News: Pfizer COVID-19 vaccine receives FDA approval

The Food and Drug Administration (FDA) officially approved the first COVID-19 vaccine, on Monday, August 23, according to a   news release stating the approval of the Pfizer vaccine. The vaccine is approved for individuals 16 years and older, and for individuals between the ages of 12 and 15 under emergency use authorization. The FDA also approved its use of a third dose in immunocompromised individuals.

“Our 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 [its] safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research. “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."

“This study is an affirmation of the dire need for health literacy and awareness, access to healthcare, and understanding of the challenges for the Black, Hispanic, and Asian American communities,” says Angelica Naylor, MBA, BSN, RN, CCDS, chair of the ACDIS Diversity and Inclusion Task Force and CDI consultant and manager with Trust Healthcare Consulting Services, a CorroHealth Company based in Plano, Texas. “Cultural competence education and training should be standard as part of new hire orientation and annual competencies to understand the differences in family, culture, and medical, especially mental health, perceptions in these communities.”

Editor’s note: The FDA press release can be found here. Additional ACDIS coverage of COVID-19 can be found here.