U.S. pharmaceutical company Pfizer announced friday that it plans to apply for an emergency authorization for its coronavirus vaccine in late November.» 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,» company CEO Albert Bourla said in an open letter posted on social media.
Transparency is important so I’d like to provide greater clarity around the timelines for @pfizer’s #COVID19 vaccine and the 3 key areas where we must demonstrate success in order to submit for Emergency Use Authorization (EU) or Approval: https://t.co/EVSnMNoeRQ — AlbertBourla (@AlbertBourla)
October 16, 2020
The Pfizer vaccine and the German company Biontech, which is in phase 3 of human experimentation, is being applied to volunteers in Argentina, at the Central Military Hospital of the city of Buenos Aires. The clinical trial of this vaccine, which is carried out simultaneously in Brazil, the United States and Germany, involves 4,500 Argentines between the age of 18 and 85 who were selected from 20,000 registered volunteers. The United States could have two vaccines ready by the end of this year, as long as ongoing clinical trials are conclusive, and the Food and Drug Administration (FDA) authorizes its distribution, as Moderna also estimates that it will have its own ready by the end of next month. The FDA had last week asked vaccine developers to wait two months after the second dose was inoculated in clinical trial participants to monitor possible serious side effects.
Photo: (EFE/University of Maryland School of Medicine)
The pharmacist could get results on the effectiveness of the vaccine in the next two weeks through its ongoing trial, involving 30,000 people, the company’s director said.
«We could know if our vaccine is effective or not by the end of October»
The FDA establishes three conditions for the approval of a vaccine: that it is effective, that it is safe and that the company is able to produce it on a large scale. Pzifer and Moderna, which receive funding from the US government, had begun phase 3 of their clinical trials at the same time by the end of July, and both began producing doses as a precautionary measure, with the goal of delivering several tens of millions of doses in the United States by the end of the year, if fda authorization was received. This institution, which promised to follow standard scientific procedures and not let political pressure interfere, is responsible for approving the vaccine or not, and deciding which populations will be given priority.