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Φωτ. Victoria Jones / Pool via REUTERS
It is one step away from being approved by the US authorities the Pfizer vaccineas documents released today by the US Food and Drug Administration (FDA) certify that the Pfizer BioNTech product is safe and effective.
The 53-page FDA report is the first indication for vaccine evaluation by US authorities, and it is the most detailed independent study to date of data published by the two companies to date.
FDA Scientists Conduct Their Own Comprehensive Investigation and Confirm Pfizer’s Assessment that is, their vaccine was 95% effective.
They also confirmed that its short-term side effects (pain in extremities, exhaustion, headaches, muscle aches) are actually tolerable, while they cease after two days.
The FDA document also states that monitoring 38,000 volunteers in the two months after their vaccination provided strong evidence of “a safe environment with no safety concerns, which could block the urgent licensing process.”
The following steps
On Thursday, an expanded group of FDA advisers will hold an all-day public meeting to discuss the data and make recommendations on whether the vaccine should be approved for immediate use.
The final decision is expected to be made in the days following this public meeting.
Delivery of the first installments is expected to begin just hours after final approval.
The goal is to distribute around 6.4 million doses of the vaccine in the first week.
– With information from the Washington Post
