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

COVID-19. (Image courtesy CDC)
The County of Stettler has now been classified as an ‘enhanced’ region for COVID-19

According to the Province, there are now 10 active cases in the County, which has a population of 12,449 people

Annette Hunter
Clearview Public Schools and Alberta Teachers Association honours retiree Annette Hunter

Hunter taught Kindergarten, Grade 2, and Grade 3 over her 35-year career

A scene from last year’s Light the Night fundraising event at the Stettler Town and Country Museum. This year’s rendition is on a drive-through basis only, but it still promises to be a not-to-be-missed seasonal event.
Independent file photo
Stettler Town and Country Museum hosts ‘Light the Night’

This year’s rendition is drive-through only, but will still prove to be a dazzling display

Alberta’s chief medical officer of health, Dr. Deena Hinshaw, confirmed eight additional virus-deaths Monday afternoon including one in central zone. (Photo by Chris Schwarz/Government of Alberta)
New record: Red Deer at 236 active COVID cases

One more death in central zone reported

Janelle Robinson owns and operates Spirit’s Respite Ranch near Stettler. The Ranch, just north of Stettler, is an animal therapy ranch that helps those with special needs and conditions ranging from PTSD to anxiety. Mark Weber/Stettler Independent
Spirit’s Respite Ranch near Stettler provides support through animal interaction

‘I also come from a family of doers - if something that is needed isn’t there, you just figure it out’

Idyllic winter scenes are part of the atmosphere of the holiday season, and are depicted in many seasonal movies. How much do you know about holiday movies? Put your knowledge to the test. (Pixabay.com)
QUIZ: Test your knowledge of holiday movies and television specials

The festive season is a time for relaxing and enjoying some seasonal favourites

Fossil finds at Mt. Stephen. (Photo: Sarah Fuller/Parks Canada)
Extreme hiking, time travel and science converge in the Burgess Shale

Climb high in the alpine and trace your family tree back millions of years – to our ocean ancestors

Deputy Prime Minister and Minister of Finance Chrystia Freeland listens to a question from a reporter on the phone during a news conference in Ottawa, Monday, Nov. 30, 2020. THE CANADIAN PRESS/Adrian Wyld
Spending too little worse than spending too much, Freeland says as Canada’s deficit tops $381B

‘The risk of providing too little support now outweighs that of providing too much’

Executive Director and Co-Founder of Rock Soup Craig Haavalsen is sleeping in a tent outside Rock Soup’s location until the Go Fund Me for Rock Soup raises $10,000. Shaela Dansereau/ Pipestone Flyer.
Putting normalcy into asking for help: New non-profit sets up in Wetaskiwin

Rock Soup non-profit is a new non-secular Food Bank putting down roots in Wetaskiwin.

Wetaskiwin Composite High School. Shaela Dansereau/ Pipestone Flyer.
Wetaskiwin Regional Public Schools prepare for transition back to online learning

Grades 7-12 will are mandated to transfer to online learning starting Nov. 30, 2020.

Lawyer Devon Page, Ecojustice Canada’s executive director, pauses during a news conference in Vancouver on Wed., Sept. 26, 2012. The environmental law group has lost its bid to pause Alberta’s inquiry into where critics of its oil and gas industry get their funding. Ecojustice sought an injunction this summer to suspend the inquiry, headed by forensic accountant Steve Allan, until there is a decision on whether it’s legal. nbsp;THE CANADIAN PRESS/Darryl Dyck
Judge tosses application to pause Alberta inquiry into funding of oil and gas foes

Ecojustice sought an injunction in the summer to suspend the inquiry

Janelle Robinson owns and operates Spirit’s Respite Ranch near Stettler. The Ranch, just north of Stettler, is an animal therapy ranch that helps those with special needs and conditions ranging from PTSD to anxiety. Mark Weber/Stettler Independent
Spirit’s Respite Ranch near Stettler provides support through animal interaction

‘I also come from a family of doers - if something that is needed isn’t there, you just figure it out’

A pedestrian makes their way through the snow in downtown Ottawa on Wednesday, Nov. 25, 2020. THE CANADIAN PRESS/Sean Kilpatrick
Wild winter, drastic swings in store for Canada this year: Weather Network

In British Columbia and the Prairies, forecasters are calling for above-average snowfall levels

NDP Leader John Horgan, left, speaks as local candidate Ravi Kahlon listens during a campaign stop at Kahlon’s home in North Delta, B.C., on April 18, 2017. THE CANADIAN PRESS/Darryl Dyck

Most Read