San Juan Basin Public Health deceives about availability of approved COVID-19 vaccine

San Juan Basin Public Health (SJBPH) and the Colorado Department of Public Health and Environment (CDPHE) are deceiving the general public about the availability of the FDA-approved COVID-19 Comirnaty vaccine.

As observed at a local pharmacy.

Alarmingly, SJBPH is following the lead of CDPHE and the FDA in saying that the approved Pfizer Comirnaty vaccine is available. However, Comirnaty is not really available in the United States, according to officials at the participating clinics and pharmacies.

Yet, these public health officials claim that the Pfizer-BioNTech COVID-19 vaccine and it’s ingredients are interchangeable with the approved Comirnaty vaccine. The implication from these officials is that the existing Experimental Use Authorized (EUA) Pfizer-BioNTech vaccines can be retroactively classified and marketed as FDA-approved vaccines.

In a media release that was issued on August 23, 2021 when Comirnaty was approved, Liane Jollon, the Executive Director for SJBPH perpetuated the deception about the EUA Pfizer-BioNTech now being FDA approved.

“For anyone who has been hesitant or putting off their vaccine, the full approval of the Pfizer-BioNTech vaccine by the FDA should give you the utmost confidence that the vaccine is extremely safe and effective.

To the contrary, the available Pfizer-BioNTech vaccine was not approved by the FDA. Instead, another product of Pfizer-BioNTech called Comirnaty was approved, according to a letter from the FDA.

EUA authorized and approved Pfizer vaccines legally distinct from each other, federal district court judge says

Vials of the EUA Pfizer-BioNTech COVID-19 vaccines cannot be retroactively converted to the FDA’s Biologics Licensure Approved (BLA) Comirnaty vaccine, according to a federal district court judge who presided over a related civil case. It’s also important to note that this judge was presiding over a case in Florida, and his opinion may not apply or have precedence in Colorado.

In particular, the 42 U.S.C. § 1983 case was DOE et al v. AUSTIN et al, which was filed in US District Court for the Northern District of Florida.

In an order issued Nov. 12, Judge Allen Winsor denied the preliminary injunction requested by more than 15 service members against the Military’s COVID-19 vaccine mandate. Despite denying the request, Winsor’s opinion was significant for establishing the problem with mandating that anyone take an EUA vaccine.

“[T]he DOD cannot mandate vaccines that only have an EUA,” Judge Winsor stated. While Pfizer’s Comirnaty vaccine received FDA approval on August 23, 2021, the vials in circulation are labeled for Emergency Use Authorization (EUA).

“FDA licensure does not retroactively apply to vials shipped before BLA approval,” Judge Winsor wrote (page 15).

As such, the two vaccines are legally different, even though the FDA concedes that they are not, the judge wrote.

Also, 21 U.S.C. § 355(a) is supposed to prohibit people from introducing drugs without them being approved beforehand.

“No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.”

As such, it is unclear how the EUA Pfizer-BioNTech COVID-19 vaccine is being introduced as an approved drug even though an application for it has not been filed and approved.

Furthermore, the false or misleading claims of Jollon and Griffin about the available Pfizer-BioNTech vaccines being approved were then converted to public advertisements (media release and Pandora radio advertisements). Those advertisements were published for the purpose of promoting the sale and consumption of the available Pfizer-BioNTech COVID-19 vaccines.

San Juan Basin Public Health uses Democratic Party marketing contractor to spread COVID-19 vaccine deceit

In addition to the deceitful press releases about the “approved” COVID-19 vaccine, was a marketing campaign that was led by SJBPH.

With a $400,000-dollar grant from the Health Resources and Human Service Administration (HRSA), SJBPH has been marketing the available Pfizer COVID-19 vaccines as being approved. Their claim in the marketing is false.

To create the advertisements, SJBPH awarded a contract to Ascend Digital Strategies out of Boulder, Colorado.

The contractor has targeted many people in La Plata County and Archuleta County with Pandora radio advertisements. Ascend is also creating custom designs for SJBPH to use in their Facebook posts.

What’s alarming is the misleading and deceptive wording of their Pandora radio advertisements. Also noteworthy is how the advertisement failed to market the EUA approved vaccine as Comirnaty, even though the state agencies said that they would.

“The Pfizer COVID-19 vaccine is now fully approved by the FDA,” said the misleading Pandora radio advertisement. “They reviewed over 300,000 pages of data and concluded that the vaccine is extremely safe and effective.”

It should be noted that Ascend Digital Strategies appears to only serve democratic political candidates, according to information on their website. Also, the company is owned and operated by registered democrats Michael Taylor Sparks and Craig Frucht.

Here is the transcript for the radio transcript that Ascend created for Pandora:
08232021 ot 10012021 Pandora Transcripts SJBPH

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EUA Pfizer-BioNTech jabs have different excipients than approved Comirnaty jabs

While the judge did not discount that Pfizer BioNTech and Comirnaty are medically interchangeable, the judge did acknowledge that the two had different excipients.

“The plaintiffs question whether the two products are, in fact, chemically identical,” said Judge Winsor. “See, e.g., ECF No. 45 at 16:17-19. Indeed, the Summary Basis for Regulatory Action lists a redacted excipient for BLA-approved Comirnaty that does not appear on the ingredient list in the EUA letter. Compare ECF No. 1-5 at 9 (listing 11 components, including .450 ml per vial of a redacted excipient), with ECF No. 1- 6 at 7 (listing 10 components, all of which also appear on the Summary Basis list). Excipients are “inactive” ingredients like “coatings, binders, and capsules,” but they sometimes “may affect the safety and effectiveness of drug products.” United States v. Generix Drug Corp., 460 U.S. 453, 454-55 (1983). In Generix, the Supreme Court held that two products with the same active ingredients were nonetheless not the same “drug” under the FDCA where the district court had found that their different excipients created a reasonable possibility that the unlicensed drug was “less safe and effective” than the licensed one. Id. at 455-57. But the Court expressly declined to decide “whether two demonstrably bioequivalent products, containing the same ingredients but different excipients, might under some circumstances be the same ‘drug.’” Id. at 461. Because an excipient is, by definition, an inactive ingredient— and because the plaintiffs haven’t shown a “reasonable possibility” that excluding .450 ml of the redacted excipient from a vial of the EUA vaccine makes it any “less safe and effective” than Comirnaty, Generix, 460 U.S. at 455—I do not discount the FDA’s conclusion that the two vaccines are medically interchangeable. See ECF No. 1-6 at 3 n.8; ECF No. 31-13 at ¶¶ 7-9. Of course, that does not mean the two vaccines are legally indistinguishable—the FDA concedes they are not. See ECF No. 1-6 at 3 n.8. Still, EUA-labeled vials that Pfizer and the FDA “consider[] BLA compliant,” ECF No. 1-5 at 28, presumably must include the redacted excipient to meet Comirnaty’s licensing requirements. Cf. ECF No. 1-4 at 4 (“You must submit information to your BLA for our review and written approval under 21 C.F.R. 601.12 for any changes in . . . the manufacturing [of Comirnaty].” (emphasis added)).”

Specifically, COMIRNATY contains 1 of the following sets of additional ingredients, according to a Pfizer document. One could ask the vaccination provider which of these two versions is being administered:

• potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose

OR

• tromethamine, tromethamine hydrochloride, and sucrose

San Juan Basin Pubic Health deceptively markets the Comirnaty vaccines as available in La Plata County

I got two different answers from two different public health officials about the availability of the Biologics License Application FDA-Approved Comirnaty vaccine.

First, the COVID-19 Public Information Officer Chandler Griffin gave me the official narrative that’s widely disseminated.

“The FDA-Approved Pfizer BioNTech (Comirnaty) COVID-19 vaccines are widely available in La Plata County,” Griffin said. “Many of the local providers listed on this page have supply of the Pfizer available (checking with them in advance is recommended). Also, eligible folks can access Pfizer through any of the clinics listed in this platform and marked as Pfizer. Scrolling through the pages at the bottom navigates for upcoming dates and planned clinics. Comirnaty is the “brand name” for the FDA-Approved Pfizer BioNTech COVID-19 vaccine.”

More recently, a contractor of San Juan Basin Public Health named Kendra said that their vaccine clinic had not received any Comirnaty yet. They would not receive any Comirnaty until they ran out of their existing supply of EUA Pfizer/BioNTech vaccines. Also, she said that they did not have any package inserts for the Pfizer/BioNTech vaccine at the clinic, as they left them at their permanent office in Bodo.

Kendra’s claim about the package inserts was false, as there is no package insert for the available Pfizer-BioNTech vaccines, according to a pharmacist at a local Walgreens.

A box of EUA Pfizer-BioNTech vials without a package insert.

Records of text messages not present in reply to CORA records request

In response to my request for records from San Juan Basin Public Health the cellular phone text messages were not present.

This is what I requested:

“I am requesting all emails and cellular phone text messages to and from Liane Jollon that mention the words ‘Comirnaty’, and/or ‘Pfizer’, and/or ‘Pfizer-BioNTech’, and/or ‘vaccine’, and/or ‘vaccines’.

I am requesting all emails and cellular phone text messages to and from Chandler Griffin that mention the words ‘Comirnaty’, and/or ‘Pfizer’, and/or ‘Pfizer-BioNTech’, and/or ‘vaccine’, and/or ‘vaccines’.”

Then, when there were no emails from Jollon on August 23rd, nor any text messages provided, I asked:

Hello Ann Oliver,

I did not see any emails included in the responsive records that were sent by Liane Jollon on August 23 and August 24th.

Also, I did not see any text messages in the responsive records.

Did you forget to include those records with the Dropbox folder?

Thank you for your assistance.”

In response, Oliver said:

“Dear Mr. Howell,

To confirm, all records pertaining to your request were included in the DropBox folder sent back to you on Monday, February 14th. No other records exist that pertain to your request. Thank you.

Best,

Ann Oliver”

This absence of any text messages from the requested records is suspicious since the health department does have work-issued cell phones. A budgetary document of theirs suggested that their response staff would have $4,000 for cell phone expenses.

D2 ELC R2 San Juan Basin_ Budget 062421 (1)

Mobile Device Policy of San Juan Basin Public Health

San Juan Basin Public Health Liaison Officer Janet Wolf said that SJBPH does not offer stipends to its employees with work-issued cellular phones.

“MOBILE DEVICES

Some employees may be issued a SJBPH mobile device; this should not be used for personal use.

With Agency approval, employees in some positions may use their personal smartphone or tablet to access work email and applications in accordance with other Agency policies; including the Anti-Harassment Policy, Confidential and Non-Disclosure Policy, Time and Attendance Policy, and Social Media Policy. Employees pre-authorized to use a personal mobile device for Agency use may be reimbursed; discuss reimbursement details with your supervisor or Director.

Use of personal mobile devices during working hours should be limited and must be handled in a manner that does not interfere with the productivity of the employee or SJBPH work.”

Also, Liane Jollon does not possess or use a work-issued cell phone, said Wolf.  SJBPH is not the custodian of records for Liane Jollon’s cellular phone devices, she said..

See Denver Post Corp. v. Ritter, 230 P.3d 1238 (Colo. App. 2009), aff’d, 255 P.3d 1083 (Colo. 2011)

Adam Howell is a writer who believes in free press and the importance of the constitution. He can be reached by clicking on this link to the contact page.