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

File photo
Gov’t of Alberta identifies estimated 300 new COVID-19 cases Sunday

Online COVID-19 dashboard unavailable as upgrades being completed

(File photo)
Town’s outdoor skating facilities closing down

Trail extension announced for the summer

COVID
Red Deer down to 313 active cases of COVID-19

Alberta reports an additional 411 COVID-19 cases

THE CANADIAN PRESS/Alex Panetta
Economists “cautiously hopeful” for economic recovery in Alberta

Charles St. Arnaud says Alberta’s recovery will rebound along with roll-out of the COVID-19 vaccine

Elvira D’Angelo, 92, waits to receive her COVID-19 vaccination shot at a clinic in Montreal, Sunday, March 7, 2021, as the COVID-19 pandemic continues in Canada and around the world. THE CANADIAN PRESS/Graham Hughes
‘It’s been a good week’: Tam hopeful on vaccines as pandemic anniversary nears

Tam says the addition of two new vaccines will help Canadians get immunized faster

A woman walks through Toronto’s financial district on Monday, July 30, 2018. A new poll suggests most Canadians believe there’s still a long way to go to achieve gender equality in this country. THE CANADIAN PRESS/Graeme Roy
Canadians, especially women, say gender equality not achieved in Canada: Poll

Poll results themselves underscore the challenge, with more men believing equality had been achieved

This image provided by Harpo Productions shows Meghan, The Duchess of Sussex, left, in conversation with Oprah Winfrey. (Joe Pugliese/Harpo Productions via AP)
Race, title and anguish: Meghan and Harry explain royal rift

Meghan said she struggled with concerns within the royal family about her son’s skin colour

Kiara Robillard is seen in an undated handout photo. When the pandemic began, Robillard had to rush back home to Alberta from California, where she had been living for five years, after she was struck by a truck that broke her spine in two places. THE CANADIAN PRESS/HO-Kiara Robillard, *MANDATORY CREDIT*
‘It kind of clicks:’ Text4Hope program helps with depression, anxiety during pandemic

Participants receive one text message every morning for three months

(The Canadian Press)
‘Worse than Sept. 11, SARS and financial crisis combined’: Tourism industry in crisis

Travel services saw the biggest drop in active businesses with 31 per cent fewer firms operating

Hockey hall-of-fame legend Wayne Gretzky, right, watches the casket of his father, Walter Gretzky, as it is carried from the church during a funeral service in Brantford, Ont., Saturday, March 6, 2021. HE CANADIAN PRESS/Nathan Denette
Walter Gretzky remembered as a man with a ‘heart of gold’ at funeral

The famous hockey father died Thursday at age 82 after battling Parkinson’s disease

Supporters rally outside court as Pastor James Coates of GraceLife Church is in court to appeal bail conditions, after he was arrested for holding day services in violation of COVID-19 rules, in Edmonton, Alta., on Thursday March 4, 2021. THE CANADIAN PRESS/Jason Franson
‘Law remains valid:’ Pastor accused of violating health orders to remain in jail

The Justice Centre for Constitutional Freedoms is representing the pastor

A decommissioned pumpjack is shown at a well head on an oil and gas installation near Cremona, Alta., Saturday, Oct. 29, 2016. The Alberta Energy Regulator says it is suspending all of the licences held by an oil and gas producer with more than 2,200 wells and 2,100 pipelines after it failed to bring its operations into compliance. THE CANADIAN PRESS/Jeff McIntosh
Alberta Energy Regulator suspends licences of oil and gas producer that owes $67M

The company is being asked to comply with past orders to clean up historic spills and contamination

Most Read