Does Novavax have a role in the COVID pandemic?

A committee of scientists and other experts advising the US Food and Drug Administration is due to meet on June 28 to decide how the US should adjust its COVID-19 vaccines before the expected fall or case increase in autumn or winter.

The same committee earlier this month supported by Novavax, a protein vaccine against COVID-19, for approval. If the FDA gives it the green light, it will be the fourth COVID-19 vaccine on the U.S. market and the first to use more traditional protein-based vaccine technology against coronavirus.

It will also be another tool that the country has in its fight against COVID-19, but another tool that is based on the ancestor of COVID-19. While vaccines made from ancestral strains continue to provide protection against serious diseases and deaths, health regulators are debating whether older vaccines 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 booster dose or two. According to a survey by the Kaiser Family Foundation, those who are hesitant or opposed to vaccinations seem to continue to do so. The percentage of adult Americans 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 noted manufacturing issues that prevented potential authorization for emergency use. In addition to examining other data on how Novavax is doing against the omicron variant, the FDA will need to sign the company’s production before the vaccine can be approved.

However, some researchers hope that Novavax can one day be used as a booster dose in combination with other vaccines, and that its primary series may meet the need for the 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 like Novavax on board because it’s another option for those who may have contraindications to other vaccination platforms,” ​​Ross Kedl, a professor of immunology and microbiology at the University of Colorado Anschutz Medical Campus, said in an email. . “Some have allergic reactions or rarer concerns, such as blood clots.”

Johnson & Johnson COVID-19 is still approved in the United States, but its use has already been authorized limited due to the rare but serious risk of blood clots. This leaves Pfizer and Moderna vaccines as the two currently recommended options for most adults.

The Novavax permit also opens the door for its use as a booster dose or as part of a mix-and-match access other COVID-19 vaccines.

Here’s what you should know.

What is Novavax? what’s the difference

Novavax is a COVID-19 vaccine that, unlike other vaccines currently available in the United States, uses more traditional protein-based technology: Pfizer-BioNTech and Moderna use mRNA technology, and Johnson & Johnson is a viral vector vaccine.

In the Novavax vaccine, the purified protein of the virus is mixed with what is called an adjuvant – an ingredient that “awakens the immune response and tells it to take this 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.

“Specifically, Novavax is very similar to the hepatitis B vaccine,” which most of us receive as children, “Wortmann said. Some vaccines against flu, shingles and other diseases use similar technology.

While offering another option, the jury may be wondering if Novavax offers better immunity to Pfizer and Moderna vaccines.

“Immunologically, in my opinion, this in itself does not bring to the table so much that is not yet well addressed by mRNA vaccines,” Kedl said.

However, it is easier to store and transport than mRNA vaccines, he said. This can be an advantage when vaccinating less accessible communities, where keeping selective vaccines in the refrigerator can be difficult. But Novavax has serious disadvantages when it comes to production, Kedl said, because it is not cheap for the company to produce and purify proteins.

“MRNA vaccines are skipping this step because they will make each individual their own vaccine manufacturer,” he said. mRNA vaccines work by teaching our cells to make a protein that triggers an immune response.

For this reason, mRNA vaccines are easier to modify than Novavax when a new variant emerges, Kedl said.

“The mRNA platform is much more modifiable than what Novavax does,” he said. “Every time a new variant of a vaccine needs to be made, Novavax will have to do a lot of work in the lab to find out which changes still allow it to produce and purify good protein in large quantities.”

How effective is Novavax?

Published study results found that Novavax was more than 90% effective against symptomatic COVID-19 and 100% effective against serious disease and death. But importantly, this experiment was performed before 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 avoid some vaccine immunity and previous infection.

Real data comparing the efficacy of Novavax with other vaccines do not yet exist. The World Health Organization states that “it is not possible to compare vaccines directly against each other due to different approaches in designing relevant studies.”

When will Novavax be available?

The FDA has yet to approve the primary series (first set of injections, not booster doses). Although it usually accepts the recommendations of its advisory committee, the Agency needs to review more data.

Once this happens, a panel 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 due to meet in public on June 28 to discuss the future formulation of COVID-19 – including the likely fall or winter increase in COVID-19.

Once approved and recommended, it is not clear exactly how Novavax will be available, compared to Moderna and Pfizer vaccines, which are stored in pharmacies, clinics and doctor’s offices across the country. The U.S. government originally planned to purchase 110 million doses of the vaccine, according to The New York Times, but the U.S. has sufficient supplies of COVID-19 vaccines for primary doses and revaccination.

How will the US pay for Novavax?

While COVID-19 vaccines were free and available to all Americans, recent funding has stopped in Congress, and federal officials have warned that we are running out of money for tests, vaccines, treatment, and related expenses. Some services for Americans without health insurance have already expired.

However, COVID-19 vaccines are likely to remain free, at least for a while. Money for testing and protective equipment at COVID-19 is being shifted to cover the cost of vaccines and treatment in the fall, according to The New York Times.

Can Novavax be used as a booster?

The FDA is considering the approval of Novavax as the primary series (first two doses). If the FDA gives it the green light, it may very well become another option in the US Booster Catalog. He signed the FDA last fall mix-and-match approach to authorized COVID-19 booster doses or a heterologous booster dose.

Once data on the use of a vaccine such as Novavax with mRNA vaccines are available, “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 Novavax is in the wider area,” Kedl said similarly. “Because it now has another vaccination platform that can be combined and compared with other vaccines.”

The information contained in this article is for educational and informational purposes only and is not intended as medical or medical advice. Always consult your doctor or other qualified healthcare provider for any questions regarding your medical condition or health goals.