Independent experts on Tuesday recommended emergency authorization in the United States for the COVID-19 vaccine from Novavax, leaving it now to the United States Medicines Agency to make its final decision on this remedy, which is available that in so many other countries.
Three vaccines are currently authorized in the United States: those with messenger RNA from Pfizer and Moderna, and those from Johnson & Johnson.
But access to the latter has been restricted recently by health authorities, due to the increased risk of severe thrombosis. It is now reserved for adults who refuse to be vaccinated by Pfizer or Moderna, or do not receive them for medical reasons or limited access.
Some therefore hope that the Novavax vaccine, which uses a different method from others, could be an additional alternative for those reluctant to messenger RNA, in a country where the vaccination rate of the adult population is stops at over 76 %.
We have a very serious problem with the use of vaccines in the United Statestaught introduction at 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 must do.
Experts were compiled at the request of 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 this willingness outweighed the risks. The final decision of FDA rarely differs from the recommendation of this committee.
While some experts regret the lack of data against the Omicron variant currently in circulation, they accept the 90% efficacy observed in clinical trials.
The question of the risks of myocarditis
Part of the debate revolves around the question of myocarditis, inflammation of the heart muscle.
The FDA recorded six cases in people who received the Novavax vaccine during the trials, and expressed concern that this side effect may be more frequent with Novavax than with vaccines from Pfizer and Moderna. A Novavax emergency authorization warning may be included.
Company officials on their part reiterated on Tuesday that they do not exist, according to them. sufficient evidence to establish a causal relationship for the moment between cases of myocarditis and the vaccine.
Novavax’s action was suspended Tuesday morning in New York over these discussions.
These two-dozen vaccines are said to be subunit : it contains the part of the virus (but not the whole virus) that triggers the immune response. A method 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.
France Media Agency
Source: Radio-Canada
