Exact definitions of PF-07305885 and PF-07302048 in BNT162b2

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Dear Medicines and Healthcare Products Regulatory Agency,

In Section 3.2 of Pfizer’s Safety Data Sheet (SDS) for BNT162b2, substances PF-07305885 and PF-07302048 appear as separate ingredients [1]. According to Pfizer’s Summary Basis for Regulatory Action (SBRA), SARS-CoV-2 spike glycoprotein mRNA (modRNA) has a per-vial quantity of 225 μg and is the active pharmaceutical ingredient (API) [2]. There is thus no obvious way therefore to map these two ingredients from the SDS to the SBRA.

You are required to clarify the distinction between PF-07305885 and PF-07302048. Disclose all documentation in possession of the MHRA concerning these two chemicals, including documentation on their respective exact definitions and the distinction between the two. Disclose all communication between the MHRA and Pfizer and between the MHRA and other medical regulators (FDA, EMA etc.) on these two ingredients.

Yours faithfully,

Jonathan Weissman BSc MSc MSc
https://www.alltherisks.com

[1] https://safetydatasheets.pfizer.com/Dire...
[2] https://www.fda.gov/media/151733/download

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________________________________________ From: Jonathan Weissman
<[FOI #835120 email]> Sent: Monday, February 21,
2022 12:45:58 AM To: MHRA Customer Services Subject: Freedom of
Information request - Exact definitions of PF-07305885 and PF-07302048 in
BNT162b2 Dear Medicines and Healthcare Products Regulatory Agency, In
Section 3.2 of Pfizer’s Safety Data Sheet (SDS) for BNT162b2, substances
PF-07305885 and PF-07302048 appear as separate ingredients [1]. According
to Pfizer’s Summary Basis for Regulatory Action (SBRA), SARS-CoV-2 spike
glycoprotein mRNA (modRNA) has a per-vial quantity of 225 ìg and is the
active pharmaceutical ingredient (API) [2]. There is thus no obvious way
therefore to map these two ingredients from the SDS to the SBRA. You are
required to clarify the distinction between PF-07305885 and PF-07302048.
Disclose all documentation in possession of the MHRA concerning these two
chemicals, including documentation on their respective exact definitions
and the distinction between the two. Disclose all communication between
the MHRA and Pfizer and between the MHRA and other medical regulators
(FDA, EMA etc.) on these two ingredients. Yours faithfully, Jonathan
Weissman BSc MSc MSc
https://eur01.safelinks.protection.outlo...
[1]
https://eur01.safelinks.protection.outlo...
[2]
https://eur01.safelinks.protection.outlo...
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