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

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Earlier this month, the Food and Drug Administration (FDA) announced an emergency use authorization (EUA) for the Novavax COVID-19 vaccine.
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.
for Novavax COVID-19 vaccine shortly.
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 .

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

Share on Pinterest Pictured, workers in a Novavax laboratory on May 25, 2022, in Gaithersburg, MD. Image credit: Matt McClain/The Washington Post via Getty Images. 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.
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