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The US government advisory panel recommended that Pfizer COVID-19 be approved for use.
The Food and Drug Administration vote to recommend approval of the vaccine represents the penultimate hurdle before the launch of the largest vaccination campaign in US history.
Depending on how quickly the FDA approves the panel’s recommendation, which it is expected to do, the hits could start in a few days.
The advisory group, in a vote of 17 to 4 and one abstention, voted to answer yes to the question: “Based on the totality of the available scientific evidence, do the benefits of Pfizer-BioNTech COVID-19 Does the vaccine outweigh its risks for use in people 16 years of age and older? “
Coronavirus it has killed nearly 300,000 people in the US so far, and infections continue to rise in the country.
The FDA’s endorsement came despite questions about allergic reactions in two people who received the vaccine earlier this week, when the UK became the first country to start dispensing the Pfizer-BioNTech injection.
Panel member Dr. Paul Offit of Children’s Hospital of Philadelphia concluded that the potential potential benefits of the injection outweigh its risks.
Despite all the remaining unknowns, in an emergency, “the question is whether you know enough,” he said.
Independent review by nongovernmental experts in vaccine development, infectious disease, and medical statistics was deemed critical to increasing Americans’ confidence in the safety of the vaccine.
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Margaret Keenan, 90, was the first person to receive the Pfizer / BioNTech vaccine outside of a clinical trial.
The vaccine was developed at an unprecedented speed, less than a year after the virus was identified.
While millions of vaccines will be shipped to begin vaccinating healthcare workers and nursing home residents as soon as approval has been granted, widespread access to the general public is not expected until spring.
With unprecedented interest in the normally obscure panel, the FDA streamed the meeting live via YouTube and thousands of people logged on.
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Former Chief Scientific Advisor Says Pfizer / BioNTech Vaccine Has Undergone ‘Regulatory Scrutiny’
“The American public demands and deserves a rigorous, complete, and independent review of the data,” said FDA’s Dr. Doran Fink, adding that the agency’s scientists had been working nights, weekends and during Thanksgiving to get there.
It comes eight days after the The United Kingdom became the first country in the world to approve the vaccine., which according to studies has an efficacy of 95%.
Meanwhile, the first 30,000 doses of the vaccine will arrive in Canada in the next few days and should be ready to be administered next Monday, senior officials said.
Canada was only the third country in the world, after Great Britain and Bahrain, to approve the vaccine.
