😎 Summer Sale Exclusive - Up to 50% off AI-powered stock picks by InvestingProCLAIM SALE

Novavax awaits FDA decision on whether its next COVID shot can be offered in US

Published 05/24/2024, 04:19 PM
Updated 05/24/2024, 04:20 PM
© Reuters. FILE PHOTO: People pose with syringe with needle in front of displayed Novavax logo in this illustration taken, December 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

By Michael Erman

(Reuters) - Novavax (NASDAQ: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 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 traditional, protein-based vaccine is developed in moth cells and takes months to manufacture. In 2023, for instance, Novavax 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 (NASDAQ:MRNA) or Pfizer (NYSE:PFE) and partner BioNTech (NASDAQ:BNTX), 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 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 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 said in a statement emailed to Reuters this week. Novavax 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 recently struck a licensing deal worth at least $1.2 billion with Sanofi (NASDAQ:SNY) 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.

© Reuters. FILE PHOTO: People pose with syringe with needle in front of displayed Novavax logo in this illustration taken, December 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

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 said.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.