Pfizer and BioNTech are filing for full approval of their COVID-19 vaccine with the FDA

pfizer vaccine
vials of the Pfizer-BioNTech Covid-19 vaccine are prepared to be administered to front-line health care workers under an emergency use authorization at a drive up vaccination site from Renown Health in Reno, Nevada on December 17, 2020.

  • Pfizer and BioNTech are the first of the three US-approved vaccines to file for non-emergency approval with the FDA.
  • If approved, the FDA would allow Pfizer to administer shots even after the pandemic state of emergency ends.
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Pfizer and BioNTech are asking the Food and Drug Administration for full regulatory approval of their jointly-produced COVID-19 vaccine. The move would allow the companies to produce and distribute the shots even after the coronavirus pandemic state of emergency is lifted.

Reports that the companies were seeking full approval first came Friday from CNN and CNBC.

The Pfizer and BioNTech two-shot vaccine was approved for emergency use in December as coronavirus cases in the US continued to spike. Under a state of emergency declaration, the companies were allowed to administer vaccines to the public based on a shorter data span, per CNN.

About 170 million doses of the Pfizer vaccine have been administered in the US under the Emergency Use Authorization, according to CNN.

The process for full FDA approval works on a rolling basis, allowing Pfizer and BioNTech to submit documents as they are prepared. The companies have also asked the FDA to expedite the process, according to CNBC.

The drug companies are seeking a Biologic License Application using clinical data, CNBC reported. If the BLA is approved by regulators, the vaccine would be permanently available to members of the US population from ages 16 and up.

Under an emergency use authorization, Pfizer and BioNTech also have less control over their pricing and distribution. Full authorization would allow them to potentially charge more for the vaccine, according to CNN.

Insider reported in April that the drug companies were increasing production in order to meet a stated goal of 300 million doses by the end of July.

And most recently, on April 23, the FDA revised standards for the Johnson & Johnson vaccine along with a warning about a potential “very rare and very serious type of blood clot in people who have received it.”

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