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What is happening
The FDA is expected to release Novavax, a new vaccine against COVID-19, although it is still under review.
Why it matters
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 has unique challenges.
The FDA and CDC will have to decide how, or if, the U.S. uses Novavax.
A committee of scientists and other experts advising the U.S. Food and Drug Administration is scheduled to meet in late June to decide how the U.S. should modify its COVID-19 vaccines before the increase. of cases expected in the fall or winter.
The same commission earlier this month, a protein-based vaccine against COVID-19, for authorization. If the FDA gives it 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 coronavirus protein-based vaccine technology.
It will also be an additional tool that the country has in its fight against COVID-19, but another that is based on an ancestral strain of COVID-19. While vaccines made with 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 pandemic, most Americans (about 67%) are fully vaccinated against COVID-19 and many have added a. Those who doubt or oppose vaccination appear to continue with these positions, according to a survey by the Kaiser Family Foundation. The percentage of American adults who responded to the survey who said they would “definitely not” receive a vaccine against COVID-19 ranged from 15% in December 2020 to 17% in April 2020. 2022.
Novavax had a contract with the federal government through Operation Warp Speed, but has experienced manufacturing issues that have hindered a possible emergency use authorization. In addition to examining more information about how Novavax works with the omicron variant, the FDA will have to sign the company’s production before authorizing the vaccine.
However, some scientists hope that Novavax may one day be used as a booster dose in combination with other vaccines and that its primary series may meet the need for a more traditional and potentially similar vaccine against COVID-19. ‘effective. It is also available in other countries, such as 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 may have contraindications for other vaccine platforms,” said Ross Kedl, a professor of immunology and microbiology at Anschutz University Medical Campus. Colorado, in an email. . “Some people have allergic reactions or rarer worries like blood clots.”
Johnson & Johnson’s COVID-19 vaccine is still licensed in the U.S., but its use has beendue to a rare but severe risk of blood clots. This leaves Pfizer and Moderna vaccines as the two currently recommended options for most adults.
Authorizing Novavax also opens the door for use as a booster dose or as part of aapproach with other vaccines against COVID-19.
Here’s what you need 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 US: Pfizer-BioNTech and Moderna use mRNA technology, and Johnson & Johnson is a vector vaccine. viral.
In the Novavax vaccine, a purified protein from the virus is mixed with what is called an adjuvant: additives that “awaken the immune response and tell you 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 base.
“Specifically, Novavax is very similar to the hepatitis B vaccine that most of us get from children,” Wortmann said. Some flu vaccines, shingles, and other diseases use similar technology.
While it offers another option, however, the jury may decide whether Novavax offers superior immunity to Pfizer and Moderna vaccines.
“Immunologically speaking, from my point of view, it doesn’t really bring much to the table on its own that mRNA vaccines aren’t yet well addressed,” Kedl said.
However, it is easier to store and send than mRNA vaccines, he said. This can be an advantage when it comes to vaccinating harder-to-reach communities where keeping delicate vaccines in the refrigerator can be difficult. But Novavax has serious manufacturing disadvantages, Kedl said, because it’s not cheap for the company to produce and purify proteins.
“MRNA vaccines skip this step because they turn each individual into their own vaccine maker,” he said. MRNA vaccines work by teaching our cells to make the protein 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 Novavax does,” he said. “Every time a new variant of the vaccine needs to be made, Novavax will have to work hard in the lab to figure out what changes will still allow it to make and purify a good protein in massive amounts.”
How effective is Novavax?
The published results of a trial found that Novavax was more than 90% effective against symptomatic COVID-19 and 100% effective against serious illness and death. But most importantly, this test was conducted before the 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 evade some vaccine immunity and previous infection.
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 compare vaccines face to face because of the different approaches that have been taken in the design of the respective studies.”
When will Novavax be available?
The FDA still needs to authorize the primary series (the first set of shots, not the booster doses). While it normally accepts the recommendation of its advisory committee, the agency needs to review more data.
Once done, 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 sign the recommendation.
The FDA Advisory Committee is scheduled to meet at a public meeting on June 28 to discuss future vaccine formulas for COVID-19, including the likely increase in COVID-19 in the fall or winter.
Once authorized and recommended, it is unclear how exactly Novavax will compare to Moderna and Pfizer vaccines, which are found in pharmacies, clinics, and medical offices across the country. The U.S. government had originally planned to buy 110 million doses of the vaccine, reports The New York Times, but the U.S. 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 testing, vaccinations, and treatments. and COVID-19 related expenses. Some services for Americansthey have already expired.
However, COVID-19 vaccines are likely to remain free for at least some time. Money for COVID-19 testing and protective equipment is being shifted to cover the costs of vaccines and treatment for the fall, reports The New York Times.
Can Novavax be used as a booster?
The FDA is considering Novavax approval as the primary series (the first two doses). If the FDA gives you the green light, it may become another option in the U.S. Reinforcement Catalog. Last fall, the FDA signed theto authorized COVID-19 boosters, or at 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 may be interested in trying a different vaccine. as part of a combination strategy, “Wortmann said. .
“I think the real advantage of the Novavax vaccine is the wider field,” Kedl said similarly. “Because now it has 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 medical or health advice. Always consult a physician or other qualified health care provider about any questions you may have about a medical condition or health goals.