Pfizer says early data signals COVID-19 vaccine is 90% effective

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The Pfizer world headquarters stands in Midtown Manhattan, in New York City, on July 29. /Drew Angerer/Getty Images

Pfizer says an early peek at its vaccine data suggests the shots may be 90% effective at preventing COVID-19, indicating the company is on track later this month to file an emergency use application with U.S. regulators.

Monday’s announcement doesn’t mean 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.

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

“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.”

Authorities have stressed it’s unlikely any vaccine will arrive before the end of the year, and limited initial supplies will be rationed.

“We need to see the data, but this is extremely promising,” said Dr. Jesse Goodman of Georgetown University.

He ticked off many questions still to be answered including how long the vaccine’s effects last and if it also protects older people as well as younger people.

If Pfizer’s vaccine ultimately pans out, “it’s going to be a while before this has a major impact at the population level,” said Goodman, a former chief of the Food and Drug Administration’s vaccine division.

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

Global markets exploded on the news from Pfizer. All major markets in Europe, where infections have soared, are up 5%. In the U.S., Dow futures also rose 5% and were up about 1,400 points just over two hours before the opening bell.

U.S. President Donald Trump welcomed the test results, and the market boost: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” he said on Twitter.

President-elect Joe Biden said the news was excellent but did not change the fact that face masks, social distancing and other health measures would be needed well into next year.

WHO chief, Tedros Adhanom Ghebreyesus also hailed Pfizer COVID-19 vaccine news as ‘encouraging’ and saluted all scientists and partners around the world who are developing new safe, efficacious tools to beat the virus.

Pfizer and German partner BioNTech SE BNTX.O are the first drugmakers to release successful data from a large-scale clinical trial of a coronavirus vaccine.

The shots made by the companies 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.

Both companies have a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year. They have also reached supply agreements with the European Union, the United Kingdom, Canada and Japan.

FDA has required that U.S. vaccine candidates be studied in at least 30,000 people. In addition to adequate numbers of older adults, those studies must also include other groups at high risk, including minorities and people with chronic health problems.

And it 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.

Pfizer said it expects to produce up to 1.3 billion doses of the vaccine in 2021.

(input from agencies)

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