GAO Report Critiques FDA’s COVID-19 Vaccine Manufacturing Oversight

November 5, 2021

COVID-19 vaccine makers didn’t undergo preapproval facility inspections before receiving Emergency Use Authorizations (EUAs) from the FDA for their jabs, the Government Accountability Office (GAO) says.

The GAO’s analysis, titled “COVID-19 — Additional Actions Needed to Improve Accountability and Program Effectiveness of Federal Response,” mainly focused on other HHS agencies and government departments and only dealt with the FDA’s role in two appendices.

It notes that the FDA was not required to conduct inspections prior to the emergency authorizations of the Pfizer/BioNTech, Moderna and Johnson & Johnson (J&J) vaccines, all of which occurred during the pandemic, when the agency drastically curtailed inspections.

The GAO’s assessment found that “14 of the 18 establishments that manufacture COVID-19 vaccines had been previously inspected at least once” within the past decade, comprising a total of 90 inspections. For all but one of the 14 facilities, the GAO said, the FDA’s most recent inspection occurred within the past four years.

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