Novavax could provide unvaccinated Americans with a new option if Regulators Agree

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, following a long-awaited submission of data to the Food and Drug Administration last month.

If approved by the FDA, Novavax’s shots could be the first COVID-19 doses available in the United States, based on a type of “protein subunit” technology that has been used in other routine vaccinations for decades. Officials believe that having this option may persuade some remaining vaccine holdouts to get the shots, as well as help the Biden administration meet its 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.

The Novavax vaccine would be available to people over the age of 18. However, the share of American adults who are still vaccinated is decreasing. According to the Centers for Disease Control and Prevention, nearly 90% of adults in the United States have already received at least one dose of the COVID-19 vaccine.

The vast majority were vaccinated with mRNA-based vaccines developed by Moderna, Pfizer, and BioNTech, which have been shown to be safe and effective in reducing COVID-19 cases and deaths in millions of Americans.

However, federal health officials have long recommended that protein-based vaccines could still be approved, in the hopes of persuading holdouts who are 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 refused to comment on whether the FDA would call a meeting of its outside vaccine experts, the Vaccines and Related Biological Products Advisory Committee, before deciding whether to approve Novavax’s shots, as it did for Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines.

Before the first doses of Novavax’s COVID-19 vaccine can be distributed, the FDA and the Centers for Disease Control and Prevention must both approve it.

Two of the vaccines supported by the Trump administration’s Operation Warp Speed early in the pandemic — Novavax’s shots and another developed by Sanofi Pasteur and GlaxoSmithKline — are protein-based.

Unlike traditional vaccines, which involve injecting a dose of the entire disabled or weakened virus, scientists working on protein subunit vaccines isolate only specific fragments of the virus to elicit an immune response. For many years, the technique has been used in vaccines against hepatitis B, pertussis (whooping cough), and other diseases.

Protein vaccines, such as Novavax doses, are also combined with adjuvants, which can stimulate the body to train a better immune response.

This differs from mRNA vaccines or Johnson & Johnson’s Janssen “viral vector” vaccine, which work by inducing an immune response by causing some of the body’s cells to produce a harmless portion of SARS-CoV-2, the virus that causes COVID-19.

Novavax’s shot has already received regulatory approval in a number of countries, including Australia and South Korea this month. The vaccine has also been approved by the World Health Organization, with production taking place in Europe and India.

The company has highlighted findings from clinical trials of its doses in North America and the United Kingdom earlier in the pandemic that showed the vaccine was safe and effective at lowering infections — around 90% overall — in published findings. According to Novavax, its vaccine should be effective against the Omicron variant, citing data from the booster and adolescent studies.

However, the company’s submission is later than expected. Novavax told investors in May that it planned to apply for FDA approval “in the third quarter of 2021.” The company has revealed over the summer that the Biden administration had paused funding for Novavax’s manufacturing until it could reach an agreement with the FDA on “analytic methods” for its vaccine.

At the end of December, the company submitted its final data on its manufacturing efforts to the FDA.

Aside from its potential use in vaccinating Americans, State Department officials say they have pushed for Novavax production to be increased in order to meet global vaccine donation goals.

“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.