10/16/2020 11:07 AM
Clarín.com
Society
Updated 10/16/2020 11:07 AM
The US pharmaceutical giant Pfizer announced on Friday that it plans to request an emergency authorization for its coronavirus vaccine in late November, about two weeks after the US presidential election.
"
Assuming the data is positive
, Pfizer will apply for an emergency use authorization in the United States shortly after the safety phase ends, in the third week of November," said company CEO
Albert Bourla
in a published open letter. in social networks.
Following this announcement, the company's shares were gaining more than 2% in the electronic market before the opening of the stock market.
Thus, the
United States could have two vaccines ready by the end of the year
- if the ongoing clinical trials are conclusive and if the Food and Drug Administration (FDA) authorizes their distribution - since Moderna also expects to have its ready by the end of November .
President Donald Trump, who is seeking a second term, had said a vaccine could be available before the November 3 election.
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 (EUA) or Approval: https: // t .co / EVSnMNoeRQ
- AlbertBourla (@AlbertBourla) October 16, 2020
Argentina was part of the Pfizer vaccine trials.
About 4,500 people received the doses that were "very well tolerated by all the participants."
The research group explained that only "mild symptoms such as fever and local pain were reported in the area of application", coinciding with "those surveyed in the United States and Germany, where the efficacy test was also carried out."
Pfizer followed the FDA's request last week to vaccine developers to wait two months after the second dose is injected into clinical trial participants to monitor for possible serious side effects.
On the other hand, Pfizer - a partner of the German company BioNTech - could obtain results on the efficacy of the vaccine in the next two weeks through its ongoing trial,
in which 30,000 people participate, said the director of the company.
"We could know if our vaccine is effective or not
by the end of October,
" wrote Albert Bourla.
The FDA sets three conditions for approval of a vaccine:
that it is effective, that it is safe, and that the company is capable of producing it on a large scale.
Pfizer expects to meet all three requirements in the third week of November, or within a month.
For its part, Moderna hopes to do the same by November 25.
Both companies, funded by the US government, had started phase 3 of their clinical trials at the same time in late July, and both also began production of doses as a precautionary measure, with the goal of delivering several tens of millions dosage in the United States by the end of the year, if cleared by the FDA.
This institution, which promised to follow standard scientific procedures and not let political pressure interfere, is in charge of approving or not approving the vaccine and deciding which populations it will be administered in priority to.
With information from AFP.
JPE