SSM Health St. Clare Hospital - Fenton: Pfizer's FDA Approval 'A Milestone'

Press release from SSM Health St. Clare Hospital - Fenton:

August 23, 2021

The U.S. Food and Drug Administration has officially approved the Pfizer vaccine to prevent COVID-19 infection in people age 15 and older. The drug remains under Emergency Use Authorization for children between 12 and 15, as well as for usage as a third dose booster for people with certain immunocompromised conditions.

Although the move was expected, Dr. Janet Woodcock, the acting FDA commissioner, said the approval “is a milestone as we continue to battle the COVID-19 pandemic.”

The FDA’s approval is also expected to provide reassurance to those who were reluctant to receive the vaccine while only approved for emergency use, and to spur organizations to mandate the vaccine for staff members. The U.S. military, for example, immediately mandated the vaccine for all service members following the FDA announcement.

Full approval of the Moderna and Johnson & Johnson vaccines are anticipated in the near future. (Pfizer was the first to apply for full approval.)

“The FDA conducted a thorough scientific review of the Pfizer vaccine, and we’re grateful for this outcome,” said Dr. Shephali Wulff, SSM Health director of infectious diseases. “Our patients and communities can have confidence in this fully vetted defense against the worst disease we have seen in our lifetimes.”

Third doses of the Pfizer and Moderna vaccines will be available at SSM Health locations beginning in mid-September, pending guidance from the Advisory Council for Immunization Practices, a subgroup of the CDC. Patients’ second doses must have been administered eight months earlier. To schedule or sign up for an account, visit MyChart.

This press release was produced by SSM Health St. Clare Hospital - Fenton. The views expressed here are the author’s own.