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US FDA approves updated COVID shots ahead of fall and winter By Reuters

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Written by Maryam Sani and Manas Mishra

(Reuters) – The U.S. Food and Drug Administration on Thursday approved updated COVID-19 vaccines from Pfizer Inc. Pfizer (New York Stock Exchange:) and accident (NASDAQ:) is targeting a new variant of the disease, just in time for a vaccination campaign in the fall.

The updated vaccines target the KP.2 strain that spread earlier this year and are expected to become available nationwide in the coming days, the companies said.

The health regulator asked vaccine manufacturers in June to target this variant, if possible.

Newer vaccines are designed to more precisely target currently circulating strains and provide better protection against severe disease. Older vaccines targeted a strain that is no longer circulating.

“Vaccination remains the cornerstone of preventing COVID-19,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

KP.2 is no longer the dominant strain but is still related to other strains currently circulating in the United States. Health regulators hope to protect against circulating strains by targeting closely related forms like KP.2.

The U.S. Food and Drug Administration has approved the Moderna vaccine, branded SpikeVax, and Comirnaty, co-developed by Pfizer Inc and BioNTech SE (NASDAQ:BNZ), for use in children ages six months and older and adults.

Vaccines are approved for children under 12 years of age under the agency’s Emergency Use Authorization pathway.

The regulator has not approved a more traditional protein-based injection made by Novavax (NASDAQ:), which could offer an alternative for people skeptical of the mRNA vaccines produced by Moderna and Pfizer.

Novavax said it is working “productively” with the FDA and expects to receive approval in time for the vaccination season.

The company’s vaccine is developed in moth cells and takes several months to manufacture. In 2023, for example, Novavax said it would take six months to bring enough vaccine to market.

The approvals come as hospitalizations and deaths linked to Covid-19 have surged over the past three months in the United States. However, demand for the vaccine has fallen sharply since the peak of the pandemic.

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