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The Novavax COVID-19 Vaccine in Pregnancy

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

Nuvaxovid, Covovax, or NVX-CoV2373, is more commonly known as the Novavax vaccine and has recently been approved for emergency use in protecting against COVID-19 by the World Health Organization (WHO).

As of January 19, 2022, the vaccine is being administered in a growing number of countries, including Austria, Belgium, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Philippines, Poland, Portugal, Republic of Korea, Romania, Slovakia, Slovenia, Spain, and Sweden.

As of late January 2022, emergency use authorization of the Novavax vaccine also appears likely in various other countries, including the United Kingdom, Australia, Canada, the United States, New Zealand, Singapore, and the United Arab Emirates.

Currently, the Novavax COVID-19 vaccine is approved for use in people of age 18 years and older; clinical trials are advancing in children ages 12-17.

There are a number of different versions of the Novavax vaccines, meaning that the version(s) of the vaccine approved and available may differ by country.

Novavax is an American biotechnology company that is based in Gaithersburg, Maryland. Currently, Novavax is collaborating with the Serum Institute of India on the production and manufacturing of the NVX-CoV2373 vaccine.

How The Novavax Vaccine Works

NVX-CoV2373 is what scientists call a protein subunit vaccine and is made of tiny units known as protein nanoparticles.

The protein molecules of these nanoparticles are genetically engineered and attached to a sub-stance called an adjuvant (adjuvants are molecules that, when combined with protein molecules, help produce a stronger immune response in people receiving the vaccine).

The specific adjuvant used in the Novavax vaccine is called a Matrix-M1 adjuvant.

In the case of the COVID-19 virus, the specific protein interest is the spike (S) glycoprotein (the protein that gives SARS-CoV2 – the virus that causes COVID-19 – the crown-like, or corona appearance when examined under an electron microscope).

There is no virus in the Novavax vaccine. The business end of the vaccine is merely the S glycoprotein attached to the Matrix-M1 adjuvant.

While the SARS-CoV2 virus uses the S glycoprotein to infect body cells, the S glycoprotein of the Novavax vaccine is locked into a particular shape that prevents it from acting like the S glycoprotein of actual virus particles; this means that the vaccine cannot harm body cells.

What the Novavax vaccine can do, and is designed to do, is to stimulate the immune system to respond the same way that it would upon detecting initial infection by the SARS-CoV2 virus. This response stimulates immune system production of special immune cells and special antibodies that attach to S glycoprotein.

Interestingly, genetically engineering and attaching a protein to an adjuvant isn’t a new concept. Scientists have used this process to successfully create other vaccines, including the HEPLISAV-B vaccine (to protect against hepatitis B and the Shingrix zoster vaccine (to prevent shingles).

How The Novavax Vaccine Is Administered

The Novavax vaccine is administered intramuscularly and injected into the deltoid muscle of your shoulder.

The initial Novavax vaccination schedule included two injections given 21-days apart.

However, and since people who have received other COVID-19 vaccines have been receiving a third booster shot, vaccinations beginning with two shots of the Novavax vaccine will now be considered up to date with a third shot. The third shot could be either another Novavax shot, or a shot of one of the mRNA vaccines (Pfizer-BioNTech, Moderna).

Furthermore, people who received two shots of a different COVID-19 vaccine (or one shot of the Janssen vaccine) will likely be able to receive Novavax as the third shot. Eventually, Novavax will also be available to those who are ready for a fourth shot.

In other words, the Novavax vaccine is likely to soon be an accepted option within the mix and match framework of current COVID-19 vaccines.

Effectiveness And Safety Of The Novavax Vaccine

Large scale studies in the United Kingdom, the United States, and Mexico have demonstrated that the Novavax vaccine effectively prevents the development of COVID symptoms in over 90 percent of COVID-19 cases that would normally occur in unvaccinated people exposed to certain SARS-CoV2 variants (including the variants that dominated the pandemic prior to the surge of the Omicron variant).

When evaluating effectiveness in preventing the severe kind of COVID-19 that leads to admission to an intensive care unit (ICU), the effectiveness of the Novavax vaccine was close to 100 percent.

Considering this, scientists expect that the Novavax vaccine, like the other approved COVID-19 vaccines, will be extremely effective in preventing severe disease and death.

Pregnancy and Lactation Issues

The World Health Organization recommends vaccination in pregnant women “when the benefits of vaccination to the pregnant woman outweigh the potential risks”. Currently, the benefits of COVID-19 vaccination far outweigh potential risks, both in pregnancy and lactation.

The only exceptions to this recommendation are in rare cases of people who previously have suffered allergic reactions to ingredients in the vaccine, such as polyethylene glycol.

Specific to the NVX-CoV2373, studies that have included pregnant women have demonstrated acceptable safety profiles for nanoparticle/Matrix-M1 used in the creation of the Novavax vac-cine.

Adverse Effects Associated With The Novavax Vaccine

Undesirable or adverse effects of the Novavax vaccine commonly occur at the injection site and include pain, redness, and swelling. Like other COVID-19 vaccines, common effects felt throughout the body include tiredness, headache, chills, fever, nausea, and muscle aches.

Pregnancy and Lactation Positions by Country for the Novavax Vaccine (Covovax)

WHO What You Need to Know

References

Formica N, Mallory R, Albert G, Robinson M, Plested JS, Cho I, Robertson A, Dubovsky F, Glenn GM; 2019nCoV-101 Study Group. Different dose regimens of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373) in younger and older adults: A phase 2 randomized placebo-controlled trial. PLoS Med. 2021 Oct 1;18(10):e1003769. doi: 10.1371/journal.pmed.1003769. PMID: 34597298; PMCID: PMC8486115.

Heath PT, Galiza EP, Baxter DN, et al.; 2019nCoV-302 Study Group. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. N Engl J Med. 2021 Sep 23;385(13):1172-1183. doi: 10.1056/NEJMoa2107659. Epub 2021 Jun 30. PMID: 34192426; PMCID: PMC8262625.

Novavax. Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial. Accessed January 19, 2022

Novavax. All Updates On Our COVID-19 Vaccine Effort. Accessed January 19, 2022

World Health Organization. COVID-19 vaccines side effects and safety. Accessed January 19, 2022

David Warmflash
Dr. David Warmflash is a science communicator and physician with a research background in astrobiology and space medicine. He has completed research fellowships at NASA Johnson Space Center, the University of Pennsylvania, and Brandeis University. Since 2002, he has been collaborating with The Planetary Society on experiments helping us to understand the effects of deep space radiation on life forms, and since 2011 has worked nearly full time in medical writing and science journalism. His focus area includes the emergence of new biotechnologies and their impact on biomedicine, public health, and society.

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