Pfizer won’t apply for COVID-19 vaccine emergency authorisation until after US election, CEO says
pharmafile | October 19, 2020 | News story | Sales and Marketing | COVID-19, Pfizer, US, Vaccine
The Chief Executive Officer of Pfizer has said that the company will now submit their vaccine for FDA Emergency Use Authorization at the end of next month, significantly changing course on the expected timeline for the treatment’s approval.
Albert Bourla, CEO and Chairman of Pfizer, penned an open letter discussing the new timeline. He said that to “ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas. First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured at the highest quality standards.”
Bourla also responded to the recent guidelines set out by the FDA to alleviate fears that no vaccine would be rushed through before election day. These guidelines would ask manufacturers who seek an emergency authorisation to follow participants in late-stage clinical trials for a median of at least two months from when they received a second vaccine shot.
“Based on our current trial enrolment and dosing pace, we estimate we will reach this milestone in the third week of November,” the Pfizer leader remarked. “Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years.”
This is a significant shift from Bourla’s previous comments, which indicated that the company would know whether the vaccine would receive approval by the end of October.
Conor Kavanagh
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