Politicians raved about it. Experts were cautious: “an interesting first signal,” many questions remain. Even Pfizer said, “as the study continues, the final vaccine efficacy percentage may vary.”
By Wolf Richter for WOLF STREET.
“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.”
We sure could use some hope amid spiking Covid-19 infections. Monday morning, as is usually the case with these vaccine announcements, Pfizer and its German partner BioNTech announced in a press release – and not in a peer-reviewed medical journal – some early tidbits about their two-dose vaccine. An announcements of early tidbits of a drug trial via a press release without further data is very unusual in itself. But hey, these are unusual times.
Pfizer said that according to the “first interim analysis” from a Phase 3 study, 94 of their 43,538 participants – some of whom got two shots of a placebo, and some of whom got two shots of the vaccine – tested positive so far for Covid-19.
Only those participants with symptoms were tested. Potentially infected participants without symptoms were not tested, and their infections remain unknown for now.
Because the study is still ongoing, Dr. Gruber couldn’t say how many participants that got the placebo and how many participants that got the vaccine had infections, according to the Associated Press. But the math indicates that almost all the infections tallied so far had to have occurred in people who got the placebo, he said.
Given the early state of the study, Gruber could also not say how many of the older participants, who are the most at risk, had been infected.
In this first interim analysis of the data, an outside panel of experts saw indications that the vaccine could be “more than 90% effective in preventing COVID-19,” according to the press release.
The clinical trials will continue until there are 194 confirmed Covid-19 cases among the participants, which is the number the FDA has said is enough to determine how effective the vaccine is.
Pfizer did not offer any details about those infections and cautioned that “as the study continues, the final vaccine efficacy percentage may vary.”
“We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks,” Pfizer said in the press release.
“We need to see the data, but this is extremely promising,” Dr. Jesse Goodman of Georgetown University, former chief of the FDA’s vaccine division, told the Associated Press. There were many questions still to be answered, he said, including how long the vaccine’s effects last and whether it protects older people as well as younger ones.
And if the vaccine ultimately works out, “it’s going to be a while before this has a major impact at the population level,” he said.
Pfizer has already begun manufacturing the vaccine. During the earnings call on October 23, Pfizer CEO Albert Bourla said that the company could have 30-40 million doses ready by the end of the year. Given that two doses are required – the initial shot and a booster shot – this would be enough to vaccinate 15-20 million people
As part of Operation Warp Speed, the government promised Pfizer $1.95 billion for an initial order of 100 million doses, which would be enough for 50 million people. The government also has the option to purchase another 500 million doses to vaccinate an additional 250 million people. Americans would get these shots for free.
The EU ordered 200 million doses with an option for another 100 million; Japan ordered 120 million, Britain 30 million.
Marylyn Addo, head of the tropical medicine unit at UKE hospital in Hamburg, Germany, told the Associated Press that the interim results were “an interesting first signal,” but questions remain.
Politicians across the spectrum raved about the news.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told the Associated Press that a 90% effectiveness is “just extraordinary,” that “not very many people expected it would be as high as that,” and that “it’s going to have a major impact on everything we do with respect to COVID.”
The timing of the announcement itself – after countless Vaccine-Mondays – created its own furor, because everything about the Pandemic has gotten politicized, even the Pandemic itself, and such mundane things as face masks. So here we’re staying on trend. Pfizer had at first announced that it might have initial vaccine data before the election; and later it announced that it would not have any initial data before the election. So now six days after the election, it made its initial data public.
Pfizer CEO Bourla told CNBC that the election had been an artificial deadline.
The independent panel of experts met on Sunday to analyze the test results so far and then notified Pfizer. Kathrin Jansen, a senior VP and the head of vaccine research and development at Pfizer, told the New York Times that she learned of the results from the panel shortly after 1 p.m. on Sunday, and that the timing was not influenced by the election. “We have always said that science is driving how we conduct ourselves – no politics,” she said.
One thing for sure we know: it involves a huge amount of money, and financial markets went all over the place. More in the next installment.
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