Hyd-based Bharat Biotech asked to submit Covaxin efficacy data before clinical trial on children

Hyderabad based drug manufacturer has applied for the clinical trial of Covaxin on children in the age group of 5 to 18 years

By Newsmeter Network  Published on  25 Feb 2021 3:53 AM GMT
Hyd-based Bharat Biotech asked to submit Covaxin efficacy data before clinical trial on children

Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) on Wednesday asked Hyderabad-based Bharat Biotech to submit efficacy data of Covaxin on adults before seeking permission to conduct a phase-3 clinical trial on children in the age group of 5 to 18 years.

Hyderabad based drug manufacturer has applied for the clinical trial of Covaxin.

Covaxin is the first indigenously developed vaccine against Covid-19. It was granted restricted use in emergencies in India despite the lack of phase 3 efficacy data

Efficacy data of Bharat Biotech's Covaxin that is being administered to front-line workers will be available in the next two weeks.

Covaxin received emergency use approval from the Drug. Controller General of India on January 3. However, since the company could not conduct its Phase 3 trials on enough volunteers, the efficacy data was due.

DGCI nonetheless approved the vaccine. The drug regulator said that the vaccine has been formulated using inactivated virus particles that will be effective against active Covid-19 strains, even the foreign mutant ones.

The grant of approval without the phase 3 efficacy data had drawn a lot of criticism, though the government clarified that the vaccine is safe to use.

Meanwhile, another Hyderabad based drug manufacturer Dr Reddy's Laboratories has sought emergency use authorization for the COVID-19 vaccine Sputnik V on Wednesday.

An expert panel of Central Drug Authority, which reviewed the application, recommended that the firm should present the immunogenicity and safety data first.

On February 19, Dr. Reddy's Laboratories said it had approached DCGI for emergency use authorization (EUA) for the Russian vaccine.

SEC on COVID-19 of the CDSCO which discussed the application by Dr. Reddy's Laboratories on Wednesday asked the firm to submit immunogenicity and safety data as per the protocol approved by the CDSCO. Once it submits the data, its EUA application will be considered.

At 91.6 percent, Sputnik V has a higher efficacy as compared to Covid vaccines that are currently being administered in India. While Oxford-AstraZeneca's Covishield vaccine, being manufactured by the Serum Institute of India, has an efficacy of around 70 percent. Bharat Biotech's Covaxin's efficacy is not known.

Sputnik V is one of only three vaccines in the world with such a high efficacy rate. The other two with high efficacy rate include Pfizer and Moderna.


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