Pfizer to hunt Japan COVID-19 vaccine approval for teenagers aged 5-11


U.S. pharmaceutical big Pfizer Inc. is in talks with Japan to use for approval to manage its COVID-19 vaccine to youngsters aged 5 to 11, sources near the matter stated Wednesday.

The revelation got here a day after a U.S. Meals and Drug Administration panel of impartial specialists voted in favor of issuing emergency use authorization for the vaccine to be administered to youngsters in that age group.

Picture reveals vials of Pfizer Inc.’s COVID-19 vaccine at a hospital in Iwamizawa, Hokkaido, northern Japan, on Feb. 19, 2021. (Kyodo) ==Kyodo

If submitted, Japan’s Ministry of Well being, Labor and Welfare plans to promptly overview the applying, in line with the sources.

Pfizer’s COVID-19 vaccine, collectively developed with German associate BioNTech SE, is at present accessible freed from cost to folks aged 12 and older in Japan, the place it has been permitted to be used.

Protection has not been prolonged to youngsters under 12 as a consequence of uncertainty over the vaccine’s efficacy and security for that group.

In medical trials performed by Pfizer in the USA and different international locations, administration of a 3rd grownup dose of the vaccine was discovered to be 90.7 p.c efficient in stopping COVID-19 infections in youngsters between 5 and 11 years, in line with information submitted to the FDA.

Though the topics skilled sore arms, fatigue and complications the following day, the negative effects disappeared shortly and there have been no questions of safety.

The outcomes led the FDA panel to conclude at a gathering Tuesday that the advantages of the vaccine outweighed the dangers even amongst youngsters.

In response to U.S. media, COVID-19 vaccination of children might begin as early as subsequent week, however some stay unconvinced of the need as a result of low danger of youngsters creating severe signs.

Some specialists have steered that the vaccine rollout ought to solely goal youngsters with underlying situations.

Pfizer is predicted to use for approval in Japan utilizing the outcomes of the identical medical trials.





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