United States secures 3.2 million doses of Covid-19 vaccine by Novavax

The US announced on Monday that it has secured 3.2 million doses of the COVID-19 vaccine by Novavax, which has partnered with the Serum Institute of India, with India's envoy in the US describing it as Indo-US "synergies in healthcare at work."

The US Department of Health and Human Services (HHS), in collaboration with the Department of Defence (DOD), announced on Monday that it has secured 3.2 million doses of Novavax's COVID-19 vaccine.

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

 

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

India-US "synergies in #healthcare at work! @Novavax @SerumInstIndia, India's Ambassador to the US Taranjit Singh Sandhu said in a tweet.

Novavax said it has established partnerships for the manufacture, commercialisation, and distribution of its COVID-19 vaccine NVX-CoV2373 worldwide. "Existing authorisations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain."

HHS Coordination Operations and Response Element (H-CORE), COO, Jason Roos said in a statement that "We remain committed to working to ensure that anyone eligible who wants a vaccine can get one. 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."

The statement added that securing these vaccines leverages preexisting US 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.

The Novavax COVID-19 Vaccine is designed and manufactured differently than the mRNA COVID-19 vaccines. 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 COVID-19 Vaccine offers an option to individuals who may have an allergic reaction to mRNA vaccines or who have a personal preference for receiving a vaccine other than a mRNA-based vaccine.

On June 7, 2022, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in support of granting EUA for the Novavax COVID-19 vaccine for individuals 18 years and older. Both FDA EUA and CDC recommendations are pending for the Novavax COVID-19 vaccine, it said.