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What is happening
The FDA is expected to approve the new COVID-19 vaccine, Novavax, although it is still under consideration.
Why it is important
Novavax will be the first protein-based vaccine for COVID-19 available in the United States, although the technology has been around for decades. Although this type of vaccine has some advantages in the pandemic, it also has its own difficulties.
The FDA and CDC must decide how the United States will use Novavax.
Expected availability of COVID-19 vaccines in the eyes of the country, most people have either received (or chosen not to take) COVID-19 vaccines and the available booster doses available to them. (If you are 50 or older, you are eligible or a total of four shots.)
But last week, a committee of scientists and other experts advised the US Food and Drug Administration, protein-based COVID-19 vaccine, for approval. 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 vaccine against coronavirus.
So why now? For more than two years after the pandemic, the majority of Americans (approximately 67%) were fully vaccinated against COVID-19, and many. According to a survey by the Kaiser Family Foundation, those who oppose or oppose vaccination continue to hold these positions. The percentage of American adults who responded to a survey saying they would not “definitely” get the COVID-19 vaccine ranged from 15% in December 2020 to 17% in April 2022.
Novavax signed a contract with the federal government through Operation Warp Speed, but faced production problems that prevented a potential emergency use permit. In addition to researching more about how Novavax rates the omicron variant, the FDA must sign the company’s production before allowing 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 main series could meet the need for a more traditional and equally effective COVID-19 vaccine. Nuvakhovid is already available in other countries, including Canada and Australia.
Ross Kedl, a professor of immunology and microbiology at the University of Colorado’s Anschutz Medical Campus, said in an email, “It’s good to have a vaccine like Novavax on board because it’s another option for those who have contraindications to other vaccination platforms.” . “Some have more rare problems, such as allergic reactions or blood clots.”
Johnson & Johnson COVID-19 vaccine is still allowed in the United States, but it has been useddue to the risk of a rare but serious blood clot. This leaves Pfizer and Moderna vaccines as the two currently recommended options for most adults.
Allowing Novavax also opens the door for its use as a booster dose or as part of a medication.approach with other COVID-19 vaccines.
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 than other vaccines currently available in the United States: Pfizer-BioNTech and Moderna mRNA technology, while Johnson & Johnson is a viral vector vaccine.
In the Novavax vaccine, the virus’s purified protein is mixed with a substance called an adjuvant – a supplement that “stimulates the immune response and tells it to take this target seriously,” Kedl said.
MedStar Health’s infectious disease specialist, Dr. Glenn Wortmann said the common approach for most vaccines is to use a protein base.
“In particular, Novavax is very similar to the hepatitis B vaccine given,” Wortmann said. Some vaccines for influenza, shingles and other diseases use similar technology.
While offering another option, the jury may be wondering whether Novavax offers superior immunity to Pfizer and Moderna vaccines.
“Immunologically speaking, I don’t think mRNA vaccines really bring much to the table,” Kedl said.
However, mRNA is easier to store and send than vaccines, he said. This can be an advantage when vaccinating more difficult-to-obtain communities, where difficult vaccines can be difficult to keep cool in the refrigerator. But Novavax has serious drawbacks when it comes to production, Kedl said, because it’s not cheap for a company to produce and refine proteins.
“mRNA vaccines skip this step because it turns each individual into a vaccine manufacturer,” he said. mRNA vaccines teach our cells to prepare the proteins themselves that will trigger the immune response.
That’s why mRNA vaccines are easier to regulate than Novavax when a new variant emerges, Kedl said.
“The mRNA platform can be changed more than Novavax does,” he said. “Every time a new vaccine needs to be developed, Novavax will have to work hard to understand what changes in the lab will still allow the mass production and purification of good protein.”
How effective is Novavax?
The published results showed that Novavax was more than 90% effective against symptomatic COVID-19 and more than 100% effective against severe disease and death. But most importantly, this test was conducted before the omicron or delta variants became widespread. 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 immunizations from vaccines and previous infection.
There is no real-world data comparing the effectiveness of Novavax with other vaccines. According to the World Health Organization, “Vaccines cannot be compared on their own because of the different approaches adopted in the design of relevant studies.”
When will Novavax be available?
The FDA still has to approve the initial series (the first set of increases, not booster doses). Although it usually accepts the recommendation of its advisory committee, the agency should consider more information.
Once this is done, a committee of experts for the Centers for Disease Control and Prevention will vote on whether or not to recommend Novavax, and to whom and then the CDC director will sign the recommendation.
The FDA’s advisory committee is scheduled to hold an open meeting on June 28 to discuss future COVID-19 vaccine formulas, including a possible fall or winter increase in COVID-19.
It is unknown to what extent Novavax will be available with Moderna and Pfizer vaccines stored in pharmacies, clinics and doctor’s offices across the country once approved and recommended. The New York Times reports that the U.S. government originally planned to receive 110 million doses of the vaccine, but the United States has enough COVID-19 vaccine for initial doses and booster injections.
How will the US pay for Novavax?
Although COVID-19 vaccines are free and accessible to all Americans, recent funding in Congress has stopped, and federal officials have warned that we are running out of money for COVID-19 tests, vaccinations, treatments, and related expenses. Some services for Americansit’s too late.
However, COVID-19 vaccines are likely to remain free for at least some time. The New York Times reports that money for the COVID-19 test and protective equipment is being transferred to cover the cost of vaccinations and treatment for the fall.
Can Novavax be used as a booster?
The FDA is considering approving Novavax as the main batch (first two doses). If the FDA gives it the green light, it could be another option in the US booster catalog. The FDA signed last fallto authorized COVID-19 amplifiers or heterologous amplifier doses.
When there is information about 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 mixing and adaptation strategy,” Wortmann said.
“I think the real advantage of the Novavax vaccine is that it covers a wider area,” Kedl said. “Because now there is another vaccination platform to mix and adapt with other vaccines.”
The information in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult your doctor or other qualified health care provider if you have any questions about your medical condition or health goals.