Pfizer Inc. said Monday that its COVID-19 vaccine may be a remarkable 90% effective, based on early and incomplete test results that nevertheless brought a big burst of optimism to a world desperate for the means to finally bring the catastrophic outbreak under control.
“I think that likely, based on impact, that will be the greatest medical advance in the last hundred years,” said Albert Bourla, CEO of Pfizer.
Pfizer, which is developing the vaccine with its German partner BioNTech, now is on track to apply later this month for emergency-use approval from the U.S. Food and Drug Administration, once it has the necessary safety information in hand.
“Which means it might be available for the rest of us in early 2021, by the spring for sure,” Dr. Sunil Joshi, former president of the Duval County Medical Society Foundation.
Even if all goes well, authorities have stressed it is unlikely any vaccine will arrive much before the end of the year, and the limited initial supplies will be rationed.
Dr. Anthony Fauci, the U.S. government's top infectious-disease expert, said the results suggesting 90% 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 as Pfizer appeared to take the lead in the all-out global race by pharmaceutical companies and various countries to develop a well-tested vaccine against the virus.
Joshi explained how Pfizer got that number.
“In the studies that they were doing, looking at people who received the vaccine versus the ones who didn’t receive the vaccine going forward, that the group of who received the vaccine was 90% less likely to be infected with COVID-19 versus the group that didn’t receive the vaccine or otherwise received placebo injections," Joshi said.
Dr. Bruce Aylward, the World Health Organization’s senior adviser, said Pfizer's vaccine could “fundamentally change the direction of this crisis” by March, when the U.N. agency hopes to start vaccinating high-risk groups.
Pfizer’s news helped send some stocks soaring. The S&P 500 finished the day with a gain of 1.2%, while the Dow Jones Industrial Average rose more than 800 points. Pfizer stock was up more than 8%.
Still, Monday’s announcement doesn’t mean for certain that 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 released no specific breakdowns, but for the vaccine to be 90% effective, nearly all the infections must have occurred in placebo recipients. The study is continuing, and Pfizer cautioned that the protection rate might change as more COVID-19 cases are added to the calculations.
Dr. Jesse Goodman of Georgetown University, former chief of the FDA’s vaccine division, called the partial results “extremely promising” but 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.
Confirmed infections in the U.S. eclipsed 10 million on Monday, the highest in the world. New cases are running at all-time highs of more than 100,000 per day. And tens of thousands more deaths are feared in the coming months, with the onset of cold weather and the holidays.
Pfizer’s vaccine is among four candidates already in huge studies in the U.S., with still more being tested in other countries. Another U.S. company, Moderna Inc., also hopes to file an application with the FDA late this month.
Both companies' shots are made with a brand-new technology. These “mRNA vaccines” aren't made with the coronavirus itself, meaning there's no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.
Pfizer initially opted not to join the Trump administration’s Operation Warp Speed, which helped fund a half-dozen vaccine makers' research and manufacturing scale-up. Pfizer instead said it has invested $2 billion of its own money in testing and expanding manufacturing capacity. But in July, Pfizer signed a contract to supply the U.S. with 100 million doses for $1.95 billion, assuming the vaccine is cleared by the FDA.
Pfizer said its only involvement in Operation Warp Speed is that those doses are part of the administration’s goal to have 300 million doses of COVID-19 vaccines ready sometime next year.
The strong results were a surprise. 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 immunizations. Earlier this year, Fauci said he would be happy with a COVID-19 vaccine that was 60% effective.
Whatever the ultimate level of protection, no one knows if people will need regular vaccinations.
Also, volunteers in the study received a coronavirus test only if they developed symptoms, leaving unanswered whether vaccinated people could get infected but show no symptoms and unknowingly spread the virus.
TESTING TIMELINE: What’s ahead for COVID-19 vaccines
Pfizer has estimated it could have 50 million doses available globally by the end of 2020, enough for 25 million people.
Public Citizen, the consumer advocacy group, called the release of the preliminary and incomplete data “bad science" and said that any enthusiasm over the results “must be tempered” until they are reviewed by the FDA and its independent experts.
“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.
On Monday, President-elect Joe Biden met with his new coronavirus advisory board and announced he wants a vaccine to be widely available for free. President Donald Trump has also said he wanted a vaccine to be free.
In addition, U.S. health officials have allowed emergency use of the first antibody drug to help the immune system fight COVID-19, an experimental approach against the virus that has killed more than 238,000 Americans.
The Food and Drug Administration on Monday cleared the experimental drug from Eli Lilly for people 12 and older with mild or moderate COVID-19 not requiring hospitalization. It’s a one-time treatment given through an IV.
The therapy is still undergoing additional testing to establish its safety and effectiveness. It is similar to a treatment Trump received after contracting the virus last month.
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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 Science Education. The AP is solely responsible for all content.