Administration secures 3.2 million doses of Novavax COVID-19 vaccine

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The U.S. Department of Health and Human Services, in collaboration with the Department of Defense, announced it has secured 3.2 million doses of Novavax's COVID-19 vaccine. 

The protein-based, adjuvanted vaccine will be made available free to states, jurisdictions, federal pharmacy partners and federally qualified health centers if it receives U.S. Food and Drug Administration Emergency Use Authorization (EUA) and recommendation from the Centers for Disease Control and Prevention. 

The company is expected to complete all necessary quality testing in the next few weeks, which would support final release of the product.

Securing these vaccines leverages pre-existing government agreements with Novavax, including a July 2020 agreement for the development and demonstration of large-scale manufacturing of a SARS-CoV2 vaccine. The government will be taking delivery of COVID-19 vaccine doses manufactured using funds remaining on the existing agreement, pending completion of all quality testing.

WHAT'S THE IMPACT?

The Novavax COVID-19 vaccine is designed and manufactured differently than the mRNA COVID-19 vaccines offered by Pfizer and Moderna. The Novavax vaccine contains a very small amount of the SARS-CoV-2 spike protein, which elicits an immune response, in combination with an adjuvant, which boosts the immune-system response to the vaccine. 

FDA-approved protein-based vaccines have been used widely for decades; examples of more recently approved vaccines that contain a purified protein combined with an adjuvant include vaccines to prevent hepatitis B and shingles. 

The Novavax vaccine offers an option to those who may have an allergic reaction to mRNA vaccines or who have a personal preference for receiving a vaccine other than an mRNA-based vaccine.

On June 7, 2022, the FDA's Vaccines and Related Biological Products Advisory Committee voted in support of granting EUA for the Novavax offering for people ages 18 and older. Both FDA EUA and CDC recommendations are pending for the Novavax vaccine.

THE LARGER TREND

An ever-increasing number of Americans are now eligible to receive COVID-19 vaccines. In June, the CDC cleared the way for children 6 months through 5 years old to receive a COVID-19 vaccine, following a recommendation from the Advisory Committee on Immunization Practices.

This expands eligibility for vaccination to nearly 20 million additional children and means that all Americans 6 months old and older are now eligible for vaccination. The CDC is advising parents of children in this age group to get either the Pfizer/BioNTech or Moderna vaccines.

Parents are also being encouraged to sign their children up for v-safe – personalized and confidential health check-ins via text messages and web surveys – where they can easily share with the CDC how a child feels after getting a COVID-19 vaccine. This, the agency said, will allow for continuing safety monitoring for the vaccines.

ON THE RECORD

"We remain committed to working to ensure that anyone eligible who wants a vaccine can get one," said HHS Coordination Operations and Response Element COO Jason Roos. "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. This latest vaccine would offer people another choice to help protect themselves from severe disease or hospitalization caused by COVID-19."
 

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com