Pfizer says no vaccine until late November
CEO: there won’t be time to test its safety this month
Pharmaceutical giant Pfizer Friday dashed prospects for a coronavirus vaccine being approved before the election with an open letter explaining the company would not apply for regulatory clearance for its vaccine candidate until the third week of November at the earliest.
President Donald Trump has for months suggested a vaccine could be imminent, raising concerns that political pressure could force a vaccine through the regulatory process prematurely so that it would be approved by Election Day without evidence that it is safe and effective. Friday ’s announcement from Pfizer puts those concerns to rest.
Chief executive Albert Bourla wrote in the letter that while the company projects it may have enough data to determine whether the vaccine is effective in October, there will not be sufficient safety follow-up to satisfy criteria laid out by the Food and Drug Administration until late November.
“A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use,” Bourla said.
“Safety is, and will remain, our number one priority.”
The letter was welcomed by Eric Topol, a physician-scientist at Scripps Research Translational Institute who joined other experts in writing to Bourla in late September, asking the company not to seek authorization for a vaccine before late November. Topol recently had a virtual meeting with company executives to express his concerns.
Bourla’s emphasis on having data in October “is what got many of us concerned, whether it was inadvertently playing into the political pressure or just because the incentives were aligned,” Topol said. “I thought (the letter) was very good. I wish it had been done potentially even earlier.”
Bourla made clear that while the company won’t seek approval until reaching the safety threshold, it could announce data on whether the vaccine candidate works before the election.
Pfizer’s trial will ultimately include 44,000 study subjects, with half receiving two shots of its experimental vaccine and the other half receiving placebo inoculations. Neither participants, study investigators nor company executives know who received a vaccine and who did not. But periodically throughout the trial, an independent committee is examining the data to see whether the vaccine is protecting participants from infection, as demonstrated by far fewer cases of COVID -19, the disease caused by the virus, in those getting the shots than those receiving a placebo.
The FDA in October issued guidance explaining the criteria for an emergency use authorization, saying a vaccine given to healthy people will be held to a higher standard than the typically low threshold that a medical product “may be effective” for emergency use. The agency put forth a requirement — despite White House objections — that vaccine candidates must have a minimum of two months of follow-up data on half of the participants in the study.
Pfizer will not have such data until the third week of November. Moderna, a biotechnology company, will not have enough safety data to apply for regulatory authorization until two days before Thanksgiving, according to spokesman Ray Jordan. Two other latestage vaccine trials, from Astrazeneca and Johnson & Johnson, are paused because of potential safety concerns and have previously predicted readouts from their trials around the end of the year.
White House spokesman Judd Deere said the Trump administration has expedited development of safe and effective treatments and vaccines that normally would have taken years. “The President continues to be optimistic that we will have one or more vaccines very soon, before the end of the year,” Deere said.