Novavax’s COVID vaccine unanimously recommended by CDC advisers

A panel of outside vaccine advisors from the Centers for Disease Control and Prevention voted unanimously on Tuesday to recommend the use of Novavax’s COVID-19 vaccine, removing one of the last hurdles for a new fourth option for patients. million unvaccinated adults.

Theoretically, the first vaccines can begin once CDC Director Dr. Rochelle Walensky formally approves the committee’s vote, though it’s unclear how many doses will actually be available for those who finally want to get vaccinated. with the two-dose Novavax vaccine.

The Biden administration announced last week that it would make 3.2 million doses available to states. Spokespersons for the Department of Health and Human Services and Novavax did not respond to requests for comment on the timeline for distribution of all those doses.

At the time, the company was still completing the final stages of its “necessary quality testing” in order to release the doses.

The panel’s support comes a week after the Food and Drug Administration Novavax vaccine authorized for emergency use as a new option for unvaccinated adults. About 1 in 10 Americans ages 18 and older have yet to receive at least one dose of the COVID-19 vaccine, according to CDC figures.

Some of those Americans could be persuaded to get vaccinated with Novavax vaccines, the company’s chief medical officer, Dr. Filip Dubovsky, told CDC advisers on Tuesday.

“Our vaccine is based on a platform that is well understood. Recombinant protein vaccines have been used around the world for decades and this can be important, especially for those who are hesitant to get vaccinated,” Dubovsky told the panel.

CDC survey data presented to advisers found that 16% of unvaccinated respondents would “probably” or “definitely” receive a protein-based vaccine like Novavax. Fifty-two percent said they would “probably” or “definitely” not get the vaccine.

Novavax’s vaccine works by giving the immune system a piece of the virus grown in insect cells and mixed with an ingredient – called an adjuvant – derived from tree bark that aims to boost its effectiveness in the body.

Already available mRNA vaccines work by providing cells with a blueprint to create spike proteins to trigger an immune response from the body. Novavax, on the other hand, includes the proteins in its vaccine.

Novavax’s approach is part of the reason the company believes its vaccine also appears to trigger fewer side effects compared to injections from Pfizer-BioNTech and Moderna. For example, Novavax’s Lisa Dunkle told the panel that it “was extremely rare, unlike some other vaccines” to see fever in their trials.

However, like mRNA injections, Novavax’s vaccine will carry a warning about the risk of rare side effects of heart inflammation called myocarditis and pericarditis.

The CDC told the panel it will issue recommendations allowing Americans receiving Novavax injections to space out their first two injections by up to 8 weeks, such as their guidance for mRNA vaccines, which may reduce the risk of myocarditis. and increase vaccine efficacy.

The agency will also generally recommend that Americans wait to avoid getting vaccinated within four weeks of getting an orthopoxvirus shot, which also carries a potential risk of myocarditis. However, the CDC said the delay would not apply to people who were offered the Jynneos or ACAM2000 vaccines to combat the growing monkeypox epidemic.

“This is because the benefit of administering an orthopoxvirus vaccine as soon as possible, when indicated for prophylaxis, outweighs the possible risk of myocarditis by administering them too close to each other,” said CDC’s Elisha Hall at the panel.

In clinical trials conducted before the Omicron variant, Novavax was found to be 90.4% effective in preventing any symptomatic COVID-19 infection and up to 100% effective against moderate to severe disease.

Novavax is also studying potential versions of its vaccine that could work as suitable boosters for the Omicron variant. Like the mRNA injections, Novavax said the data suggests antibodies to its vaccine waned after six months.

However, the company presented data to CDC advisers which it said suggested that its current vaccine formulation may also be highly effective – after a booster dose – in protecting against Omicron’s BA.5 subvariant. which now represents more than three out of four newcomers. infections in the current wave nationwide.

“As we immunize with additional doses of our recombinant spike protein vaccine, we minimize antigenic distance and begin to see a more universal response against variants,” Dubovsky said.

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