What to Know About Novavax, the Fourth COVID Vaccine Approved by the FDA

·5 min read
03 March 2022, Bavaria, Freising: A nurse holds a tray of syringes containing the vaccine Nuvaxovid from the manufacturer Novavax at the Freising Vaccination Center. Photo: Matthias Balk/dpa (Photo by Matthias Balk/picture alliance via Getty Images)
03 March 2022, Bavaria, Freising: A nurse holds a tray of syringes containing the vaccine Nuvaxovid from the manufacturer Novavax at the Freising Vaccination Center. Photo: Matthias Balk/dpa (Photo by Matthias Balk/picture alliance via Getty Images)

A fourth COVID vaccine could be available in the US soon. The shot, created by Maryland-based biotechnology company Novavax, was authorized for emergency use by the FDA on July 13. The Centers for Disease Control and Prevention still need to okay the use of the Novavax vaccine before it will be available, Reuters notes, but that may be coming soon: The New York Times reports that the CDC is expected the discuss the vaccine and who it should be recommended for during its meeting next week.

On Monday July 11, the Biden administration announced it had secured 3.2 million doses of the Novavax vaccine. The usage recommendation for the two-dose vaccine is being made for adults ages 18 and older, with a three-week wait period between the initial and second dose of the series.

Pushback has been expressed from health officials and citizens about the necessity and safety of the fourth vaccine. The FDA recently published data showing the vaccine may cause myocarditis and pericarditis, albeit rarely, news that caused the company's stock price to dip, reports Science. (Myocarditis and pericarditis is "the inflammation of the heart muscle" and "inflammation of the lining outside the heart," respectively, per the CDC - a side effect also reported after the use of some mRNA vaccines.) In Monday's announcement, the Biden administration noted that Novavax would be completing quality testing "in the next few weeks," without which the vaccine couldn't be released.

But when FDA advisers were asked to vote whether the benefits of the Novavax vaccine outweighed the risks, 21 members voted yes, one voted no, and one abstained, thus moving the recommendation forward to the entire FDA for emergency use, which was approved yesterday and sent to the CDC's Advisory Committee on Immunization Practices for review. Here's what you need to know about the possible fourth vaccine.

Why do we need another vaccine option?

"I think the menu for COVID vaccine should be as large as as we can make it because there are important problems we still have to solve," says Amesh Adalja, MD, senior scholar at the Johns Hopkins University Center for Health Security. Those problems, he says, include finding the best booster strategy and combating the anti-vaccination movement which has "maligned the mRNA vaccines," causing vaccine hesitancy (about 1 in 3 Americans remain unvaccinated, per CNN).

A new vaccine provides scientists and citizens with another option. "From a scientific standpoint, I think the fact that we have another tool to be able to mix and match with other vaccines to come up with the optimal cocktail of boosters and an initial vaccine series is going to be important," Dr. Adalja adds.

How does the Novavax vaccine differ from other COVID vaccines?

"The chief difference that this is a protein-based vaccine, as Moderna and Pfizer vaccines are mRNA-based and the Johnson & Johnson uses a different virus to deliver the spike protein of SARS-CoV-2," Dr. Adalja says. Novavax is a vaccine that delivers the spike protein "directly in the form of a protein," which produces an immune response in the body that will protect against a future interaction with the virus. It's a more traditional approach in that it uses the same technology used in influenza vaccines, HPV, hepatitis B, and shingles.

That being said, because the Novavax vaccine uses a spike protein based on the "ancestral" strain of the virus (Omicron), "it will likely have difficulty in preventing all infections from Omicron variants, just like the current other current vaccines," Dr. Adalja says. But one thing that differs in Novavax is that the spike protein is coupled with an adjuvant, "a substance that stimulates the immune system," Dr. Adalja says, which could play a role in how broad the response is in terms of protection against new variants that differ from the vaccine strain.

It also can be stored in standard refrigeration, which is unique to Novavax, and may help with distribution because it's easier to transport and store in low-income settings

How effective is the Novavax vaccine?

In clinical trials, the Novavax vaccine had an 90.4% overall efficacy rate, per Novavax. The company also announced that the vaccine shows "broad" immune response to variants like Omicron sub-varients BA.4 and BA.5.

Common side effects are similar to other vaccines, including fatigue, tenderness or pain at the injection site, headache, and muscle pain. There has also been some concern over the vaccine's ability to cause myocarditis and pericarditis. Still, chief safety officer, Denny Kim told FDA advisers: "We believe that the totality of the clinical evidence here is not enough to establish an overall causal relationship with the vaccine," as reported by the AAAS. Novavax is reportedly monitoring these cases. What's more, the vaccine has already been approved in more than 170 countries, per CNBC.

When will the Novavax vaccine be approved?

The vaccine has to get several green lights before it becomes available in the US. Right now, the FDA has approved the vaccine for emergency use in adults. Now, it moves to the the Advisory Committee on Immunization Practices, which is scheduled to meet July 19. From there, the CDC director has to sign off on the recommendation. As far as timeline goes, "in the best case scenario," Dr. Adalja says it could take less than a week from now. "If everybody moves fast."

After it's added to the approved primary series of shots, Novavax hopes to receive authorization to use its vaccine as a booster to the others, like Moderna and Pfizer. "We've talked with the FDA quite a bit about this," Novavax president and CEO Stanley Erck told CNN. "I believe the FDA will be addressing that approval within weeks."

According to WHO, the vaccine is not recommended for people younger than 18 years of age, until enough data is available to be reviewed. Erck said Novavax hopes to offer the vaccine to children as young as two later this year, once data on its effectiveness on kids becomes available, "in the coming months."

- Additional reporting by Melanie Whyte