Pfizer COVIS-19 vaccine clears last hurdle before US FDA nod

An expert committee convened by the US Food and Drug Administration (USFDA) voted heavily in favor of recommending the Pfizer-BioNTech Covid-19 vaccine for emergency use approval on Thursday.

The final voting tally was 17 in favor, four against and one abstention.

The committee was tasked with answering whether, “based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh its risk for use in individuals 16 years of age and older?”

The vote by the independent experts and researchers, including infectious disease specialists, biostatisticians and other scientists, isn’t binding but the FDA is expected to follow the recommendation within the coming days.

Britain, Canada, Bahrain and Saudi Arabia have already approved the vaccine, the first in the world to complete a large-scale, phase 3 clinical trial.

Russian and Chinese vaccines are already being administered on a large scale, but without having completed comparable clinical trials.

The full results of the trial, which included nearly 44,000 people, were published Thursday in the New England Journal of Medicine, another major milestone.

Next week, the FDA will review a second vaccine, from Moderna and the National Institutes of Health, that appears about as protective as Pfizer-BioNTech’s shot. A third candidate, from Johnson & Johnson, which would require just one dose, is working its way through the pipeline. Behind that is a candidate from AstraZeneca and Oxford University.

Leave a Comment

Your email address will not be published.

x

COVID-19

India
Confirmed: 31,695,958Deaths: 424,773