The American pharmaceutical giant Pfizer wait to request a emergency use authorization for your Covid-19 vaccine at the end of November, about two weeks after the US presidential election on November 3.
“Let me be clear, assuming the data is positive, Pfizer will request an emergency use authorization in the United States shortly after the end of the security phase, in the third week of November, “he said. “This means that we can know if our vaccine is effective or not by the end of october”.
“There are three key areas where, as with all vaccines, we must demonstrate success in order to gain approval for public use. First, the vaccine should prove its effectiveness, which means that it can help prevent disease in at least the majority of vaccinated patients. In second place, and equally important, the vaccine should prove your safety, with robust safety data generated from thousands of patients. And finally, we must show that the vaccine can be manufacture steadily with the most high quality standards ”, Bourla argued.
“All the data contained in our US application would be reviewed. not just by the FDA’s own scientists (regulatory body in the country), but also by a external panel of independent experts in a public meeting called by the agency ”, the company declared.
In addition, this week the company indicated that it is already planning the tests of its experimental vaccine against Covid-19 in children from the age of 12, being the first one that includes this age range in the United States.
According to Dr. Robert Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital, it will begin with adolescents 16 and 17 years, to later include people from 12 to 15 years. However, the company assured that it also has authorization to enroll children up to 12 years old.
According to Pfizer, to obtain the respective approval or authorization, wait up to 100 million doses by the end of 2020 Y 1.3 billion doses by the end of 2021.