​What Do You Need to Know About Novavax? - Reeve Foundation

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to use a fourth vaccine to prevent COVID-19, Novavax's Adjuvanted. The Centers for Disease Control and Prevention (CDC) supported the FDA's EUA by recommending the use of Novavax. The authorization of the vaccine increases the options people have when receiving their initial or booster shots. But you may have questions about Novavax and if it's right for you.

To help you navigate the progress and availability of COVID-19, we'll discuss some questions you may have about Novavax's Adjuvanted.

Why is Novavax Authorized but not Approved by the FDA?

Novavax had a contract with the federal government when Operation Warp Speed began. However, manufacturing issues slowed down a quick emergency use authorization. Since then, the makers of Novavax have conducted successful stage I/II clinical trials.

Peer-reviewed and published results from a trial found that Novavax's primary vaccine was more than 90% effective against symptomatic COVID-19 and 100% effective against severe disease and death. Testing continues to determine how effective it is against various COVID-19 variants.

Novavax is still undergoing stage III clinical trials. However, based on the results from stage I/II clinical trials, the European Union and the United States have authorized the use of Novavax for initial and booster shots.

Which COVID-19 Vaccines are Approved by the FDA?

The FDA has approved the Pfizer - BioNTech and Moderna COVID-19 vaccines to prevent COVID-19. Both vaccines are safe and effective. Furthermore, the vaccines are approved as booster shots and can be "mixed and matched." Mixed and matched means you can receive the Pfizer or Moderna vaccines as your initial shots and have the other administered as your booster. This method is as effective at preventing or lessening the effects of COVID-19 as having the same initial and booster shots.

The FDA authorized the Johnson & Johnson COVID-19 vaccine. You may wonder if you can receive the Johnson & Johnson shot instead. Because of adverse reactions, the FDA has limited the use of the vaccine to:

• Those who can't take the Pfizer or Moderna vaccine (severe response to an mRNA vaccine dose or are allergic to one of the ingredients found in the Pfizer or Moderna vaccine)
• Won't be vaccinated unless they have the Johnson & Johnson shot
• Wants the Johnson & Johnson shot regardless of the health concerns associated with it

What Are the Differences in the Authorized or Approved Vaccines?

mRNA Vaccines

Pfizer BioNTech and Moderna's vaccines are Messenger RNA (mRNA), a single-stranded RNA ( which existed before DNA) involved in protein synthesis. mRNA carries protein information from your DNA's nucleus to the cytoplasm. Once there, the mRNA is read and translated. So, while mRNA involves your DNA, it doesn't change it.

Viral Vector

Johnson & Johnson's COVID-19 vaccine is a viral vector vaccine. Viral vector vaccines use a modified version of different viruses to deliver information to your cells.

Protein Subunit Vaccines

Novavax is a protein subunit vaccine. It has pieces of SARS-CoV-2 (COVID-19)

spike proteins in the vaccine. These spike proteins (produced in insect cells) are essential because Novavax's other ingredient, Matrix-M adjuvant (saponin extracts from the soapbark tree), aids your immune system in responding to the spike protein in the future. Your immune system learns how to respond to the spike protein, which means it can react to COVID-19's spike protein virus and protect you from COVID-19.

How Can Novavax be Used?

The FDA authorized Novavax

• As a two-dose primary vaccine for people 12 years and up
• A booster shot six months after a person completed their primary vaccine shots with an approved or authorized COVID-19 vaccine

• Individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate.
• Individuals 18 years of age and older can elect to receive the Novavax COVID-19 vaccine (Adjuvanted) because they would not receive a booster dose of a COVID-19 vaccine.

What are the Advantages of Novavax?

Novavax is more like a traditional vaccine (smallpox, chickenpox, flu) because it uses pieces of the virus to help build immunity.

• Some people may be more comfortable with the use of small doses of the virus rather than mRNA or viral vector vaccines.

• Another aspect of Novavax that makes it a viable option for many is that it can be used by those who may have (or have had) allergic reactions to the other vaccines.
• Novavax is easier to ship and store because it doesn't need to be refrigerated.

As with other vaccines, there are side effects. However, Novavax's side effects are mild, common, and can occur within a week of receiving the shot.

One in 40,000 people may experience myocarditis after receiving Novavax. However, it is rare and commonly clears itself up.

Where Can I Get the Novavax Vaccine?

You can stay up to date with the availability of Novavax by checking here: https://www.cdc.gov/vaccines/covid-19/reporting/vaccinefinder/about.html.

The addition of Novavax's Adjuvanted COVID-19 vaccine increases your options if you haven't received a COVID-19 primary series or booster vaccine. In addition, because it uses the same technology as traditional vaccines, it can alleviate concerns about newer technology. Also, since it is an alternative for those who have allergies or have had an allergic reaction to one of the ingredients in Pfizer-BioNTech or Moderna's vaccines, it is a viable option.

You can talk to your doctor about Novavax and decide if it is right for you.

Christina Sisti, DPS, MPH, MS is a bioethicist and health care policy advocate. She works to create awareness and improve health care policy for those with long-term health issues.

This publication was supported by the Administration for Community Living (ACL), U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totaling $160,000 with 100% funding by ACL/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, ACL/HHS or the U.S. government.