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. On Monday, Nov. 9, 2020, Pfizer said an early peek at its vaccine data suggests the shots may be 90% effective at preventing COVID-19. (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. On Monday, Nov. 9, 2020, Pfizer said an early peek at its vaccine data suggests the shots may be 90% effective at preventing COVID-19. (Courtesy of University of Maryland School of Medicine via AP, File)

Pfizer says COVID-19 vaccine is looking 90% effective

Pharmaceutical companies and various countries are in a global race to develop a vaccine against the virus

Pfizer said Monday that an early peek at the data on its coronavirus vaccine suggests the shots may be a surprisingly robust 90% effective at preventing COVID-19, putting the company on track to apply later this month for emergency-use approval from the Food and Drug Administration.

The announcement, less than a week after a presidential election that was seen as a referendum on President Donald Trump’s handling of the crisis, was a rare and major piece of encouraging news lately in the battle against the scourge that has killed more than 1.2 million people worldwide, including almost a quarter-million in the United States alone. Confirmed cases in the U.S. were expected to eclipse 10 million on Monday, the highest in the world.

“We’re in a position potentially to be able to offer some hope,” Dr. Bill Gruber, Pfizer’s senior vice-president of clinical development, told The Associated Press. “We’re very encouraged.”

Dr. Anthony Fauci, the government’s top-infectious disease expert, said the results suggesting 90% effectiveness are “just extraordinary,” adding: “Not very many people expected it would be as high as that.”

“It’s going to have a major impact on everything we do with respect to COVID,” Fauci said.

Pharmaceutical companies and various countries are in a global race to develop a vaccine against the virus. Fauci said that the Pfizer vaccine and virtually all others in testing target the spike protein the coronavirus uses to infect cells, so the results validate that approach.

Monday’s announcement doesn’t mean for certain that a vaccine is imminent: This interim analysis, from an independent data monitoring board, looked at 94 infections recorded so far in a study that has enrolled nearly 44,000 people in the U.S. and five other countries. Some participants got the vaccine, while others got dummy shots.

Pfizer Inc. did not provide any more details about those infections and cautioned that the initial protection rate might change by the time the study ends. Even revealing such early data is highly unusual.

Whenever any vaccine arrives, initial supplies will be scarce and rationed, with priority likely to be given to health care workers and others on the front lines. Pfizer has estimated that 50 million doses of its vaccine could be available globally by the end of the year, which could cover 25 million people, since it is given in two doses.

“We need to see the data, but this is extremely promising,” said Dr. Jesse Goodman of Georgetown University, former chief of the FDA’s vaccine division. He ticked off many questions still to be answered, including how long the vaccine’s effects last and whether it protects older people as well as younger ones.

Marylyn Addo, head of the tropical medicine unit at UKE hospital in Hamburg, Germany, said the interim results were “an interesting first signal,” but questions remain.

Global markets, already buoyed by the victory of President-elect Joe Biden, exploded on the news from Pfizer. Major markets in Europe, where infections have soared, were up 5%. In the U.S., the S%P 500 surged 3.7% after the opening bell, and the Dow Jones Industrial Average was up more than 1,300 points.

Trump, who had suggested during the presidential campaign that a vaccine could be ready by Election Day, tweeted on Monday: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!”

The timing is likely to feed unsubstantiated suspicions from Trump supporters that the pharmaceutical industry was withholding the news until after the election. Donald Trump Jr. tweeted: “The timing of this is pretty amazing. Nothing nefarious about the timing of this at all right?”

Pfizer Chairman and CEO Albert Bourla said on CNBC that the election was always an artificial deadline and that the data was going to be ready when it was ready. The independent data monitors met on Sunday, analyzing the COVID-19 test results so far and notifying Pfizer.

“I am very happy,” Bourla said, “but at the same time, sometimes I have tears in my eyes when I realize that this is the end of nine months, day-and-night work of so many people and how many people, billions, invested hopes on this.”

He added: “I never thought it would be 90%.”

ALSO READ: Feds pledge customer refunds before ‘we spend one penny’ on aid package for airlines

Earlier this year, Fauci said he would be happy with a COVID-19 vaccine that was 60% effective. Scientists have warned for months that any COVID-19 shot may be only as good as flu vaccines, which are about 50% effective and require yearly shots.

Pfizer opted not to join the Trump administration’s Operation Warp Speed, which helped a half-dozen drugmakers accelerate their vaccine testing and helped fund the work. Instead, Pfizer funded all its testing and manufacturing costs itself. The company said it has invested billions of dollars.

The coronavirus shots, made by Pfizer and its German partner BioNTech, are among 10 possible vaccine candidates in late-stage testing around the world — four of them so far in huge studies in the U.S. Another U.S. company, Moderna Inc., also has said it hopes to be able to file an application with the FDA later this month.

Volunteers in the final-stage studies, and the researchers, don’t know who received the real vaccine or a dummy shot. But a week after their second required dose, Pfizer’s study began counting the number who developed COVID-19 symptoms and were confirmed to have the coronavirus.

Because the study hasn’t ended, Gruber couldn’t say how many in each group had infections. But the math suggests that almost all the infections counted so far had to have occurred in people who got the dummy shots.

Pfizer doesn’t plan to stop its study until it records 164 infections among all the volunteers, a number that the FDA has agreed is enough to tell how well the vaccine is working. The agency has made clear that any vaccine must be at least 50% effective.

ALSO READ: COVID-19 continues to surge in parts of Canada, new daily high reported in Ontario

No participant so far has become severely ill, Gruber said. Nor could he provide a breakdown of how many of the infections had occurred in older people, who are at highest risk from COVID-19.

Participants were tested only if they developed symptoms, leaving unanswered whether vaccinated people could get infected but show no symptoms and unknowingly spread the virus.

FDA has told companies they must track half their participants for side effects for at least two months, the time period when problems typically crop up. Pfizer expects to reach that milestone later this month, but said Monday no serious safety concerns have been reported.

Because the pandemic is still raging, manufacturers hope to seek permission from governments around the world for emergency use of their vaccines while additional testing continues — allowing them to get to market faster than normal but raising concerns about how much scientists will know about the shots.

The FDA’s scientific advisers last month said they worry that allowing emergency use of a COVID-19 vaccine could damage confidence in the shots and make it harder to ever find out how well they really work. Those advisers said it’s critical these massive studies are allowed to run to completion.

___

AP writers Marilynn Marchione, Frank Jordans and Charles Sheehan 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 Lauran Neergaard, 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

Bulldogs forward Brandon Buhr is knocked off the puck by Grizzlies defenceman Lindsay Reid. (ELENA RARDON / ALBERNI VALLEY NEWS)
BCHL: Alberni Valley Bulldogs beaten back-to-back by Victoria Grizzlies

Victoria Grizzlies named Island Champions while Bulldogs take second place

In 1903, if you were looking north down First Avenue with Alberni in the distance, this is what you would have seen. Scattered houses along River Road are visible, as is the corner of Watson Block building in the lower lefthand corner of the photograph. This photo is part of the 24,000 online collection of the Alberni Valley Museum. View this one and more at https://portalberni.pastperfectonline.com. (PHOTO PN02975 COURTESY ALBERNI VALLEY MUSEUM)
LOOK BACK: Historic street scenes of Port Alberni

Take a peek back in time with the Alberni Valley Museum’s digital archives

This photo shows Franklin River Camp "B" circa 1940. Logging was started in the Franklin River area by Bloedel, Stewart & Welch in 1934. This is one of 42 photos of the Franklin River area, donated together in an album put together by the donor's husband, Stanley Young. Young worked as a highrigger in the Franklin River area from 1939-46. This is one of 24,000 photos contained in the Alberni Valley Museum’s digital archives, available for public viewing at https://portalberni.pastperfectonline.com. (PHOTO PN10830 COURTESY ALBERNI VALLEY MUSEUM)
LOOK BACK: Logging along Franklin River

Take a peek at Alberni Valley history with the Alberni Valley Museum

Getting enough Vitamin D can be challenging for Canadians, especially during winter months. (CONTRIBUTED)
ACTIVE LIVING: The ‘sunshine vitamin’ plays a vital role in our health

Port Alberni registered dietitian Sandra Gentleman writes about health issues

Courtenay-Alberni NDP MP Gord Johns gives a thumbs up to active transportation during a presentation of the Alberni Valley Chamber of Commerce's Bike SEAT program at McLean Mill National Historic site in Port Alberni on April 16, 2021. (SUSAN QUINN/ Alberni Valley News)
QUINN’S QUIPS: MP Gord Johns takes victory ride for cycling strategy

Johns gained a reputation as the bicycle-riding MP during his first year

A bullet hole is seen in the windshield of an RCMP vehicle approximately 4 km from Vancouver International Airport after a one person was killed during a shooting outside the international departures terminal at the airport, in Richmond, B.C., Sunday, May 9, 2021. THE CANADIAN PRESS/Darryl Dyck
Homicide team IDs man in fatal YVR shooting as police grapple with spate of gang violence

Man, 20, charged in separate fatal shooting Burnaby over the weekend

Dr. Victoria Lee, CEO of Fraser Health, hosts an update on efforts to contain B.C.’s COVID-19 transmission in Surrey and the Fraser Valley and protect hospitals in the Lower Mainland, May 6, 2021. (B.C. government video)
B.C.’s COVID-19 infection rate slowing, 20 more people die

Deaths include two people in their 40s, two in their 50s

Oak Bay resident Hugh Thompson died Friday, May 7. (GoFundMe photo)
Oak Bay dad dies mountain biking near Shawnigan Lake

Community rallies around family with online fundraiser

The Canadian Forces Snowbirds are in the Comox Valley for their annual spring training. Photo by Erin Haluschak
Suspected bird strike on Snowbirds plane during training in Comox

Pilot followed protocols and landed the aircraft on the ground without any problems

The Village on Third in Nanaimo won the Judges’ Choice award as top overall entry at the Vancouver Island Real Estate Board Commercial Building Awards. (Photo submitted)
Top developments north of the Malahat honoured by Vancouver Island Real Estate Board

Nanaimo’s Village on Third takes top honour at VIREB Commercial Building Awards

BCIT. (Wikimedia Commons)
BCIT apologizes after employee’s ‘offensive and hurtful’ email leaked to Métis Nation

BCIT says employee’s conduct has been investigated and addressed

An adult male yellow-breasted chat is shown in this undatd photograph on lands protected in collaboration between the En’owkin Centre and Penticton Indian Band with support through ECCC. The rescue from near extinction for a little yellow bird hinges on the wild rose in British Columbia’s Okanagan Valley, a researcher says. THE CANADIAN PRESS/HO, A. Michael Bezener/ En’owkin Centre 2020 *MANDATORY CREDIT*
Rare yellow birds need wild roses to survive in British Columbia: researcher

The importance of local wild roses emerged over a nearly 20-year experiment

RCMP officers search around rows of luggage carts as screens block off an area of the sidewalk after a shooting outside the international departures terminal at Vancouver International Airport, in Richmond, B.C., Sunday, May 9, 2021. THE CANADIAN PRESS/Darryl Dyck
Police say gang conflict in Metro Vancouver may be behind shooting death at airport

Police said this generation of gangsters is taking things to new level and have no regard for community safety

Cannabis bought in British Columbia (Ashley Wadhwani/Black Press Media)
Is it time to start thinking about greener ways to package cannabis?

Packaging suppliers are still figuring eco-friendly and affordable packaging options that fit the mandates of Cannabis Regulations

Most Read