "vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains."
Important milestone in vaccine discovery: Bharat Biotech MD
Bharat Biotech Chairman and Managing Director, Dr. Krishna Ella, said, "Today is an important milestone in vaccine discovery, for science and our fight against coronavirus." "With today's results from our Phase III clinical trials, we have now reported data on our COVID-19 vaccine from Phase I, II, and III trials involving around 27,000 participants," Dr. Ella added.
Earlier, COVAXIN's emergency approval had drawn criticism
Data from the Phase III trials of COVAXIN was highly anticipated amid concerns over the vaccine's safety. The Drugs Controller General of India (DCGI) had cleared the vaccine in early January along with Serum Institute of India's Covishield. However, COVAXIN was granted restricted emergency approval in clinical trial mode, which drew criticism from the public and experts alike.
Government repeatedly offered assurances on vaccine's safety, efficacy
Since the backlash, the government has repeatedly assured that COVAXIN is safe and effective. Since the vaccine uses a whole inactivated virion, the government had also pointed out that it is more likely to be effective against mutated strains of the coronavirus.
