FDA Gives Full Approval to Pfizer COVID-19 Vaccine

The U.S. Food and Drug Administration has given full approval to Pfizer’s COVID-19 vaccine for people 16 and older. “The public can be very confident that this vaccine meets the high standards of safety effectiveness and manufacturing quality the FDA requires of an approved product,” acting FDA Commissioner Janet Woodcock said in a statement Monday.The vaccine produced by Pfizer-BioTech was approved for emergency use last December. Some experts are hopeful that the full approval will encourage more vaccine skeptics to get inoculated – especially as the U.S. battles a surge in cases driven by the more contagious delta variant.In a statement released following the formal approval, Pfizer CEO Albert Bourla said he hopes the decision “will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.”The shot will now be marketed in the U.S. by the brand name “Comirnaty.”Pfizer is one of three COVID-19 vaccines for which the FDA granted emergency use authorization. Such approval requires the same scientific evidence and number of clinical trials proving the safety and effectiveness of the vaccine, but it skips some steps and technicalities concerning labeling and distribution.How Does FDA Approve Vaccines?Experts stress that 3 major COVID vaccines have already been proven safe and that full FDA approval is largely a formality involving logistics issues More than 200 million Pfizer doses have been administered in the U.S. and hundreds of millions more worldwide.Information from AP and Reuters was used in this report.

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