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

Artist Daniel Cline discusses his sculpture, Harmony Humpbacks, during the June 20 walking tour of Oak Bay’s 2019 ArtsAlive sculptures. Harmony Humpbacks was purchased by Oak Bay as the 2019 people’s choice winner and is permanently installed at the Beach Drive entrance to Willows Park. (Kevin Murdoch Photo)
Influx of donated art a ‘fantastic problem to have,’ says Oak Bay mayor

Oak Bay goes from zero to 10 permanent art pieces since 2015

An economic recovery plan in progress since April offers various recommendations for the region to overcome the impacts of COVID-19. (Nina Grossman/News Staff)
Greater Victoria economic ‘reboot’ plan tackles impacts of COVID-19

Newly-formed task force looks at various sectors, industries

The back seat of a car with four bags of Christmas gifts and decor. (123rf.com)
EDITORIAL: Support local business this holiday season

That small business you love may not be around come spring if it’s not supported now

Parksville’s French Creek Harbour experienced a diesel spill on Nov. 23 after a barge and fishing vessel collided. (Mandy Moraes photo)
Coast Guard cleans up diesel spill in Parksville’s French Creek Harbour

Barge carrying fuel truck collides with fishing vessel

Tourists are being asked to postpone their non-essential trips to Tofino as COVID-19 cases rise across Vancouver Island, but at least one accommodation provider is offering conflicting messaging. (Westerly file photo)
Victoria woman says Tofino Airbnb host encouraged travel despite provincial restrictions

“The only way I would get a refund is if she would be able to rebook the suite for that weekend.”

Provincial health officer Dr. Bonnie Henry updates B.C.’s COVID-19 situation at the B.C. legislature, Nov. 23, 2020. (B.C. government)
B.C. daily COVID-19 cases hits record 941 on Tuesday

Further restrictions on indoor exercise take effect

The Campbell River disc golf course was in need of some repairs, and the society that oversees the facility says the city has come through for them big time. Photo by Alistair Taylor – Campbell River Mirror
Course improvements drawing more to Campbell River disc golf course

Disc golf society says city went ‘above and beyond’ earlier this year in fixing up the facility

Victoria-based guitarist Eric Harper performs at the Port Theatre on Nov. 27. (Photo credit Tatum Duryba)
Classical guitarist to play at the Port Theatre

Eric Harper to play new songs composed during the pandemic

(Pixabay.com)
Man, 28, warned by Kootenay police to stop asking people to marry him

A woman initially reported the incident to police before they discovered others had been popped the question

Winston Blackmore (left) and James Oler (right) were sentenced on separate charges of polygamy this week in Cranbrook Supreme Court.
No more charges expected in Bountiful investigation, special prosecutor says

Special prosecutor says mandate has ended following review of evidence from Bountiful investigations

(Ashley Wadhwani/Black Press Media)
Refuse to follow B.C.’s mask mandate? Face a $230 fine

Masks are now required to be worn by all British Columbians, 12 years and older

Port Alberni court house (Alberni Valley News)
Alberni man gets four years for multiple sex assault charges

Colin Robert Hall was found guilty in the Port Alberni Law Courts

Most Read