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Experts recommend authorization of Novavax’s COVID-19 vaccine in the United States | Coronavirus

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Three vaccines are currently authorized in the United States: those with messenger RNA from Pfizer and Moderna, and that from Johnson & Johnson.

But access to the latter has recently been restricted by health authorities, due to an increased risk of serious thrombosis. It is now reserved for adults who refuse to be vaccinated with Pfizer or Moderna, or cannot receive them for medical or limited access reasons.

Some hope that the Novavax vaccine, which uses a different technique from the others, could be an additional option for those reluctant to messenger RNA, in a country where the vaccination rate of the adult population is stagnating at just over 76. %.

We have a very serious problem in the use of vaccines in the United Statespointed out in the introduction to the meeting Peter Marks, of the American Medicines Agency (FDA). Anything we can do to make people more comfortable accepting these life-saving products, we should do.

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The experts were brought together at the request of the FDA to analyze Novavax clinical trial data in public discussions.

In a vote at the end of the day, they decided that the benefits of allowing it outweighed the risks. The final decision of the FDA rarely differs from the recommendation of this committee.

While some experts regretted the lack of data against the Omicron variant currently in circulation, they welcomed the 90% efficacy observed during clinical trials.

The question of the risks of myocarditis

Part of the debate revolved around the question of myocarditis, inflammation of the heart muscle.

The FDA noted six cases among people who received the Novavax vaccine during the trials, and expressed concern that this side effect could be more frequent with Novavax than with the vaccines from Pfizer and Moderna. A warning could be included in Novavax’s emergency authorization.

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Company officials for their part repeated on Tuesday that they did not exist, according to them. sufficient evidence to establish a causal relationship for the moment between the cases of myocarditis and the vaccine.

The action of Novavax had been suspended Tuesday morning in New York during these discussions.

This two-dose vaccine is said subunit : it contains a component of the virus (but not the whole virus) triggering an immune response. A technique used for vaccines against whooping cough, meningococcal meningitis and hepatitis B.

It is already authorized in more than forty countries, including the United Kingdom, France, Canada, Japan and India.

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