The Food and Drug Administration authorized the COVID-19 vaccine from Novavax for emergency use on Wednesday, providing the U.S. with a fourth option.
Shots from the Gaithersburg, Maryland, company are arriving late in the pandemic and may play a limited role in the vaccination campaign, but regulators think it is good to have an option beyond the messenger-RNA shots from Pfizer-BioNTech and Moderna.
Novavax’s shots use a protein-based technology that has been used in prior vaccines, so it might appeal to some holdouts. The vaccination rate in the U.S. has been stuck in neutral — about two-thirds of the population — for many weeks.
“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert M. Califf said. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”
The vaccine is given in two doses, 21 days apart. It is authorized for those 18 and older.
The shots use a very small amount of the virus spike protein, which sparks an immune response, in combination with an adjuvant, which boosts the immune system’s response to the vaccine. The technology has been used for decades in other vaccines, including ones that target hepatitis B and shingles.
The Biden administration recently said it ordered 3.2 million doses of the vaccine in anticipation of authorization.
By contrast, more than 200 million people in the U.S. have been fully vaccinated with the Pfizer and Moderna shots, and tens of millions more have received boosters from those companies.
The vaccine from Johnson & Johnson is also available, but regulators, citing a rare but severe blood-clotting disorder tied to some recipients, have limited its use to those who cannot access another vaccine or risk an adverse medical reaction to one of the other types.
Novavax was among several promising vaccine candidates in “Operation Warp Speed” but it fell behind other companies in the vaccine race in 2020.
Manufacturing issues further delayed its submission to the FDA, though it already has been authorized in other countries.
For more information, visit The Washington Times COVID-19 resource page.