Pfizer boss Albert Bourla announced important key data for the planned approval of the corona vaccine candidate BNT162 in an open letter on Friday. Together with partner BioNTech, the company is currently in the final phase of the clinical study phase, on the basis of which the approval of BNT162 is to be applied for. The two companies are currently in the top position in the “race” for a vaccine against the SARS-CoV-2 virus.
BioNTech and Pfizer want to publish data from the clinical study with the corona vaccine in October. In the third week, further safety data on BNT162 should be available. By then, Pfizer also wants to have all the information it needs about the production process – all three data sets are necessary in order to finally apply to the US FDA for approval of BNT162 for public use. The application should be made immediately as soon as the security data are available in the third week of November, Bourla announced on Friday afternoon. The schedules reflect “the best estimates of when these important milestones might be reached,” said Bourla.
“There are three key areas in which, as with all vaccines, we need to demonstrate success in order to gain approval for public use. First, the vaccine must be proven to be effective; it can help prevent COVID-19 disease in at least the majority of vaccinated patients. Second, and equally important, the vaccine has been shown to be safe, with robust safety data from thousands of patients. And finally, we have to prove that the vaccine can be manufactured consistently to the highest quality standards, ”said the Pfizer boss in the open letter.