Fauci Ready to Approve a COVID-19 Vaccine Only 50/50 Effective
While Hahn at the FDA Demonizes Hydroxychloroquine
FDA Twists Medical Logic to Favor an Ineffective COVID-19 Vaccine over Clinical Evidence HCQ Protocol Is Effective in Treating Early-Stage COVID-19
Physicians Urge Trump to Issue an Executive Order Approving Hydroxychloroquine as a “Right to Try” COVID-19 Medication
Jerome R. Corsi
Last Friday, Dr. Anthony Fauci, Director of the NIH Institute for Allergy and Infectious Diseases, made clear that the FDA was prepared to approve a COVID-19 vaccine, even if the vaccine proves only 50 percent effective in preventing a person from contracting the disease.
This means the FDA is ready to declare a COVID-19 vaccine as approved under an Emergency Use Authorization (EUA) if there is a 50/50 chance a person could get COVID-19 after taking the vaccine.
Detailed examination of the FDA standards also makes clear that for a COVID-19 vaccine to be approved under an EUA, the FDA must not approve hydroxychloroquine as an approved medication for COVID-19.
In other words, official FDA policy is currently rigged to approve the use of a relatively ineffective COVID-19 vaccine provided that hydroxychloroquine remains demonized by the FDA for treatment of COVID-19 despite clinical results worldwide that suggest the efficacy of Dr. Vladimir Zelenko’s protocol (hydroxychloroquine + zinc + azithromycin or doxycycline) for treatment of early stage COVID-19 and prophylaxis.
Fauci’s statement that a COVID-19 vaccine will be approved for COVID-19 under a FDA EUA as long as it is 50 percent effective derives from a FDA policy articulated on July 29, 2020, by Doran Fink, MD, Ph.D., in the FDA/CBER (Center for Biologics Evaluation and Research) Office of Vaccines Research and Review. In a series of eight slides, Dr. Fink articulated the standards for the FDA issuance of Emergency Use Authorization (EUA) for COVID-19 vaccines.
The fifth slide in the presentation was the most important, articulating the qualifying criteria required under a declaration by the Secretary of Health and Human Services of an “emergency situation leading to serious or life-threatening disease or condition.” Once the HHS Secretary makes this declaration, the FDA standard for issuing an EUA is that a medical treatment “may be effective.”
Slide #5 is presented here
Slide #5: Doran Fink, MD, Ph.D., “Considerations for FDA Licensure vs. Emergency Use Authorization of COVID-19 Vaccines,” July 29, 2020
Interestingly the last point on the slide specifies an additional condition, a FDA EUA can be authorized for a treatment of a possibly effective medication in a health emergency provided the FDA has no adequate, approved, and available alternative. Clearly, this condition necessitates the FDA must refrain from approving hydroxychloroquine as an approved COVID-19 treatment, or the COVID-19 vaccine would have to undergo the more rigorous tests for a vaccine to be FDA licensed – tests that might require the COVID-19 vaccine to establish efficacy after undergoing Randomized Controlled Tests (RCT).
In twisted logic that reflects a desire by the NIH, CDC, and FDA to favor only medical treatments developed by major pharmaceutical companies, FDA Director Dr. Stephen Hahn has insisted hydroxychloroquine must be proved effective in treating COVID-19 by RCT evidence. This despite the abundant clinical evidence that today would qualify hydroxychloroquine to be approved right now by the FDA under the EUA “may be effective” standard given that currently there is no FDA approved medical treatment for COVID-19.
The FDA logic is further twisted when we realize Dr. Hahn has left hydroxychloroquine as a FDA approved medication for malaria, lupus, and rheumatoid arthritis. Hahn has acknowledged MDs are today allowed under FDA rules to prescribe hydroxychloroquine for COVID-19 as an “off label” medication.
Thus, MDs are free to use their professional judgment to ignore the FDA’s warnings that prescribing hydroxychloroquine for COVID-19 may risk causing heart complications. Ironically, the FDA does not issue similar “heart complication” warnings for the prescription of hydroxychloroquine for malaria, lupus, and rheumatoid arthritis.
In an interview archived on CorsiNation.com, physician Stella Immanuel, MD, has urged President Trump to issue an executive order allowing the over-the-counter sale of hydroxychloroquine as a COVID-19 treatment under “Right to Try” authority.