May 24 (Reuters) - Novavax ( NVAX ) will only be able to

offer a COVID-19 vaccine in the United States this autumn if

regulators accept the shot it has started manufacturing that

targets a variant that was dominant earlier this year, the

company said.

Novavax's ( NVAX ) updated vaccine targets a variant called JN.1,

which is in line with European recommendations. The European

Union's regulator told vaccine makers last month to update their

vaccines for that variant because they would likely be effective

against its descendant lineages.

The U.S. Food and Drug Administration has not yet made a

decision on the makeup 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 ( NVAX ) traditional, protein-based vaccine is developed in

moth cells and takes months to manufacture. In 2023, for

instance, Novavax ( NVAX ) said it needed six months to bring an adequate

supply of vaccine to the market.

Vaccines based on messenger RNA (mRNA), like those from

Moderna ( MRNA ) or Pfizer ( PFE ) and partner BioNTech

, can be developed more quickly. In the past, Pfizer ( PFE )

has said it could make the shots in 100 days.

Moderna ( MRNA ) and Pfizer ( PFE ) each told Reuters they are waiting for

the FDA's advisers to discuss vaccine design at a June 5 meeting

before settling on which variant their next vaccines will

target.

Novavax ( NVAX ) disclosed on 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 for the U.S. population," Novavax ( NVAX ) said in a statement

emailed to Reuters this week. Novavax ( NVAX ) makes the only

protein-based COVID vaccine for the U.S.

The Maryland-based company said in the statement it has data

showing good cross-reactivity between its vaccine and the

currently dominant KP.2 variant.

Novavax ( NVAX ) recently struck a licensing deal worth at least $1.2

billion with Sanofi for its COVID vaccine, bolstering

a company that had lost most of its value since the pandemic.

It was only able to take a low-single-digit percentage

market share in the U.S. during the 2023-2024 vaccination

campaign as demand for COVID vaccines was smaller than hoped and

the company got its shot to market later than rivals.

In 2024, the company expects revenue in the range of $400

million to $600 million, down significantly from last year, when

it recorded $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 U.S. and Europe settled on the same

targets for their vaccine designs. In 2022, the European

Medicines Agency (EMA) initially endorsed vaccines targeting a

different variant than the ones authorized in the U.S.

The FDA recently postponed its vaccine advisory meeting from

May 16 in order to have more time to "obtain surveillance data

and other information" on the circulating virus.

The FDA did not immediately comment on its plans.

"Our hope is that the (FDA vaccine advisory committee)

discussion and recommendation consider the public health benefit

of chasing newer variants as well as the role of diverse vaccine

options in supporting vaccine uptake," Novavax ( NVAX ) said.