'Great day for humanity': Pfizer says COVID-19 vaccine over 90% effective

‘Great day for humanity’: Pfizer says COVID-19 vaccine over 90% effective

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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.

Announced less than a week after the presidential election was seen as a referendum on President Donald Trump’s handling of the crisis. This is a rare major encouraging news recently. It is in the battle against this scourge, which has already been killed. 1.2 million people died globally, including nearly 250,000 cases in the United States alone. The number of confirmed infections in the United States is expected to exceed 10 million on Monday.

“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/regions are developing vaccines against the virus on a global scale. Fauci said the Pfizer vaccine and almost all other vaccines being tested target the spike protein used by the coronavirus to infect cells, so the results confirm this approach.

The news announced on Monday does not imply an upcoming vaccine: an interim analysis from an independent data monitoring committee investigated the 94 infections recorded so far, and the study has recruited nearly 44,000 people in the United States and five other countries. Some participants were vaccinated, while others received fake vaccines.

Pfizer Inc. did not provide more detailed information about these infections and warned that the initial protection rate may change at the end of the study. Even revealing such early data is very unusual.

The authorities emphasized that any vaccine is unlikely to arrive before the end of this year, and the initial vaccine will be quantitative.

“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.

If Pfizer’s vaccine ultimately pans out, “it’s going to be a while before this has a major impact at the population level,” Goodman said.

Maryyn Addo, head of the Tropical Medicine Department at UKE Hospital in Hamburg, Germany, said that the interim result is “an interesting first signal”, but there are still doubts.

The global market, the celebrated victory of President-elect Biden, exploded with news from Pfizer. Major European markets with soaring infection rates rose by 5%. After the US stock market opened, the S%P 500 rose 3.7%, and the Dow Jones Industrial Average rose 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%.”

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.

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.

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.

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