Covid-19: Pfizer and BioNTech submit application for vaccine approval in the US
The American pharmaceutical group Pfizer and the German company BioNTech confirmed today that they will deliver an application for approval for the commercialization of the vaccine against covid-19, that they have developed, this Friday to the competent American authorities.
They will be the first to do so in the United States of America (USA).
The announcement of the order with the FDA (Food and Drug Administration), the US federal agency responsible for control and supervision of the food and pharmaceutical sector, comes a few days after the pharmaceutical company Pfizer and BioNTech (German biotechnology company) announced that their vaccine is 95% effective in preventing covid-19 disease, without serious side effects, according to the results of a clinical trial.
The vaccine clinical trial, developed since July, involved 44,000 volunteers in several countries.
The FDA has not indicated how long it will take to evaluate the data, but the incumbent US administration expects the authorization to be approved in the first half of December.
Original article available in Portuguese at http://postal.pt/