According to a person familiar with the choice but not approved to explain it publicly, the United States gave the final go-ahead yesterday to the nation’s first Covid-19 vaccine, considering what could be the opening of the end of an outbreak that has killed nearly 300,000 Americans.
Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia said, “I don’t think you would have found a scientist on this planet that would have predicted this 11 months ago.” BioNTech’s Sahin said, “We would need at least until March, April, to have an impact on the pandemic.”
The FDA is different in investigating drugmakers’ raw data, a manner that takes longer than many other countries’ supervisory reviews. Also, the FDA requested that large COVID-19 vaccine subjects track at least half the cooperators for two months to look for side effects, a period when historically any vaccine problems seem.
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