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FDA approves Novavax COVID vaccine with new conditions
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FDA approves Novavax COVID vaccine with new conditions
May 26, 2025 9:56 AM

May 17 (Reuters) - The U.S. Food and Drug Administration

on Friday approved Novavax's ( NVAX ) COVID-19 vaccine, but

placed additional conditions on individuals who would be able to

receive the vaccine.

According to the approval letter, the license restricts the

use of the vaccine called Nuvaxovid to individuals aged 65 and

older, and those between 12 and 64 who have at least one

underlying condition that increases their risk of developing

severe illness from COVID.

The letter did not specify what qualified as an underlying

condition.

The FDA also deferred submission of pediatric studies from

birth to less than 12 years for the application, as pediatric

studies had not been completed.

Novavax ( NVAX ) CEO John Jacobs said the approval was a "significant

milestone" that solidifies a path for people to access the

vaccine.

The vaccine's prospects were thrown into doubt after the FDA

missed its April 1 target to approve the shot. U.S. Health and

Human Services Secretary Robert F. Kennedy Jr. attributed the

delay to the shot's composition in a CBS interview earlier that

month.

Novavax ( NVAX ), whose protein-based shot uses an older technology,

missed out on the pandemic vaccine windfall - enjoyed by rivals

Moderna ( MRNA ) and Pfizer ( PFE ) which make messenger

RNA-based vaccines - due to manufacturing issues and regulatory

hurdles.

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