The Food and Drug Administration recently gave formal approval for the two-dose Pfizer-BioNTech coronavirus vaccine for those 16 and older – a decision which the federal agency called “a milestone.”
“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,” Acting FDA Commissioner Janet Woodcock said in a statement Monday, Aug. 23.
The Pfizer vaccine still remains under emergency use authorization for youth 12 to 15 years old.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Monday on PBS News Hour the FDA should have additional data for those teenagers by the fall.
“The FDA will have to make a risk-benefit analysis of whatever safety signals, depending upon what it means for the benefit of the children,” he said.
In regard to why Pfizer received approval before the other companies that also manufactured a vaccine, Moderna and Johnson & Johnson, Fauci said Pfizer presented its data first.
“People need to understand it’s a timing issue – not an efficacy or a safety issue,” he said.
Fauci said the formal approval could convince school and college officials and business owners to “feel comfortable” instituting vaccine mandates.
The mandates began the same day with announcements from several major agencies and businesses including the Pentagon (which will include all members of the military), the State University of New York system and CVS.
Locally, school officials in the District of Columbia and Prince George’s, Howard and Montgomery counties in Maryland have already announced mask mandates for students, teachers and other staff. Employees must receive a vaccine by a specified date or adhere to regular COVID-19 testing.
Maryland Gov. Larry Hogan sent a letter Monday to President Joe Biden requesting the administration take immediate action on COVID-19 vaccine distribution.
The governor’s request includes making booster shots immediately available for the more than 280,000 Marylanders who received the one-dose Johnson & Johnson vaccine, advance full approval for Johnson & Johnson and the two-dose Moderna vaccine and expedite a vaccine for children ages 5 to 12.
Maryland remains one of the most vaccinated states in the country with 80% of adults receiving at least one dose. As of Tuesday, Aug. 24, the state Department of Health notes 875,795 Blacks have been vaccinated.
“The challenges states around the country are facing with the Delta variant have proven we cannot becomplacent and must continue taking all possible steps to protect our citizens, particularly those most vulnerable to serious illness and death,” Hogan wrote. “Now is not the time for bureaucratic delays.”
A vaccine remains unavailable for children younger than 12 but clinical trials continue as the FDA waits for more data.
The American Academy of Pediatrics issued a statement Monday at https://bit.ly/3B8BSBo which “strongly recommends” for adolescents 12 and older to get a shot in the arm. The organization also urges physicians to refrain from prescribing a vaccine for younger children.
Editor’s Note: The FDA’s announcement has full authorization has many public health officials hopeful that it will encourage people who had been reluctant to get a shot now. During his interview with PBS reporter Judy Woodruff, Dr. Fauci shared more about the following: booster shots and the Delta variant’s threat to children; his hope that other COVID-19 vaccines will receive full approval by the FDA within weeks; the additional pain and suffering which lies ahead as COVID-19 cases rise; and the CDC’s revisions for mask guidelines, vaccine requirements and criticisms lodged by Republicans against thosepolicies.
For the full transcript, visit www.pbs.org/newshour/tag/anthony-fauci.