In a nearly unanimous vote, a panel of Food and Drug Administration experts recommended Novavax's Covid vaccine for emergency use, and NVAX stock jumped Wednesday.
All but one member of the FDA's Vaccines and Related Biological Products Advisory Committee voted in favor of Novavax's two-dose vaccine. One panelist abstained.
"The data we've seen today have been impressive and support the original vision for this vaccine from its beginning," panelist Dr. Bruce Gellin said, explaining his yes vote. He noted the lower level of protein used in Novavax's shot appears to lead to lower side effects. "But we don't know whether that attribute continues to be relevant today."
That puts Novavax in good company. Novavax tested its Covid shot against the dominant strain two years ago, just like Pfizer and Moderna. But the effectiveness of all three vaccines has waned as the virus mutates and creates new variants.
The benefit of Novavax's shot, however, is that it uses a protein-based technology, which could sway people hesitant to receive shots comprised of newer messenger RNA technology. Panelist Dr. Michael Nelson said the vaccine will likely require a third dose.
"I do feel that it does offer something for fulfilling that unmet need, including those populations who have hesitancy with regards to the messenger RNA vaccines," he said after the vote. There are other advantages in terms of storage and supply chain challenges.
On today's stock market, NVAX stock yo-yoed, but eventually settled up 5.4% at 50.11.
NVAX Stock: FDA Decision Next
The meeting is an important step ahead of potential authorization of the two-dose vaccine. Out of 22 panelists, 21 said the benefits of the Novavax shot outweigh its risks for adults. The FDA often follows the committee's recommendation.
After that, the vaccine heads to the Centers for Disease Control and Prevention.
Dr. Peter Marks, of the FDA, acknowledged the benefit of offering another vaccine option to help prevent severe cases of Covid. But it will be up to the CDC to determine where it lies in the lineup of preferred vaccines.
Panelist Dr. Mark Sawyer notes the audience for the Novavax vaccine is largely "vaccine-hesitant people," many of whom have likely already experienced natural Covid infections.
In one of its key studies, 7% of participants had prior Covid infections before receiving Novavax's shot. Their responses were not calculated in the effectiveness analysis. However, in general, they experienced a boost in antibodies, Novavax Chief Medical Officer Filip Dubovsky said. They also didn't have any additional side effects compared to previously uninfected participants.
Roughly two-thirds of the U.S. is considered fully vaccinated, according to the CDC. On the flip side, 22% of Americans have yet to receive any Covid shot. That number includes children under the age of 5 who are not eligible for a Covid shot.
"We haven't given up on them," Dubovsky said of unvaccinated Americans.
Data Updates Desired
Novavax tested its Covid shot against an ancestral strain of the Covid-causing virus — just like its predecessors Pfizer, Moderna and Johnson & Johnson. And it's beginning to look like vaccine-induced immunity lasts six months or less with new variants on the loose.
"It is disappointing that we don't have more updated information because we're looking at the (effectiveness) against strains that don't exist any longer," panelist Dr. Eric Rubin said. But "if there's a population of patients who are going to take this and not existing vaccines, then I think it's pretty compelling."
SVB Securities analyst Mani Foroohar says it's difficult to estimate Novavax sales in the U.S.
"As a late entrant into the Covid-19 vaccine space with a relatively poor competitive position, a logical strategy to build market share for Novavax is to use price as a lever to counter the existing mRNA duopoly," he said in a report to clients. "This would make increasing vaccine prices more difficult in the endemic phase of Covid-19."
Meanwhile, NVAX stock remains under pressure. As of Monday's close, shares were below their 50-day and 200-day moving averages, according to MarketSmith.com. The stock also experienced a dive last week when the FDA posted briefing documents ahead of the advisory committee meeting.
The documents suggested Novavax's shot could cause heart inflammation known as myocarditis and pericarditis. The FDA noted there were six cases in recipients of the vaccine. In comparison, there was just one case in a placebo recipient.
Young Males Are More Susceptible
Of the six cases, four occurred in males under the age of 30. The FDA said it couldn't rule out a causal relationship between Novavax's vaccine and the cases of myocarditis, causing NVAX stock to dive. But Novavax argued this demographic is at a heightened risk of myocarditis due to viral infection. In fact, myocarditis is a risk of Pfizer's and Moderna's vaccines in young men and boys.
"We have learned that we can expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk," Novavax said in a written statement. "Myocarditis is most often caused by nonspecific viral infections."
The company said there's "insufficient evidence to establish a causal relationship" between its shot and episodes of myocarditis/pericarditis. Still, NVAX stock tumbled 20% on Friday.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
