COVID-19 vaccine: Pfizer targets emergency approval next month, says CEO in an open letter

Pfizer Inc on Friday said that it could apply for emergency use of its coronavirus vaccine as "soon as a safety milestone is achieved" in November. The drugmaker should have enough data from its late-stage trial to know whether its coronavirus vaccine works by this month, CEO Albert Bourla wrote in an open letter. "In the instance of Emergency Use Authorization in the US for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine. Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November," Bourla mentioned.

Pfizer is developing a COVID-19 vaccine with German partner BioNTech. The experimental vaccine contains genetic material called messenger RNA, or mRNA which provokes the immune system to fight the virus, scientists believe.

Illustrating the three key areas where the Pfizer COVID-19 vaccine muysy demonstrate success in order to seek approval for public use, Bourla said, "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."

"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," Bourla wrote.

The drugmaker should have key data from its late-stage trial for the Food and Drug Administration by the end of October. "As I’ve said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October," Bourla added.

"As Pfizer is blinded to who received the vaccine versus the placebo, a committee of independent scientists will review the complete data and they will inform us if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial," he added.

"The second requirement is to prove that the vaccine is safe. Our internal standards for vaccine safety and those required by regulators are set high," he mentioned.

"All the data contained in our US application 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," he assured.

The final "requirement will be the submission of manufacturing data that demonstrates the quality and consistency of the vaccine that will be produced."

"Pfizer has been investing at risk since the early days of the pandemic to perfect our manufacturing processes and rapidly build up capacity. We expect to have our manufacturing data ready for submission before the safety milestone is reached," he added.

Pfizer’s coronavirus vaccine could be distributed to Americans before the end of the year if found to be safe and effective, CEO Albert Bourla believed. If the FDA approves the vaccine, the company is prepared to distribute “hundreds of thousands of doses," he said. "The timelines above reflect our best estimates of when these important milestones could be achieved," CEO concluded.