This Friday (20), Pfizer and BioNTech filed for authorization for emergency use of the covid-19 vaccine developed by them in the United States. The companies intend to start applying to high-risk groups in December, in the country, if the application is approved by the Food and Drug Administration (FDA).
First immunization against the new coronavirus to seek release in the USA, the Pfizer vaccine proved to be 95% effective in preventing the disease, in addition to not having serious side effects. The data are in the results of the phase 3 clinical study, released this week.
Called BT162b2, the immunization jointly developed by the American pharmaceutical company Pfizer and the German biotechnology company BioNTech brings a messenger RNA. It carries instructions for the immune system to recognize the coronavirus as a threat and produce a response against it, protecting the body from future infection.
The genetic vaccine, as it is also known, needs to be applied in two doses, with a few weeks between them. According to pharmaceutical companies, protection against the Sars-CoV-2 virus, which causes covid-19, is achieved about 28 days after the initial injection.
When does the answer come out?
For now, there is no set deadline for the FDA to respond to the request for emergency authorization of the Pfizer vaccine in the U.S. But according to sources heard by CNN, the decision is likely to come out on December 10, after meetings of experts from the regulatory agency.
In an official statement, the two companies claim to have the potential to deliver 50 million doses of the immunizer by the end of this year, globally, with part going to American territory, if government authorization is granted.
For 2021, the partners report that the combined manufacturing network has the potential to provide up to 1.3 billion doses worldwide.