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The US Food and Drug Administration analyzed data provided by the manufacturers of the BNT162b2 coronavirus vaccine: the US company Pfizer and the German company BioNTech. – and concluded that there were no “specific safety problems” that would prevent the authorization of vaccines in an emergency.
The United States Food and Drug Administration (FDA) confirms the safety and efficacy of the BNT162b2 coronavirus vaccine, produced by the American company Pfizer in conjunction with the German BioNTech.
This is indicated in an FDA information report released Dec. 8 ahead of an advisory committee meeting, which is expected to approve the use of the vaccine for those 16 and older.
The FDA reviewed the data provided by the manufacturers of BNT162b2 in an application for authorization for use of the vaccine in an emergency and concluded that there were no “specific safety concerns” that prevented authorization from being granted.
The agency confirmed that the vaccine was 95% effective seven days after the second dose and was consistent across all demographics.
Side effects were short-term (lasting up to two days), with injection site pain, fatigue, headache, muscle pain, chills, and joint pain being the most common.
The advisory council meeting is scheduled for December 10.
The UK has already approved the BNT162b2 vaccine for general use. The UK was the first in the world to launch a large-scale immunization campaign on December 8. The first dose was given to a 90-year-old woman.
Head of the World Health Organization Tedros Adhanom Ghebreyesus called the Pfizer vaccine “very promising”.
Pfizer announced on November 18 that the BNT162b2 vaccine against COVID-19 is 95% effective.
Companies Pfizer and BioNTech They expect to produce up to 50 million doses of the vaccine in 2020 and up to 1.3 billion by the end of 2021. Pfizer has already sold about 82% of doses.
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