FDA advisers to weigh in on Covid hits by Novavax

“We believe there is insufficient evidence to establish a causal relationship,” Novavax said in a statement. “We will continue to monitor all adverse events, including myocarditis and pericarditis. »

Moderna and Pfizer-BioNTech found no cases of myocarditis or pericarditis in their early clinical trials. But after licensing, once the vaccines were given to millions of people, they were both found to create a small additional risk of myocarditis in boys and young men.

The Novavax vaccine has been licensed in dozens of countries, including India, South Africa and Britain, and has also received clearance from the European Union and the World Health Organization.

But the vaccine is well below initial hopes, both in terms of the number of vaccines distributed around the world and the number of people who receive them. In February 2021, Novavax pledged 1.1 billion doses to Covax, the United Nations program providing vaccines to developing countries. But because of the delays, Covax has yet to order doses from Novavax.

Vaccine demand also appears tepid in other countries. Novavax shipped 42 million doses in the first quarter of this year, to 41 countries. In its briefing documents, the FDA said Australia, Canada, the European Union, New Zealand and South Korea provide data on the number of people who actually received the vaccine. The grand total in these countries was less than 750,000 doses.

When contacted for comment, Novavax did not provide the total number of doses administered worldwide in other countries, such as India.

As part of its initial support for Novavax’s research, the United States agreed to buy 110 million doses of the vaccine if it won approval. But two years later, with the country already brimming with effective mRNA vaccines, the government needs little more.

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