Update: On November 18, Pfizer announced its first set of complete results from it's late-stage vaccine trial. Researchers found that the COVID-19 vaccine was 95% effective starting 28 days after receiving the first dose, with no serious side effects. There were 170 confirmed cases of COVID-19 among trial participants. Of those cases, 162 occurred in folks who got the placebo shot, versus 8 in those who received the actual vaccine, according to a Pfizer press release.
This article was originally published on Nov. 9, 2020. The original text continues below.
The race toward a workable COVID-19 vaccine had been an area of intense interest for the duration of the pandemic. Today, a glimmer of hope came in the form of a press release. An early analysis found that the COVID-19 vaccine candidate being developed by Pfizer and BioNTech was more than 90% effective at protecting people from COVID-19 compared to a placebo shot, Pfizer said in a press release on November 9.
It didn’t take long for President Donald Trump to weigh in on the promising (though not conclusive) analysis. “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” Trump tweeted early Monday morning, taking a break from redistributing Fox News clips about the presidential election, which on Saturday was called in former Vice President Joe Biden’s favor.
In this tweet, Pence seems to be referring to a deal Pfizer struck in July with Operation Warp Speed, a project that uses federal resources to help accelerate the development, testing, and distribution of effective, safe vaccines and therapies to combat COVID-19.
But as they've made clear, Pfizer not did not accept money to help with the development or testing of the vaccine candidate. The $1.95 billion contract the pharmaceutical company signed with the federal government was specifically regarding distributing the vaccine. Once they had a working vaccine approved, Pfizer would use the money to provide 100 million doses to Americans, helping to support Operation Warp Speed's ultimate goal of producing and delivering "300 million doses of safe and effective vaccines with the initial doses available by January 2021." So while Pence is right that there is a partnership, the arrangement between Operation Warp Speed and Pfizer didn't have anything to do with the trial's early success.
Companies such as Moderna, AstraZeneca, and Johnson & Johnson, on the other hand, accepted money to help develop or test their vaccine candidates, according to a fact sheet provided by the U.S. Department of Health and Human Services. Pfizer, however, sunk $2 billion of its own money into the project, according to The Washington Post.
"While Pfizer did reach an advanced purchase agreement with the U.S. government, the company did not accept BARDA [Biomedical Advanced Research and Development Authority] funding," Pfizer said in a statement provided via email to Refinery29. "Pfizer’s COVID-19 vaccine development and manufacturing costs have been entirely self-funded. We have already invested about $2 billion, at risk, and are prepared to continue bearing the costs of all development and manufacturing, in an effort to help find a solution to this pandemic. We decided to self-fund our efforts so we could move as fast as possible"
“We were never part of the Warp Speed,” Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, further emphasized to The New York Times. “We have never taken any money from the U.S. government, or from anyone.”
Jansen also made clear that Pfizer has no agenda. Yes, the promising results were made public this morning, shortly after the presidential election was called in favor of Biden — but that was just because the company had received the results on Sunday afternoon, she told The Times. "We have always said that science is driving how we conduct ourselves — no politics,” Jansen said.
While these results are a step in the right direction, they have not been peer-reviewed or published yet, and it's too soon to say for sure whether the promising early results will bear out. "We need to see the actual data, and we’re going to need longer-term results,” Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University, told The New York Times.
Still, the early analysis looks promising, Pfizer notes. "This first interim analysis of our trial evaluated 94 confirmed cases of COVID-19 in participants without prior SARS-CoV-2 infection among participants 16 to 85 years of age," Pfizer told Refinery29 in an email. "Meaning, 90 percent of those cases came from the placebo group, which means we are showing 90 percent efficacy against infection."
If all continues to go well, the Food and Drug Administration would need to give emergency use authorization before the vaccine could be distributed. Pfizer plans to ask the FDA to approve their vaccine candidate — which is a shot that's given in two doses, three weeks apart — in the third week of November. So far, no major safety concerns have been reported thus far in the trial. There are 11 other late-stage COVID-19 vaccine trials.
While many are taking issue with the White House's attempt to seemingly take credit for work they weren't involved in, that shouldn't blot out the fact that these early analysis results are fantastic news. “Today is a great day for science and humanity,” Albert Bourla, PhD, Pfizer’s chairman and CEO, said in Monday's press release. "With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.”
This story was originally published on Nov. 9, but was updated with a statement from Pfizer on Nov. 11.