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

Just Posted

(Black Press Media file photo)
Saanich health and safety manager named one of Canada’s top 40 women in safety

Canadian Occupational Safety magazine celebrates women leading safety sector in 2021

Sofia Watts, Charlotte Magill and Harriet Knight were among the KELSET Elementary School students releasing salmon fry into Reay Creek May 7. (Ian Bruce/Submitted)
Saanich Peninsula elementary students help restock, clean up local creeks

Salmon fry releases took place at Reay Creek and Tetayut Creek

The City of Victoria hopes to improve its cultural spaces this year and it wants non-profits to help. (Black Press Media File Photo)
Grants up to $125,000 open to Victoria non-profit arts and cultural organizations

Victoria Cultural Infrastructure Grant applications close at the end of May

North Saanich has started the design of a crosswalk at the intersection of Mills and Littlewood roads near Garden Child Care Centre, whose owner Tracey McCullough has been calling for such a sidewalk. As such, she has been echoing a previous appeal by the building’s owner, Heather and Cory Hastings, standing respectively with seven-year-old Jack Hastings and five-year-old Felix Hastings. (Black Press Media File)
North Saanich moves ahead with crosswalk near child care centre

Crosswalk proposed for Littlewood and Mills roads parts of approved active transportation plan

Colwood city council did a last minute adjustment to this year’s budget, dropping the planned property increase to five per cent. Last year they didn’t increase taxes at all. (Black Press Media file photo)
Colwood agrees to 5% tax increase for 2021, deferring some expenses to next year

Last-minute changes will save the typical Colwood homeowner $56

Daily confirmed COVID-19 cases reported to B.C. public health, seven-day rolling average in white, to May 12, 2021. (B.C. Centre for Disease Control)
B.C. preparing ‘Restart 2.0’ from COVID-19 as June approaches

Daily infections fall below 500 Friday, down to 387 in hospital

A vial of AstraZeneca vaccine is seen at a mass COVID-19 vaccination clinic in Calgary, Alta., Thursday, April 22, 2021. Dr. Ben Chan remembers hearing the preliminary reports back in March of blood clots appearing in a handful of European recipients of the Oxford-AstraZeneca COVID-19 vaccine. THE CANADIAN PRESS/Jeff McIntosh
Science on COVID, VITT constantly changing: A look at how doctors keep up

While VITT can represent challenges as a novel disorder, blood clots themselves are not new

Poached trees that were taken recently on Vancouver Island in the Mount Prevost area near Cowichan, B.C. are shown on Sunday, May 10, 2021. Big trees, small trees, dead trees, softwoods and hardwoods have all become valuable targets of tree poachers in British Columbia as timber prices hit record levels. THE CANADIAN PRESS/Jen Osborne.
Tree poaching from public forests increasing in B.C. as lumber hits record prices

Prices for B.C. softwood lumber reached $1,600 for 1,000 board feet compared with about $300 a year ago

The warm weather means time for a camping trip, or at least an excursion into nature. How much do you know about camps and camping-related facts? (John Arendt - Summerland Review)
QUIZ: Are you ready to go camping?

How many camp and camping-related questions can you answer?

On Friday, May 14 at Meadow Gardens Golf Club in Pitt Meadows, Michael Caan joined a very elite club of golfers who have shot under 60 (Instagram)
Crowds at English Bay were blasted with a large beam of light from an RCMP Air-1 helicopter on Friday, May 14. THE CANADIAN PRESS/Marc Grandmaison
Police enlist RCMP helicopter to disperse thousands crowded on Vancouver beach

On Friday night, police were witness to ‘several thousand people staying well into the evening’

Sinikka Gay Elliott was reported missing on Salt Spring Island on Wednesday, May 12. (Courtesty Salt Spring RCMP)
Body of UBC professor found on Salt Spring Island, no foul play suspected

Sinikka Elliott taught sociology at the university

The first Black judge named to the BC Supreme Court, Selwyn Romilly, was handcuffed at 9:15 a.m. May 14 while walking along the seawall. (YouTube/Screen grab)
Police apologize after wrongly arresting B.C.’s first Black Supreme Court Justice

At 81 years old, the retired judge was handcuffed in public while out for a walk Friday morning

Queen Elizabeth II and Clive Holland, deputy commonwealth president of the Royal Life Saving Society, top left, virtually present Dr. Steve Beerman, top right, with the King Edward VII Cup for his drowning-prevention work. Tanner Gorille and Sarah Downs were honoured with Russell Medals for their life-saving resuscitation. (Buckingham Palace photo)
Queen presents Vancouver Island doctor with award for global drowning prevention

Dr. Steve Beerman receives Royal Life Saving Society’s King Edward VII Cup at virtual ceremony

Most Read