- With the July FDA authorization of the Novavax COVID-19 vaccine, Americans have another option for protecting themselves against the coronavirus.
- Novavax is a protein-based vaccine that delivers a piece of the coronavirus’ spike protein to the cells, which trains the immune system to recognize the virus.
- The vaccine had an efficacy of 90.4% against mild, moderate or severe COVID-19, similar to what was seen in the original trials of the Moderna and Pfizer-BioNTech vaccines.
Americans have another COVID-19 vaccine to choose from after the Food and Drug Administration
This vaccine is based on a more traditional technology that has been used in other vaccines, which may appeal to some people hesitant about the newer mRNA vaccine platform.
After input from its vaccine advisory committee in early June, the FDA issued an emergency use authorization (EUA) for the Novavax vaccine as a two-dose primary series in people 18 years and older.
Before the vaccine can be rolled out to the public, the vaccine advisory committee of the Centers for Disease Control and Prevention will meet to review the company’s data,
“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” FDA Commissioner Dr. Robert M. Califf said in a
“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” he added.
The United States has received 3.2 million doses of the vaccine, reports STAT News. These can be shipped to states once the CDC director signs off on the vaccine.
With the FDA authorization, Novavax is entering a crowded field, with millions of Americans already vaccinated and boosted with the Pfizer-BioNTech, Moderna or Johnson & Johnson vaccines.
In addition, the FDA has only authorized the Novavax vaccine for the initial two doses, separated by three weeks — not as a booster, which may limit the vaccine’s reach in the United States.
The FDA will need to separately evaluate the use of this vaccine as a booster.
Despite the hurdles faced by the company, Dr. Bruce Y. Lee, a professor at the CUNY Graduate School of Public Health & Health Policy, thinks there is room for another vaccine for Americans to choose from.
“There is a need to continue to look at different ways to stimulate the immune system [against the coronavirus],” he said. “so when you’re talking about a different approach like the Novavax vaccine, then that adds to the [country’s] arsenal.”
Novavax is a protein-based vaccine that delivers a piece of the coronavirus’ spike protein to the cells, which trains the immune system to recognize the virus.
This vaccine also contains a chemical adjuvant that boosts the immune response to the protein. This comes from naturally occurring compounds in the bark of a tree found in Chile, the company said on its website.
The current hepatitis B and acellular pertussis vaccines are both protein subunit vaccines.
In contrast, mRNA COVID-19 vaccines such as those made by Pfizer-BioNTech and Moderna teach cells to make a harmless piece of the spike protein, which then stimulates an immune response.
Because the Novavax vaccine is based on a “traditional” platform, some people hope this might encourage people who are hesitant about the newer mRNA technology to get vaccinated.
“We do have a problem with vaccine uptake that is very serious in the United States,” Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said at the June 7 meeting of the agency’s vaccine advisory committee, which was focused on the Novavax vaccine.
So “having a protein-based [vaccine] alternative may be more comfortable for some, in terms of their acceptance of the vaccine,” he added.
Lee agreed that some people who are hesitant might be more open to getting the Novavax vaccine.
However, he emphasized that while the mRNA COVID-19 vaccines were the first vaccines using this platform to be approved by the FDA, scientists have been working on this technology for decades.
The Novavax vaccine will also provide another option for the small number of people who have a known allergy to a component of the mRNA vaccines or who had an allergic reaction after receiving the mRNA vaccine.
In its review of the Novavax data, the FDA found that the vaccine’s benefits outweighed the risks in people 18 and older.
The authorization is based on a clinical trial conducted in the United States and Mexico with more than 25,000 participants.
Like those earlier trials, the Novavax study was carried out before the emergence of the Delta and Omicron variants, which can overcome some of the protection against infection offered by the vaccines (and by prior infection).
So the Novavax vaccine is expected to have lower effectiveness against infection caused by the currently circulating variants.
However, even though the mRNA vaccines offer less protection against infection caused by Omicron, they still provide strong protection against severe disease and hospitalization.
In April, unvaccinated people were six times more likely to die of COVID-19 compared to people who were vaccinated with at least two doses, according to CDC data.
Regarding safety, the most common side effects of the Novavax vaccine were similar to those seen with other COVID-19 vaccines — pain, tenderness, redness or swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea and fever.
The trial also found an increased risk of myocarditis and pericarditis, or inflammation of the heart and its lining. This side effect is rare, occurring more often in adolescent males and young men. A similar risk occurs with the mRNA vaccines.
The FDA said in a statement that the fact sheets for the Novavax vaccine will include a warning about these increased risks.
People who experience any of the following symptoms within 10 days after vaccination should seek medical attention immediately, the FDA said: chest pain, shortness of breath, or feelings of having a fast-beating, fluttering or pounding heart.