FDA To Release Guidelines for COVID-19 Vaccine Approval

U.S. FDA to release guidance on COVID-19 vaccine approval – WSJ

Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli/Reuters

(Reuters) – The U.S. Food and Drug Administration plans to release guidance on Tuesday outlining its conditions for approving a vaccine for the coronavirus, the Wall Street Journal reported, citing a summary of the guidance.

The agency would require drugmakers to show “clearly demonstrated” proof of a vaccine’s safety and effectiveness through a clinical study, and at least 50% more effectiveness than a placebo, the report here said.

There is currently no U.S.-approved treatment or vaccine for the respiratory illness that has claimed over 126,100 lives in the country, according to a Reuters tally.

More than 100 vaccines are being tested worldwide against the virus, with only a handful in the human testing phase, including candidates from AstraZeneca Plc and Moderna Inc.

Experts have suggested that it could take a minimum of 12 to 18 months to guarantee a safe and effective vaccine through clinical trials.

The guidance is expected to be discussed by FDA Commissioner Stephen Hahn in an appearance before a Senate committee on Tuesday, the report said.

Carol Duff, MSN, BA, RN

Carol graduated from Riverside White Cross School of Nursing in Columbus, Ohio and received her diploma as a registered nurse. She attended Bowling Green State University where she received a Bachelor of Arts Degree in History and Literature. She attended the University of Toledo, College of Nursing, and received a Master’s of Nursing Science Degree as an Educator.

She has traveled extensively, is a photographer, and writes on medical issues. Carol has three children RJ, Katherine, and Stephen – one daughter-in-law; Katie – two granddaughters; Isabella Marianna and Zoe Olivia – and one grandson, Alexander Paul. She also shares her life with her husband Gordon Duff, many cats, and two rescues.

• Carol’s Archives 2009-2013