22 Jun 2021: Bharat Biotech submits COVAXIN phase-3 trial data, review meet today
Bharat Biotech has submitted the phase three clinical trial data for its coronavirus vaccine COVAXIN to the Drugs Controller General of India (DCGI). The Subject Expert Committee of the country's top drug regulator will meet today to discuss the submitted results. COVAXIN, India's first fully indigenous COVID-19 jab, was granted the emergency use approval this January.
Details: Data was submitted over the weekend, sources say
The trial data was submitted over the weekend, government sources told the media today. "The required data has been submitted, and the meeting of the expert panel is likely to take place today," an official said, according to Hindustan Times. In March, the company said an initial analysis of phase three trials indicated "81% interim efficacy in preventing COVID-19 in those without prior infection."
Controversy: Bharat Biotech faced flak for not sharing data on time
Bharat Biotech has been facing criticism in India for failing to share its phase three trial data even six months after receiving the emergency use approval. In January, the company had said it would submit results by March, but recently stated the data would be made public only in July. Earlier this month, the US FDA had rejected the emergency use authorization for COVAXIN.
WHO meeting: Biotech also has a 'pre-submission' meeting with the WHO
The Hyderabad-based vaccine maker is also expected to hold a "pre-submission" meeting with the representatives of the World Health Organization (WHO) as it seeks an international emergency use listing (EUL) of its vaccine. That meeting is scheduled to take place on June 23. A WHO nod will allow the company to widely export its vaccines and recipients of this jab to easily travel abroad.
Fact: COVAXIN trials on children are also underway
Bharat Biotech is also carrying out COVAXIN trials on children aged between two and 18 years. The testing is being conducted on 525 volunteers at AIIMS, Delhi and other locations across the country. Results are expected in the next few months, experts say.
Vaccination in India: How is the vaccination drive going in India?
Other than COVAXIN, India has two other approved coronavirus vaccines - Oxford-AstraZeneca's Covishield and Russia's Sputnik V. More than 28 crore vaccine doses have been administered in India and nearly 17% of the population has received at least one shot. However, less than 4% Indians are fully vaccinated as yet. The government aims to inoculate all Indian adults by the end of this year.
Record: 'Well done India': Over 80 lakh were vaccinated yesterday
On Monday, India administered more than 80 lakh vaccine doses to its eligible citizens, the highest-ever one-day coverage in the country so far. The development came on a day India kicked off a new vaccination policy, under which free jabs are being provided to all adults. Celebrating the feat, Prime Minister Narendra Modi tweeted, "Today's record-breaking vaccination numbers are gladdening...Well done India!"
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Also see: COVAXIN phase 2/3 trials for 2-18-year-olds recommended by expert panel
Bharat Biotech reduces COVAXIN price to Rs. 400 for states
COVAXIN Phase-II trial interim data shows better reactogenicity, safety: Lancet
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