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.
The announcement came less than a week after an election seen as a referendum on President Donald Trump’s handling of the scourge, which has killed more than 1.2 million people worldwide, including almost a quarter-million in the United States alone.
“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.”
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.
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.
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.
Global markets, already buoyed by the victory of President-elect Joe Biden, rallied on the news from Pfizer. 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.
Trump, who had suggested repeatedly during the presidential campaign that a vaccine could be ready by Election Day, tweeted: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!”
Biden, for his part, welcomed the news but cautioned that it could be many months before vaccinations become widespread in the U.S., and he warned Americans to rely on masks and social distancing in the meantime. He said the country still faces a “dark winter.”
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.
The timing of Pfizer’s announcement is likely to feed unsubstantiated suspicions from Trump supporters that the pharmaceutical industry was withholding the news until after the election. Donald Trump Jr. tweeted: “The timing of this is pretty amazing. Nothing nefarious about the timing of this at all right?”
Pfizer has insisted that its work is not influenced by politics and that it was “moving at the speed of science.” Its independent data monitors met on Sunday, analyzing the COVID-19 test results so far and notifying Pfizer.
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.
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.
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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.
As to this article about vaccines, that’s why the words “Spin Doctor” were created, the only verifiable facts in the whole article was that Pfizer spent $2 Billion of their own money on developing their vaccine.
Yet, except, however, but, and, Pfizer was paid, already, $1.95 Billion for future doses of vaccines. Which if you un-SPIN that malarkey, we can extrapolate from 2nd grade grade elementary school arithmetic, that Pfizer actually only spent $50 Million of their own money.
And their own money in a simple ratio of 195 to 5 was only 2% of the Spin on $2 Billion. Harrumph, guffaw, chortle…!
And that 98% of the $2 Billion actually was paid for by the government from our own tax dollars.
And spin it some more, it’s allegedly 90% effective but there not sure if it will be on elderly or the young, or is it children, teens or middle age…?
In fact, since about 98% of those getting the Covid-19 virus have Zero to mild symptoms, and of those who die the CDC says that only 6% of those deaths, of which almost all are elderly, can be blamed on the actual virus; and the other 94% of the deaths are attributed to the end of life diseases those people already have had for decades, along with the toxic prescription drugs they have been polluting their bodies with for decades, and all while under medical care.
Which is a scary indictment for prescription drug treatment for early on in life diagnoses at age 30+ for Heart and Stroke diseases, High Blood Pressure, Obesity and Diabetes, Cancers, Alzheimer’s, and Kidney, Lung, and Liver failure, all avoidable due to their causes from Non-Nutrient chemically polluted food, Alcohol, Tobacco, and the side effects of the prescription drugs themselves, amounting to an American epidemic of national proportions, hoodwinking 80% of the American public into thinking they must take at least 1 or more of Pfizer, et. al., petrochemical carcinogenic prescription drugs every day of their now obviously shortened life span. All that in trade of the old fashioned way of getting well by removing or voiding the causes of diseases so that you actually get well and do not need to pollute yourself with toxic side effect producing prescription drugs.
Of course getting well from your disease would cut out the $4 Trillion per year spent by tax payers (and non payers) on the pharmaceutical industry’s prescription drugs and their salesmen and women, the doctors.
And we cannot even get rid of the prescription drug and doctor myth, in lieu of getting well, because we psychologically need them, you know the whole White Coat, the little hose around the neck with the ear phones on one end, and the giant hospital buildings, well not giant compared to insurance company buildings, but also that fake medical image gives the public false confidence and blind faith in that belief that prescription drugs and vaccines can take the place of being well and healthy and having an internal immune system strong against any virus.
Human immune systems without vaccines proving 98% of the people, whether tested or not, get either only Zero to Mild or Moderate Symptoms and thus do not require medical treatment and drug intervention, thank God.
Did anyone ever stop to ask Trump and Biden as to how many prescription drugs do they take every day? Or at 80% on prescription drugs, how many are you taking?
And the vaccine companies claim they are not going to use live Covid-19 virus in the vaccine, thank God, why, because you can get the virus for free by not wearing a mask or not 6’ distancing, and still have Zero to Mild or Moderate Symptoms, which makes the vaccine, itself, a proposed Pandemic, seems a lot silly. Unless of course you are elderly and on long term diseases and prescription drugs and under medical care already, and the yo can die. Wow, when would you ever face the fact that being under medical care and on prescription drugs would put you at high risk?
All it took for South Korea to recently stop its vaccine program was 35 of their human experiment victims to die. And Astra Zeneca, 1 of the giant pharmaceutical companies, recently halted their virus testing on humans due to too many got sick.
And lab scientists claiming the vaccine is going to train the human immune system to recognize a fragment of a virus DNA, is that true or a spin, wow, gee, a whole fragment, so we can develop antibodies against the whole Covid-19 virus? That’s called beyond all hope and a wish, but you can say your prayers for it.
All this, when humans have been relying on our own immune systems since time on earth for humans began, and that track record of immune systems’ capabilities in our “cousin” vertebrates has been successfully going on for 550 million years. And now all of a sudden in vertebrate life on earth years we need fake vaccines to attempt to train natural already capable immune systems dating 550 million years.
And now all of a sudden in human laboratory history someone invents a vaccine and it becomes mandatory because only 98% of the people do not need it…!
We don’t need another “stinking” vaccine we need healthy people. Vaccines will never replace healthy people.
For healthy people we need God given nutrient rich food, Healthy Lifestyles, and an end to petrochemicals in the food, air, water, and land that all life depends on, without modern pollution inside of and outside of our precious bodies, add to that we do need human body education for all students an hour a day for their entire education. That way people will not have to risk blind faith in such experiments as vaccines that have only shown they are capable to more than likely cause Autism in children, in consideration there is no other known cause of Autism.
It will be interesting to see if another vaccine produced more Autism in children. But is that worth the discovery of another side effect of vaccines, an actual another prescription drug?