Novavax COVID-19 vaccine receives emergency use authorization from FDA

July 13, 2022

The data support that the known and potential benefits of the [Novavax] vaccine outweigh its known and potential risks in people 18 years of age and older, and that this vaccine may be effective in preventing COVID-19.

The United States Food and Drug Administration, granting emergency use authorization (EUA) for the Novavax COVID-19 vaccine.

Why It Matters: After the Centers for Disease Control and Prevention officially recommend the vaccine and quality testing is complete, the Novavax series is set to become a fourth COVID-19 vaccine option for approx. 1 in 10 U.S. adults (ages 18 and up) who have not yet been vaccinated.

  • The recommendation from the CDC could come as early as next week, when the agency’s external vaccine advisory group is scheduled to meet.
  • What were the supporting data? In a clinical trial conducted *prior to the emergence of omicron and delta variants,* researchers found that the vaccine was 90.4% effective in preventing COVID-19 in a group of approx. 17,200 adults 18 years of age and older. In a smaller subset of participants ages 65 and up, “the vaccine was 78.6% effective” in preventing COVID-19.
  • The most common side effects of the vaccine in clinical trial participants included muscle pain, fatigue, headache, nausea/vomiting, fever and joint pain.
  • *Important To Note*: “… clinical trial data provide evidence for increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following administration of Novavax COVID-19 Vaccine, Adjuvanted … As a condition of authorization, the company will conduct studies to further assess its safety, including studies to further assess the risks of myocarditis and pericarditis.”
  • The Novavax vaccine is to be given as a two-dose series, “three weeks apart.”
  • Unlike the current vaccines available, the protein-based Novavax vaccine uses a more “traditional” approach by exposing the body to small particles of the coronavirus “in combination with an adjuvant, which boosts the immune system response to the vaccine” (HHS). Click HERE to learn more about how this vaccine works.

Big Picture: This week, the Biden administration announced purchasing 3.2 million doses of the Novavax vaccine for the American public, “pending completion of all quality testing.”

Click HERE to view an update on COVID-19 in the United States from the Centers for Disease Control and Prevention.

Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted (U.S. Food and Drug Administration)

FDA authorizes Novavax Covid vaccine, in hopes the traditional shot will convince holdouts (STAT News)

FDA authorizes Novavax COVID vaccine for emergency use (Axios)

Like A Moth To Flame (SmartHER News)

by Jenna Lee,