The U.S. Food and Drug Administration on Monday issued formal approval of the Pfizer COVID-19 vaccine, clearing a hurdle for many who worried that the life-saving vaccine wasn’t yet fully approved.
Last December, the vaccine received an emergency use authorization from the agency for those aged 16 and up, and dropped the age to 12 and up in May.
“We have high levels of disease transmission in every county throughout the state. COVID-19 vaccination will help keep our communities safe and our children in school,” said Alabama State Health Officer Dr. Scott Harris in a statement Monday.
Harris said that for those who have only received one dose of the Pfizer or Moderna vaccines and have delayed completing the two-dose series, it is not too late to get their second dose.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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 Dr. Janet Woodcock in a statement.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” Woodcock said.
Dr. David Kimberlin, co-director of UAB and Children’s of Alabama’s Division of Pediatric Infectious Diseases, at a press briefing Monday urged everyone 12 and older to get vaccinated. The only virus better at spreading among people today is measles, which he described as a “heat-seeking missile.”
“Delta is a very concerning turn of events for us. No question, and I think we’re seeing that across our state. We’re seeing it in our pediatric hospitalizations,” Kimberlin said.
“We definitely are seeing more severe disease and in larger numbers in severe cases with delta. That’s a given,” Kimberlin said of children being hospitalized with COVID-19, noting that approximately 40 percent of those children have no other pre-existing conditions.
Kimberlin also discussed COVID-19’s impact on pregnant women and their babies and urged pregnant women to get vaccinated to prevent premature births and deaths.
“We know that the COVID vaccines are safe and highly effective in pregnant women, and we have had a number of newly-delivered women who have died from their COVID disease, and their babies are going home with their dads, or maybe even dad has died as well, and they’re going home as an orphan,” Kimberlin said.
Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a statement that the scientific and medical experts conducted an “incredibly thorough and thoughtful evaluation of this vaccine.”
“We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” Marks said.
“We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,” Marks said.