Sunday, August 7, 2022

Here is how the government and industry came up with a way to wiggle out of liability for monkeypox vaccine injuries: split the dose, then give it an EUA

I am warning you that the moneypox vaccine Jynneos is a huge scam, in every way, including the supposed shortage.  I will disclose more about that soon.  The government purchased 20 million doses of Jynneos between 2003 and 2013, and purchased 8 million doses after 2013 but before the COVID pandemic, and millions more since.  It has purchased both bulk liquid frozen vaccine, and freeze-dried vaccine.

The US government has also spent about $75 million on Jynneos' manufacturer, Bavarian Nordic's "fill and finish" facility over the past 10 years, so the vaccine could be placed into vials onsite in Denmark.  In fact, the company bragged that these funds allowed it to be a "fully fledged" pharmaceutical company in a press release.

The facility was completed in 2021.  But where are the vaccines purchased by the US government?  The NY Times (below) says the manufacturer is sending frozen vaccine in bulk to the US to be filled and finished. What happened to the Bavarian Nordic factory that should have done this?  The current story is that FDA never got around to doing the factory inspection earlier...which was finally completed on July 28.  Would FDA deliberately stall an inspection to cause a vaccine shortage?

The claim was made that the original bulk vaccine expired.  But there was a "shelf life extension" program conducted with FDA that extended its life.  Did the more recent purchases expire?  What happened to them?

Since it is actually licensed, the moneypox vaccine (like other licensed drugs and vaccines) has liability attached to it.  You can currently sue government program planners, the doctor who recommended it, the manufacturer, etc. if anything goes wrong.

To forestall that, some crook came up with the idea of splitting the doses, under the guise of a fake shortage, which provides an excuse to make the lower dose an EUA (emergency use authorization)--in other words, turning it into a product for which you cannot sue anyone if something goes wrong.  Pretty clever, eh?  

Licensed products are not supposed to receive EUAs unless they are used for something different than what they were licensed for.  Splitting the dose does not change the fact it is licensed for monkeypox and being used for moneypox.  But FDA has successfully played with the definitions before.  Below is the actual law (2B) on turning a licensed product into an EUA.
(1) Emergency uses

Notwithstanding any provision of this chapter and section 351 of the Public Health Service Act [42 U.S.C. 262], and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an “emergency use”).

(2) Approval status of product 
An authorization under paragraph (1) may authorize an emergency use of a product that—
is not approved, licensed, or cleared for commercial distribution under section 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] or conditionally approved under section 360ccc of this title (referred to in this section as an “unapproved product”); or
is approved, conditionally approved under section 360ccc of this title, licensed, or cleared under such a provision, but which use is not under such provision an approved, conditionally approved under section 360ccc of this title, licensed, or cleared use of the product (referred to in this section as an “unapproved use of an approved product”).

Here is another possible but diabolical reason to split (dilute) the dose:  it potentially allows the federal government access to the vials--so the vials won't go straight from the manufacturer to the wholesaler but instead go somewhere else to be diluted.  And what is in the diluent?

From the NY Times:

...Federal officials have ordered nearly seven million doses of Jynneos, but the shots will not arrive for months. So far, the Biden administration has shipped about 600,000 doses to states. It said last week that 800,000 additional doses were being allocated to states, but the distribution could take weeks.

Faced with shortages, some cities, including Washington and New York, are restricting second doses to stretch their supplies. Officials at the Food and Drug Administration and the C.D.C. have disagreed with that strategy, noting that Jynneos is approved as a vaccine to be given in two doses spaced 28 days apart.

But as federal health officials declared a public health emergency on Thursday, Dr. Robert Califf, the commissioner of the F.D.A., said the agency was now considering authorizing shots that contain just one-fifth of the regular dose, delivered between layers of the skin instead of under it.

The F.D.A. would need to grant Jynneos an emergency use authorization in order for it to be administered this way.

The dose-sparing approach has been used when supplies of other vaccines are scarce. But giving intradermal shots requires more skill than is needed for more traditional immunizations.

One shot is probably enough to forestall severe symptoms in most people, and the dose-sparing strategy may work just as well. But it’s unclear whether a scaled-back regimen is enough to prevent infection, and if so, how long that immunity may last, federal health officials said...

On August 8, the NY Times announced that a decision had been made over the weekend and the 1:5 split dose plan, with intradermal injections, would go into effect.  The plan is based on a single study performed by some of CDC's favorite vaccine experts, some even members of its Advisory Committee on Immunization Practices (ACIP). And liability vanishes!

Who were the investigators on this study?  Chen is a current ACIP member.  Frey was an ACIP member until last June.  Wendy Keitel is a past ACIP member.  El Sahly is a principal investigator on a $619 million NIH vaccine grant.  And I am only scratching the surface of you scratch my back and I scratch yours.

Sharon E.FreyaAnnaWaldb  SrilathaEdupuganti   cLisa A.Jacksond  Jack T.Stapletone  Hana ElSahlyf  Samer S.El-Kamaryg  KathrynEdwardsh  HarryKeyserlingi PatriciaWinokurWendyKeitelf  HeatherHillj  Johannes B.GollEdwin L.Andersona  Irene L.GrahamChristineJohnstonb  MarkMulliganc  NadineRouphaelc. RobertAtmarf  ShitalPatelf  WilburChenkKarenKotloffk. C. BuddyCreechh. PaulChaplinl  Robert B.Belshea

Saint Louis University School of Medicine, Department of Internal Medicine, St. Louis, MO, USA
University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA
Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, Atlanta, GA, USA
Group Health Cooperative, Seattle, WA, USA
University of Iowa and Iowa City VA Medical Center, Department of Internal Medicine, Iowa City, IA, USA
Baylor College of Medicine, Departments of Molecular Virology and Microbiology and Medicine, Houston, TX, USA
University of Maryland School of Medicine, Department of Epidemiology and Public Health, Center for Vaccine Development, Baltimore, MD, USA
Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA
Emory University, Emory Children's Center, Department of Pediatrics, Atlanta, GA, USA
EMMES Corporation, Rockville, MD, USA
University of Maryland School of Medicine, Center for Vaccine Development, Baltimore, MD, USA
Bavarian Nordic GmbH, Martinsried, Germany



Anonymous said...

''*Sizzling On The Net*!''

Fourteen young Canadian docs die after getting the shot. Normally would be ~0 over 30 years.

This is a list of just the docs my doctor friend in Canada heard about passively. In the past 30 years, he's never heard of a single death like this. Not one. Now there are 14.

Anonymous said...

"Heads Up"!

The Secret is there are no Secrets!

New Food and Drug Administration documents show the agency knew almost nothing about how well mRNA boosters might work when it okayed them. It was mainly using public Israeli data like everyone else.