Sec'y of HHS extends PHE for another 90 days
How does this effect EUA products?
Just announced, the Secretary of HHS Xavier Becerra extends the Public Health Emergency (PHE) declaration for another 90 days. This has been an automatic function of the Secretary’s office since the original COVID related PHE was declared in January 2020.
Some confusion out on social media channels and several questions have been asked.
Are the Emergency Use Authorizations (EUA) effected by the PHE? Short answer, No.
The Secretary of HHS has authority under Section 319 of the Public Health Service Act to declare a PHE. However, the Emergency Use Authorization jurisdiction and authority comes from Section 564 under the Federal Food, Drug and Cosmetic Act (FD&C).
Before the FDA can issue an EUA for a drug, medicine, vaccine or medical device, the Secretary of HHS must declare why it is needed. What circumstances warrant the use of a product under Emergency Use Authorization.
An EUA declaration can continue without a PHE declaration, until the Secretary of HHS terminates the EUA provision.
The original EUA designation for the COVID era was declared on February 4, 2020 for the following:
In vitro diagnostics
Respiratory devices
Other medical devices
Drugs and biologics
December 11, 2020, Pfizer received their initial EUA declaration for their vaccine.
December 18, 2020, Moderna received their initial EUA declaration for their vaccine.
February 27, 2021, J&J received their initial EUA declaration for their vaccine.
Can the FDA or Secretary of HHS terminate a C19 vaccine for a specific age group? The answer is yes.
Pfizer’s Bi-valiant C19 vaccine has EUA designation for 6 month old babies to 4 years of age. Another EUA is for children 5 years of age and older. FDA or the Secretary of HHS can terminate the EUA status for 6 month olds without effecting the EUA status for older kids and adults.
If the Secretary of HHS terminates the EUA designation for a specific product, then any EUA declaration will cease to be in effect. The notice of termination will be published in the Federal Register with an effective date. This original notice will include a transition period.
A specific EUA may be revoked by the FDA if the circumstances justifying issuance no longer exist or the criteria for its issuance are no longer met.
Now some speculation.
If The PREP Act is scheduled to be terminated starting in 2024, it does appear that the EUA products will be continue to receive their immunity protections from lawsuits until when?
My bet is on the actions of the Secretary of HHS announcing the BLA versions will be added to the NVICP with 6-8 months notice to the public, which in turn gives Pharma ample time to ramp up production of the BLA product. FDA’s fully approved designation of a biologic product such as a vaccine is referred to as BLA. Pfizer’s vaccine, Comirnaty, is not being administered to the general population. Only the EUA version. When BLA versions are added to the NVICP, then the EUA designations will be terminated. What a disaster this has become.
Keep learning, keep challenging yourself and always, always question authority.
Wayne Rohde, author of 2 books on the National Vaccine Injury Compensation Program. www.thevaccinecourt.com
upcoming projects include papers on compensation programs or schemes from other countries around the world and a future book called “The Rise of Medical Fascism”.
They want to bridge over until the time when the international health rules-based order by the WHO takes effect. Being worked on in closed meetings since this Tuesday in Geneva Switzerland, in parallel with WEF MTG in Davos Switzerland.
Hi Wayne, great article and I’ve heard you speak on a Higherside chat podcast last year. I’ve learned a lot from you! I’ve done research on what allows the HHS/FDA to issue EUAs.
PREP act was a result of Project Bioshield, which was a result of 9/11, the 2001 Anthrax “scare”, and then fear of terrorism threats from Chemical, Biological, Radiological, or Nuclear (CBRN) agents. Keyword “terrorist” or intentional warfare threats.
Pandemics or any disease not caused by intentional acts was added in 2013 via the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) allowing the FDA to grant EUA of unapproved drugs, vaccines and other medical countermeasures during a Pandemic. PAHPRA of 2013 allowed the 2004 Section 564 (b)(1) amendment of the FD&C Act to not only allow EUA during bioterrorism emergencies but also any other medical emergency declared by the President or HHS Secretary.
Anyone who doesn’t like what is going on with Covid and the ability for unapproved vaccines to be used on the public should ask their congress representatives to repeal PAHPRA, PREP, and Bioshield.