Statement of Support for US FDA: Science & Evidence-based Review and Approval of COVID-19 Vaccines for Use in the US

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American College of Clinical Pharmacology

Dec 08, 2020, 08:26 ET

ASHBURN, Va., Dec. 8, 2020 /PRNewswire/ -- The COVID-19 pandemic has resulted in an immense number of deaths, disrupted economies worldwide and is a public health emergency. The US Food & Drug Administration (FDA) is the federal authority assuring vaccines are effective and safe before approval for use in humans in the US. FDA Leadership stated approvals of COVID-19 vaccines will be evidence-based, transparent and follow sound science and established legal and regulatory standards. This assurance will enhance public confidence and facilitate uptake of vaccines for effective management of the pandemic.

Prior to the start of large-scale human vaccine trials, the FDA issued a guidance to enable vaccine developers understand FDA expectations for approval for human use. To ensure vaccines are safe and effective for widespread use, the guidance specifies inclusion of racial and ethnic minorities, the elderly and individuals with underlying medical conditions. The FDA proactively implemented steps for emergency use authorization based on data from ongoing clinical trials to make an informed risk-benefit assessment before releasing vaccines to the public.

This communication by the American College of Clinical Pharmacology^® (ACCP), a leading US professional society representing academia, industry, government and clinical settings whose members have drug and vaccine development expertise and are dedicated to improved health by optimizing therapeutics, aims to enhance public understanding of the FDA's focus on approving vaccines for COVID-19 based on sound scientific principles and evidence-based approaches. ACCP believes transparent approaches are the foundation of the FDA's long-standing mandate of protecting public health in the US and the Agency consistently follows its mandate during this health emergency. ACCP fully supports and commends the FDA in its endeavor to approve or authorize vaccines based on science and evidence-based approaches for the prevention of COVID-19.

Dr. Donald E. Mager, President, ACCP emphasized, "The challenges of rapidly developing safe and effective vaccines for the prevention of COVID-19 make it clear that decisions must be based on the principles of clinical pharmacology and good science. In keeping with the mission of the ACCP Public Policy Committee and the traditional regulatory paradigm of the FDA, this Policy Statement should raise public awareness and support for the objective, transparent and evidence-based review and approval of COVID-19 vaccines."

About ACCP
ACCP is a non-profit providing Continuing Education and career-enhancing opportunities to clinical pharmacology professionals.

SOURCE American College of Clinical Pharmacology