Pfizer CEO Albert Bourla said that the earliest the company will apply for FDA emergency-use authorization (EUA) for its COVID-19 vaccine program would be shortly after a key safety milestone is met, which is currently expected to be in the third week of November. “As we get closer to an important data readout…I would like to provide greater clarity around the development timelines for Pfizer’s and our partner BioNTech’s COVID-19 vaccine,” Mr. Bourla remarked.
A phase 3 trial of the mRNA-based vaccine, dubbed BNT162b2, began earlier this year, with the original plans of enrolling 30,000 subjects boosted to 44,000. Last month, the companies announced that participants in the study have so far exhibited only mild-to-moderate side effects, with fatigue and headache being the two most common. At the time, Pfizer reaffirmed that it expects to get conclusive data on the efficacy of BNT162b2 by the end of October.
Three goals to hit
On Friday, Bourla noted that along with efficacy data, the companies must demonstrate the safety of the vaccine and that it can be consistently manufactured at the highest quality standards before an EUA application is submitted. “We may know whether or not our vaccine is effective by the end of October,” Bourla said, although safety data that are required by the FDA would not be available until the following month. “FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine,” Mr. Bourla noted, adding “based on our current trial enrolment and dosing pace, we estimate we will reach this milestone in the third week of November.”
Mr. Bourla’s comments come shortly after the FDA published briefing documents related to an upcoming advisory committee meeting on COVID-19 vaccines, as well as guidance for industry, in which it outlined stricter criteria that need to be met in order to support an EUA request. The briefing documents came amid reports the White House wanted to block the FDA from releasing its updated industry guidance. Controversy about the updated guideline centred on the requirement that companies will have to monitor patients enrolled in their late-stage studies for at least two months after the final vaccination before seeking an EUA.
Safety data to be final requirement
According to Mr. Bourla, Pfizer expects to have manufacturing data demonstrating the quality and consistency of BNT162b2 ready for submission before the safety milestone is reached. “So let me be clear, assuming positive data, Pfizer will apply for [EUA] in the US soon after the safety milestone is achieved ,” Mr. Bourla reiterated, adding that “all the data…would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.”
Mr. Bourla said Friday’s statement was made, in part, to “ensure public trust and clear up a great deal of confusion” surrounding the timeline for a possible COVID-19 vaccine. US President Donald Trump has recently claimed that a vaccine is only “weeks away,” contradicting federal health officials who have projected that one would be available possibly at the end of the year or in early 2021. Mr. Bourla has previously spoken out about “the amplified political rhetoric” around development of the vaccines, noting that a recent US presidential debate discussed them “in political terms rather than scientific facts…people, who are understandably confused, don’t know whom or what to believe.”