The mRNA coronavirus vaccine being developed by Pfizer Inc. (NYSE: PFE) and BioNTech SE – ADR (NASDAQ: BNTX) is unlikely to become available under emergency use authorization before the Nov. 3 U.S. presidential election.
What Happened: Assuming positive safety and efficacy data from the interim Phase 3 readout, Pfizer will apply for emergency use authorization in the U.S. soon after the safety milestone is expected to be achieved in the third week of November, Pfizer CEO Albert Bourla said in an open letter Friday.
To prove efficacy, a certain number of COVID-19 cases have to be accumulated in the trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo, the CEO said.
“Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates,” he said.
With Pfizer blinded to the study, the complete data will be reviewed by a committee of independent scientists, who in turn will notify the company if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial, Bourla said.
“Pfizer will continue running the trial through its final analysis point even if it is declared effective at an earlier stage.”
The FDA is mandating that companies should provide two months of safety data on half of the trial participants following the final dose of the vaccine in order to obtain emergency use authorization.
Based on the trial enrollment and dosing pace, Pfizer estimates that this milestone will be reached in the third week of November.
Pfizer has been investing in manufacturing since the early days of the pandemic and will likely have manufacturing data ready to be submitted to the FDA before the safety milestone is reached, Bourla said.
Why It’s Important: The Pfizer-BioNTech combo is viewed as a frontrunner in the coronavirus vaccine race, as other big pharma names such as AstraZeneca plc (NASDAQ: AZN) and Johnson & Johnson (NYSE: JNJ) have fallen behind due to safety concerns.
Moderna Inc (NASDAQ: MRNA), which was running neck-to-neck with Pfizer, is also expected to see a delay due to slowing enrollment in its late-stage study.
If Pfizer and BioNTech do not release the first interim readout by October, it likely means the independent, external data monitoring committee decided to continue the study through the first two interim analysis points, SVB Leerink analyst Daina Graybosch said in a note earlier this week.
A November readout does not mean the vaccine candidate isn’t efficacious, the analyst said.
PFE, BNTX Price Action: At last check, Pfizer shares were gaining 2.5% to $37.46 and BioNTech shares were up 2.8% to $92.91.
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