The announcement from Pfizer and its German partner BioNTech, just a week after they revealed the first promising preliminary results, comes as the team is preparing within days to formally ask U.S. regulators to allow emergency use of the vaccine. Anticipating that, a Food and Drug Administration advisory panel is on standby to publicly debate the data in early December.
The companies also have begun “rolling submissions” for the vaccine with regulators in Europe, the U.K. and Canada and soon will add this new data.
Pfizer and BioNTech had initially estimated the vaccine was more than 90% effective after counting a group of the earliest infections that occurred in its final-stage testing. With the new announcement, they have accumulated more infections — 170 — and said only eight of them occurred in volunteers who got the actual vaccine rather than a comparison dummy shot. One of those eight developed severe disease, the companies said.
“This is an extraordinarily strong protection,” Dr. Ugur Sahin, BioNTech’s CEO and co-founder, told The Associated Press.
Even if regulators agree, he dispelled any notion that an end to the pandemic is around the corner, warning “we are now awaiting a hard winter.”
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