FDA Advisory Committee Recommends Novavax COVID-19 Vaccine for Use in the U.S.

Coronavirus vaccine.
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Americans could have access to a new COVID-19 vaccine as early as this week after a panel of Food and Drug Administration experts voted in favor of recommending Novavax’s shot for emergency use.

In a 21-to-0 vote that included one abstention, the committee supported the proposition that the vaccine’s benefits outweigh its risks, Barron’s reported. Novavax’s stock was halted prior to the vote, butshares surged in after-hours trading and were up over 9% early Wednesday.

Despite the near-unanimous vote, the panel also voiced disappointment that more data wasn’t available on the vaccine’s efficacy against more recent variants of the virus.

“The data we’ve seen today have been impressive and support the original vision for this vaccine from its beginning,” panelist Dr. Bruce Gellin, who voted yes, said during the all-day public meeting. “But we don’t know whether that attribute continues to be relevant today.”

Gellin added that the lower level of protein used in Novavax’s shot appears to lead to lower side effects, Investor’s Business Daily reported.

The FDA typically follows the committee’s recommendations, though it doesn’t necessarily have to. According to CNBC, Novavax’s vaccine could be approved for U.S. distribution as soon as this week. However, the Centers for Disease Control and Prevention would still need to sign off on the shots before pharmacies and other healthcare providers can start administering them.

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If approved, Novavax’s shot would be the fourth COVID vaccine authorized for use in the United States. Like Pfizer and Moderna, Novavax tested its shot against the dominant COVID strain two years ago, but the effectiveness of all three vaccines has weakened against new variants and mutations of the virus.

Novavax’s shot does have one advantage, though: It uses a protein-based technology that might appeal to people who are hesitant to get vaccines that include messenger RNA technology, such as those offered by Pfizer and Moderna.

“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,” Nelson said after the vote.

Another panelist, Dr. Eric Rubin, said “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.” However, he added that “if there’s a population of patients who are going to take this and not existing vaccines, then I think it’s pretty compelling.”

The Novavax vaccine will likely require a third dose, according to panelist Dr. Michael Nelson.

Novavax shares remained halted throughout the June 7 trading session — which might have been welcome relief for investors who have watched the company’s stock price shed more than three-quarters of its value over the past year.

The stock took another hit last week when the FDA posted briefing documents ahead of the advisory panel meeting that suggested Novavax’s shot might cause heart inflammation known as myocarditis and pericarditis.

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