The Food and Drug Administration (FDA) on Monday granted full approval for the Pfizer-BioNTech COVID-19 vaccine, opening the door for vaccine mandates across the US.
This comes just days after the Director of the Center for Disease Control (CDC) Rochelle Walensky said that COVID-19 “vaccine effectiveness against SARS-CoV-2 is waning,” adding that those who were “vaccinated early” are at an “increased risk of severe disease.”
The FDA has fully approved the Pfizer coronavirus vaccine for people ages 16 and older, paving the way for vaccine mandate policies, according to mainstream media reports. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock in an FDA news release. The Pfizer vaccine will now be marketed as “Comirnaty” (koe-mir’-na-tee). (READ MORE: Tennessee Woman Left Paralyzed And Unable To Walk After Taking Pfizer Vaccine)
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“The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy,” the release states. (READ MORE: CNN Shocked When NFL Legend Brett Favre Expresses Skepticism Toward COVID Vaccines)
The FDA approval of the Pfizer vaccine comes just days after the Director of the CDC admitted that the effectiveness of the COVID-19 vaccines are “waning,” confirming earlier reports by National File. “We are seeing concerning evidence of waning vaccine effectiveness over time and against the Delta variant,” Rochelle Walensky said during a White House Press Briefing. “Reports from our international colleagues, including Israel, suggest increased risk of severe disease amongst those vaccinated early.”