Are we entering an era of continuous PHE and Prep Act Declarations??

With the signing of the 90 day renewal (October 13, 2022) of the Public Health Emergency declaration by the Sec’y of HHS, we need to start asking the question, “Are we in a state of perpetual approval of the Public Health Emergency and continuation of The PREP Act(s)?”

For the COVID era, the first PHE was issued in January 2022 and The PREP Act was declared active in March 2020. The PHE has been renewed every 90 days since then.

The PREP Act declared active by the Sec’y of HHS for a four year term plus a six month wind down.

The renewal of the PHE has been automatic by both Sec’y Azar in the Trump Administration and the current Sec’y Becerra in the Biden Administration. The Biden Administration wrote a letter (Jan 21, 2021) to all the governors telling them if and when a decision is made to NOT renew the PHE, each governor will be given a 60 day advance notice.

Without the renewal of the PHE for COVID, all sorts of dominos start to fall. The PREP Act will start its sundown process earlier than Oct 2024. EUA status with all the COVID countermeasures including products from Moderna, Pfizer, Gilead Sciences (makers of Remdesivir) would all have their nearly exclusive indemnification and liability free status removed.

The Sec’y of HHS has full authority to determine what products will be used under the EUA umbrella. Under section 564 of the Food, Drug and Cosmetic Act, if the Sec’y of HHS declares EUA is appropriate, the FDA may approve unauthorized medical products or medical uses to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear (CBRN) threat agents when certain criteria are met, including when the known and potential benefits of the authorized use outweigh the known and potential risks.

This is where we witnessed the coordinated effort to discredit the repurpose use of certain exiting medicines that would, if allowed to be used, undermine the EUA status of Project Worp Speed initiatives.

In addition, there are billions of dollars being sent to your school, school district, colleges and universities authorized by the $2.3 trillion dollar CARES Act passed in March 2020. For these monies to continue to flow, the PHE must be in place.

Yet if you think The Public Health Emergency is just for COVID, think again. Do you know that we have another PHE declared running simultaneously with the COVID declaration?

Previous declarations of PHE were originally for specific geographical regions affected by hurricanes, tornado and storm damage or flooding. Then came H1N1 outbreak with the first declaration of a PHE in April 2009 and extended thru May 2010.

The Zika virus PHE declaration in Puerto Rico in August 2016 was later expanded to a national PHE in November 2016 and extended every three months until June 2017.

Hurricanes, wildfires, earthquakes and storm damage still dominated the use of declaring a PHE. Then Sec’y Azar declared a national PHE for the opioid crisis in October 2017 that continues today with the last renewal, Sept 29, 2022.

Sec’y of HHS Becerra declared on August 4, 2022, a public health emergency against monkeypox with over 6,600 cases. More than any other country. Hmm

With this PHE, the Sec’y now issues a PREP Act declaration and amends the existing Act with the following for smallpox medical countermeasures

• Reflects a determination by the Secretary that there is a credible risk that smallpox (variola virus), monkeypox virus, or other orthopoxviruses and the resulting disease or conditions in the future may constitute a public health emergency and that the 2022 outbreak of monkeypox cases in the United States presents a public health emergency;

• Provides liability immunity (except for willful misconduct) to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures;

• Authorizes additional providers to administer vaccines and therapeutics for the identified diseases, threats, and conditions during a declared emergency; and

• Provides liability immunity for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to the identified diseases, threats and conditions.

As with any injuries or death suffered from the COVID countermeasures, any injuries or death from the monkeypox vaccine or other EUA products, the petitioner must file for compensation in the blackhole known as the CounterMeasures Injury Compensation Program.

But we are not finished.

Keep you eye on the Ebola outbreak in Uganda, Africa. An Ebola vaccine countermeasure that is currently stored in the US Strategic National Stockpile. UNICEF also plays a role here. They are the stockpile for the Ebola vaccine with financial support from Gavi, The Vaccine Alliance.

Do you remember the Ebola scare in the US several years ago. The media does and will start ramping up propaganda efforts soon. 11 people were treated for Ebola during the 2014-2016 treatment campaign in the US. Only one medical practitioner developed Ebola in the US while caring for a patient that was transported from Africa to Dallas, Tx. That medical practitioner was treated and recovered. The two patients that died from Ebola in the US were transported from Africa while infected. The others were all successfully treated and later released.

Continuous use of PHE is expected. Natural disasters and related storms are expected. I get that. And the use of PHE to respond to those emergencies is warranted.

However, I get the feeling that the use of PHE to keep The PREP Act in operation is suspect.

Keep learning, keep challenging yourself and always, always question authority.