Pfizer says COVID-19 vaccine appears to be 90% effective

0
43


Pfizer said on Monday that the first results of its coronavirus vaccine suggested the vaccines could be surprisingly 90% robust to prevent COVID-19, putting the company on track to seek approval later this month. emergency use of the Food and Drug Administration.

The announcement, less than a week after an election deemed a referendum on President Donald Trump’s handling of the crisis, was rare and encouraging major news of late in the battle against the scourge that has killed more than 1 , 2 million people worldwide, including nearly a quarter of a million in the United States alone.

“We are potentially in a position to offer some hope,” Dr. Bill Gruber, senior vice president of clinical development at Pfizer, told The Associated Press. “We are very encouraged.”

Dr Anthony Fauci, the US government’s leading infectious disease specialist, said the results suggesting 90% effectiveness are “just amazing,” adding: “Few people expected it to be as high as that. ”

“This is going to have a major impact on everything we do with regards to COVID,” Fauci said as Pfizer appeared to be leading the total global race of pharmaceutical companies and various countries to develop a well-tested vaccine against the virus. .

Dr Bruce Aylward, senior advisor to the World Health Organization, said Pfizer’s vaccine could “fundamentally change the direction of this crisis” by March, when the UN agency hopes to start vaccinating people. high risk groups.

Yet Monday’s announcement doesn’t mean for sure a vaccine is imminent: This interim analysis, from an independent data watchdog, looked at 94 infections recorded so far in a study that recruited nearly 44,000 people in the United States and five other countries. Some participants received the vaccine, while others received dummy injections.

Pfizer Inc. warned that the rate of protection could change at the end of the study. Even the revelation of this early data is highly unusual.

Dr Jesse Goodman of Georgetown University, former head of the FDA’s vaccine division, called the partial results “extremely promising” but ticked off many unanswered questions, including how long the vaccine lasted and if it protects the elderly as well as the young.

In addition, whenever a vaccine arrives, initial supplies will be scarce and rationed, with priority likely given to health workers and other people on the front lines. Pfizer has estimated that 50 million doses of its two-dose vaccine could be available worldwide by the end of 2020, which could cover 25 million people.

Global markets, already buoyed by the victory of President-elect Joe Biden, have exploded on the news from Pfizer. The S% P 500 jumped 3.7% after the opening bell, and the Dow Jones Industrial Average rose more than 1,300 points. Pfizer jumped more than 9%. Other vaccine stocks have also increased.

Trump, who had repeatedly suggested during the presidential campaign that a vaccine could be ready by election day, tweeted: “THE STOCK MARKET IS GROWING, VACCINE COMING. 90% EFFICIENT REPORT. SUCH GREAT NEWS! ”

Biden, for his part, welcomed the news but warned it could be several months before vaccinations become mainstream in the United States, and he warned Americans to rely on masks and distancing social in the meantime.

News of the possible breakthrough came ahead of what could be a terrible winter in the United States, with tens of thousands more feared coronavirus deaths in the months to come. Confirmed infections in the United States are expected to eclipse 10 million on Monday, the highest in the world. Business is hitting all-time highs of over 100,000 a day.

The timing of Pfizer’s announcement is likely to fuel unfounded suspicions on the part of Trump supporters that the pharmaceutical industry is withholding the news until the election is over. Donald Trump Jr. tweeted, “The timing is pretty amazing. Nothing bad about the timing, right?

Pfizer chief executive officer Albert Bourla told CNBC the election was still an artificial deadline and the data was going to be ready when it was ready. Independent data monitors met on Sunday, analyzing the COVID-19 test results so far and briefing Pfizer.

“I’m very happy,” said Bourla, “but at the same time I sometimes have tears in my eyes when I realize it’s the end of nine months, the day and night work of so many. people and how many people, billions, have invested hopes in this area.

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

Scientists have warned for months that any vaccine against COVID-19 could be as good as flu shots, which are about 50% effective and require annual vaccinations. Earlier this year, Fauci said he would be happy with a 60% effective COVID-19 vaccine.

Pfizer has chosen not to join the Trump administration’s Operation Warp Speed, which has helped half a dozen drugmakers speed up their vaccine tests and fund the work. Instead, Pfizer funded all of its testing and manufacturing costs on its own. The company said it had invested billions of dollars.

The president’s boasting that a vaccine could be ready before Election Day has raised concerns that the Trump administration is pressuring regulators and scientists to cut costs for political gain. After the first presidential debate, Bourla told his employees he was disappointed their work was drawn into political debates and vowed that the company “is moving at the speed of science.”

The snapshots, taken by Pfizer and its German partner BioNTech, are among 10 possible vaccine candidates in advanced testing around the world – four of them so far in huge studies in the United States. American, Moderna Inc., also hopes to file an application with the FDA this month.

Final study volunteers and researchers don’t know who got the real vaccine or a dummy vaccine. But a week after their second dose, the Pfizer study began counting the number of people who developed symptoms of COVID-19 and confirmed to have coronavirus.

Since the Pfizer study is not complete, Gruber could not say how many people in each group had infections. But calculations suggest that almost all of the infections so far must have occurred in people who received the dummy injections.

Pfizer does not plan to stop its study until it registers 164 infections among all volunteers, a number the FDA has agreed is enough to say how well the vaccine works. The agency has made it clear that any vaccine must be at least 50% effective.

No attendee so far has fallen seriously ill, Gruber said. He could not provide a breakdown of the number of infections that have occurred in older people, who are most at risk for COVID-19.

Participants were only tested if they developed symptoms, leaving it unanswered whether those vaccinated could be infected but had no symptoms and spread the virus unknowingly.

Fauci said the Pfizer vaccine and virtually everyone else in testing targeted the spike protein that the coronavirus uses to infect cells, so the latest results validate this approach.

Public Citizen, the consumer advocacy group, called the release of the preliminary and incomplete data “bad science” and said any enthusiasm about the results “must be tempered” until they are reviewed by the FDA. and its independent experts.

“The crucial information missing from the companies announcement is evidence that the vaccine prevents severe cases of COVID-19 or reduces hospitalizations and deaths from the disease,” the organization said.

The FDA has told companies that they should follow half of their participants for side effects for at least two months, the time when problems usually arise. Pfizer expects to reach this milestone later this month.

Because the pandemic is still raging, manufacturers are hoping to gain permission from governments around the world for emergency use of their vaccines while further testing continues. This would allow them to get their vaccines to market faster, but it also raises safety concerns.

——

AP Editors Marilynn Marchione, Frank Jordans and Charles Sheehan contributed to this report.

——

The Associated Press’s Department of Health and Science receives support from the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content

LEAVE A REPLY

Please enter your comment!
Please enter your name here