India’s Serum Institute has broken new ground for itself and the Indian vaccine industry by receiving regulatory approval in the United States for made-in-India vaccines, a first of sorts.

The vaccine major has a manufacturing tie-up with American biotechnology firm Novavax that has just received an emergency use authorization from the US Food and Drug Administration (USFDA) for the use of its adjuvanted Covid-19 vaccine in those over 18 years. 

“It is the first vaccine from India to be approved by the USFDA,” Serum Institute of India’s Chief Executive Adar Poonawalla confirmed to BusinessLine, adding that SII’s site was the only one approved by the USFDA amongst all Novavax’s partners. “In India, the vaccine is branded as Covovax, and in other international markets, including the US, it is branded as Nuvaxovid by Novavax,” he added. 

A vaccine industry veteran explained that Indian vaccine-makers have in the past supplied to global markets and international agencies like Unicef, for example, but not directly to the US.

Poonawalla said, “Our production capacity is 100 million doses a month, but we will not be producing that much. We have supplied around 100 million doses globally and the US is the latest addition to that list.” Furthermore, he added, “We are expected to sell around 50-100 million doses of Novavax branded vaccines globally this year. Pricing will vary across countries.”

In its statement on receiving the USFDA approval, Novavax said, “Doses of the Novavax Covid-19 Vaccine, Adjuvanted were shipped from the Serum Institute of India..., the world’s largest vaccine manufacturer by volume, and are now in the US.” The next step for the vaccine is a policy recommendation for use from the Centres for Disease Control and Prevention (CDC). Earlier this week, the US secured 3.2 million doses of the COVID-19 vaccine by Novavax.

WHO approvals

Novavax’s vaccine and Serum Institute’s Covovax have also received emergency use listings from the World Health Organisation. In fact, the Serum Institute has approvals for Covovax in India as well, though it is yet to become part of the government’s immunisation programme.

The Novavax Covid-19 vaccine, adjuvanted, is administered as a two-dose primary series, three weeks apart. It contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. The FDA said adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual. The spike protein in this vaccine is produced in insect cells; the Matrix M-adjuvant contains saponin extracts from the bark of the soapbark tree that is native to Chile, it added.

Trial data

The vaccine was assessed in an ongoing randomised, blinded, placebo-controlled study conducted in the United States and Mexico. The effectiveness of the vaccine was assessed in clinical trial participants 18 years of age and older who did not have evidence of SARS-CoV-2 infection through 6 days after receiving the second vaccine dose, the regulator said.

Among these participants, approximately 17,200 received the vaccine and approximately 8,300 received saline placebo. Overall, the vaccine was 90.4 percent effective in preventing mild, moderate or severe Covid-19, with 17 cases of the disease occurring in the vaccine group and 79 cases in the placebo group. No cases of moderate or severe COVID-19 were reported in participants who received the vaccine, compared with nine cases of moderate COVID-19 and four cases of severe COVID-19 reported in placebo recipients, it said. In the subset of participants 65 years of age and older, the vaccine was 78.6 percent effective, the note said. The clinical trial was conducted prior to the emergence of delta and omicron variants, it added.

Safety data

The safety of the vaccine was assessed in approximately 26,000 clinical trial participants who received the vaccine and approximately 25,000 who received placebo. The most commonly reported side effects by vaccine recipients included pain/tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting and fever. Approximately 21,000 vaccine recipients had at least two months of safety follow-up after their second dose, the FDA said.

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