On Monday, Pfizer said that the first results of its coronavirus vaccine suggested the injections 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 later this month.
The announcement, less than a week after the election deemed a referendum on President Donald Trump’s handling of the crisis, has been rare and important encouraging news of late in the fight against the plague that is affecting more than 1 2 million people, including nearly a quarter of a million in the United States alone.
Dr. Anthony Fauci, the U.S. government’s leading infectious disease expert, said the results suggesting a 90% effectiveness is “just extraordinary,” adding, “Not many people expected it would be as high as that.”
Dr. Bruce Aylward, the World Health Organization, said the vaccine could “fundamentally change the direction of this crisis” in March when the U.N. agency hopes to start vaccinating groups at high risk.
Still, Monday’s announcement doesn’t mean for sure that a vaccine is imminent: This interim analysis, carried out by an independent data watchdog, looked at 94 infections recorded so far in a study involving nearly 44,000 people in the U.S. and five other countries. Some of the participants received the vaccine, while others received dummy shots.
Pfizer Inc. warned that the rate of protection could change at the end of the study. Even the revelation of this early data is also extremely unusual.
Georgetown University’s Dr. Jesse Goodman, former head of the FDA’s vaccine division, called the partial results “extremely promising,” but ticked many questions that remained to be answered, including how long the vaccine lasted and if it protects the elderly as well as the young.
Global markets, already accepted the victory of President-elect Joe Biden, exploded on the news from Pfizer. The S% P 500 was up 3.7% after the opening bubble, and the Dow Jones Industrial Average rose more than 1,300 points. Pfizer jumped more than 9%. Other vaccine stocks have also increased.
Confirmed infections in the United States are expected to eclipse 10 million on Monday, the world’s highest. Cases in the United States have a record high of over 100,000 new cases per day.
The timing of Pfizer’s announcement likely fuels Trump supporters’ unsubstantiated suspicions that the pharmaceutical industry would hide the news until after the election. Donald Trump Jr. tweeted, “The timing is pretty excellent. Nothing wrong with the timing, right?
Pfizer president and chief executive Albert Bourla told CNBC that elections have always been an artificial deadline, and the data would be ready when it was done. Independent data monitors met on Sunday, analyzed the COVID-19 test results so far, and briefing Pfizer.
Scientists have been warning for months that any vaccine against COVID-19 could be as good as flu shots, which are about 50% effective and require annual immunizations. 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 Warp Speed operation, which helped half a dozen drug manufacturers speed up vaccine testing and fund the work. Instead, Pfizer funded all it’s testing and manufacturing costs. The company said it had invested billions of dollars.
The recordings, taken by Pfizer and its German partner BioNTech, are among 10 possible late-stage vaccine candidates worldwide, four of them so far in considerable studies in the U.S. Another U.S. company, Moderna Inc., is hoping to apply with the FDA this month.
End-phase study volunteers and researchers don’t know who got the real vaccine or a dummy vaccine. But a week after the second dose, Pfizer’s study began counting the number of those who developed symptoms of COVID-19 and confirmed they had the coronavirus.
Because the Pfizer study did not end, Gruber could not say how many in each group had infections. But the math suggests that almost all of the diseases so far must have occurred in people who received the dummy injections.
Participants were only tested if they developed symptoms, leaving it unanswered whether those vaccinated could be infected but had no signs and spread the virus unknowingly.
Fauci said the Pfizer vaccine and pretty much everything else in testing targets the spike protein the coronavirus uses to infect cells, so the latest results confirm that approach.
Public Citizen, the consumer advocacy group, called the release of the preliminary and incomplete data “bad science” and said any enthusiasm for the results “must be mitigated” until the FDA. and its independent experts review them.
“Crucial information absent from the companies’ announcement is any evidence that the vaccine prevents serious COVID-19 cases or reduces hospitalizations and deaths due to the disease,” the organization said.
FDA has told companies to monitor half of their participants for side effects for at least two months, which is the period when problems usually arise. Pfizer expects to reach this milestone by the end of the month.
Because the pandemic is still raging, manufacturers are hoping to gain permission from governments worldwide for emergency use of their vaccines while additional testing continues. This would allow them to get vaccines to market more quickly, but it also raises safety concerns.
FDA has told companies to monitor half of their participants for side effects for at least two months, which is the period when problems usually arise. Pfizer expects to reach this milestone by the end of the month.
Because the pandemic is still raging, manufacturers are hoping to gain permission from governments worldwide for emergency use of their vaccines while additional testing continues. This would allow them to get vaccines to market more quickly, but it also raises safety concerns.
