Saturday, November 21, 2020

Pfizer and BioNTech submit their Covid vaccine for US approval


 Pfizer and BioNTech submitted their Covid-19 shot for emergency authorisation in the US  becoming the first pharmaceutical companies to apply for regulatory approval of a coronavirus vaccine .

If Pfizer’s application is approved, the vaccine will likely be limited and rolled out in phases, with health-care workers, the elderly and people with underlying health conditions getting the first inoculations. Essential workers, teachers and people in homeless shelters and prisons would likely be next, followed by children and young adults.

The FDA process is expected to take a few weeks, and an advisory committee meeting to review the vaccine has been tentatively scheduled  for early December. Some Americans could get their first dose of the vaccine in about a month.

The final analysis evaluated 170 confirmed Covid infections among the late-stage trial’s more than 43,000 participants. The companies said 162 cases of Covid were observed in the placebo group versus eight cases observed in the group that received its two-dose vaccine. That resulted in an estimated vaccine efficacy of 95%, they said.


 


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