Update 7/20-2022 10:35 a.m. ET: The Centers for Disease Control and Prevention on Tuesday approved the use of Novavax’s COVID-19 vaccine for unvaccinated adults ages 18 and older. The vaccine, which is intended to tempt vaccine holdouts with its more traditional design, should become available in the coming weeks, the CDC said.
On Tuesday afternoon, a panel of independent expert advisors to the CDC – the Advisory Committee on Immunization Practices – voted unanimously (12 to 0) to recommend the use of the Novavax vaccine after reviewing efficacy and safety data. CDC director Rochelle Walensky reaffirmed their recommendation hours later, completing the final step before the vaccine can be taken into battle.
“Today, we expanded the options available to adults in the US by recommending another safe and effective COVID-19 vaccine,” Walensky said in a statement Tuesday evening. “If you’ve been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated. Now the number of COVID-19 cases increasing again in parts of the world, vaccination is critical to help protect against the complications of severe COVID-19 disease.”
Original story 7/13/2022 6:41 PM ET: The US Food and Drug Administration issued a long-awaited authorization for Novavax’s COVID-19 vaccine on Wednesday. It is the fourth COVID-19 vaccine to be approved in the US, but it is the first to use a more conventional protein subunit design.
For now, the two-dose vaccine is primarily aimed at the approximately 72 million Americans who have yet to receive one dose of a COVID-19 vaccine. The FDA emergency use authorization only allows use as a primary series, not as a booster for those already vaccinated. While Novavax is expected to apply for booster authorization at a later date, the company and the FDA hope the vaccine’s traditional formulation will now trigger vaccinations, especially as BA.5 floods the country.
Some consider the vaccine protein subunit design to be a more proven design compared to the newer mRNA-based platform used in the leading COVID-19 vaccines made by Pfizer-BioNTech and Moderna. While mRNA-based vaccines made their public debut during the pandemic, protein subunit-based vaccines were already in use against several diseases, including hepatitis B, flu, whooping cough (whooping cough) and meningococcal infections.
To fight COVID-19, the Novavax vaccine directly delivers the SARS-CoV-2 spike protein, which is widely produced in insect cells. The vaccine also contains an adjuvant, an additive that boosts the immune response. In this case, the adjuvant includes saponin extracts from the Chilean soap bark tree previously used in FDA-approved vaccines.
Long awaited option
At a meeting of FDA advisors last month, Peter Marks, the agency’s chief vaccine regulator, expressed the need for more vaccine options in the US. “We have a vaccine uptake problem that is very serious in the United States, and anything we can do to make people more comfortable accepting these potentially life-saving medical products is something we think we can do.” forced to do so,” said Marks. As such, many experts were eager for the Novavax vaccine to be approved. But the vaccine, which has been in development for two years, had suffered significant delays due to a series of production setbacks that had only recently occurred. have been rectified.
Still, at the June meeting, FDA advisors voted almost unanimously in favor of the FDA’s approval of the vaccine. In a large trial of more than 25,000, the vaccine was found to be 90.4 percent effective against COVID-19, although the trial was conducted before the delta and omicron variants emerged. The vaccine also appears to be generally safe, although it is associated with an increased risk of myocarditis and pericarditis (inflammation of the heart and surrounding tissue). In the end, 21 of the 22 FDA advisors voted for authorization, while one expert abstained, citing the lack of variant-specific efficacy data.
“Today’s authorization provides adults in the United States who have not yet received a COVID-19 vaccine with another option that meets the FDA’s rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against serious illness caused by COVID-19,” FDA Commissioner Robert Califf said in a statement on Wednesday. “And I encourage anyone who is eligible for but has not yet received a COVID-19 vaccine to consider this.”
The authorization is coming to fruition as federal officials renew their efforts to increase vaccination coverage, which has largely stalled. Last week, Novavax announced that the US government had signed a deal to buy 3.2 million doses. But before Novavax injections can begin, the Centers for Disease Control and Prevention must sign up. CDC advisers are expected to meet next week to discuss the vaccine.
