On Tuesday, the Centers for Disease Control and Prevention recommended Novavax’s two-dose Covid vaccine, paving the way for 3.2 million doses to be shipped to the states.
Last week, the Food and Drug Administration approved the Novavax vaccine for emergency use, but the U.S. Centers for Disease Control and Prevention had to grant approval before the doses could be distributed to the public. On Tuesday, the CDC’s independent advisory panel voted unanimously to recommend a vaccine, and soon after, CDC Director Dr. Rochelle Walensky endorsed the panel’s recommendation.
Some public health officials hope the vaccine will fill a gap in U.S. vaccination efforts because it does not use mRNA technology. According to the CDC, about 22% of people in the US have not yet received a single Covid vaccine.
“If you have been waiting for a Covid-19 vaccine based on technology other than those previously available, now is the time to join the millions of vaccinated Americans,” Walensky said in a statement Tuesday. “With Covid-19 cases on the rise again in parts of the country, vaccination is critical to protect against the complications of severe Covid-19 illness.”
In a presentation to an advisory panel on Tuesday, CDC officials said people aged 18 and older who are not immunocompromised should receive two doses of Novavax vaccine three to eight weeks apart. Those who are immunocompromised should receive two doses three weeks apart.
The vaccine has already been approved in more than 40 countries and the European Union. More than 1 million doses have been administered worldwide as of June 30, according to Novavax.
The Novavax vaccine stimulates antibody production by injecting purified coronavirus spike protein into the body along with an immune-boosting ingredient called an adjuvant. The FDA has approved several protein-based vaccines in the past, including one for hepatitis B and one for herpes zoster.
In contrast, the Pfizer-BioNTech and Moderna vaccines were the first approved mRNA vaccines. They use a fragment of the coronavirus genome to instruct the body to make a spike protein inside, which triggers antibody production.
However, the availability of Novavax vaccines may not materially affect vaccination rates in the US at the moment. In a small CDC survey earlier this year, only 16% of unvaccinated respondents said they would likely or definitely receive a protein-based Covid vaccine. And a June survey by Morning Consult found that 77% of unvaccinated adults said they would not get a protein-based Covid vaccine if it were allowed in the US.
However, the Novavax vaccine has another advantage: it can be stored in a conventional refrigerator for up to six months, so it is easier to transport than mRNA vaccines, which must be stored at sub-zero temperatures.
Efficacy and side effects of the Novavax vaccine
In a pilot group of over 30,000 people in the US and Mexico, the Novavax vaccine was found to reduce the risk of symptomatic Covid by 90% and reduce the risk of moderate to severe disease by 100%.
Common side effects included pain or tenderness at the injection site, fatigue, muscle pain, and headache. Fever was extremely rare.
The Novavax vaccine, like the two mRNA vaccines, carries a small risk of myocarditis, or inflammation of the heart muscle. Novavax’s trials identified three cases of myocarditis that were likely vaccine-related from more than 41,000 vaccine recipients in the company’s clinical trials worldwide.
The risk of myocarditis is much higher after contracting Covid. Of the 1.45 million people diagnosed with Covid in the US between March 2020 and February 2021, about 5,000 developed myocarditis, according to the CDC.
However, due to the risk of myocarditis, CDC officials said in a presentation on Tuesday that people who have recently received the monkeypox vaccine but have not been vaccinated against Covid may consider waiting four weeks before receiving any from coronavirus vaccines.
Novavax said its vaccine was highly effective against the alpha variant, but its trials were too early to assess efficacy against the omicron variant. However, at the end of December, the company released additional data showing that two doses elicited a strong immune response against the original omicron variant.
The version of omicron that currently dominates the US, BA.5, appears to evade vaccine defenses more easily than its predecessors. Novavax said Tuesday it still expects its vaccine to provide good protection against new omicron sub-variants.
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