For the latest news and information about the coronavirus pandemic, visit the WHO and CDC websites.
FDA advisers have recommended that the agency approve Novavax, another vaccine against COVID-19. Like other vaccine manufacturers, Novavax is working on an omicron-specific vaccine for possible use this fall or winter.
Why it matters
If approved, Novavax will be the first protein-based vaccine for COVID-19 available in the US, although the technology has been around for decades.
The FDA and CDC will have to decide how, or if, the US uses Novavax.
The U.S. Food and Drug Administration recommended Thursday that makers of COVID-19 vaccines change their vaccine formulas to target the omicron —it becomes more and more contagious. While vaccines that target the ancestral strains of the virus that cause COVID-19 continue to protect against severe disease and death, declining efficacy requires doses tailored to the omicron-specific component, according to the FDA.
While vaccine makers including Pfizer and Moderna have announced work on omicron-targeted vaccines, a new vaccine maker is also joining the race. FDA committee last month, a protein-based vaccine against COVID-19, for approval of its primary vaccine. If given the green light by the FDA, it will be the fourth COVID-19 vaccine on the market in the US and the first to use more traditional vaccine technology based on coronavirus proteins.
While it will be another additional tool the country has in its fight against COVID-19 if approved, it is another one built on the ancestral strain of COVID-19. Following the FDA’s recommendation to introduce the booster in the fall, Novavax released a statement saying the company will “accelerate our focus” on creating the omicron BA.4/BA.5 vaccine.
More than two years after the pandemic, most Americans (about 67%) are fully vaccinated against COVID-19, and many have added. Those who are hesitant or opposed to vaccination appear to continue to hold those views, according to a survey by the Kaiser Family Foundation. The percentage of American adults who responded to the survey and said they would “definitely not” get the 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 experienced manufacturing problems that hindered potential approval for emergency use. In addition to examining more data on how Novavax fares against the omicron variant, the FDA will have to sign off on the company’s production before approving the vaccine.
However, some scientists hope that Novavax could one day be used as a booster dose in combination with other vaccines and that its primary series could fill 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,” Ross Kedle, professor of immunology and microbiology at the University of Colorado Anschutz Medical Campus, said in an email. “Some have allergic reactions or, more rarely, problems like blood clots.”
The Johnson & Johnson vaccine against COVID-19 is still approved in the US, but the use of the samebecause of the rare but serious risk of blood clots. This leaves Pfizer’s and Moderna’s vaccines as the two currently recommended options for most adults.
Authorizing Novavax also opens the door for it to be used as a dose or part of aapproach with other vaccines against COVID-19.
As the FDA and vaccine companies iron out the details of future COVID-19 vaccines and booster doses, here’s what we know about Novavax.
What is Novavax? How is it different?
Novavax is a COVID-19 vaccine that uses a 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 virus protein is mixed with what’s called an adjuvant — additives that “get the immune response going 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” that most of us receive as children, Wortmann said. Some vaccines for flu, shingles and other diseases use similar technology.
However, while it offers another option, the jury may be out on whether Novavax offers superior immunity to Pfizer’s and Moderna’s vaccines.
“Immunologically, in my opinion, it doesn’t do much by itself that isn’t already well addressed 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 keeping picky vaccines in the fridge might be difficult. But Novavax has serious drawbacks when it comes to manufacturing, Kedl said, because it’s not cheap for the company to produce and purify the proteins.
“mRNA vaccines skip that step because they turn each individual into their own vaccine producer,” he said. mRNA vaccines work by teaching our cells to produce a protein on their own that will trigger an immune response.
For that reason, mRNA vaccines are easier to adapt than Novavax when a new variant emerges, Kedl said.
“The mRNA platform is much more customizable 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 make it possible to make and purify a good protein in large quantities.”
How effective is Novavax?
Published trial results found that Novavax was more than 90% effective against symptomatic COVID-19 and 100% effective against severe disease and death. But it is important that this trial was conducted before the omicron or delta variants were widely circulated. Both the delta and omicron variants — including omicron subvariants such as BA.2, BA.2.12.1 and BA.4 — are more infectious and avoid some immunity from vaccines and prior infection.
Real-world data comparing the effectiveness of Novavax to other vaccines do not yet exist. According to the World Health Organization, “it is impossible to compare vaccines directly because of the different approaches used in designing the respective studies.”
When will Novavax be available?
The FDA still has to approve the primary series (the first set of injections, not the dose set). While it usually accepts the recommendation of its advisory board, the agency must review more data.
Once it does, a panel of Centers for Disease Control and Prevention experts will vote on whether to recommend Novavax and for whom, and then the CDC director will sign off on the recommendation.
The FDA’s advisory board is scheduled to meet in a public meeting on June 28 to discuss future COVID-19 vaccine formulations — including a possible fall or winter surge of COVID-19.
Once approved and recommended, it’s unclear how exactly Novavax will compare to the Moderna and Pfizer vaccines, which are found in pharmacies, clinics and doctors’ offices across the country. The US government initially planned to buy 110 million doses of the vaccine, reports The New York Times, but the US has sufficient stocks of the COVID-19 vaccine for primary doses and booster shots.
How will the US pay for Novavax?
Although the COVID-19 vaccines have been free and available to all Americans, funding has recently stalled in Congress, and federal officials have warned that we are running out of money for COVID-19 tests, vaccines, treatments and related costs. Some services for Americanshave already expired.
However, it is likely that the COVID-19 vaccines will remain free, at least for a while. Money for COVID-19 testing and protective gear is being shifted 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 (first two doses). If the FDA gives it the green light, it could very well become another option in America’s booster catalog. Last fall, the FDA signed offto authorized COVID-19 boosters or a heterologous booster dose.
When there are data on the use of a vaccine like 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 mix-and-match strategy,” Wortmann said.
“I think the real advantage of the Novavax vaccine is in a broader sense,” Kedl said. “Because now it 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 with any questions you may have about your health condition or health goals.