Independent experts on Tuesday recommended emergency authorization in the United States of the vaccine against COVID-19 from Novavax, leaving it now to the United States Medicines Agency to make its final decision on this remedy, already available in very many other countries.
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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
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 refusing to be vaccinated with Pfizer or Moderna, or unable to receive them for medical or limited access reasons.
Some thus hope that the Novavax vaccine, which uses a different technique from the others, could constitute an additional alternative for those reluctant to messenger RNA, in a country where the vaccination rate of the adult population stagnates at just over 76 %.
“We have a very serious problem in the use of vaccines in the United States”, underlined 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. »
The experts were brought together at the request of the FDA to analyze, during public discussions, the data from the clinical trials of Novavax.
In a vote at the end of the day, they decided that the benefits of allowing it outweighed the risks. The FDA’s final decision rarely differs from this committee’s recommendation.
90% efficiency
While some experts regretted the lack of data against the Omicron variant currently in circulation, they welcomed the 90% efficacy observed during clinical trials.
Part of the debate revolved around the question of myocarditis, inflammation of the heart muscle.
The FDA has indeed identified six cases among people who received the Novavax vaccine during the trials, and expressed concern that this side effect may be more common with Novavax than with the vaccines from Pfizer and Moderna. A warning could be included in Novavax’s emergency authorization.
Company officials for their part repeated on Tuesday that there was, in their view, ” insufficient evidence to establish a causal relationship ” for the moment between the cases of myocarditis and the vaccine.
Novavax’s stock was suspended Tuesday morning in New York pending those talks.
This two-dose vaccine is called “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.
