Pfizer, BioNTech expect COVID-19 vaccine approval as early as December

New York City-based drugmaker Pfizer and BioNTech, the German biotech company it partnered with to develop a COVID-19 vaccine, estimate their vaccine could win regulatory approval as early as this December, according to a July 10 report from The Wall Street Journal.

The vaccine candidate, which uses messenger RNA, is entering phase 3 of testing at the end of July. Researchers plan to enroll 30,000 participants in the upcoming round of trials and complete testing by the end of the year.

BioNTech CEO Ugur Sahin, MD, told The Wall Street Journal the candidate's success in early testing rounds makes him confident the vaccine will earn regulatory approval sooner than expected, as early as the end of this year.

"Our early data so far has shown that our vaccine candidate can produce antibodies at a higher level than those found in people who have recovered from a COVID-19 infection," Dr. Sahin said.

Pfizer and BioNTech are ready to produce hundreds of millions of doses before winning approval and could manufacture more than 1 billion doses by the end of 2021, according to Dr. Sahin. 


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