For the latest news and information on the coronavirus pandemic, visit the WHO and CDC websites.
What’s going on
The FDA is expected to license Novavax, a new vaccine against COVID-19, although it is still under review.
why does it matter
Novavax will be the first protein-based vaccine for COVID-19 available in the US, even though the technology has been around for decades. While this type of vaccine has some advantages in the pandemic, it also presents unique challenges.
The FDA and CDC will have to decide how, or if, the US uses Novavax.
A committee of scientists and other experts advising the US Food and Drug Administration is scheduled to meet in late June to decide how the US should modify its COVID-19 vaccines before the anticipated surge in fall or winter cases.
The same committee earlier this month, a protein-based COVID-19 vaccine, for authorization. If given the green light by the FDA, it will be the fourth COVID-19 vaccine on the US market and the first to use a more traditional protein-based vaccine technology against the coronavirus.
It will also be an additional tool that the country has in its fight against COVID-19, but another one that is based on an ancestral strain of COVID-19. While vaccines made from ancient strains continue to provide protection 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%) are fully vaccinated against COVID-19, with many adding a. Those who are hesitant or opposed to vaccination appear to continue to do so, according to a survey by the Kaiser Family Foundation. The percentage of US adults who responded to the survey and said they would “definitely not” receive a COVID-19 vaccine ranged from 15% in December 2020 to 17% in April 2022.
Novavax was under contract to the federal government through Operation Warp Speed, but has experienced manufacturing issues that have prevented a potential emergency use authorization. In addition to examining more data on how Novavax fares against the omicron variant, the FDA will need to approve the company’s production before licensing the vaccine.
However, some scientists are hopeful that Novavax could one day be used as a booster dose in combination with other vaccines, and that its main series could fill the need for a more traditional and potentially equally effective COVID-19 vaccine. It is also 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 Medical Campus, said in an email. Anschutz. . “Some have allergic reactions or more rare problems, like blood clots.”
The Johnson & Johnson COVID-19 vaccine is still licensed in the US, but its use has beendue to a rare but serious risk of blood clots. This leaves the Pfizer and Moderna vaccines as the two currently recommended options for most adults.
Novavax’s authorization also opens the door for it to be used as a booster dose or as part of aapproach with other COVID-19 vaccines.
This is what you should know.
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 virus protein is mixed with what’s called an adjuvant, additives that “rouse the immune response and tell it to take this goal seriously,” Kedl said.
Dr. Glenn Wortmann, an infectious disease specialist at MedStar Health, said the general approach for most vaccines is to use a protein-based one.
“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 similar technology.
While offering another option, however, the jury is out on whether Novavax offers superior immunity to vaccines from Pfizer and Moderna.
“Immunologically speaking, in my opinion, it doesn’t really add much on its own that isn’t 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 it can be difficult to keep sensitive vaccines cold in the refrigerator. 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 make each individual their own vaccine maker,” he said. mRNA vaccines work by teaching our cells to make the protein on their own that will trigger an immune response.
For this reason, mRNA vaccines are easier to adjust than Novavax when a new variant appears, Kedl said.
“The mRNA platform is much more modifiable than what Novavax does,” he said. “Every time a new vaccine variant needs to be made, Novavax will have to do a lot of work in the lab to figure out what changes will allow a good protein to be produced and purified in massive quantities.”
How effective is Novavax?
Published results from one trial found that Novavax was more than 90% effective against symptomatic COVID-19 and 100% effective against severe illness and death. But more importantly, that trial was carried out 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 contagious and evade some immunity from vaccinations and previous infection.
There are no real-world data yet comparing the effectiveness of Novavax with other vaccines. According to the World Health Organization, “it is impossible to compare vaccines head-to-head due to the different approaches taken in the design of the respective studies.”
When will Novavax be available?
The FDA has yet to authorize the primary series (the first set of injections, not the booster doses). While it normally accepts its advisory committee’s recommendation, the agency needs to review more data.
Once it does, a committee of experts from the Centers for Disease Control and Prevention will vote on whether to recommend Novavax and for whom, and then the CDC director will approve the recommendation.
The FDA advisory committee is scheduled for a public meeting on June 28 to discuss future COVID-19 vaccine formulations, including for the likely rise of COVID-19 in the fall or winter.
Once it’s licensed and recommended, it’s unclear exactly how widely available Novavax will compare to Moderna and Pfizer’s vaccines, which are stocked in pharmacies, clinics and doctors’ offices across the country. The US government had originally planned to buy 110 million doses of the vaccine, The New York Times reports, but the US has a sufficient supply of COVID-19 vaccines for primary doses and boosters.
How will the US pay for Novavax?
While COVID-19 vaccines have been free and available to all Americans, recent funding has stalled in Congress and federal officials have warned that we are running out of money for tests, vaccines, treatments and related expenses. the COVID-19. Some services for Americanshave already expired.
Still, COVID-19 vaccines are likely to remain free, at least for a while. Money for COVID-19 tests and protective gear is being moved to cover the costs 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 it the green light, it may very well become another option in the US booster catalog. Last fall, the FDA approved theto authorized COVID-19 boosters, or to a heterologous booster dose.
Once there is data on the use of a vaccine like Novavax with mRNA vaccines, “there may be people who have received three or four of the mRNA vaccines and might be interested in trying a different vaccine as part of a mix-and-match strategy.” Wortman said. .
“I think the real advantage of the Novavax vaccine is to the broader field,” Kedl said similarly. “Because now you have one more vaccine platform to mix and match with the 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 provider regarding any questions you may have about a medical condition or health goals.