In an open letter, October 16, Pfizer chairman and CEO Albert Bourla, announced that BioNTech COVID-19 vaccine will be ready for FDA submission by late November.
“As we get closer to an important data readout from our COVID-19 vaccine program, I wanted to speak directly to the billions of people, millions of businesses and hundreds of governments around the world that are investing their hopes in a safe and effective COVID-19 vaccine to overcome this pandemic. I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer’s and our partner BioNTech’s COVID-19 vaccine.” – Albert Bourla said.
3 Key Areas
In the letter were highlighted three key areas where, as with all vaccines, must be demonstrated successful effects of the vaccine in order to seek approval for public use. 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 third, must be demonstrated that the vaccine can be consistently manufactured at the highest quality standards.
“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,” – was published in letter.
BioNTech COVID-19 Vaccine Will Be Available On The Third Week Of November
Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November. All the data contained in U.S. 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.
“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. To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates,” – Pfizer said.
Since the company is blinded to who received the vaccine versus the placebo, a committee of independent scientists will review the complete data and they will inform, if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial.
Second key area requires to prove that the vaccine is safe. “In the instance of Emergency Use Authorization in the U.S. 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,” – company comment. Based on these factors Pfizer estimate to reach this milestone in the third week of November.
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,” – the head of the company said. At the end need to be said, that the main key point is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for Pfizer to apply for approval for public use.