FDA grants priority review for full approval of Pfizer/BioNTech Covid-19 vaccine;

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Mon, 2021-07-19 19:12 — mike kraft

FDA grants priority review to Pfizer/BioNTech Covid-19 vaccine; agency official says approval decision expected within two months Pfizer and BioNTech said Friday the FDA has granted priority review designation to their application for approval of their Covid-19 vaccine, and an FDA official said the decision will come within months. Jamie Gumbrecht, CNN CNN

(CNN) Pfizer and BioNTech said Friday that the US Food and Drug Administration has granted priority review designation to their application for full approval of their Covid-19 vaccine, and an FDA official said the decision will come "soon".

The FDA official told CNN on Friday that a decision on full approval is likely to come within two months. The agency considers this matter a priority, said the official, who asked not to be named because they were not authorized to speak publicly on the matter.

Pfizer and BioNTech began the application for full approval of their Covid-19 vaccine -- called a Biologics License Application -- in May, and have completed the submission. The companies are seeking approval for the two-dose series for people age 16 and older, and expects to apply for approval for people ages 12 to 15 when the data are available. Moderna has also begun submitting data for approval of its two-dose coronavirus vaccine, and Johnson & Johnson is expected to seek FDA approval.

While the FDA must make its decision by January, it's likely to come much sooner, acting FDA commissioner Dr. Janet Woodcock said. "...the review of this BLA has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the ... Goal Date," Woodcock tweeted.

All three vaccines currently have emergency use authorization from the FDA. ...

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