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What is happening
The FDA is expected to clear Novavax, a new COVID-19 vaccine, although it is still under review.
Novavax will be the first protein-based vaccine for COVID-19 available in the United States, although 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 the CDC will have to decide how or if the United States will use Novavax.
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. should modify its COVID-19 vaccines ahead of the expected increase in fall or winter cases.
The same committee earlier this month, a protein-based COVID-19 vaccine, for clearance. If the FDA gives it the green light, it will be the fourth COVID-19 vaccine on the market in the United States and the first to use a more traditional protein-based coronavirus vaccine technology.
It will also be one more tool the country has in its fight against COVID-19, but another one based on an ancestral strain of COVID-19. As vaccines made from ancestral strains continue to provide protection against serious illness and death, health regulators are debating whether older vaccine formulas should be the way forward.
More than two years after the start of the pandemic, the majority of Americans (about 67%) are fully vaccinated against COVID-19, and many have added a. Those who hesitate or oppose vaccination appear to continue those positions, according to a poll by the Kaiser Family Foundation. The percentage of American adults who responded to the survey saying they “definitely would not” receive a COVID-19 vaccine ranged from 15% in December 2020 to 17% in April 2022.
Novavax had a federal government contract through Operation Warp Speed, but encountered manufacturing issues that thwarted a potential emergency use authorization. In addition to reviewing more data on how Novavax fares than the omicron variant, the FDA will need to approve the company’s manufacturing before authorizing the vaccine.
However, some scientists hope that Novavax could someday be used as a booster dose in combination with other vaccines and that its primary series will meet the need for a more traditional and potentially equally effective COVID-19 vaccine. It is already available in other countries, including Canada and Australia, under the name Nuvaxovid.
“It is good to have a vaccine on board like Novavax because it is another option for those who may have contraindications to other vaccine platforms,” Ross Kedl, professor of immunology and microbiology at Anschutz Medical Campus, said in an email. ‘University of Colorado. “Some have allergic reactions or rarer concerns like blood clots.”
The Johnson & Johnson COVID-19 vaccine is still licensed in the United States, but use has beendue to a rare but serious risk of blood clots. This leaves Pfizer’s and Moderna’s vaccines as the two options currently recommended for most adults.
The authorization of Novavax also paves the way for use as a booster dose or as part of aapproach with other COVID-19 vaccines.
Here’s what to know.
What is Novavax? How is it different?
Novavax is a COVID-19 vaccine that uses more traditional protein-based technology, unlike other vaccines currently available in the United States: Pfizer-BioNTech and Moderna use mRNA technology, and Johnson & Johnson is a viral vector vaccine.
In the Novavax vaccine, a purified protein from the virus is mixed with what’s called an adjuvant, additives that “awaken the immune response and tell it to take that goal 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 get as children, Wortmann said. Some vaccines for influenza, shingles, and other ailments use similar technology.
Although it offers another option, however, the jury may not know if Novavax offers superior immunity to Pfizer and Moderna vaccines.
“Immunologically speaking, from my point of view it doesn’t really bring a lot on its own to the table that isn’t already well addressed by mRNA vaccines,” Kedl said.
However, it’s easier to store and ship than mRNA vaccines, he said. This can be an advantage when vaccinating harder-to-reach communities where it can be difficult to keep picky vaccines cool in the refrigerator. But Novavax has serious drawbacks when it comes to manufacturing, Kedl said, because it’s not cheap for the company to make and purify the proteins.
“MRNA vaccines skip this 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 regulate than Novavax when a new variant arrives, Kedl said.
“The mRNA platform is much more editable than Novavax does,” he said. “Whenever a new variant of the vaccine needs to be produced, Novavax will have to do a lot of work in the lab to figure out which modifications will still make it possible to produce and purify a good protein in massive quantities.”
How effective is Novavax?
Published results of a study found 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 omicron or delta variants were widely circulated. Both delta and omicron variants, including omicron sub-variants such as BA.2, BA.2.12.1, and BA.4, are more contagious and escape some immunity from vaccines and previous infections.
There is still no real data 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 clear the primary series (the first series of injections, not the booster doses). While it generally accepts its advisory board’s recommendation, the agency needs to review more data.
Once that’s done, a panel of experts from the Centers for Disease Control and Prevention will vote on whether to recommend Novavax and for whom, then the CDC director will sign the recommendation.
The FDA Advisory Committee will meet for a public meeting on June 28 to discuss future COVID-19 vaccine formulas, including for the likely fall or winter COVID-19 spate.
Once licensed and recommended, it is unclear how exactly Novavax will compare to the vaccines from Moderna and Pfizer, which are available in pharmacies, clinics and doctor’s offices nationwide. The US government originally planned to purchase 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 booster injections.
How will the US pay for Novavax?
Although 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 COVID-19 testing, vaccines, treatments and related expenses. . Some services for Americanshave already expired.
However, COVID-19 vaccines are likely to remain free, at least for a while. The New York Times reports that money for COVID-19 tests and protective equipment is being shifted to cover the costs of vaccines and treatments for the fall.
Can Novavax be used as a booster?
The FDA is considering clearing Novavax as a primary series (the first two doses). If the FDA gives it the green light, it could very well become another option in the US booster catalog. Last fall, the FDA signed theauthorized COVID-19 boosters or a heterologous booster dose.
Once there is data on using 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 a different vaccine as part of a mix-and-match strategy.” , Wortmann said.
“I think the real benefit of the Novavax vaccine is on the ground more broadly,” Kedl similarly said. “Because he now has another vaccine platform to combine with the other vaccines.”
The information contained in this article is for educational and informational purposes only and is not intended as medical or health advice. Always consult a doctor or other qualified health care practitioner with any questions you may have about a medical condition or health goal.