FILE - This May 4, 2020, file photo provided by the University of Maryland School of Medicine, shows the first patient enrolled in Pfizer’s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore. Pfizer announced Wednesday, Nov. 18, 2020, more results in its ongoing coronavirus vaccine study that suggest the shots are 95% effective a month after the first dose. (Courtesy of University of Maryland School of Medicine via AP, File)

FILE - This May 4, 2020, file photo provided by the University of Maryland School of Medicine, shows the first patient enrolled in Pfizer’s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore. Pfizer announced Wednesday, Nov. 18, 2020, more results in its ongoing coronavirus vaccine study that suggest the shots are 95% effective a month after the first dose. (Courtesy of University of Maryland School of Medicine via AP, File)

Pfizer: COVID-19 shot 95% effective, seeking clearance soon

The study has enrolled nearly 44,000 people in the U.S. and five other countries.

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.

They 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 94 infections had been counted in a study that included 44,000 people. With the new announcement, the company now has accumulated 170 infections in the study — and said only eight of them occurred in volunteers who got the actual vaccine rather than a dummy shot. One of those eight developed severe disease, the company said.

“This is an extraordinarily strong protection,” Dr. Ugur Sahin, BioNTech’s CEO and co-founder, told The Associated Press.

The companies have not yet released detailed data on its 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.

But all eyes are on the progress of potential vaccines as the grim infection rate jumps in the U.S. and abroad as winter weather forces people indoors, in the close quarters that fuels viral spread.

Pfizer and BioNTech said the vaccine was more than 94% effective in adults over age 65, though it is not clear exactly how that was determined with only eight infections in the vaccinated group to analyze and no breakdown provided of those people’s ages.

Sahin said there were enough older adults enrolled in the study and among the placebo recipients who became infected that he is confident “this vaccine appears to work in the higher-risk population.”

Earlier this week Moderna, Inc. announced that its experimental vaccine appears to be 94.5% effective after an interim analysis of its late-stage study.

Similar results from two vaccines both made with a 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 — likely will add to experts’ reassurance about the novel approach.

While initial supplies will be scarce and rationed, as the supply grows Sahin said the companies have a responsibility to help ensure access for lower income countries as well.

Pfizer and BioNTech also say now have the required data on the vaccine’s safety needed to seek emergency authorization from the Food and Drug Administration.

The companies didn’t disclose safety details but said no serious vaccine side effects have been reported, with the most common problem being fatigue after the second vaccine dose, affecting about 4% of participants.

The study has enrolled nearly 44,000 people in the U.S. and five other countries. The trial will continue to collect safety and effectiveness data on volunteers for two more years.

Pfizer and BioNTech said they expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.

U.S. officials have said they hope to have about 20 million vaccine doses each from Moderna and Pfizer available for distribution in late December. The first shots are expected to be offered to vulnerable groups like medical and nursing home workers, and people with serious health conditions.

VIDEO: Growing number of Canadians plan to get vaccinated for COVID-19

___

AP medical writer Lauran Neergaard contributed to this report.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Linda A. Johnson And Frank Jordans, The Associated Press


Like us on Facebook and follow us on Twitter.

Want to support local journalism during the pandemic? Make a donation here.

Coronavirusvaccines

Get local stories you won't find anywhere else right to your inbox.
Sign up here

Just Posted

Montrose resident Kimba McLean has hiked Antenna Trail every day since October and counting. Photo: Jim Bailey
Montrose man makes daily trek up Antenna Trail

Kimba McLean put on more than 800-km hiking Antenna Trail every day for the past six months

Trail Times file photo
Trail RCMP nab wanted man

Police responded to a call for assistance in East Trail on April 7, at 2 a.m.

The Canadian Real Estate Association says home sales in March hit a record high as they continued their rebound from the lows of earlier this year when the COVID-19 froze the market. THE CANADIAN PRESS Jonathan Hayward
Seller’s market continues for Kootenay homeowners

In Trail, sales were up almost 40 per cent from the same time last year …

Trail Coffee Company’s Maddie Van Horn is making the best out of the province’s latest health orders, and invites patrons to enjoy a hand-roasted coffee on her new patio. Photo: Jim Bailey
Trail coffee shop owner serving it up on outdoor patio

March 31, the PHO shut down pubs and restaurants to indoor dining.

Interior Health nurses administer Pfizer-BioNTech COVID-19 vaccines to seniors and care aids in Kelowna on Tuesday, March 16. (Phil McLachlan/Kelowna Capital News)
69 new cases of COVID-19 in Interior Health

The total number of cases in the region is now at 9,840 since the pandemic began

Rainbow trouts thrashing with life as they’re about to be transferred to the largest lake of their lives, even though it’s pretty small. These rainbows have a blue tinge because they matched the blue of their hatchery pen, but soon they’ll take on the green-browns of their new home at Lookout Lake. (Zoe Ducklow/News Staff)
VIDEO: B.C. lake stocked with hatchery trout to delight of a seniors fishing club

The Cherish Trout Scouts made plans to come back fishing soon

Paper Excellence took over Catalyst Paper operations in B.C. in 2018. (Paper Excellence photo)
The plane blasted through an airport fence and down a hill, before stopping before a cement barrier on Highway 5A, right in front of a school bus. Photo submitted.
Student pilot crashes plane onto Highway 5A almost hitting school bus

Aircraft hit pavement right in front of school bus

Eight-year-old Piper and her family were raising money to help Guinevere, the bearded dragon, get a gynecological surgery. Sadly, the reptile didn’t survive the procedure. (Jackee Sullivan/Special to Langley Advance Times)
Lizard fails to survive surgery, GoFundMe dollars help Langley family offset medical bills

Guinevere, a pet bearded dragon, underwent an ovariectomy on Tuesday

A driver stopped by Saanich police following a road rage incident on April 15 was found to be impaired, in violation of a license restriction and in a damaged vehicle. They received a 90-day driving prohibition and a 30-day vehicle impound. (Saanich Police Traffic Safety Unit/Twitter)
Road rager fails breathalyzer on busy B.C. highway in vehicle he shouldn’t be driving

Saanich police say man was operating vehicle without required ignition lock

B.C. Premier John Horgan wears a protective face mask to help prevent the spread of COVID-19. THE CANADIAN PRESS/Jonathan Hayward
B.C. Premier John Horgan booked to get AstraZeneca shot Friday

‘Let’s show all British Columbians that the best vaccine is the one that’s available to you now,’ he said

Doses of the Moderna COVID‑19 vaccine in a freezer trailer, to be transported to Canada during the COVID-19 pandemic. THE CANADIAN PRESS/Nathan Denette
Pfizer to increase vaccine deliveries in Canada as Moderna supply slashed

Moderna plans to ship 650,000 doses of its vaccine to Canada by the end of the month, instead of the expected 1.2 million

Dr. Bonnie Henry speaks about the province’s COVID-19 vaccine plans during a news conference at the legislature in Victoria. THE CANADIAN PRESS/Chad Hipolito
P.1 variant likely highest in B.C. due to more testing for it: Dr. Henry

Overall, just under 60% of new daily cases in the province involve variants

Most Read