In a letter to FDA, AGA along with the Council of Medical Specialty Societies ask that the COVID-19 vaccine approval process be fully transparent and not circumvent regulatory standards. Specifically:
- Sound safety and efficacy data that are reviewed by FDA and independent vaccine experts must support the authorization or licensure of a COVID-19 vaccine.
- The vaccine should be studied in the populations who are at greatest risk of serious illness and death due to COVID-19, including older individuals, health care workers and people with chronic conditions.
- The vaccine should also be studied in populations that face disparities in care and who have been disproportionately impacted by the pandemic.
AGA, along with the council, is concerned that approving a vaccine that has not been shown through clinical trials to be safe and effective could cause more harm by significantly undermining COVID-19 vaccination efforts and seriously eroding public confidence in all vaccines.
