By Michael Erman
(Reuters) – Novavax (NASDAQ:) will only be able to offer a COVID-19 vaccine in the United States this fall if regulators accept the shot it has started production that targets a variant that was dominant earlier this year, the company said .
Novavax’s updated vaccine targets a variant called JN.1, which is in line with European recommendations. The European Union’s regulator last month told vaccine makers to update their vaccines for that variant because it was likely to be effective against its descendants.
The U.S. Food and Drug Administration has not yet made 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 United States over the past month.
Novavax’s traditional protein-based vaccine is developed in moth cells and takes months to produce. In 2023, for example, Novavax said it needed six months to bring enough vaccine to market.
Vaccines based on messenger RNA (mRNA), such as the one from Modern (NASDAQ:) or Pfizer (NYSE:) and partner BioNTech (NASDAQ:), can be developed more quickly. In the past, Pfizer has said it could make the shots within 100 days.
Moderna and Pfizer each told Reuters they are waiting for FDA advisers to discuss vaccine design at a June 5 meeting before deciding which variant their next vaccines will target.
Novavax announced during its earnings call earlier this month that it had already advanced a version of its vaccine targeting JN.1 to 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 US population,” Novavax said in a statement emailed to Reuters this week. Novavax makes the only protein-based COVID vaccine for the US
The Maryland-based company said in the statement that it has data showing good cross-reactivity between its vaccine and the currently dominant KP.2 variant.
Novavax recently signed a licensing deal worth at least $1.2 billion Sanofi (NASDAQ:) for its COVID vaccine, strengthening a company that had lost most of its value since the pandemic.
It was only able to capture a single-digit market share in the US during the 2023-2024 vaccination campaign as demand for COVID vaccines was lower than hoped and the company entered the market later than its rivals.
In 2024, the company expects revenue of between $400 million and $600 million, significantly lower than last year, when it posted $983.7 million in revenue.
Since 2022, regulators have asked vaccine makers to design new versions of the COVID shots to better target currently circulating variants.
Last year, both the US and Europe agreed on the same targets for their vaccine designs. In 2022, the European Medicines Agency (EMA) initially approved vaccines targeting a different variant than those approved in the US
The FDA recently postponed its vaccine advisory meeting until May 16 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 FDA Vaccine Advisory Committee’s discussion and recommendation takes into account the public health benefit of pursuing newer variants, as well as the role of various vaccine options in supporting vaccine uptake,” Novavax said.
