Pfizer said today that an early peek at the data on its coronavirus vaccine suggests the shots may be a 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.
The announcement, less than a week after a presidential election that was seen as a referendum on President Donald Trump’s handling of the crisis, was a rare and major piece of encouraging news lately in the battle against the scourge that has killed more than 1.2 million people worldwide, including almost a quarter-million in the U.S. alone.
Pharmaceutical companies and various countries are in a global race to develop a vaccine against the virus.
“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.”
Today’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. Some participants got the vaccine, while others got dummy shots.
Pfizer Inc. did not provide any more details about those infections and cautioned that the initial protection rate might change by the time the study ends. Even revealing such early data is highly unusual.
Authorities have stressed it’s unlikely any vaccine will arrive much before the end of the year, and initial supplies will be rationed.
“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.
Marylyn Addo, head of the tropical medicine unit at UKE hospital in Hamburg, Germany, said the interim results were “an interesting first signal,” but questions remain.
Global markets, already buoyed by the victory of President-elect Joe Biden, exploded on the news from Pfizer. Major markets in Europe, where infections have soared, were 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.
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!”
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, Dr. Anthony Fauci, the government’s top infectious-disease expert, 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.
