FDA panel votes to approve fourth Covid vaccine option for American adults

(CN) — A group of advisers to the Food and Drug Administration voted Tuesday to recommend the authorization of a Covid-19 vaccine made by Novavax, a Maryland-based startup that received funding early on from the government program Operation Warp Speed.

The move to greenlight the non-mRNA vaccine option for use in adults was certified in a 21-0 vote taken after a full day of review of the company’s clinical trial data at a virtual meeting. The two-dose vaccine would be the fourth authorized Covid-19 shot in the country. The protein-based jab utilizes the same technology as the hepatitis B and HPV vaccines.

Before the shot can be distributed to the public, the Centers for Disease Control and Prevention will also need to sign off on the shots, but the FDA panel's recommendation marks a big step toward full authorization.

During the virtual meeting, Dr. Gregory Poland of the Mayo Clinic advocated for the approval of the Novavax shots, which held a 90% efficacy rate against mild to severe Covid-19 in clinical trials, in light of the need to have an additional vaccine platform available to Americans as more virus variants evolve.

“The combination of the immunogenicity data showing robust antibody responses across multiple variants with clinical efficacy data from the phase three trials, signals broad cross protection,” Poland said Tuesday. “This will be vital as we head into an era where we simply don't know what the next variant will be.”

Dr. Filip Dubovsky, executive vice president and chief medical officer at Novavax, added Tuesday that the company's vaccine has few side effects “with most symptoms resolving after one or two days.”

None of those who received the vaccine experienced moderate or severe infection. Notably, the trial took place before the delta and omicron variants evolved. 

While Dubovsky admitted the vaccine hadn’t yet had time to prove itself against the latest Covid-19 variant, he expressed confidence in his company’s product.

“It’s factual that we don’t have efficacy data against omicron. What we do have is a technology that we think generates a broad immune response, demonstrated against a broad array of variants,” Dubovsky said.

Still, it remains to be determined when the vaccine will become available — or how widely.

There is no shortage of Pfizer, Moderna and Johnson & Johnson shots — the three vaccines approved in the United States, which have been authorized for over a year — at this time. Still, Novavax could occupy a unique niche in the market among the roughly 27 million American adults who have yet to be vaccinated, some of whom have been waiting for a non-mRNA vaccine.

Dubovsky emphasized too that Novavax’s jab could “be a useful tool in addressing the ongoing pandemic, providing a different options that might be helpful in increasing the incomplete vaccination rates in the US.” 

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, also referenced this point Tuesday.

“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,” he said.

The federal government will coordinate to adhere a “limited” quantity of Novavax vaccines in the short term, according to the Department of Health and Human Services.

While Novavax is already approved in the European Union, it hasn’t received much interest from the unvaccinated. Just 220,000 doses of the vaccine have been given in the EU since the vaccine’s approval last December. 

One concern about heart inflammation associated with the Novavax vaccine was brought to light in briefing documents released Friday by the FDA. The documents said that six cases of myocarditis and pericarditis occurred in 40,000 trial volunteers, flagging a potential “causal association.”

Novavax brushed off the concern in a statement Friday. 

“We believe there is insufficient evidence to establish a causal relationship,” the company said. “We will continue to monitor all adverse events, including myocarditis and pericarditis.”

While no cases of myocarditis or pericarditis were found in Pfizer or Moderna’s clinical trials, both were found after authorization to slightly increase the risk of myocarditis for boys and young men.

Delayed by development and manufacturing issues, Novavax filed for U.S. authorization in late January, a year behind when it had first intended to. 

In the last week, the U.S. saw approximately 1.5 million Covid-19 cases, according to data from The New York Times. Around 76% of American adults have already received two doses of Covid-19 vaccines, according to the CDC. 

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