SII Applies for Emergency Use Authorisation of Novavax Vaccine to Central Drugs Body

The Serum Institute of India applied for Emergency Use Authorisation (EUA) for the Novavax vaccine to the Central Drug Standard Organisation on Friday.

US-based Novavax Inc has a vaccine manufacturing agreement with Serum Institute of India, which also manufactures the Covishield vaccine which is being currently administered in the country.

Apart from India, the vaccine manufacturer has asked that its Covid-19 vaccine, branded Covovax, be allowed emergency use in Indonesia and the Philippines.

The Novavax two-dose shot is manufactured with lab-grown replicas of the coronavirus spike protein coat. This is in stark contrast to other frequently-used vaccinations, which provide genetic instructions to the body for the production of spike protein.

Novavax revealed in June that the vaccine was 90 percent effective against symptomatic Covid-19 in a study involving approximately 30,000 patients in the United States and Mexico. It also worked against variants that were circulating at the time in those countries. The majority of the side effects were minor.

Novavax claimed that delivering a booster six months after a second shot boosted virus-fighting antibodies capable of combating the highly contagious Delta variant.

Additional research is being conducted in the United Kingdom and internationally to see if the Novavax shot may be used as a booster following other forms of Covid-19 vaccinations. Indonesia has already showed interest in utilising the Novavax vaccine as a booster after receiving some Chinese-made doses, according to the company.

SII CEO Adar Poonawalla on Friday said he was hopeful that Covovax will be launched in October for adults and for children by the first quarter of 2022. He also thanked the government for all the support provided to Serum Institute and said the company is always trying to expand its Covishield production capacity to meet the demand.

Poonawalla met Home Minister Amit Shah in Parliament and the meeting between the two lasted for 30 minutes. “The government is helping us and we are facing no financial crunch. We are thankful to Prime Minister Narendra Modi for all the cooperation and support,” Poonawala said.

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