‘Can’t launch vaccine till…’: Serum MD talks of issues between FDA and Novavax

Cyrus Poonawalla is hopeful that the issues will be resolved by October-end so that the vaccine, Covovax, can be launched in India.
Vials labelled "COVID-19 Coronavirus Vaccine" and sryinge are seen in front of displayed Novavax logo in this illustration (Reuters).
Vials labelled "COVID-19 Coronavirus Vaccine" and sryinge are seen in front of displayed Novavax logo in this illustration (Reuters).
Published on Aug 13, 2021 04:16 PM IST
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Byhindustantimes.com, New Delhi

In another indication that the launch in India of the second batch of Novavax’s vaccine candidate against the coronavirus disease (Covid-19) could get delayed, Serum Institute of India (SII) chairperson Cyrus Poonawalla said on Friday that there are issues between the US Food and Drug Administration (USFDA) and Novavax. These issues, Poonawalla said, are likely to be cleared by October-end.

“We can’t launch Novavax’s vaccine unless we get a license to launch it. The parent American company has some issues with the USFDA, which should be cleared by the end of October. We will get the license only when the company gets one from the FDA. We are trying to obtain the license ahead of the parent company, but it’s an uphill task,” the Serum chairman and MD said, according to news agency ANI. 


Poonawalla’s remarks are on the lines of those made by his son, Serum CEO Adar Poonwalla, who said last Friday that the company hopes to manufacture the vaccine, Covovax, for adults by October and by early 2022 for children.

Also Read | 'Hope to launch Covovax for adults in October, in early 2022 for kids': Adar Poonwalla

Pune-based SII, the world’s largest vaccine manufacturer, has partnered with the American pharmaceutical firm to manufacture the latter’s coronavirus vaccine in India. SII manufactured the first batch of Covovax vaccines in June. The second batch, meanwhile, was expected to be manufactured in September.

Also Read | SII to introduce Novavax vaccine in India by September: Report

Novavax has developed Covovax in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI). The company said that its protein-based vaccine offered 100% protection against moderate and severe Covid-19, with an overall efficacy of 100%.

Thus far, five coronavirus vaccines have been approved in India, of which two --Covaxin and Covishield-- were the first to be cleared, and are the two most prominently used shots. Covishield, just like Covovax, is manufactured by the SII and is the local name of the shot developed by Oxford University and AstraZeneca Inc. India’s vaccination drive began on January 16 and a total of 529,582,956 doses have been administered till now, including 5,731,574 in the last 24 hours, according to the Union ministry of health and family welfare (MoHFW) dashboard.


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