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

Correlieu Secondary School students Hanna Fitchett, Justin Pugh and Jaeana Dumais (missing from photo) were recently recognized by the Quesnel and District Arts Council for their poetry submissions to the community writing contest. The students’ work was inspired by the novel Wenjack and the film The Secret Path. (Photo Submitted)
LETTER: Quesnel high school students’ poetry recognized

CSS thanks the Quesnel and District Arts Council and its community writing contest partners

The director of the Wells Snowmobile Club, Dexter Knorr, shared what is in his safety kit when sledding. Included are spare parts for his machine, like sparkplugs, and specially-designed tow ropes. (Submitted Photo)
Wells Snowmobile Club director shares tips for safe sledding

Two Prince George men were recently stranded on Yanks Peak, one overnight

In this file photo from 2019, Tammy Burrows of the Wild Women of the North Society organizes the donations before the group of volunteers begins assembling Christmas hampers Dec. 22 at the Quesnel Tillicum Society Native Friendship Centre. The society is collecting food hamper items again this winter, along with winter clothing and warm gear. (Quesnel Cariboo Observer File Photo)
There are many ways to help fill Christmas hampers in and around Quesnel

Many businesses, volunteers and the RCMP are collecting hamper items over the next few weeks

A masked statue of Billy Barker sits on top of his namesake casino in downtown Quesnel. As we head into the weekend, Northern Health is urging residents to follow all provincial health orders, which include mandatory masks inside all indoor spaces. (Cassidy Dankochik Photo - Quesnel Cariboo Observer)
A masked statue of Billy Barker sits on top of his namesake casino, eight months to the day it was closed to help stop the spread of COVID-19. Owner Brad Kotzer said they won’t be opening in 2020. (Cassidy Dankochik Photo - Quesnel Cariboo Observer)
Northern Health urges residents to respect COVID-19 rules

The number of COVID-19 cases has been growing, and Northern Health saw 35 new cases from Nov. 26-27

Coralee Oakes won 48.42 per cent of ballots in the Cariboo North district in the October election, en route to winning a third term as MLA. (Photo Submitted)
Cariboo North MLA sworn in, despite technical difficulties

Coralee Oakes began her third term as the region’s MLA but couldn’t attend the virtual ceremony

Mary Cox and Jack Plant dance in their pyjamas and slippers at the morning pyjama dance during the Rhythm Reelers’ 25 Annual Rally in the Valley Square Dance Festival in Chilliwack on June 4, 2011. Sunday, Nov. 29, 2020 is Square Dancing Day. (Jenna Hauck/ Chilliwack Progress file)
Unofficial holidays: Here’s what people are celebrating for the week of Nov. 29 to Dec. 5

Square Dancing Day, Disability Day and International Ninja Day are all coming up this week

Black Press Media and BraveFace have come together to support children facing life-threatening conditions. Net proceeds from these washable, reusable, three-layer masks go to Make-A-Wish Foundation BC & Yukon.
Put on a BraveFace: Help make children’s wishes come true

Black Press Media, BraveFace host mask fundraiser for Make-A-Wish Foundation

Kevin Bieksa during his days playing with the Vancouver Canucks. (Photo: commons.wikimedia.org)
Bieksa to guest on free Canucks Alumni ‘Hot Stove’ on Zoom app

Former NHL player has become a game analyst on Sportsnet

114 Canadians were appointed Nov. 27 to the Order of Canada. (Governor General of Canada photo)
Indigenous actor, author, elder, leaders appointed to Order of Canada

Outstanding achievement, community dedication and service recognized

More than 60 cm of snow has fallen at Ulkatcho First Nation near Anahim Lake in the Chilcotin since a snowfall warning went into effect Thursday, Nov. 26. (Graham West photo)
VIDEO: More than 60 cm of snowfall in Chilcotin since Thursday, Nov. 26

Graham West of Ulkatcho First Nation captures the scene on video

Screenshot of Pastor James Butler giving a sermon at Free Grace Baptist Church in Chilliwack on Nov. 22, 2020. The church has decided to continue in-person services despite a public health order banning worship services that was issued on Nov. 19, 2020. (YouTube)
2 Lower Mainland churches continue in-person services despite public health orders

Pastors say faith groups are unfairly targeted and that charter rights protect their decisions

A big job: Former forests minister Doug Donaldson stands before a 500-year-old Douglas fir in Saanich to announce preservation of some of B.C.’s oldest trees, July 2019. (B.C. government)
B.C. returning to ‘stand-alone’ forests, rural development ministry

Horgan says Gordon Campbell’s super-ministry doesn’t work

Peter Wilson, left, and Micah Rankin, right, formed the Special Prosecutor team that was tasked with reviewing and litigating charges stemming from the Bountiful investigation. Trevor Crawley photo.
End of Bountiful prosecution wraps up decades of legal battles

Constitutional questions had to be settled before a polygamy prosecution could move forward

Alexandre Bissonnette, who pleaded guilty to a mass shooting at a Quebec City mosque, arrives at the courthouse in Quebec City on February 21, 2017. THE CANADIAN PRESS/Mathieu Belanger - POOL
Court strikes down consecutive life sentences; mosque shooter has prison term cut

The decision was appealed by both the defence and the Crown

Most Read