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COVID-19: FDA Authorizes Novavax Vaccine, Administration Releases BA.5 Strategy

The Food and Drug Administration announced July 13 the emergency use authorization of the Novavax COVID-19 vaccine, Adjuvanted, widening options for the prevention of COVID-19 for adults not yet vaccinated in the United States. In collaboration with the U.S. Department of Defense, the U.S. Department of Health and Human Services has secured 3.2 million doses of the vaccine, which will be available at no cost to states, jurisdictions, federal pharmacy partners, and federally qualified health centers.

The Novavax vaccine, administered in a primary series of two doses given three weeks apart, contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are substances used in some vaccines that help the body create a stronger immune response to protect people from the disease against which they are being vaccinated.

Because the Novavax COVID-19 vaccine is designed and manufactured differently than the mRNA COVID-19 vaccines, the authorization notably opens the possibility of vaccination to individuals who may have an allergic reaction to mRNA vaccines or who have voiced a personal preference and have remained unvaccinated as a result.

In a clinical trial with participants 18 years of age and older, conducted prior to the emergence of delta and omicron variants, the vaccine was 90.4 percent effective in preventing mild, moderate, or severe COVID-19. Zero moderate or severe COVID-19 cases were reported in participants who received the vaccine.

To comply with authorization regulations, Novavax will continue conducting studies to evaluate vaccine safety and efficacy, including further assessing the risks of myocarditis and pericarditis.

White House Releases Strategy for BA.5 Subvariant Surge

The Biden-Harris administration has released an action plan to take on the BA.5 omicron subvariant of SARS-CoV-2, the virus that causes COVID-19. BA.5 is the most infectious and transmissible subvariant yet and now accounts for 65 percent of COVID-19 cases in the United States.

Administration officials warned against the potential for infections to rise in the coming weeks as fewer people are up to date on their vaccinations and immunity dwindles.

“The message that I want to get across to the American people is this: BA.5 is something we’re closely monitoring and, most importantly, we know how to manage it,” said White House COVID-19 Response Coordinator Ashish Jha, MD, MPH, during a July 12 press briefing.

While stressing that vaccines remain the most important and effective way of slowing the spread of COVID-19, Jha stated that the administration plans on managing the rise in cases by increasing access to vaccines and boosters, treatments, tests, and masks. The administration, which has previously provided billions of dollars in federal funds to improve indoor air quality in schools, public buildings, and other settings, also encourages building owners to continue improving indoor ventilation.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org  or 202.585.0127 with questions.

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