BACK IN 2020, FDA SET VAX GOAL OF JUST 30% PRIMARY EFFICACY

Jan 18, 2022

Rob Lauer Political Reporter

On Aug 1, 2020, 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 before Congress about the progress of vaccine research. The FDA released their CV19 vaccine guidelines as some 30 vaccines were currently in trials around the world.

The U.S. had conducted some 51 million CV19 tests and had 4.5 million positive test results at the time. They did not indicate whether any of the tests were performed on infected folks or folks in quarantine. 151,000 Americans had died from CV19 which was a death rate of .0004% of the total National population of 330,000,000 at the time.

The three Government scientists reviewed the vaccine research and approval guidelines issued by the FDA. CDC Director Redfiled said he was looking for a minimum of 50% effectiveness but the FDA guidelines issued accepted 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

Today, hospitals are flooded with vaccinated Americans sick with the Delta and omicron variants. The FDA has now approved a 3rd booster within 12 months of the original CV19 vaccine release date. The CDC and Dr. Fauci now insist that everyone should wear masks even those vaccinated with boosters.

The vaccine has neither prevented folks from contracting CV19 and the variants nor from transmitting it nor from dying from it. Vermont has the highest number of vaccinated folks in the country and the highest infection rate.