The FDA is expected to approve Novavax, a new vaccine against COVID-19, although it is still under review.
Why it matters
Novavax will be the first COVID-19 protein-based vaccine available in the United States, although the technology has been around for decades. Although this type of vaccine has some advantages in a pandemic, it also has unique challenges.
The FDA and other health agencies will have to decide how, or whether, the U.S. will use Novavax as it progresses.
An expert committee that advised the U.S. Food and Drug Administration last week, a protein-based vaccine against COVID-19, for approval. If the FDA gives it the green light, it will be the fourth COVID-19 vaccine on the U.S. market and the first to use more traditional coronavirus protein-based vaccine technology.
So why now? More than two years after the pandemic, most Americans (about 67%) have been fully vaccinated against COVID-19, and many have added. Those who hesitate or oppose vaccination appear to be firm and steadfast in their stance, according to a survey by the Kaiser Family Foundation. Twelve to 17% of American adults who responded to the survey said they would “definitely not” get vaccinated against COVID-19, ranging from December 2020 (13% against) to April 2022 (17% “definitely not”).
Novavax had a contract with the federal government through Operation Warp Speed, but experienced manufacturing problems that hampered potential approval for emergency use. In addition to examining more data on how Novavax behaves in relation to the omicron variant, the FDA will have to sign the company’s production before approving the vaccine.
However, some scientists hope that Novavax could one day be used as an extra dose in combination with other vaccines, and that its primary series could meet the need for a more traditional and potentially equally effective vaccine against COVID-19. It is also already available in other countries, including Canada and Australia, under the name Nuvaxovid.
“It’s good to have a vaccine like Novavax because it’s another option for those who may have contraindications to other vaccine platforms,” said Ross Kedl, a professor of immunology and microbiology at the Anschutz School of Medicine at the University of Colorado. email. “Some have allergic reactions or less common problems like blood clots.”
Johnson & Johnson is still authorized in the US, but its use has beendue to a rare but serious risk of blood clots. This leaves Pfizer and Modern Vaccine as the two currently recommended options for most adults.
By authorizing Novavax, it also opens the door to its use as a dose dose or as part of a mix-and-match approach with other COVID-19 vaccines.
Here’s what you need to know.
What is Novavax? How is it different?
Novavax is a vaccine against COVID-19 that uses more traditional protein-based technology, unlike 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, the purified protein of the virus is mixed with what is called an adjuvant – additives that “be 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 to most vaccines is to use a protein base.
“In particular, Novavax is very similar to the hepatitis B vaccine that is given,” said Wortmann, who most of us receive as children. But some flu, shingles and other vaccines use similar technology.
However, while offering another option, the jury may not be sure whether Novavax offers superior immunity compared to what is available with Pfizer and Modern vaccines.
“Immunologically, in my opinion, it does not in itself bring much that is not already well resolved by mRNA vaccines,” Kedl said.
However, it is easier to store and ship than mRNA vaccines, he said. This can be an advantage when vaccinating hard-to-reach communities where it can be difficult to keep picky vaccines cold in the refrigerator. But Novavax has serious shortcomings when it comes to production, Kedl said, because it is not cheap for the company to produce and purify proteins.
“Vaccine mRNAs skip that step because they turn each individual into their own vaccine manufacturer,” he said. mRNA vaccines work by teaching our cells to produce a protein that will trigger an immune response.
For that reason, mRNA vaccines are easier to adapt than Novavax when a new variant appears, Kedl said.
“The mRNA platform is much more flexible than what Novavax does,” he said. “Every time a new variant of the vaccine needs to be made, Novavax will have to do a lot of work in the lab to figure out what changes will still allow good protein to be made and purified in large quantities.”
How effective is Novavax?
Published test results found that Novavax was more than 90% effective against symptomatic COVID-19 and 100% effective against severe illness and death. But importantly, that study was conducted before omicron or delta variants were widely circulated. Both delta and omicron variants – including omicron subvariants such as BA.2, BA.2.12.1 and BA.4 – are more contagious and avoid some immunity from vaccines and previous infections.
Real-world data comparing the effectiveness of Novavax with other vaccines do not yet exist. According to the World Health Organization: “It is impossible to directly compare vaccines due to the different approaches used in designing appropriate studies.”
When will Novavax be available?
The FDA itself still needs to approve the primary series (first set of injections, not booster dose). Although it usually accepts the recommendation of its advisory board, the agency needs to review more information.
When this happens, the Centers for Disease Control and Prevention usually meets in the same way as the FDA: a panel of experts will vote on whether to recommend Novavax and for whom, and then the CDC director will sign the recommendation.
The FDA’s advisory board is scheduled to meet in public on June 28 to discuss future vaccines for the COVID-19 vaccine – including a likely fall or winter increase in COVID-19.
Once approved and recommended, it is unclear exactly how much Novavax will compare to Moderna and Pfizer vaccines, which are found in pharmacies, clinics and doctors’ offices across the country. The U.S. government originally planned to buy 110 million doses of the vaccine, according to The New York Times, but the U.S. has sufficient supplies of COVID-19 vaccines for primary doses and supplementary injections.
How will the US pay for Novavax?
Although vaccines against COVID-19 were free and available to all Americans, funding was recently stopped in Congress, and federal officials warned that we were running out of money for COVID-19 tests, vaccines, treatments and more. Some services for Americanshave already expired.
However, it is likely that vaccines against COVID-19 will remain free, at least for some time. Money for testing on COVID-19 and protective equipment is being moved to cover the cost of vaccines and treatment for the fall, writes the New York Times.
Can Novavax be used as an enhancer?
The FDA is considering approving Novavax as the primary batch (first two doses). If the FDA gives it the green light, it could very easily become another option in the U.S. Booster Catalog. Last fall, the FDA signedto authorized COVID-19 potentiation drugs, or a heterologous booster dose.
When there are data on the use of a vaccine such as Novavax with mRNA vaccines, “there may be people who have received three or four mRNA vaccines and may be interested in trying another vaccine as part of a mixing and merging strategy,” Wortmann said.
“I think the real advantage of the Novavax vaccine is in the wider field,” Kedl said. “Because it now has another vaccine platform to mix and match with other vaccines.”
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 care professional regarding any questions you may have about your health condition or health goals.