(CNN) — In a open letter Published on Friday by Pfizer Chairman and CEO Albert Bourla, the pharmaceutical company announced that it plans to apply for an Emergency Use Authorization (US) for its COVID-19 vaccine in the US. in November.
“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 data contained in our US application will 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 letter says.
However, Bourla explained that they must show that the vaccine is a success in order to gain approval from the US Food and Drug Administration for public use.
‘First, the vaccine must be shown to be effective, which means that 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 show that the vaccine can be consistently manufactured to the highest quality standards, ”Bourla wrote.
Additionally, Bourla explained that the FDA requires companies to provide two months of safety data on half of the trial participants after the final dose of the vaccine and based on their current trial enrollment and dosing schedule. , they estimate that they will meet all the requirements by the third week of November, and it is possible that we will know if our vaccine is effective or not by the end of October.