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This Article is From Aug 18, 2021

U.K. Authorizes Moderna Covid-19 Vaccine for Use in Adolescents

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Britain's drug regulator authorized Moderna Inc.'s Covid-19 shot for children as young as 12, though few are likely to receive it in the near term as the country remains an outlier in its policy on vaccinating kids.

The U.K. Medicines and Healthcare products Regulatory Agency extended the existing conditional marketing authorization for the Spikevax shot to 12- to 17-year-olds, the regulator said in a statement Tuesday. It is up to the government's advisory committee -- the Joint Committee on Vaccination and Immunisation -- to decide if and when the vaccine will be offered to this age group.

The vaccine is the second after Pfizer Inc.'s to be authorized in the U.K. for use in older children, though Britain is currently only offering shots to those aged 16 and up, and to vulnerable kids aged 12 to 15 who have underlying health conditions such as Down's syndrome or who live with immunosuppressed adults.

That puts the U.K. at odds with many of its closest neighbors in Europe and the U.S., which have offered Covid-19 shots to all adolescents ahead of the fall school year. The U.K.'s decision not to roll out vaccines to healthy children over 12 was based partly on some rare side effects seen particularly in male teenagers. 

The conditions myocarditis and pericarditis -- inflammation of the heart muscle and its surrounding membrane -- were linked to the mRNA vaccines earlier this year, leading the U.K. to conclude that the benefits don't yet outweigh the risks. 

“We have in place a comprehensive safety surveillance strategy for monitoring the safety of all U.K.-approved Covid-19 vaccines and this surveillance will include the 12- to 17-year age group,” June Raine, chief executive officer of the MHRA, said in a statement Tuesday.

©2021 Bloomberg L.P.

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