The world reacted with great optimism at the news announced Monday morning that test subjects given a COVID-19 vaccine being developed by Pfizer had 90 percent fewer symptomatic infections of the China coronavirus than those given a placebo. For example, the Dow Jones stock market index jumped over three percent in value Monday morning on the news. (CNBC reported: “The Dow Jones Industrial Average traded 1,100 points higher, or 3.9% and hit an all-time high. At its session high, the 30-stock average was up nearly 5.7%, or more than 1,600 points.”)
A report by Stat News states that at the end of October Pfizer changed their planned testing protocol, placing samples in cold storage and not testing them until the after the November 3 election, supposedly to test a larger sample.
…“I’ve been in vaccine development for 35 years,” William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told STAT. “I’ve seen some really good things. This is extraordinary.” He later added: “This really bodes well for us being able to get a handle on the epidemic and get us out of this situation.”
…In their announcement of the results, Pfizer and BioNTech revealed a surprise. The companies said they had decided not to conduct the 32-case analysis “after a discussion with the FDA.” Instead, they planned to conduct the analysis after 62 cases. But by the time the plan had been formalized, there had been 94 cases of Covid-19 in the study. It’s not known how many were in the vaccine arm, but it would have to be nine or fewer.
Gruber said that Pfizer and BioNTech had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of Covid-19 in the study, instead leaving samples in storage. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday. When the samples were tested, there were 94 cases of Covid in the trial. The DSMB met on Sunday.
This means that the statistical strength of the result is likely far stronger than was initially expected. It also means that if Pfizer had held to the original plan, the data would likely have been available in October, as its CEO, Albert Bourla, had initially predicted.
Newsweek reports that while Pfizer did not take federal government money for research and development of the vaccine candidate, the firm signed an Operation Warp Speed contract worth $1.95 billion for 100 million doses with an option for 500 million more.
Pfizer’s head of vaccine research has distanced the firm’s COVID-19 vaccine development from the White House’s Operation Warp Speed.
…While government figures welcomed the program’s progress, Kathrin Jansen, the head of vaccine research and development at Pfizer, sought to distance it from them.
She told The New York Times: “We have never taken any money from the U.S. government, or from anyone.”
Jansen also told The Times that Pfizer was “never part” of Operation Warp Speed.
However, a Pfizer press release from July announced that, in agreement with Operation Warp Speed, the U.S. government would receive 100 million doses of the vaccine—subject to FDA approval—for $1.95 billion, with the option to acquire up to 500 million more.
A Pfizer spokesperson told Newsweek that while per this agreement Pfizer’s vaccine was tied to Operation Warp speed, it had never taken government funding for its research and development.
…”Pfizer has not taken federal money for R&D,” Sharon Castillo, a spokesperson for the company based in Washington, D.C., told Newsweek.
President Trump repeatedly said in the past few months that it looked like a vaccine might be announced in October. It appears he was on the right track, but the science community decided to hold off until after the election.
President Donald Trump again suggested that a coronavirus vaccine would “probably” be available in October, contradicting assessments this week by top health officials who have said it would be very unlikely.
Trump said in a press briefing Friday that there would be a vaccine “before the end of the year and maybe even before Nov. 1. I think we can probably have it sometime in October.”
…The federal government’s top infectious disease expert, Anthony Fauci, also cautioned this week that result could take longer.
“If you look at the projection of the enrollment and the kinds of things you’ll need to get a decision about whether the vaccine is safe and effective, most of us project that that’s going to be by November and December, by the end of this year,” Fauci, director of the National Institute of Allergy and Infectious Disease, said on CNN. “It is conceivable that you could have it by October, though I don’t think that that’s likely.”
Pfizer CEO Albert Bourla told reporters this week that the company will know if its coronavirus vaccine works by the end of October. But it is unclear whether the Food and Drug Administration, the agency responsible for reviewing vaccines, would issue an emergency use authorization or approve the shot based on that data.
One can’t help but wonder what last week would have looked like if Pfizer had held to its original schedule and not stopped testing samples until after the election.