CRITICAL UPDATE! In response to my Freedom of Information (FOI) request, on 11 November 2021, the MHRA provided the below heavily redacted excerpt from a confidential Pfizer document. Table 3.2.P.1-1, Pfizer's raw ingredients table for BNT162b2, appears to list up to 7 fully redacted ingredients.
When I asked the MHRA to unredact the entire raw ingredients table, they confirmed, "The full quantitative composition of each COVID-19 vaccine is exempt under Section 41* and Section 43* of the FOI Act."
COMIRNATY is a trade name of Pfizer’s experimental SARS-CoV-2 genetic vaccine BNT162b2, the same experimental product deployed in the UK under Regulation 174 from the MHRA, the UK’s Medicines and Healthcare Regulatory Agency. According to the CDC, “There has been no change in the formulation of the vaccine since the name change.” The FDA's document Summary Basis for Regulatory Action - COMIRNATY, dated 23 August 2021, outlined the full approval of COMIRNATY. As below, Table 2 protected a 0.450ml excipient from public disclosure, according to U.S.C. § 552(b)(4), in lieu of “[t]rade secrets and commercial or financial information obtained from a person and privileged or confidential”.
Without reversioning their document, as below, the FDA later spontaneously updated Table 2 to supposedly reveal this previously undisclosed excipient to simply be water for injection (UNII: 059QF0KO0R).
However, this new disclosure cannot be reconciled with Table 3 in the same FDA document. Therefore, on 20 October 2021, I raised a Freedom of Information (FOI) request to the MHRA entitled: Exact quantity of Water for Injection pre and post dilution in BNT162b2. On 28 October 2021, the MHRA responded with the following: The duty in Section 1(1)(a) of the Freedom of Information (FOI) Act 2000 does not apply, by virtue of Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of that Act.
Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.
Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm whereby the information can be used by competitors to inform their own product development and overcome regulatory hurdles.
This immediately prompted me to think about the following questions:
What could possibly warrant the MHRA's decision to not disclose the exact amount of water for injection (UNII: 059QF0KO0R) in BNT162b2 by invoking an absolute exemption (Section 41) and a qualified exemption (Section 43)?
Why would the disclosure of the exact amount of water for injection (UNII: 059QF0KO0R) in BNT162b2 inflict any "commercial harm" on Pfizer, as the MHRA claim?
If the only solution present in BNT162b2 in liquid or frozen state is water for injection (UNII: 059QF0KO0R) then how could confirmation that it comprises the entire solution of BNT162b2 in its pre-dilution and post-dilution state "be used by competitors to inform their own product development and overcome regulatory hurdles"?
A diagram of mine illustrating dilution and post-dilution dosing of BNT162b2 is shown below.
The quantity of water changes again
As of 8 November, 2021, the FDA's Summary Basis for Regulatory Action - COMIRNATY was updated to show the quantity of water for injection in the pre-dilution vial as being q.s., which stands for quantis satis (as much as is required). This matches the amount listed in the raw ingredients table 3.2.P.1-1.
What is the water's weight?
Even the weight of the water for injection is listed as proprietary in Pfizer's Safety Data Sheet (SDS) for Comirnaty/BNT162b2, the only such publicly disclosed ingredient designated as such.
Manufacturing process of Pfizer's water for injection
Further scrutiny of the manufacturing process of Pfizer's water for injection is warranted. Hospira, Inc., a subsidiary of Pfizer, are known to manufacture sterile water for injection. On 4 May, 2021, Hospira announced a voluntary recall of lot DN9185 of their product, Sterile Water for Injection, USP, 100mL Single Dose Glass Fliptop Vial, "due to a confirmed customer report for a single vial with a visible particulate."
"Hospira’s assessment of the potential risk to patients concluded that in rare instances the use of the impacted product can be associated with potential adverse events such as anaphylaxis, fever, gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot." [emphasis mine]
It is publicly known that Hospira are one of two manufacturers for the diluent fluid, providing 10mL single-use vials of 0.9% Sodium Chloride Injection (i.e., water for injection and sodium chloride), used to dilute vials of BNT162b2.
Immediate questions that must be investigated include:
What exactly were the visible particulates the customer alerted Hospira to?
Are other lots susceptible to these same "potential adverse events" due to the same (albeit invisible) particulate contamination?
Does the nature of these "potential adverse events" indicate potential manufacturing processes of the water for injection?
Do Hospira also manufacture the water for injection used to suspend the LNPs and solid excipients in the pre-dilution vial?