CDC Recommends Novavax, the 4th COVID Vaccine to Be Authorized
The CDC's director signed off late Tuesday, making Novavax available to adults who haven't been vaccinated yet.
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The US Centers for Disease Control and Prevention recommended Novavax's COVID-19 vaccine Tuesday for adults who haven't been vaccinated yet. The official sign-off from CDC Director Dr. Rochelle Walensky followed an endorsement from the CDC's panel of public heath experts that advise the agency.
Novavax is the first protein-based COVID-19 vaccine to be authorized in the US -- a more "traditional" vaccine type that's been around for decades.
The US Food and Drug Administration last week authorized Novavax's COVID-19 vaccine for people 18 and older as a two-dose primary series vaccine, with each dose given three weeks apart. Because it's authorized as a primary series vaccine, Novavax can't be used as a booster shot by people who've already been vaccinated. But making Novavax available means adults who've held out on getting a COVID-19 vaccine will have another option.
The CDC said in its recommendation that Novavax will be available in the coming weeks.
"COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19," FDA Commissioner Dr. Robert M. Califf said in a news release last week. "And I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so."
Pfizer's and Moderna's COVID-19 vaccines use new mRNA technology. The Johnson & Johnson vaccine, though its use has been restricted in the US, is a viral vector type. Protein-based vaccines with adjuvants, like Novavax's, have been around for decades.
The Novavax vaccine was 90% effective against symptomatic COVID-19 in a clinical trial against older variants of COVID-19 (mostly alpha), but more research is needed to determine its response against omicron. Novavax's authorization comes as omicron's extremely contagious BA.5 subvariant is responsible for most cases of COVID-19 in the country, but the available vaccines are expected to remain protective against severe disease and death.
The FDA has recommended that vaccine manufacturers create vaccine formulas for booster doses this fall or winter that target the newer version of omicron. Novavax said it's working on an omicron-specific vaccine.
Side effects of Novavax include typical, temporary symptoms like soreness at the injection site, fatigue, headache and fever. Novavax might carry an increased risk of myocarditis (inflammation of the heart), according to the FDA. Six out of 40,000 vaccine recipients developed myocarditis in a clinical trial, compared with one in the placebo group.
Novavax was an early beneficiary of the Operation Warp Speed program, but the company has experienced manufacturing problems. Novavax submitted to the FDA for emergency use authorization in January -- well into the COVID-19 vaccine response --and its vaccine is authorized for use in other countries, including Canada.
Read more: Everything We Know About Novavax