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

Read the full 2019-2020 annual report report online at www.seabirdisland.ca.
Seabird Island looks back in 2019-20 report

Highlights include COVID response, new development, upgrades

Morning mist clears over the Hope Slough at Camp River Road on Sunday, Nov. 29, 2020. (Jessica Peters/ Chilliwack Progress)
WEATHER: Sunny skies in the forecast for Chilliwack and Abbotsford

Rain and wind expected Sunday night through Monday morning, then clear skies

LEFT: Krista Macinnis, with a red handprint across her face that symbolizes the silencing of First Nations people, displays the homework assignment that her Grade 6 daughter received on Tuesday. (Submitted photo)
RIGHT: Abbotsford School District Kevin Godden says the district takes responsibility for the harm the assignment caused.
Abbotsford school district must make amends for harmful residential school assignment: superintendent

‘The first step is to unreservedly apologize for the harm … caused to our community’: Kevin Godden

File photo
Outdoor recreation generates close to $1 billion annually in Fraser Valley: report

Camping, hiking and sportfishing generate the most spending, report finds

A new Sardis secondary school logo designed by a former student, Jason Roberts. (Facebook photo)
Chilliwack’s Sardis secondary unveils new logo done in Coast Salish style

The new-look Falcon is meant strengthen connections between Indigenous students and their school

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

Black Press Media and BraveFace have come together to support children facing life-threatening conditions. Net proceeds from these washable, reusable, three-layer masks go to Make-A-Wish Foundation BC & Yukon.
Put on a BraveFace: Help make children’s wishes come true

Black Press Media, BraveFace host mask fundraiser for Make-A-Wish Foundation

(File photo)
Vancouver police warn of toxic drug supply after 7 people overdose at one party

Seven people between the ages of 25 to 42 were taken to hospital for further treatment.

A man walks by a COVID-19 test pod at the Vancouver airport in this undated handout photo. A study has launched to investigate the safest and most efficient way to rapidly test for COVID-19 in people taking off from the Vancouver airport. The airport authority says the study that got underway Friday at WestJet’s domestic check-in area is the first of its kind in Canada. THE CANADIAN PRESS/HO, Vancouver Airport Authority *MANDATORY CREDIT*
COVID-19 rapid test study launches at Vancouver airport for departing passengers

Airport authority says that a positive rapid test result does not constitute a medical diagnosis for COVID-19

Elissa McLaren broke her left elbow in the Sept. 20, 2020 collision. (Submitted)
Surviving victims of fatal crash in Fraser Valley asking for help leading up to Christmas

‘This accident has taken a larger toll financially, mentally and physically than originally intended’

Chilliwack school trustee Barry Neufeld (left) and former BCTF president Glen Hansman (right).
BC Court of Appeal left to walk tightrope of freedom of expression in Neufeld-Hansman case

Is defamation lawsuit aimed at stifling free expression or does the defamation hinder free speech?

114 Canadians were appointed Nov. 27 to the Order of Canada. (Governor General of Canada photo)
Indigenous actor, author, elder, leaders appointed to Order of Canada

Outstanding achievement, community dedication and service recognized

Screenshot of Pastor James Butler giving a sermon at Free Grace Baptist Church in Chilliwack on Nov. 22, 2020. The church has decided to continue in-person services despite a public health order banning worship services that was issued on Nov. 19, 2020. (YouTube)
2 Lower Mainland churches continue in-person services despite public health orders

Pastors say faith groups are unfairly targeted and that charter rights protect their decisions

A big job: Former forests minister Doug Donaldson stands before a 500-year-old Douglas fir in Saanich to announce preservation of some of B.C.’s oldest trees, July 2019. (B.C. government)
B.C. returning to ‘stand-alone’ forests, rural development ministry

Horgan says Gordon Campbell’s super-ministry doesn’t work

Most Read