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One of the companies that is working hard to develop a vaccine for COVID-19 is Pfizer. President and CEO Albert Bourla has written an open letter to provide further clarity on the vaccine program, which you can read here-
As we approach an important data reading 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 who are investing their hopes in a COVID. safe and effective. 19 vaccine to overcome this pandemic. I know there is a great deal of confusion as to what exactly will be needed to ensure its development and approval, and given critical public health considerations and the importance of transparency, I would like to provide further clarity on development timelines for Pfizer and our the COVID-19 vaccine from partner BioNTech.
There are three key areas in which, as with all vaccines, we must demonstrate success in order to gain approval for public use. First, the vaccine must prove itself effective, which means it can help prevent COVID-19 disease in at least the majority of vaccinated patients. Second, and equally important, the vaccine must prove its safety, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured to the highest quality standards.
To ensure public trust and clear up a lot of confusion, I think it is essential that the public understand our estimated timelines for each of these three areas.
As I have said before, we are operating at the speed of science. This means that we can know if our vaccine is effective or not by the end of October. To do this, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals with those who received a placebo. Since we have to wait for a certain number of cases to occur, this data can come sooner or later depending on changes in infection rates. As Pfizer does not know who received the vaccine versus placebo, a committee of independent scientists will review the complete data and inform us whether the vaccine is effective or not based on predetermined criteria at key points of interim analysis throughout the trial. Pfizer will continue to run the test until its final analysis point even if it is declared effective at an earlier stage. In a spirit of frankness, we will share any conclusive readings (positive or negative) with the public as soon as possible, usually a few days after independent scientists notify us.
One key point that I would like to make clear is that efficacy would satisfy only one of the three requirements, and alone would not be sufficient for us to apply for approval for public use.
The second requirement is to demonstrate that the vaccine is safe. Our internal standards for vaccine safety and those required by regulators are high. In the case of the US Emergency Use Authorization for a potential COVID-19 vaccine, the FDA requires companies to provide two months of safety data on half of the trial participants after the final dose of the vaccine. Based on our current trial enrollment and dosing rate, we estimate that we will reach this milestone in the third week of November. Safety is, and will continue to be, our number one priority, and we will continue to monitor and report the safety data of all trial participants for two years.
And finally, if we achieve a positive efficacy reading and a strong safety profile, the last requirement will be to submit manufacturing data that demonstrates the quality and consistency of the vaccine that will be produced. Pfizer has been investing in risk since the early days of the pandemic to refine our manufacturing processes and rapidly increase capacity. We hope to have our manufacturing data ready to ship before the safety milestone is reached.
Let me be clear, assuming positive data, Pfizer will apply for the use of emergency authorization in the US shortly after the safety milestone is achieved in the third week of November. All the data contained in our US application would be reviewed not only by the FDA’s own scientists, but also by an outside panel of independent experts at a public meeting called by the agency.
The schedules above reflect our best estimates of when these important milestones could be achieved. For 171 years, Pfizer has been known for our high quality standards. Our purpose is to discover advances that change the lives of patients. I cannot think of a breakthrough that is more meaningful to more people than an effective and safe COVID-19 vaccine.
In the meantime, I hope that you and your loved ones are safe and sound.
