WASHINGTON: Pfizer announced a big hope for people across the globe saying that the data on its coronavirus vaccine suggests the shots may be a surprisingly robust 90 per cent effective at preventing COVID-19.
It has put the company on track to apply for emergency-use approval from the Food and Drug Administration, said Dr. Bill Gruber, Pfizer’s senior vice president of clinical development.
Dr. Bill Gruber went on to say, “We’re in a position potentially to be able to offer some hope, We’re very encouraged.”
Dr. Anthony Fauci, the government’s top-infectious disease expert, said the results suggesting 90 per cent 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 are in a global race to develop a vaccine against the virus. Fauci said that the Pfizer vaccine and virtually all others in testing target the spike protein the coronavirus uses to infect cells, so the results validate that approach.
Monday’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 US 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.
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 US, the SOP 500 surged 3.7% after the opening bell, and the Dow Jones Industrial Average was up more than 1,300 points.
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 US Another US 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.
