On Friday Pfizer Inc said it could apply for emergency use of its coronavirus vaccine as “soon as a security milestone is achieved” in November.
CEO Albert Bourla wrote in an open letter saying the drug manufacturer should have enough data from its late-stage trial to know whether its COVID vaccine works or not by end of this month.
Bourla mentioned, “In the instance of Emergency Use Authorization within the US for a possible COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the ultimate dose of the vaccine. Based on our current trial enrollment and dosing pace, we estimate we’ll reach this milestone within the third week of November.”
Transparency is important so I’d like to provide greater clarity around the timelines for @pfizer’s #COVID19 vaccine and the 3 key areas where we must demonstrate success in order to submit for Emergency Use Authorization (EUA) or Approval: https://t.co/EVSnMNoeRQ
— AlbertBourla (@AlbertBourla) October 16, 2020
With German partner BioNTech, Pfizer is developing a COVID-19 vaccine. Scientists believe this experiment contains genetic material called messenger RNA , or mRNA which provokes the system to fight the virus, reported reuters.
Pfizer Illustrated three key areas of COVID-19 vaccine muysy to demonstrate success in order to seek approval for public use, on which Bourla said, “First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in a minimum of 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 very best 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.
Food and Drug Administration should provide the key data from its late-stage trial to the drug manufacture 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 top of October,” Bourla added.
“As Pfizer is blinded to who received the vaccine versus the placebo, a committee of independent scientists will review the entire data and that they will inform us if the vaccine is effective or not supported predetermined criteria at key interim analysis points throughout the trial,” he further added.
The world is waiting for a safe and effective #COVID19 vaccine. Today our Chairman & CEO penned an open letter to help people understand the criteria we must meet and the expected timelines for our investigational vaccine program. https://t.co/RlhDYq4vK0
— Pfizer Inc. (@pfizer) October 16, 2020
To prove that the vaccine is safe is the second requirement. Our internal standards for vaccine safety and people 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.
“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.
CEO Albert Bourla believed, The Americans can get Pfizer’s coronavirus vaccine before the end of the year if found to be safe and effective. He said, “If the FDA approves the vaccine, the corporate is ready to distribute “hundreds of thousands of doses.”