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

Qualicum Beach resident Harold MacDougall won $75,000 off a Casino Royale II Scratch & Win ticket, purchased the ticket at Qualicum Foods on Memorial Avenue. (BCLC photo)
Qualicum Beach man $75K richer thanks to scratch-and-win ticket windfall

MacDougall plans on trips to Cape Breton and Scotland

David Darmadi, owner of Kalvas - The Log House restaurant, is offering a sweet initiative for SOS. Guests can bring in a new, unwrapped gift or financial donation for SOS, and receive a free dessert. (Lissa Alexander photo)
Sweet initiative to support Parksville Qualicum Beach residents

‘A lot of our guests are very generous and they want to help out’

The property at 113 and 161 Island Highway is currently being dismantled as the developer attempts to salvage ‘usable’ lumber for their development application to the City of Parksville. (Mandy Moraes photo)
Development application delayed for high-profile Parksville property

Council refers application to staff for further improvements

(File photo)
RCMP warn of counterfeit bill use in Parksville Qualicum Beach area

Police have received four calls in November regarding bogus bills

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

A photo from 2017, of Nuchatlaht First Nation members outside court after filing a land title case in B.C. ( Submitted photo/Nuchatlaht First Nation).
Vancouver Island First Nation calls on B.C. to honour UNDRIP in historic title case

Nuchatlaht First Nation says Crown counsel continues to stall the case using the ‘distasteful’ argument that the Nation ‘abandoned’ their land

West Vancouver Island’s Ehattesaht First Nation continues lock down after 9 active cases were reported today after a visitor tested positive last week. (Ehattesaht First Nation/Facebook)
Ehattesaht First Nation’s COVID-19 nightmare: nine active cases, a storm and a power outage

The Vancouver Island First Nation in a lockdown since the first case was reported last week

The Ahousaht First Nation confirmed its first case of COVID-19 on Nov. 26, 2020. (Westerly file photo)
Ahousaht First Nation on lockdown over COVID-19

“Emotions are high. The anxiety is high. We want our community to pull through.”

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

Penny Hart is emotional outside the Saanich Police Department as she pleads for helpt to find her son Sean Hart last seen Nov. 6 at a health institution in Saanich. (Devon Bidal/News Staff)
VIDEO: Mother of missing Saanich man begs public to help find her son

Sean Hart last seen leaving Saanich mental health facility Nov. 6

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

Most Read