Novavax awaits FDA decision on whether its next COVID vaccine can be offered in the United States

By Michael Erman

(Reuters) – Novavax will only be able to offer a COVID-19 vaccine in the United States this fall if regulators accept the vaccine it began making that targets a dominant variant earlier this year, the company said .

Novavax’s updated vaccine targets a variant called JN.1, which meets European recommendations. Last month, the European Union regulator asked vaccine makers to update their vaccines against this variant because they would likely be effective against its descendant lines.

The US Food and Drug Administration has yet to make a decision on the composition of the next round of Covid vaccines and a JN.1 subvariant known as KP.2 has become dominant in the states. -United over the past month.

Novavax’s traditional protein-based vaccine is developed from butterfly cells and takes months to manufacture. In 2023, for example, Novavax said it would take six months to bring an adequate supply of vaccines to market.

Vaccines based on messenger RNA (mRNA), such as those from Moderna or Pfizer and its partner BioNTech, can be developed more quickly. In the past, Pfizer has said it could make the shots in 100 days.

Moderna and Pfizer each told Reuters they were waiting for FDA advisers to discuss the vaccine design at a June 5 meeting before deciding which variant their next shots will target.

Novavax revealed during its earnings call earlier this month that it had already advanced a version of its vaccine targeting JN.1 into commercial development.

“If a strain other than JN.1 is selected this late in the development process, a protein-based option will not be available to the U.S. population,” Novavax said in a statement emailed to Reuters this week. Novavax makes the only protein-based COVID vaccine for the United States

The Maryland-based company said in the release that it has data showing good cross-reactivity between its vaccine and the currently dominant KP.2 variant.

Novavax recently struck a licensing deal worth at least $1.2 billion with Sanofi for its COVID vaccine, strengthening a company that had lost most of its value since the pandemic.

It was only able to capture a low single-digit percentage market share in the United States during the 2023-2024 vaccination campaign as demand for COVID-19 vaccines was lower than expected and the company came to market later than its competitors.

In 2024, the company expects revenue to be between $400 million and $600 million, a significant decline from last year when it reported revenue of $983.7 million.

Since 2022, regulators have asked vaccine makers to design new versions of COVID vaccines to better target the variants currently circulating.

Last year, the United States and Europe set the same goals for their vaccine design. In 2022, the European Medicines Agency (EMA) initially approved vaccines targeting a different variant than those authorized in the United States.

The FDA recently postponed its May 16 vaccine advisory meeting to allow more time to “obtain surveillance data and other information” about the circulating virus.

The FDA did not immediately comment on its plans.

“Our hope is that the discussion and recommendation (from the FDA’s vaccine advisory committee) considers the public health benefits of chasing new variants as well as the role of various vaccine options in supporting the vaccine adoption,” Novavax said.

(Reporting by Michael Erman; editing by Caroline Humer and Bill Berkrot)