FDA panel backs Novavax Covid jab with hopes of persuading sceptics
US government advisers have recommended the approval of a fourth Covid-19 jab developed by Novavax, expressing hopes that it can help boost the nation’s flagging immunisation programme as a new wave of infections sweeps across the population.
Scientists on a US Food and Drug Administration advisory panel on Tuesday voted overwhelmingly in favour of authorising the first protein-based Covid vaccine — a type of technology that has been used for decades against diseases including shingles and the flu.
Some healthcare experts believe the vaccine could win over vaccine sceptics who have so far resisted getting jabs. Anti-vaccine campaigners have taken aim at shots developed by BioNTech/Pfizer and Moderna, despite their effectiveness, over their use of mRNA, a new technology.
The panel vote represents an important milestone for Novavax, a Maryland-based biotech company which signed a $1.6bn deal with the US government in 2020 to develop a Covid vaccine.
Public doubts has caused the US to lag many developed nations in Covid vaccination rates, with about two-thirds of Americans failing to complete their primary round, which involves two doses, and less than a third receiving a booster shot.
By contrast, more than four out of five people in Australia and Canada have received two doses of a Covid vaccine.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told the panel that Novavax’s jab would provide an alternative for people who did not feel comfortable with mRNA vaccines.
“We do have a problem with vaccine uptake in the United States, which is very serious. Anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do,” Marks said.
Last month the FDA restricted the use of Johnson & Johnson’s Covid vaccine due to a rare but serious risk of blood clots, which left the Moderna and the BioNTech/Pfizer shots as the only “frontline vaccines” available in the US.
The recommendation in favour of authorising the Novavax jab comes as the US faces a fresh wave of Covid infections caused by the spread of several Omicron sub-variants. The country is averaging about 100,000 new cases a day, more than triple the level recorded two months earlier, according to the Centers for Disease Control and Prevention.
Hospitalisations in the US are also rising, but the seven-day average of daily deaths has fallen below one-tenth of its January 2021 peak.
Arthur Reingold, a member of the FDA advisory committee and a professor at University of California, said he was sceptical about the contention that there are a lot people who are “just waiting” for the Novavax vaccine to get inoculated against Covid.
“I’m hoping to be proved wrong,” Reingold added.
Clinical trials show Novavax vaccine has 90 per cent efficacy against symptomatic Covid, similar to mRNA vaccines. Some members of the panel said that they would have liked to see data on how the jab performed against new coronavirus variants, including the Omicron strain.
There were also questions by members about the potential risks posed by myocarditis, a rare condition associated with inflammation of the heart.
But in the final vote, just one member of 22 on the advisory panel abstained, while the remaining 21 members agreed the benefits of authorising the vaccine outweighed any potential risks.
Analysts expect the FDA to support the recommendation and authorise the Novavax jab, which has already been authorised in more than three dozen countries worldwide.