Health

FDA advisers are recommending the Novavax Covid-19 vaccine

The committee agreed that the FDA should reach an agreement with Novavax on how to identify the company and assess the possible causal link between its vaccine and the cases of heart disease. FDA reviewers said they suspected such an association based on several cases of myocarditis and pericarditis that arose during a clinical trial within a few days of immunization, although the company insists that there is still insufficient evidence to establish a definitive link. The FDA last summer added warning leaflets to Pfizer’s and Moderna’s Covid-19 vaccines about the rare risk of developing inflammatory heart disease.

In a late-stage clinical trial in approximately 25,657 adults in the United States and Mexico, the Novavax Covid-19 vaccine was more than 90 percent effective in preventing all infections of the Covid-19 vaccine and 100 percent effective in preventing moderate to severe cases. Of the approximately 17,272 people who received the vaccine, 17 developed mild Covid-19 within one week of the second injection, compared with 79 people who developed mild, moderate, or severe Covid-19 in the 8,385 placebo group.

Most of the Covid-19 cases in the trial were the result of an alpha variant.

Novavax’s product is a recombinant protein-based inoculation derived from hay cells – an older technology that is more time-consuming to produce than its competitors Pfizer-BioNTech and Moderna. Ahead of the Advisory Committee meeting, Novavax executives expressed optimism that their vaccine would be an attractive alternative for those who are still hesitant to receive mRNA-based vaccines.

But at least one member said he was skeptical that offering a Novavax shot as an option would persuade vaccine skeptics to drop their hands.

“I hope it’s wrong,” said Arthur Reingold, a professor of epidemiology at the University of California, Berkeley and a member of the committee on temporary voting.

The advisers also expressed frustration with the fact that they did not provide data on vaccine efficacy during Omicron-induced surges that have dominated the US disease trajectory since late 2021, citing information about vaccine efficacy that the panel had previously assessed. Covid vaccine candidates.

Bruce Gellin, Rockefeller Foundation’s Global Public Health Strategy Leader and Interim Voting Member, abstained from voting, but indicated he would vote “yes”.

“My conditional vote ‘yes’ is based on my expectation that the FDA will review the integrity of the data available to them, including data we have not seen today, to notify them of the authorization decision,” he said.

There was little discussion about the lack of available data on Novavax manufacturing capabilities, the problems of which have long plagued the company. Novavax said on Tuesday it had submitted updated production data to the FDA on Friday.

Რa is the following: While the FDA is not required to follow the recommendations of its advisory panels, it usually does. It is unclear how quickly regulators will decide whether to grant Novavax EUA. The FDA did not immediately respond to a request for comment.

If this happens, independent advisers from the Centers for Disease Control and Prevention will meet to discuss whether the vaccine should be administered.

FDA advisers are recommending the Novavax Covid-19 vaccine

Source link FDA advisers are recommending the Novavax Covid-19 vaccine

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