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

The welcome sign is the first thing new employees moving to Prince Rupert will see as they drive the road into the city. The ‘Prince Rupert - Make it Home’ employment campaign to draw people to the region was launched on Feb. 16. (Photo: K-J Millar/The Northern View)
Stakeholders respond to employee recruitment campaign housing ‘disconnect’

‘Prince Rupert -Make it Home’ is 5-year recruitment and retention campaign

More than 35 families received renoviction notices on Feb. 26, 2020 at Pinecrest Townhomes in Prince Rupert. (K-J Millar/The Northern View)
Renovictions will be tightened in proposed changes to renters laws

Rent freeze, and changes to procedures will benefit Prince Rupert tenants and landlords

Chloe and Koy are two participants in the talent show format of the 2021 annual Children's Fest to be broadcast on community television March 5th and 6th. ()Photo: supplied by Prince Rupert Special Event Society)
30th Annual Children’s Fest takes on a new format

2021 Prince Rupert Children’s Fest will feature a show of local talent

(Phil McLachlan/Capital News)
Murder charge laid in February 2020 stabbing death of Smithers man

Michael Egenolf is charged with the second-degree murder of Brodie Cumiskey

Families on the North Coast will benefit from 70 new childcare spaces Ministry of Children and Family Development announced on March 1. Seen here are children from Growing Together Child Care Centre in Surrey. (Photo supplied by Jennifer Rice, MLA for Northcoast)
Northcoast families to benefit from new childcare spaces

62 Childcare spaces in Lax Kw’alaams and 8 in Haida Gwaii are part of Childcare BC New Spaces Fund

A vial of Oxford-AstraZeneca COVID-19 vaccine is pictured at a family doctor office, Thursday, Feb. 25, 2021 in Paris. THE CANADIAN PRESS/AP -Christophe Ena
Trudeau ‘optimistic’ that timeline for rollout of COVID vaccines can be accelerated

Canada set to receive more than 6M COVID-19 vaccine dose than initially expected, by end of March

Beginning late Tuesday, anti-pipeline protesters blocked the intersection of Hastings Street and Clark Drive in Vancouver. (Instagram/Braidedwarriors)
Demonstrators block key access to Vancouver port over jail for pipeline protester

They group is protesting a 90-day jail sentence handed to a fellow anti-pipeline protester

Langley RCMP will be collecting donations for the local food bank at the Willoughby Town Centre parking lot (20678 Willoughby Town Centre Drive near the Royal Bank) on Saturday Dec. 19 from noon till 4 p.m. (file)
Vancouver police rammed with car as passenger arrested for alleged fraudulent food order

Two officers are in stable condition, suffering with soft tissue injuries following the incident

A discarded blue surgical mask is shown hanging in a bush in Montreal, Sunday, Dec. 6, 2020, as the COVID-19 pandemic continues in Canada and around the world. THE CANADIAN PRESS/Graham Hughes
B.C. RMT suspended for not wearing a mask after confirmed by undercover clients

College of Massage Therapists has 5 open files, said suspension necessary to protect public

A boat caught fire in Ladysmith Harbour on Saturday morning. (Photo submitted)
Missing woman’s remains recovered after Vancouver Island boat fire

Remains of a 60-year-old woman recovered after Feb. 27 boat fire took her life

This poster, spreading misinformation regarding COVID-19 restrictions, has been popping up in communities across Vancouver Island.
Poster popping up on Vancouver Island falsely claims COVID restrictions are over

Unattributed poster claims COVID restrictions ended March 1; Island Health responds

Most Read