[ad_1]
The CEO of the US company has announced in a letter that Pfizer will ask for a green light for its vaccine the third week of November. “We have a date,” Burioni stresses on social media
The pharmaceutical company Pfizer plans to request authorization for its coronavirus vaccine from the US agency FDA in the third week of November. This was announced by Pfizer CEO Albert Bourla on the company’s website with a letter, which was later relaunched by Professor Roberto Burioni on Twitter. “There are three areas in which, as with all vaccines, we must show that we are successful in obtaining approval for public use in the first place – writes Bourla – First, the vaccine must be effective, which means that it can help prevent Covid-19 in the majority of vaccinated patients. Second, we must demonstrate that the vaccine is safe, with reliable data generated from thousands of patients. Finally, we must demonstrate that the vaccine can be produced consistently with the highest quality standards “.
Verdict on efficacy at the end of October
deepening
Coronavirus, 10 countries with more cases in 24 hours: half are in Europe
“I know there is confusion about what it will take to get approval and, given critical public health considerations and the importance of transparency, I would like to provide more clarity on the timelines for Pfizer regarding our partner BioNTech coronavirus vaccine. . “continues the letter from CEO Albert Bourla.” It is possible that we will know if our vaccine is effective – explains the general director – at the end of October and to do so we must accumulate a certain number of cases of Covid-19 in our study to compare the efficacy of the vaccine in vaccinated individuals with those who received a placebo ”. At that time, a committee of independent scientists will examine the US pharmaceutical company’s vaccine and establish its effectiveness in treating the virus.
Key date, the third week of November
In case the expert response is positive, Pfizer explains that in order for the US Food and Drug Administration to authorize the emergency use of a possible vaccine, the US Food and Drug Administration requires companies to provide two months of safety data on half of the trial participants after the final dose of cure. A goal that the company hopes to achieve 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 study participants for two years,” said Albert Bourla, confirming: “Pfizer will request the use of the US authorization immediately. after reaching the safety milestone in the third week of November ”.
