On July 27th, the Maryland Department of Health (MDH) circulated a health provider bulletin detailing updates to Maryland’s COVID-19 Vaccine Plan, including a recommendation to administer the Novavax COVID-19 vaccine.
The Novavax product received emergency use authorization (EUA) through the U.S. Food and Drug Administration (FDA) on July 13th. According to the MDH bulletin, providers should provide a primary series of the Novavax vaccine to individuals 18 years of age and older. Neither the FDA nor MDH have approved Novavax boosters or the administration of the vaccine to individuals younger than 18 years old.
Novavax, a company based in Gaithersburg, Maryland, is the only vaccine producer to receive an EUA for a more traditional protein-based, as opposed to an RNA- or DNA-based, vaccine. FDA Commissioner Robert M. Califf, M.D. discussed the safety and efficacy of the Novavax vaccine in a press release:
‘Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,’ said Commissioner Califf. ‘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. 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.’
As noted in previous Conduit Street coverage, the vaccine had cleared a significant hurdle toward approval in June, when an FDA panel voted for its approval. Moreover, Novavax’s development of a COVID-19 vaccine has resulted in as many as 400 new jobs in Montgomery County.
Individuals seeking additional information regarding Emergency Use Authorization can do so here.