FDA: >30% COVID-19 VACCINE EFFECTIVENESS ACCEPTABLE

Aug 1, 2020

Rob Lauer Political Reporter

The National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci, Centers for Disease Control and Prevention director Dr. Robert Redfield and Assistant Secretary for Health at Department of Health and Human Services, Admiral Brett P. Giroir, testified this week before Congress about the progress of vaccine research. The FDA released their CV 19 vaccine guidelines as some 30 vaccines are currently in trial around the world.

U.S. has conducted some 51 million Cv19 tests and had 4.5 million positive test results. They did not indicate whether any of the tests were follow tests for sick folks or folks in quarantine. 151,000 Americans have died from CV19 which is an death rate of .0004% of the total National population of 330,000,000.

The three reviewed the vaccine research and approval guidelines issued by the FDA. CDC Director Redfiled said he is looking for a minimum of 50% effectiveness but the FDA guidelines issued accept lower efficacy standards.

Page 17, Section E. states the FDA will approve a vaccine “the statistical success criterion should be that the lower bound of the appropriately alpha-adjusted confidence interval around the primary efficacy endpoint point estimate is >30%.”

Statistical Considerations
• To ensure that a widely deployed COVID-19 vaccine is effective, the primary
efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at
least 50%, and the statistical success criterion should be that the lower bound of
the appropriately alpha-adjusted confidence interval around the primary efficacy
endpoint point estimate is >30%.

https://www.fda.gov/media/139638/download