Pfizer Chief Vows to Resist Political Pressure on COVID-19 Vaccine

Pfizer will not allow political arm-twisting to speed up or delay its COVID-19 vaccine candidate trials, the company’s CEO Albert Bourla stressed in an open letter last week.

The senior Pfizer executive vowed that the company will not bow to outside influence and will instead proceed “at the speed of science.”

“The amplified political rhetoric around vaccine development, timing and political credit is undercutting public confidence … Imagine the compounded tragedy if we have a safe and effective vaccine that many people didn’t trust,” he said.

Bourla previously announced that the company could have vaccine data ready for submission to the FDA by October and potentially 100 million doses delivered by year’s end and said in his open letter that the company is on track toward that goal. Yet “despite not having any political considerations with our pre-announced date, we find ourselves in the crucible of the U.S. presidential election,” he said.

To date, Pfizer has recruited more than 35,000 participants for its vaccine trials in multiple countries and has put up nearly $2 billion at its own risk, the CEO said.

It has become increasingly unlikely that a viable vaccine will be ready before election day, contrary to Trump’s claims, and alarms are sure to be raised if one does receive authorization or approval before its trials are completed. Pfizer appears to be the company closest to filing its vaccine data with the FDA.

Moderna CEO Stéphane Bancel recently announced that the company won’t be ready to submit data on its far-along vaccine to the agency until next year, while late-stage trials for AstraZeneca’s promising vaccine candidate remain on hold in the U.S. as an adverse event is investigated.

Similarly, Inovio’s phase 2/3 vaccine trial was recently placed on a partial clinical hold by the FDA, which had questions about the trial and its vaccine delivery device.

Johnson & Johnson only recently began a late-stage trial for its COVID-19 vaccine candidate, dosing the first participants on Sept. 23.

Read Bourla’s open letter here: www.fdanews.com/10-02-20-Pfizer.pdf. — James Miessler