What You Should Know About Novavax

The US Food and Drug Administration authorized Novavax’s COVID-19 vaccine on Wednesday, adding another primary series to the market. A committee that gives advice to the US Centers for Disease Control and Prevention on how to recommend vaccines is scheduled to meet next week, presumably to discuss Novavax.

Because it’s authorized as a primary series vaccine — two doses three weeks apart — it can’t be used as a booster yet in people who’ve already been vaccinated. But making Novavax available means people who’ve been holding out for a protein-based or more “traditional” vaccine type may now be more inclined to get COVID shots.

More than two years into the pandemic, a majority of Americans (about 67%) are fully vaccinated against COVID-19, and many have added a booster dose or two. But the number of those who are fully vaccinated has not changed very much in recent weeks, and those hesitant about vaccination seem to be firm in their stance, according to a poll from the Kaiser Family Foundation. The percentage of American adults who answered the poll who said they would “definitely not” get a COVID-19 vaccine ranged from 15% in December 2020 to 17% in April 2022.

Novavax had a contract with the federal government through Operation Warp Speed ​​but has experienced manufacturing problems that have hindered a speedy emergency use authorization. Its COVID vaccine is already available in other countries, including Canada and Australia, under the name Nuvaxovid.

“It’s good to have a vaccine on board like Novavax because it’s another option for those who might have contraindications to the other vaccine platforms,” ​​Ross Kedl, a professor of immunology and microbiology at the University of Colorado Anschutz Medical Campus, said in an email . “Some have allergic reactions or more rare concerns like blood clots.”

The Johnson & Johnson COVID-19 vaccine is still authorized in the US, but use of it has been limited because of a rare but serious risk of blood clots. This leaves Pfizer’s and Moderna’s vaccines as the two currently recommended options for most adults.

Here’s what to know about Novavax.

When can I get a Novavax shot?

Before the Novavax rollout officially begins, the CDC will need to give its stamp of approval. The agency’s vaccine advisory committee is scheduled to meet on July 19, presumably to discuss Novavax and recommend who should get a Novavax shot, or single out anyone who shouldn’t.

Then, the CDC itself typically accepts the independent committee’s recommendation, and Novavax would become widely available. The Biden administration announced this month that it has secured more than 3 million doses of Novavax. Pending final sign-off from the CDC, the vaccine will be released for free to states.

Who can get Novavax?

Novavax’s COVID-19 vaccine is authorized as a two-dose primary series for adults age 18 and up. The CDC will have the final word in the coming days on who should get Novavax and who it’s recommended for. But it’s meant to be an additional option for adults who haven’t been vaccinated at all yet.

Because it’s authorized as a primary series, people who’ve already been vaccinated can’t get it as an additional shot or booster right now. But as the FDA has authorized a mix-and-match approach with other COVID-19 vaccines in the past, Novavax’s authorization may be extended to more people in the future.

“I think that the real advantage of the Novavax vaccine is to the field more broadly,” Kedl said prior to the FDA’s authorization. “Because it now has one more vaccine platform to mix and match with the other vaccines.”

It’s also possible that Novavax could have a new, omicron-specific booster ready this fall or winter. After the FDA announced its plans for the fall vaccine rollout, Novavax said it’s speeding up work on an omicron-specific vaccine that targets the super-contagious BA.5. But like the other new, future boosters made by other vaccine companies, the FDA will need to authorize this separately.

What is Novavax? How is it different?

Novavax is a COVID-19 vaccine that uses a more traditional protein-based technology, unlike the other vaccines currently available in the US: Pfizer-BioNTech and Moderna use mRNA technology, and Johnson & Johnson is a viral-vector vaccine.

In the Novavax vaccine, a purified protein of the virus is mixed with what’s called an adjuvant — additives that “wake up the immune response and tell it to take this target seriously,” Kedl said.

dr. Glenn Wortmann, an infectious disease specialist with MedStar Health, said the general approach of most vaccines is to use a protein base.

“Specifically, Novavax is very similar to the hepatitis B vaccine” that most of us received as children, Wortmann said. Some vaccines for influenza, shingles and other ailments use a similar technology.

While it offers another option, however, the jury may be out on whether Novavax offers superior immunity to Pfizer’s and Moderna’s vaccines.

“Immunologically speaking, in my view it does not really bring an awful lot on its own to the table that is not already well-addressed by the mRNA vaccines,” Kedl said.

However, it is easier to store and ship than mRNA vaccines, he said. This may be an advantage when vaccinating harder-to-reach communities where keeping finicky vaccines cool in the fridge may be difficult. But Novavax has serious disadvantages when it comes to manufacturing, Kedl said, because it isn’t cheap for the company to produce and purify the proteins.

“mRNA vaccines skip that step because they turn each individual into their own vaccine manufacturer,” he said. mRNA vaccines work by teaching our cells to make the protein themselves that will trigger an immune response.

For this reason, mRNA vaccines are easier to adjust than Novavax when a new variant comes along, Kedl said.

“The mRNA platform is far more modifiable than what Novavax does,” he said. “Every time a new variant vaccine needs to be made, Novavax is going to have to do a lot of work in the lab to figure out which changes will still allow a good protein to be made and purified at mass quantities.”

How effective is Novavax?

Published results from a trial found that Novavax was more than 90% effective against symptomatic COVID-19, and 100% effective against severe disease and death. But importantly, that trial was conducted before the omicron or delta variants were widely circulating. Both the delta and omicron variants — including omicron subvariant BA.5 — are more contagious and evade some immunity from vaccines and prior infection.

Real-world data comparing the effectiveness of Novavax to other vaccines does not exist yet. Per the World Health Organization, “It is impossible to compare vaccines head to head due to the different approaches taken in designing the respective studies.”

How will the US pay for Novavax?

While COVID-19 vaccines have been free and available to all Americans, recent funding stalled in Congress and federal officials have warned we’re running out of money for COVID-19 tests, vaccines, treatments and related spending. Some services for Americans without health insurance have already expired.

However, it is likely that COVID-19 vaccines will remain free, at least for a while. The US government already purchased 3.2 million doses of Novavax. Money for COVID-19 testing and protective equipment is being moved around to cover the costs of vaccines and treatment for the fall, The New York Times reports.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.