BREAKING: Pfizer has started application for FULL FDA approval for its COVID-19 vaccine for people over the age of 16

  • Pfizer said Friday it has begun its application for full FDA approval of its COVID-19 vaccine 
  • The firm’s shot was given emergency use authorization for its shot on December 11. Emergency use authorization has a lower bar than approval 
  • Pfizer will submit necessary data over the coming weeks, but likely won’t get approval for at least a month 
  • It hopes that full approval will ease vaccine hesitancy because it requires more proof the shot is safe and works compared to authorization  

Pfizer Inc and German partner BioNTech SA said on Friday they have started an application process with the U.S. Food and Drug Administration for full approval of their COVID-19 vaccine, currently only authorized for emergency use.

If approved, the vaccine will be the first fully approved COVID-19 shot and could help ease vaccine hesitancy due to longer-term data required for an FDA approval.

The companies said they would submit data to support the so-called biologic license application, which requires longer-term follow-up data, on a rolling basis over the next few weeks.

The FDA will set a goal date for a regulatory decision once the application is complete and formally accepted for review by the agency.

Under an emergency use authorization, the FDA makes a product available to the public based on the best available evidence during an emergency, without waiting for all the evidence needed for FDA approval or clearance, according to the regulator.

More than 170 million doses of Pfizer-BioNTech’s vaccine have been delivered across the U.S. since it was authorized for emergency use in December.

Last month, the companies asked U.S. to allow the emergency use of their vaccine in adolescents aged 12 to 15, with the FDA set to give the nod by next week.

There are three vaccines available in the United States: Pfizer-BioNTech, Moderna and Johnson & Johnson. All have been authorized for emergency use.

(Reporting by Ankur Banerjee in Bengaluru; Editing by Shinjini Ganguli)

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