The committee agreed that the FDA should reach agreement with Novavax on how the company will identify and assess a possible causal link between its vaccine and cases of heart inflammation. FDA reviewers said they suspected such an association based on a handful of myocarditis and pericarditis cases that arose during the clinical trial within days of immunization, although the company said there is not yet enough evidence to establish a definitive link. . Last summer, the FDA added a warning to Pfizer and Moderna’s Covid-19 vaccine fact sheets about the rare risk of developing inflammatory heart disease.
In an advanced stage clinical trial with approximately 25,657 adults in the United States and Mexico, Novavax’s Covid-19 vaccine was more than 90% effective in preventing all Covid-19 vaccine infections and 100% in preventing moderate or severe cases. Of the approximately 17,272 people who received the vaccine, 17 developed mild Covid-19 within a week after the second injection, compared with 79 people who developed mild, moderate, or severe Covid-19 in the 8,385-member placebo group.
Most of the Covid-19 cases in the study were the result of the Alpha variant.
Novavax’s product is a moth cell-derived recombinant protein inoculation, an older technology that takes longer to produce than its rivals made by Pfizer-BioNTech and Moderna. Prior to the advisory committee meeting, Novavax executives expressed optimism that their vaccine would be an attractive alternative for those who remain reluctant to receive mRNA-based vaccines.
But at least one insider suggested he was skeptical that offering Novavax injection as an option would get vaccine skeptics to roll up their sleeves.
“I hope to be proven wrong,” said Arthur Reingold, professor of epidemiology at the University of California, Berkeley, and a temporary voting member of the committee.
The consultants also expressed disappointment that they were not presented with vaccine performance data during the spikes caused by Omicron that have dominated the disease trajectory in the United States since late 2021, while noting available information on efficacy traces. of the vaccine with what the panel of experts previously evaluated Covid vaccine candidates.
Bruce Gellin, head of global public health strategy at the Rockefeller Foundation and a member with temporary voting rights, abstained from voting but indicated that he would vote “yes” under certain conditions.
“My conditional ‘yes’ vote is based on my expectation that the FDA will review all of the data that will be available to it, including data we haven’t seen today, to inform their authorization decision,” he said.
Little has been said about the lack of data made available on Novavax’s manufacturing capabilities, the problems of which have plagued the company for a long time. Novavax said on Tuesday that it had submitted updated manufacturing data to the FDA on Friday.
What’s next: While the FDA is not required to follow the recommendations of its advisory committees, it typically does. It is unclear how quickly regulators will decide whether to grant EUA to Novavax. The FDA did not immediately respond to a request for comment on a timing for a decision on the Novavax EUA request.
If so, independent consultants from the Centers for Disease Control and Prevention will meet to discuss whether and how to administer the vaccine.