CDC recommends Novavax COVID vaccine after unanimous vote

A panel of outside vaccine advisers from the Centers for Disease Control and Prevention voted unanimously on Tuesday to recommend the use of Novavax’s COVID-19 vaccine. Now, the CDC says it has officially passed the Immunization Practices Advisory Committee vote, officially opening up a fourth option for unvaccinated adults.

“Today we have expanded the options available to adults in the United States by recommending another safe and effective COVID-19 vaccine. If you have been waiting for a COVID-19 vaccine based on a different technology than those previously available, this is the time to join the millions of Americans who have been vaccinated,” CDC Director Dr. Rochelle Walensky said in a statement.

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

Some of those Americans could be persuaded to get vaccinated with Novavax’s 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.

Typically, vaccinations can begin once Walensky formally approves the committee’s recommendations. The Biden administration announced last week that it would make 3.2 million doses available to states.

However, it is unclear when the 3.2 million doses will be distributed and how the first supplies will be distributed. Novavax said on Tuesday that the first batch of its vaccine had passed quality testing and would be shipped for distribution to the U.S. government “in the coming days.” The CDC said in a statement that the vaccine “will be available in the coming weeks.”

A spokesperson for the Department of Health and Human Services did not respond to a request for comment.

In rollouts for other brands, vendors had already begun receiving shipments after the FDA granted clearance, though vaccinators had to wait for the CDC’s green light to begin injections.

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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