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Coronavirus

Pfizer Aims for Full FDA Approval of Vaccine

NEW YORK — Drugmaker Pfizer has begun the process to earn full U.S. regulatory approval for its COVID-19 vaccine for people aged 16 and older.

That gives Pfizer and German partner BioNTech a shot at winning the first full approval from the U.S. Food and Drug Administration.

The two companies say they’ve started a “rolling submission” of data from their studies of the two-dose vaccine, first giving the FDA data from laboratory and human testing. That includes their latest analysis from a key late-stage study that followed the participations for up to six months after they received their second dose. The companies plan to soon submit data on manufacturing quality controls and the factories making the vaccine.

Pfizer Chief Executive Albert Bourla said in a statement that the companies are aiming to win full regulatory approval “in the coming months.”

The shot received emergency use authorization from the FDA on Dec. 11. Since then, the companies have delivered more than 170 million doses across the U.S., and many more to other countries that also have authorized emergency use amid the coronavirus pandemic. Such emergency authorizations only last until countries declare an end to the emergency, so the vaccine must undergo a more stringent review by regulators to earn full approval for continued use.

Dr. Ugur Sahin, co-founder of BioNTech, said the submission “is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future.”

The partners also applied to the FDA to expand the current emergency authorization to people ages 12 to 15. They plan to seek full approval for that age group once they have the required six months of follow-up data from the volunteers tested in that group. They’re also testing the shot in younger children and pregnant women.

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