F.D.A. Advisers To Weigh In On Covid Shots 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 did not find any cases of myocarditis or pericarditis in their initial clinical trials. But after authorization, once the vaccines were given to millions of people, they were both found to create a small extra risk of myocarditis in boys and young men.

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

But the vaccine is falling far short of initial hopes, both in terms of the number of vaccines distributed around the world and the number of people who are receiving them. In February 2021, Novavax pledged 1.1 billion doses to Covax, the United Nations program supplying shots to developing countries. But because of the delays, Covax has not yet ordered any doses from Novavax.

Demand for the vaccine also appears to be tepid in other countries. Novavax has shipped 42 million doses through the first quarter of this year, to 41 countries. In its briefing documents, the F.D.A. said that Australia, Canada, the European Union, New Zealand and South Korea provide data on how many people have actually received the vaccine. The grand total in these countries came to fewer than 750,000 doses.

When contacted for comment, Novavax did not provide a 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 authorization. But two years later, with the country already flush with effective mRNA vaccines, the government has little need for more.

Article source: https://www.nytimes.com/2022/06/07/health/novavax-covid-vaccine.html