The Food and Drug Administration granted emergency use authorization for Novavax’s COVID-19 vaccine, paving the way for a new fourth option for the 10% of American adults who have not yet received at least one dose of any other injection.
“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards of safety, efficacy, and manufacturing quality necessary to support the authorization of emergency use,” FDA Commissioner Dr. Robert Califf said in a release on Wednesday.
Like the other available COVID-19 vaccines, Novavax injections will need to be formally recommended by the Centers for Disease Control and Prevention before they can be made available. That could happen as early as next Tuesday, when the agency’s outside vaccine advisers are the next scheduled meet up.
The FDA’s decision comes more than a month after the vaccine garnered nearly unanimous support from the regulator’s own panel of outside advisers.
“The American public can trust that this vaccine, like all vaccines used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review,” said FDA’s Dr. Peter Marks.
On his June 7 meetingFDA officials said the agency was still reviewing the company’s process for manufacturing and checking the quality of the injections, an issue company executives acknowledged as one of the biggest obstacles to completing its submission to the regulator.
“However, what really took the most time was not the manufacturing of the product. It was the generation of the tests to illustrate that we could make the product over and over again, in the same way, and deploy those tests against multiple batches,” said Filip Dubovsky of Novavax.
The Biden administration has secured some 3.2 million doses of the Novavax vaccine. The company is among the original list of shots contracted by Operation Warp Speed. of 2020.
But it’s unclear when or how many of those doses will initially be available for states and pharmacies to order. The Department of Health and Human Services said monday which is still performing quality tests on the Novavax vaccine.
In clinical trials conducted before the Omicron variant, Novavax was found to have 90.4% efficacy in preventing any symptomatic COVID-19 infection and as much as 100% effective against moderate to severe disease.
A spokesman for the Department of Health and Human Services did not respond to a request for comment.
The FDA also said last month that it disagreed with Novavax on whether to attach a warning of myocarditis potentially related to the injections. This type of heart inflammation side effect has also been noted by the CDC as a “rare risk” associated with mRNA vaccines from Pfizer-BioNTech and Moderna, according to multiple studies.
Authorized fact sheets for Novavax injections will eventually include the warning, the FDA said.
Novavax has otherwise promoted its use of older vaccine technology for its COVID injection as a good alternative to the country’s stable of effective vaccines because it has been administered with fewer side effects during trials than injections from Pfizer or Moderna.
The Novavax vaccine works by giving the immune system a part of the cultured virus in insect cells and mixed with an ingredient, called an adjuvant, derived tree bark which aims to enhance its effectiveness in the body.
The mRNA vaccines that are already available work by providing cells with a blueprint to create spike proteins to trigger an immune response from the body. Novavax, on the other hand, includes the proteins in its vaccine. This type of technique, called protein subunit vaccinesit has been widely used for a long time in other shots.
Early in their development, studies of these two vaccines included tests in a controversial cell line linked to an abortion in the 1970s that is widely used in medical research, although neither was shot finally uses any fetal tissue in the manufacture of its vaccines. Johnson & Johnson’s janssen vaccine uses a cell line that was originally developed from an abortion.
“No human fetal-derived tissue or cell lines, including HEK293 cells, are used in the development, manufacturing, or production of the Novavax COVID-19 vaccine candidate, NVX-CoV2373,” Alison Chartan, a Novavax spokeswoman, told Reuters. CBS News last month.
Like the manufacturers of mRNA vaccines, Novavax says it is It is also studying a version of its shots redesigned to target the Omicron BA.4 and BA.5 sub-variants that now dominate across the country. The first data on those shots is expected “in late summer or fall,” the company says.
However, Novavax has argued that “there remains a role” for the current version of its vaccine.
The company has said it plans to seek authorization for its current vaccine to also be used as a booster shot. It is also testing the combination booster with its vaccine in people who initially received a primary series from Pfizer or Moderna.
“Our vaccine has been shown to be effective against variants, induce broad immune responses against Omicron variants, and this may be the best option for people who prefer a vaccine with a broad database of safety and efficacy,” he said. Gregory Glenn of Novavax to FDA advisors. in a meeting At the end of june.