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The FDA is expected to approve Novavax, a new COVID-19 vaccine, although it is still under review.
Why it matters
Novavax will be the first protein-based vaccine for COVID-19 available in the U.S., although the technology has been around for decades. While this type of vaccine has some benefits during the pandemic, it also has unique challenges.
The FDA and CDC must decide how and whether the U.S. uses Novavax.
To solidify a vaccine plan for the anticipated winter COVID-19 wave, a committee of scientists and other experts advising the U.S. Food and Drug Administration will meet in late June to decide how the U.S. will handle its COVID-19 response. I19 vaccines. increase should change.
The same committee approved Novavax, a protein-based COVID-19 vaccine, for authorization earlier this month. If the FDA gives the green light, it will be the fourth COVID-19 vaccine on the market in the U.S. and the first to use a more traditional protein-based vaccine technology against the coronavirus.
It will also be an additional tool the country has in its fight against COVID-19, but another tool based on an ancestral strain of COVID-19. While vaccines based on traditional strains continue to protect against serious illness and death, health regulators are debating whether older vaccine formulations should be the way forward.
More than two years into the pandemic, most Americans (about 67%) have been fully vaccinated against COVID-19, and many have added a booster dose or two. According to a poll by the Kaiser Family Foundation, those who are hesitant or against vaccination appear to continue those views. The percentage of U.S. adults who answered the vote and said they would receive “absolutely no” 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 encountered manufacturing issues that have prevented a potential emergency use authorization. In addition to examining more data on how Novavax performs against its omicron variant, the FDA must clear the company’s products before approving the vaccine.
However, some scientists are hopeful that Novavax will one day be used as a booster dose in combination with other vaccines and that the primary series could meet a need for a more traditional and potentially equally effective COVID-19 vaccine. It is also available in other countries, including Canada and Australia, under the name Nuvaxovid.
“It’s good to have a vaccine like Novavax on board because it’s another option for those who may have contraindications to the other vaccine platforms,” said Ross Kedl, a professor of immunology and microbiology at the University of Groningen. Anschutz Medical Campus of the University of Colorado, in an email. “Some have allergic reactions or more rare concerns like blood clots.”
The Johnson & Johnson COVID-19 vaccine is still approved in the U.S., but its use is limited due to a rare but serious risk of blood clots. Pfizer and Moderna vaccinesares the two currently recommended options for most adults.
Authorizing Novavax also opens the door to use it as a booster dose or as part of a mix-and-match approach with other COVID-19 vaccines.
Here’s what you need to know.
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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 U.S.: Pfizer-BioNTech and Moderna use mRNA technology, and Johnson & Johnson is a virus vector vaccine.
In the Novavax vaccine, a purified protein from the virus is mixed with 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 at MedStar Health, said the general approach of most vaccines is to use a protein base.
“In particular, Novavax is very similar to the hepatitis B vaccine,” most of us get as children, Wortmann said. Some vaccines for the flu, shingles and other conditions use similar technology.
While it offers another option, the jury is out on whether Novavax provides superior immunity to Pfizer’s and Moderna’s vaccines.
“Immunologically, in my opinion, it doesn’t bring a whole lot to the table that isn’t already well addressed by the mRNA vaccines,” Kedl said.
However, he said it is easier to store and ship than mRNA vaccines. This can be an advantage when vaccinating harder-to-reach communities where it can be difficult to keep finicky vaccines cool in the fridge. But Novavax has serious drawbacks 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 make each individual their vaccine manufacturer,” he said. mRNA vaccines teach our cells to make themselves the protein that will trigger an immune response.
For this reason, mRNA vaccines are easier to adapt than Novavax when a new variant comes along, Kedl said.
“The mRNA platform is much more customizable than what Novavax does,” he said. “Every time a new vaccine variant needs to be created, Novavax will have to do a lot of work in the lab to figure out what changes still allow it to make a good protein and purify it in large quantities. ”
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How effective is Novavax?
Published results of a study showed that Novavax was over 90% effective against symptomatic COVID-19 and 100% effective against serious illness and death. More importantly, that trial was conducted before the omicron, or delta variants were widely circulated. The delta and omicron variants — including omicron subvariants such as BA.2, BA.2.12.1, and BA.4 — are more contagious and evade some immunity from vaccines and previous infection.
Real-world data comparing the effectiveness of Novavax with other vaccines do not yet exist. The World Health Organization states, “It is impossible to compare vaccines among themselves because of the different approaches taken in designing the respective studies.”
When will Novavax be available?
The FDA still has to authorize the primary series (the first series of shots, not the booster doses). While it typically accepts its advisory committee’s recommendation, the agency must review more data.
Once that is the case, a committee of experts from the Centers for Disease Control and Prevention will vote on whether Novavax is recommended and for whom, and then the CDC director will sign the recommendation.
The FDA’s advisory committee will meet on June 28 for a public meeting to discuss future COVID-19 vaccine formulations, including for the likely fall or winter COVID-19 peak.
Once authorized and recommended, it’s unclear exactly how Novavax will be available and compared to Moderna and Pfizer’s vaccines, found in pharmacies, clinics, and doctor’s offices nationwide. The U.S. government originally planned to buy 110 million doses of the vaccine, The New York Times reports, but the U.S. has ample stock of COVID-19 vaccines for primary amounts and booster shots.
How will the U.S. pay for Novavax?
While COVID-19 vaccines are free and available to all Americans, recent funding in Congress has stalled, and federal officials have warned we are running out of money for COVID-19 testing, vaccines, treatments, and related spending. Some services for Americans without health insurance have already expired.
However, COVID-19 vaccines will likely remain free, at least for a while. Funds for COVID-19 testing and protective equipment are being moved to cover the cost of vaccines and treatment for the fall, The New York Times reports.
Can Novavax be used as a booster?
The FDA is considering approval of Novavax as a primary series (the first two doses). If the FDA gives the green light, it could become another option in the U.S. booster catalog. Last fall, the FDA approved the mix-and-match approach of the authorized COVID-19 boosters or a heterologous booster dose.
Once there is data on using a vaccine like Novavax with mRNA vaccines, “There may be people who have received three or four of the mRNA vaccines and may be interested in trying another vaccine as part of a mix-and-match strategy,” Wortmann said.
“I think the real benefit of the Novavax vaccine to the field is broader,” Kedl said similarly. “Because it now has one more vaccine platform to mix and match with the other vaccines.”
The information 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 healthcare professional if you have any questions about a medical condition or health goals.