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.