The FDA has issued an emergency use authorization for Maryland-based biotech company Novavax’s new COVID-19 Vaccine, Adjuvanted. File photo by Jim Lo Scalzo/EPA-EFE
July 13 (BP) — The Food and Drug Administration issued an emergency use authorization Wednesday for the protein-based Novavax COVID-19 Vaccine, Adjuvanted.
“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 need to support emergency use authorization,” FDA Commissioner Dr. Robert M. Califf said in a statement.
Novavax’s protein-based, adjuvanted vaccine is approved for people 18 years of age and older.
The vaccine contains an added ingredient to produce a stronger immune response. It is also a more traditional type of vaccine, in that it employs a whole, deactivated virus, while the two widely used vaccines by Moderna and Pfizer are mRNA-based.
The single-dose Johnson & Johnson vaccine is the only non-mRNA shot approved for use in the United States by the FDA, though it was limited in May to adults who cannot receive other versions of the vaccine due to a risk of thrombosis, which can cause rare but potentially life-threatening blood clots.
The Maryland-based biotech company applied for the EUA in February, with an independent advisory committee voting last month to recommend the Novavax vaccine for FDA approval.
“This vaccine product is the first traditional protein-based vaccine to achieve this level of protection,” said Dr. Mitchell Goldstein, professor of pediatric medicine at Loma Linda University, said during the June meeting.
“Data, from two separate studies involving over 30,000 participants, demonstrated a composite efficacy of approximately 90% in preventing significant infection,” Goldstein said.
Novavax COVID-19 Vaccine, Adjuvanted is administered in two primary doses, three weeks apart. Japanese health officials authorized the use of the U.S.-produced vaccine in April.
On Monday, the Biden administration announced it had secured 3.2 million doses of the new vaccine.
The U.S. Department of Health and Human Services said the Novavax vaccine will be made available for free to states, jurisdictions, federal pharmacy partners and qualified health centers.
“While more than two-thirds of the American public are already fully vaccinated, we must maintain a sense of urgency to ensure all eligible individuals get vaccinated, particularly heading into the fall,” said chief operating officer Jason Roos at HHS Coordination Operations and Response Element.
“This latest vaccine would offer people another choice to help protect themselves from severe disease or hospitalization caused by COVID-19.”