BackMandavia meets WHO chief scientist to discuss Covaxin approval
Hyderabad-based Bharat Biotech International Ltd has received a certificate of Good Manufacturing Practice compliance for Covaxin, its indigenously developed covid-19 vaccine, from Hungarian authorities
PremiumNEW DELHI: Union health minister Mansukh Mandaviya met World Health Organization (WHO) chief scientist Soumya Swaminathan on Thursday to discuss the UN agency's approval for Bharat Biotech's covid-19 vaccine Covaxin.
“Held a meeting with Dr Soumya Swaminathan, Chief Scientist of @WHO. We had a productive discussion on WHO’s approval of @BharatBiotech’s COVAXIN.@DoctorSoumya also appreciated India’s efforts for the containment of #COVID19," Mandavia said in a post on Twitter.
Swaminathan in July had said that the WHO may take a decision on granting Emergency Use Listing (EUL) to Covaxin in four-six weeks.
WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply to other countries. The EUL assesses the quality, safety, and efficacy of covid-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under what conditions. So far, the WHO has given EUL to six vaccines.
On Wednesday, Mariangela Simao, WHO assistant director-general for vaccines, according to reports, had said that the UN health agency’s assessment of the Bharat Biotech vaccine was "quite advanced" and officials hoped for a decision by mid-September.
Hyderabad-based Bharat Biotech International Ltd has received a certificate of Good Manufacturing Practice (GMP) compliance for Covaxin, its indigenously developed covid-19 vaccine, from Hungarian authorities.
Covaxin, India's first indigenous covid vaccine, has also received EUAs from 14 countries and another 50 in the process.
In June, the drug maker had said that its US partner, Ocugen, has received a recommendation from the US Food and Drug Administration to pursue Biologics License Applications (BLA) path for Covaxin, which is a full approval. Applications have to follow the BLA process, which is the standard for vaccines.
A study done by Indian Council of Medical Research-National Institute of Virology (ICMR-NIV) recently showed that Covaxin elicits strong antibody response against Beta and Delta variants of SARS CoV2. A vaccine based on whole inactivated coronavirus has an efficacy rate of 77.8% against symptomatic covid-19 infections, phase 3 trial data suggests.
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