Following a long-awaited submission of data to the Food and Drug Administration last month, Novavax announced Monday that it had formally filed a request for emergency use authorization of its protein-based COVID-19 vaccine in the United States.
If greenlighted by the FDA, Novavax's shots could be the first COVID-19 doses available in the U.S. based on a kind of "protein subunit" technology that has been used for decades in other routine vaccinations. Officials say having this option could help persuade some remaining vaccine holdouts to get the shots, as well as boost the Biden administration's international vaccine donation goals.
"We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," Novavax's president and CEO Stanley Erck said in a statement announcing the submission.
Novavax's vaccine would be for people aged 18 and over. But the share of American adults left to vaccinate is shrinking. Close to 90% of U.S. adults already have at least one dose of COVID-19 vaccine, according to the Centers for Disease Control and Prevention.
However, federal health officials have long said that protein-based vaccines might still have a path to authorization, in the hopes of persuading holdouts unwilling or unable to receive the mRNA shots.
"There are some people in the United States who still will not take our mRNA vaccines and they are waiting for a protein-based vaccine. And for us, anything we can do to help get a larger portion of our population vaccinated is something that we need to do," Dr. Peter Marks, the FDA's top vaccines official, said at a conference last year.
A spokesperson did not comment on whether the FDA would convene a meeting of its outside vaccine experts, the Vaccines and Related Biological Products Advisory Committee, before deciding whether to authorize Novavax's shots, as it did for the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines.
Both the FDA and the Centers for Disease Control and Prevention must sign off on Novavax's COVID-19 vaccine before the first doses can be rolled out.
Of the portfolio of vaccines whose development was backed by the Trump administration's Operation Warp Speed early in the pandemic, two — Novavax's shots as well as another developed by Sanofi Pasteur and GlaxoSmithKline — are protein-based.
Unlike traditional vaccines, which rely on injecting a dose of the entire disabled or weakened virus, scientists developing protein subunit vaccines pick out only specific fragments of the virus to trigger an immune response. The technique has been used for years in vaccines against hepatitis B, pertussis (whooping cough) and other diseases.
Protein vaccines like Novavax's doses are also combined with ingredients called adjuvants that can stimulate the body to train a better immune response.
This is different from the mRNA vaccines orJanssen "viral vector" vaccine, which work by getting some of the body's cells to produce a harmless portion of SARS-CoV-2, the virus that causes COVID-19, in order to trigger an immune response.
Novavax's shot has already won regulatory approvals in several countries around the world, including Australia and South Korea this month. The vaccine has also been greenlighted by the World Health Organization, manufactured by sites in Europe and India.
The company has touted results showing the vaccine was safe and effective at curbing infections — around 90% overall — in published findings of clinical trials of its doses in North America and the United Kingdom earlier in the pandemic. Novavax also says its vaccine should work against the Omicron variant, citing data from booster and adolescent studies.
However, the company's submission comes later than initially hoped for. Last May, Novavax told investors it expected to file for the FDA's authorization "in the third quarter of 2021." Over the summer, the company disclosed the Biden administration had paused funding for Novavax's manufacturing until it could strike an agreement with the FDA over "analytic methods" for its vaccine.
The company completed submitting its final data on its manufacturing efforts to the FDA at the end of December.
Beyond its potential use in vaccinating Americans, State Department officials say they have pushed for scaling up Novavax's production in hopes of meeting goals for vaccine donations abroad.
"Novavax is another big, big variable at this point, and I think if Novavax comes through fairly soon, that will be wonderful and that will be a big help because they're a major part of the COVAX portfolio," Jeremy Konyndyk, head of the U.S. Agency for International Development's COVID-19 task force, told reporters in October.
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