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Pfizer said on Monday that early results of its coronavirus vaccine suggest the shots could be surprisingly 90% effective in preventing COVID-19, putting the company on track to seek emergency use approval from. Food and Drug Administration later this month.
The announcement, less than a week after an election seen as a referendum on crisis management by President Donald Trump, was rare and important news recently in the battle against the scourge that killed more than 1.2 million. people around the world, including nearly a quarter of a million in the United States alone.
“We have the potential to offer some hope,” Dr. Bill Gruber, Pfizer’s senior vice president of clinical development. “We are very encouraged.”
Dr Anthony Fauci, the US government’s leading infectious disease expert, said the results suggesting 90% efficacy are “simply extraordinary,” adding, “Not many people expected it to be that high.” .
“It will have a major impact on everything we do regarding COVID,” Fauci said as Pfizer appeared to be taking the lead in the all-out global race of pharmaceutical companies and various countries to develop a well-tested vaccine against the virus.
Dr Bruce Aylward, senior adviser 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 begin vaccinating high-income groups. risk.
However, Monday’s announcement doesn’t mean for sure a vaccine is imminent: This interim analysis, by an independent data monitoring committee, looked at 94 infections recorded so far in a study that enrolled nearly 44,000 people in the United States and in five other countries. Some participants received the vaccine, while others received dummy injections.
Pfizer Inc. warned that the protection rate could change after the study ends. The disclosure of such early data is also extremely unusual.
Dr Jesse Goodman of Georgetown University, former head of the FDA vaccines division, called the partial results “extremely promising” but raised many questions that have not yet been answered, including how long the vaccine lasts and whether it protects older and younger people.
Furthermore, whenever a vaccine arrives, initial supplies will be scarce and rationed, with the likelihood of priority being given to healthcare workers and others at the forefront. Pfizer has estimated that 50 million doses of its two-dose vaccine could be available globally by the end of 2020, which could cover 25 million people.
Global markets, already buoyed by the victory of president-elect Joe Biden, exploded on the news from Pfizer. The S% P 500 was up 3.7% after the opening bell and the Dow Jones Industrial Average was up more than 1,300 points. Pfizer jumped more than 9%. Other vaccine stocks had also increased.
Trump, who had suggested several times during the presidential campaign that a vaccine might be ready by Election Day, tweeted: “STOCK MARKET BIG, VACCINE COMING. 90% EFFECTIVE RATIO. GREAT NEWS! “
Biden, for his part, welcomed the news but warned that it could be several months before vaccinations spread to the United States, and warned Americans to rely on masks and social distancing in the meantime.
News of the possible breakthrough came before what could be a terrible winter in the United States, with tens of thousands more feared coronavirus deaths in the coming months. Confirmed infections in the United States were expected to eclipse 10 million on Monday, the highest in the world. Cases are reaching all-time highs of over 100,000 per day.
The timing of Pfizer’s announcement is likely to fuel unfounded suspicions from Trump supporters that the pharmaceutical industry would hide the news until after the election. Donald Trump Jr. tweeted: “The timing of this is pretty amazing. Nothing bad about the timing of this, right? “
Pfizer president and chief executive Albert Bourla told CNBC that elections have always been an artificial deadline and that the data would be ready when it was ready. The independent data monitors met on Sunday, analyzing the COVID-19 test results so far and informing Pfizer.
“I am very happy,” said Bourla, “but at the same time, sometimes I have tears in my eyes when I realize that this is the end of nine months, I work day and night of so many people and how many people, billions, they have invested hope in this “.
He added: “I never thought it would be 90%.”
Scientists have warned for months that any COVID-19 injection can only 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 COVID-19 vaccine that was 60% effective.
Pfizer chose not to join the Trump administration’s Warp Speed operation, which helped half a dozen drug manufacturers speed up vaccine testing and helped fund the work. Pfizer instead funded all of its testing and production costs. The company said it has invested billions of dollars.
The president bragging that a vaccine could be ready before election day has raised fears that the Trump administration may put pressure on regulators and scientists to cut corners for political gain. After the first presidential debate, Bourla told his employees that he was disappointed that their work had been dragged into political debates and promised that the company “was moving at the speed of science.”
The shots, taken by Pfizer and its German partner BioNTech, are among 10 possible late-stage vaccine candidates around the world – four of them so far in huge studies in the U.S. Another U.S. company, Moderna Inc., he also hopes to file an application with the FDA this month.
The volunteers in the final phase studies and the researchers don’t know who got the real vaccine or a dummy shot. But a week after their second dose, Pfizer’s study began counting the number of those who developed COVID-19 symptoms and confirmed they had the coronavirus.
Since the Pfizer study did not end, Gruber was unable to say how many in each group had infections. But the math suggests that nearly all of the infections counted so far must have occurred in people who received the sham shots.
Pfizer does not plan to stop its study until it records 164 infections among all volunteers, a number the FDA has agreed is enough to tell how well the vaccine is working. The agency made it clear that any vaccine must be at least 50% effective.
So far, no participant has been seriously ill, Gruber said. It hasn’t been able to provide a breakdown of how many of the infections have occurred in older people, who are at higher risk for COVID-19.
Participants were only tested if they developed symptoms, leaving no response if vaccinated people could be infected but show no symptoms and unknowingly spread the virus.
Fauci said the Pfizer vaccine and virtually everyone else in the test targets the spike protein used by the coronavirus to infect cells, so the latest results validate this approach.
Public Citizen, the consumer advocacy group, called the publication of the preliminary and incomplete data “bad science” and said that any enthusiasm for the results “must be mitigated” until they are reviewed by the FDA and its experts. independent.
“The crucial information missing from the companies announcement is any evidence that the vaccine prevents severe cases of COVID-19 or reduces hospitalizations and deaths from the disease,” the organization said.
The FDA told companies that they must monitor half of the participants for side effects for at least two months, the period when problems typically arise. Pfizer expects to reach this milestone by the end of the month.
As the pandemic is still ongoing, manufacturers hope to get permission from governments around the world for emergency use of their vaccines as additional testing continues. This would allow them to get vaccines to market more quickly, but it also raises safety concerns.
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AP writers Marilynn Marchione, Frank Jordans and Charles Sheehan contributed to this report.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Education. The AP is solely responsible for all content
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