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The U.S. Food and Drug Administration (FDA) recently authorized the Novavax coronavirus vaccine (brand names: Novaxovid and Covovax), which has already been used to prevent COVID-19 in 40 other countries. It’s another key way to protect against COVID-19, along with the other suite of vaccines now available and preventive measures like Evusheld.
Here’s everything you need to know about the Novavax vaccine as an immunocompromised individual, and why some people who were originally hesitant about the COVID-19 vaccines may feel more comfortable with the Novavax shot.
How Does Novavax Work Against COVID-19?
The fourth vaccine authorized by the FDA, the Novavax vaccine is another tool to protect against COVID-19 — and may be an option for those who were uncertain about getting the other vaccines that use newer technology or who have an allergy to an ingredient in another vaccine.
Like other COVID-19 vaccines, Novavax helps cells in your body recognize that a spike protein doesn’t belong, spurring the immune system to activate immune cells and produce antibodies to attack the SARS-CoV-2 virus if you get infected, per Yale Medicine.
However, it’s different from other COVID-19 vaccines because it directly injects a version of the spike protein (along with an immune system stimulant) into the body to create antibodies and T-cells. This version of the spike protein has been created in a lab and doesn’t have genetic material inside — and can’t cause disease.
In other words, instead of using genetic material to deliver a set of instructions to your cells (as with the Johnson & Johnson or mRNA vaccines) the Novavax vaccine already has the spike protein pre-made and can be thought of as a shortcut to an immune response, per Nebraska Medicine.
Novavax, which only includes the parts of a virus that stimulate your immune system the best, is a more traditional vaccine method that has been used before to prevent conditions like HPV and shingles.
“There are people who were reluctant to get the adenovirus vaccine or the mRNA vaccine because they were uncomfortable with how new the technologies were for those vaccines,” says David Aronoff, MD, Chair of the Department of Medicine at Indiana University School of Medicine. “The Novavax vaccine is made using a process that has been used for many currently licensed vaccines. This might be the reason some people would be willing to be immunized now, and that’s great.”
Each ingredient in the Novavax vaccine serves a specific purpose, per the U.S. Centers for Disease Control and Prevention:
- SARS-CoV-2 recombinant spike protein causes an immune response that helps to protect the body from getting sick with COVID-19 in the future.
- Cholesterol and phosphatidylcholine work together to help the recombinant spike protein enter cells.
- Fraction-A and Fraction-C of Quillaja saponaria Molina extract helps activate the cells of the innate immune system.
The following ingredients work together to help keep vaccine molecules stable while the vaccine is manufactured, shipped, and stored:
- Disodium hydrogen phosphate heptahydrate
- Disodium hydrogen phosphate dihydrate
- Potassium chloride (common food salt)
- Potassium dihydrogen phosphate (common food salt)
- Sodium chloride (basic table salt)
- Sodium dihydrogen phosphate monohydrate
- Sodium hydroxide or hydrochloric acid
The Novavax vaccine does not contain eggs, preservatives, latex, or metals. It also does not include polyethylene glycol (PEG), an ingredient in the Pfizer and Moderna vaccines that some people are allergic to.
Who Is Eligible for Novavax?
Novavax is approved for individuals aged 18 and over, per the FDA. Of course, as with other vaccines, it shouldn’t be used in individuals with a known history of severe allergic reaction to any component of the Novavax COVID-19 Vaccine.
What Is the Dosing Schedule for Novavax?
The Novavax vaccine is currently authorized for a two-dose regimen, given three to eight weeks apart (it’s recommended that the immunocompromised only wait three weeks between doses). Even if you’re immunocompromised, there is not a third dose authorized quite yet, as there is for Pfizer and Moderna.
There is also currently no Novavax booster available, but the company is studying its efficacy as a booster and the vaccine has also been included in studies analyzing the mixing and matching of different vaccines.
“There is no language that says Novavax will not be approved in the future for booster,” says Mohamed Yassin, MD, Chief of Infectious Diseases at UPMC Mercy. “However, it makes sense to give at least one booster of the mRNA vaccine to assure efficacy in protection from mortality.”
In general, it’s recommended that certain people ages 12 years and older who are moderately or severely immunocompromised and adults ages 50 years and older get two boosters, per the CDC.
As of today, Novavax is not mixed with Pfizer of Moderna — your primary series should include the same vaccines for both doses, per Nebraska Medicine. However, if you can’t get the second Novavax dose for some reason, you could ask your doctor or pharmacist about getting a different second dose.
“If someone was in a real pinch, without access to the Novavax second shot, they could get another variety of vaccine like the mRNA dose, but we are in a bit of a data-free zone there,” says Dr. Aronoff. “We should have data regarding this mix-and-match issue from clinical trials that have included Novavax in them in the future.”
If you’re taking certain immunosuppressant medications, your doctor may recommend you hold doses before or after receiving the Novavax vaccine. Remember, you shouldn’t navigate this on your own — always talk to your doctor about starting, stopping, or changing the timing of your medication.
For instance, the American College of Rheumatology has suggested holding Abatacept shots and JAK inhibitors for one to two weeks (as disease activity allows) after each mRNA vaccine dose. It also recommended discussing the optimal timing of dosing and vaccination of rituximab with your rheumatology provider.
“Depending on the exact nature of the immunomodulatory therapy you are receiving, your licensed health care professional may advise holding such treatment prior to vaccination with any of the available COVID-19 vaccines to optimize the immune response,” says Dr. Aronoff. “However, not all immunomodulatory treatments interfere with antibody responses to the available COVID-19 vaccines, so there is not a one-size-fits-all approach here. I recommend patients speak with the licensed health care professional who is prescribing and monitoring their immunomodulatory treatments.”
What Are the Side Effects of Novavax?
The most common side effects reported in the clinical trial for Novavax were pain/tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting, and fever.
A handful of Novavax clinical trial participants also experienced myocarditis (a rare form of inflammation of the heart muscle usually caused by nonspecific viral infections), per Yale Medicine. All of the participants who this occurred in were men.
In a company statement, Novavax said “there is insufficient evidence to establish a causal relationship” and that the company “will continue to monitor all adverse events, including myocarditis and pericarditis.”
You should seek immediate medical attention if you have any of the following symptoms after receiving the vaccine, per the FDA:
- Chest pain
- Shortness of breath
- Feelings of having a fast-beating, fluttering, or pounding heart
There have been similar rare reports around the mRNA vaccines. For instance, there is an FDA-issued warning label on both the Moderna and Pfizer vaccines about myocarditis and pericarditis in adolescents and young adults.
It’s still not clear why this occurs in some people, but in most cases with the mRNA vaccines, the inflammation gets better on its own without treatment.
How Well Does Novavax Work?
In the Novavax Phase 3 clinical trial that involved 30,000 participants, the vaccine was found to be 90 percent effective against mild, moderate, and severe disease, per the FDA. However, this study was conducted before the more infectious Delta and Omicron variants started circulating — so its efficacy against the currently dominant Omicron subvariants is unknown.
“The real-world use of Novavax, just like we’ve seen in the real-world use for the mRNA vaccines or the adenovirus vaccine, is probably that it’s not as protective against the Delta or Omicron variants of SARS-CoV-2 as the vaccines were against older strains,” says Dr. Aronoff. “That said, even in the immunocompromised, the vaccines are still providing a lot of protection against serious consequences of COVID-19, such as hospitalization or death.”
In May, Novavax launched a Phase 3 clinical trial to test a booster targeting the Omicron variant. In particular, the company is accelerating research on shots tailored for circulating subvariants BA.5 and BA.4.
“The game might change a little bit as we start to see more options for vaccines that are tailored toward more recent variants,” says Dr. Aronoff. “Once we have vaccines targeted toward the more recent variants, it is likely that those would be the ones to go for first if you are immunocompromised.”
But of course, if you’re not already vaccinated, Dr. Aronoff adds that the most important thing is to talk to your licensed health care professional about whether a particular vaccine might be better for you — and to get vaccinated.
All FDA-approved or authorized COVID-19 vaccines, including Novavax, provide substantial protection against COVID-19 hospitalization and death.
What Does Novavax Mean for Immunocompromised Patients?
Each of the currently available vaccines can be used in immunocompromised patients.
“One of the challenges is that we don’t have head-to-head trials of all the different vaccines in immunocompromised or immunocompetent people, so it’s hard to know if one is better suited for somebody who is immunocompromised than somebody who doesn’t share that degree or type of immunosuppression,” says Dr. Aronoff. “Right now, we recommend using any of the available vaccines according to their indicated schedule, which involves getting boosters for some vaccines.”
Even if the vaccines are less effective against infection itself, it is still important to protect yourself from hospitalization or death if you’re high-risk.
“Immunocompromised individuals are at a special vulnerable place when it comes to infections and vaccine protection,” says Dr. Yassin. “Variants reduce the protection against infection, but the protection against severe disease and mortality should be less affected.”
The authorization of Novavax also delivers one final bit of promising news for both the immunocompromised and immunocompetent: Having a new vaccine on the market could help protect against potential supply chain issues.
“While we haven’t seen shortages recently due to supply chain issues, this certainly helps provide avenues to circumvent supply chain issues should they arise,” says Dr. Aronoff. “As of now, it’s nice to know that we have some ability to work around a supply chain problem, should it affect one of the types of vaccines that’s available.”
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COVID-19 Vaccine Clinical Guidance Summary for Patients with Rheumatic and Musculoskeletal Diseases. American College of Rheumatology. February 2, 2022. https://www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf.
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Interview with Mohamed Yassin, MD, Chief of Infectious Diseases at UPMC Mercy.
Interview with David Aronoff, MD, Chair of the Department of Medicine at Indiana University School of Medicine.
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The new Novavax COVID vaccine: Why it’s different and when you can get it. Nebraska Medicine. July 21, 2022. https://www.nebraskamed.com/COVID/novavax-vaccine-results-how-effective-is-it-against-variants.
Vaccines and Related Biological Products Advisory Committee Meeting. U.S. Food and Drug Administration. June 7, 2022. https://www.fda.gov/media/158912/download.