Associated Press

Pfizer said Wednesday that new test results show its coronavirus vaccine is 95% effective, is safe and also protects older people most at risk of dying — the last data needed to seek emergency use of limited shot supplies as the catastrophic outbreak worsens across the globe.

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.”

“The available vaccine doses are just too small to ensure that we could make a significant difference to the society” right away, Sahin said. But next year if several companies’ vaccine candidates also work, “we might be able to get control of this pandemic situation late summer 2021.”

The companies have not yet released detailed data on their study, and results have not been analyzed by independent experts. Also still to be determined are important questions such as how long protection lasts and whether people might need boosters — leading experts to caution that people should focus less on the specific numbers and more on the overall promise.

Earlier this week, competitor Moderna Inc. also announced similar effectiveness of its own COVID-19 vaccine candidate, which is made with the same, brand-new technology — using a snippet of the genetic code of the coronavirus to train the body to recognize if the real virus comes along.

For both, “there’s every reason to be enormously optimistic,” said Dr. Paul Offit of Children’s Hospital of Philadelphia, one of FDA’s advisers.

“When these vaccines roll out, you’re only going to know it’s effective for a limited period of time,” he cautioned, adding that more follow-up information will come. “You don’t want to oversell it, but you don’t want to undersell it.”