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After being approved for use by the Food and Drug Administration last week, Novavax became the first authorized COVID vaccine in the U.S. to be manufactured in India. The FDA has issued an emergency use authorization to the vaccine, and the doses can be given out to people aged 18 and older.

The FDA approval adds to the vaccine choices available in the fight against COVID.

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur, such as hospitalization and death," said FDA Commissioner Robert M. Califf in a statement.

FDA’s authorization signifies that Novavax meets the FDA’s standards for safety, effectiveness and manufacturing quality. According to statements from the FDA, the approval comes after a “thorough analysis and evaluation of the available safety and effectiveness data.” The nod came six months after Novavax submitted its proposal seeking emergency authorization for its vaccine in January.

Novavax is administered twice, with an ensuing time interval of three weeks in between doses. In 2021, Novavax conducted two clinical trials involving 30,000 individuals in the U.S. and Mexico, and subsequently published its findings where it claimed that its vaccines recorded an efficacy rate of 92 percent against “any variant of concern” and 100 percent against occurrences of “moderate-to-severe diseases.”

The FDA has noted that the commonly reported side effects of this vaccine include pain and tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting and fever.

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Although the formula of Novavax was created by the American vaccine manufacturer that goes by the same name — Novavax, the parent company teamed up with India’s Serum Institute last year for mass-scale production of the vaccine for developing and low-income countries.

After the approval, Serum Institute shared a picture on Twitter of the team of scientists who were on the vaccine project and wrote, “It in an important milestone for the vaccine industry this week as #Nuvaxovid (@Novavax) made by @SerumInstIndia in India is approved by the @US_FDA and is being exported to the United States of America for the first time.” The vaccine has been released in the market branded as Nuxavoid and Covovax.

The update on approval was also shared by the official Twitter handle of the U.S. Embassy in India. The post read, “This will be the first authorized vaccine in the U.S. that is manufactured in India.”

Highlighting vaccine diplomacy and cooperation between the two countries, the post added that the feat is “yet another success in the longstanding collaboration between the U.S. and India on vaccine development.”

In India, all individuals above the age of 12 can register for vaccination through the national vaccination portal CoWIN. As of July 17, India had already administered 2 billion vaccinations across the country. According to the official government website, as of July 20, India’s COVID numbers stand at 145,000 active cases, while the total death toll has touched 525,000 cases.

In the U.S., there have been 1,021,048 COVID deaths, with 125,827 active cases. About 107,468,726 Americans have received at lest one dose of a vaccine, according to the Centers for disease control and prevention.


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