Novavax COVID-19 vaccine: When will it be available in the US?

  • Earlier this month, the Food and Drug Administration (FDA) announced an emergency use authorization (EUA) for the Novavax COVID-19 vaccine.
  • Research shows Novavax to be 100% effective in preventing moderate to severe COVID-19.
  • Novavax uses a traditional vaccine model used previously for influenza and shingles vaccines.
  • The United States Department of Health and Human Services has secured 3.2 million doses of Novavax for distribution in the U.S., with ordering opening to medical professionals in the coming weeks.

On July 13, 2022, the FDA announced it had granted emergency use authorization for Novavax — a new vaccine for COVID-19.

Novavax marks the fourth COVID-19 vaccine available in the U.S. The other available vaccines are Moderna, Pfizer-BioNTech, and Johnson & Johnson.

What is Novavax?

Novavax, Inc. manufactures the Novavax vaccine, NVX-CoV2373. A clinician administers the vaccine in a two-dose regimen in the upper arm, with doses spaced between 3 to 8 weeks apart.

The Centers for Disease Control and Prevention (CDC) now also recommend the vaccine for adults 18 years and older.

According to a spokesperson for Novavax, the manufacturer has submitted adolescent clinical data to the FDA and expects a rapid review of its adolescent filing.

Additionally, the spokesperson said Novavax intends to file for authorization for boosting in the U.S. for Novavax COVID-19 vaccine shortly.

How is this vaccine different?

Some of the previous COVID-19 vaccines — namely Pfizer and Moderna — utilize mRNA technology. Instead of using weakened or dead viral cells to teach your body how to protect itself from the live disease, mRNA vaccines provide instructions to the body on how to create a spike protein. Spike proteins are also found in SARS-CoV-2 virus cells.

The body recognizes the spike protein as something foreign it needs to defend itself from, causing an immune response. This teaches the body how to react if ever infected by the SARS-CoV-2 virus with the same spike proteins.

The Novavax vaccine does not use mRNA technology. Instead, it is a protein-based vaccine that contains stabilized forms of the spike proteins from SARS-CoV-2, plus an adjuvant — a substance included in a vaccine to cause the body to have an immune response.

Novavax uses an adjuvant made from saponins that naturally occur in the bark of the Soapbark tree native to Chile.

“Novavax is built on a well-understood protein technology used for many years in other vaccines to protect against diseases such as influenza, shingles, and HPV,” a representative from Novavax explained for Medical News Today.

“The protein is derived from the coronavirus spike protein and is formulated with Novavax’s patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause COVID-19,” they added.

Dr. Fady Youssef, a board-certified pulmonologist, internist, and critical care specialist at MemorialCare Long Beach Medical Center in Long Beach, CA, said many clinicians have been waiting for the Novavax vaccine to become available because it uses a traditional-based vaccine-making model.

“My hope is a lot of patients that have had hesitancy about the mRNA vaccines, because they’re using novel and new technology, will be less reluctant to get vaccinated for COVID-19 using a traditional vaccine like Novavax,” he told MNT.

“It will be interesting to see how it compares to the mRNA vaccines in terms of efficacy, as well as breakthrough infections and how long the protection that it provides lasts,” Dr. Youssef continued. “So that will be interesting to see over the next few months [and] years.”

How effective is Novavax? 

The phase 3 PREVENT-19 clinical trial conducted between December 2020 and February 2021 included almost 30,000 adults from the U.S. and Mexico. Participants received either two doses of Novavax or two doses of a saline placebo.

According to the results of the study published in the New England Journal of Medicine, researchers found Novavax to be 90.4% effective in preventing symptomatic COVID-19. They also reported the vaccine as 100% effective in preventing moderate to severe COVID-19.

When will Novavax be available in the U.S.?

On July 11, 2022, the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD), announced they had secured 3.2 million doses of Novavax for distribution within the U.S.

On July 22, 2022, Novavax Inc. stated that the doses had shipped from its warehouse and the U.S. government’s distribution centers would receive them later that day.

According to the CDC’s Novavax COVID-19 Vaccination Operational Planning Guide, healthcare officials should be able to begin ordering doses of Novavax the week of July 25, 2022.

When asked when Novavax would be available in the United States, MNT received the following statement from an HHS spokesperson:

“Open ordering is expected to begin in the coming weeks. Vaccine will be made available to states, jurisdictions, pharmacy partners, and federal entities for administration. Pro rata thresholds for jurisdictions have been set based on the unvaccinated adult population in each jurisdiction. A limited quantity of doses will be held in reserve and distributed based on need.”

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