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BNT162b2
3.2.A.2. Adventitious Agents Safety Evaluation [Kalamazoo ]
PFIZER CONFIDENTIAL
Page 13.2.A.2. ADVENTITIOUS AGENTS SAFETY EVALUATION [KALAMAZOO]
Multiple mechanisms, procedures, and assay s are used to minimize the entry of adventitious
agents into the process stream and detect those agents that do enter the process stream. The
adventitious agent control program includes the
.
3.2.A.2.1. Introduction
The main theoretical risk associated with these ingredients is a contamination of the product
by Transmissible Spongiform Encephalopathy (TSE) agents. A multifaceted program has
been established to ensure the viral safet y of the drug product , including
Management of transmissible spongiform encephalopathy (TSE) / bovine spongiform
encephalopath y (BSE) risks is part of the comprehensive adventitious agent control program
for COVID -19Vaccine .
All raw materials used in the production of BNT162b2 are evalua ted as part of a
comprehensive program to identify and manage TSE/BSE risks. Under this program, the risk
of transmission of TSE/BSE through the use of animal -derived materials is managed b y
sourcing such materials in a manner consistent with the current i ndustry guidelines including
those from the European Medicines Agency (EMA), the Therapeutic Goods Administration
(TGA), and the World Health Organization (WHO).
The conclusion from the TSE/BSE risk evaluations performed for raw materials is that the
riskof transmitting TSE/BSE via BNT162b2 has been minimized.
Details of an y material, reagent ,or component containing material of animal origin including
its source and preparation are discussed in the following sections.
Moreover, equipment and materials are
according to validated procedures.
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(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
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PFIZER CONFIDENTIAL
Page 23.2.A.2.2. Non-Viral Adventitious Agents
3.2.A.2.2.1. Raw Material Sourcing and Testing
Raw material vendors are qualified to sourcing materials from them for use in the
manufacturing process . Raw material information is provided in 3.2.S.2.3 Control of
Materials used in Manufacturing.
In particular, the human or animal -derived materials are provided in Table 3.2.A.2-1 . All
other materials are of s ynthetic and/or biological origin.
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3.2.A.2. Adventitious Agents Safety Evaluation [Kalamazoo ]
PFIZER CONFIDENTIAL
Page 3Table 3.2.A.2-1. Materials of Animal Origin Used in the Manufacture of BNT162b2 DP
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(b) (4)
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3.2.A.2. Adventitious Agents Safety Evaluation [Kalamazoo ]
PFIZER CONFIDENTIAL
Page 43.2.A.2.3. Conclusion
In summary , a comprehensive, multifaceted program is in place to ensure that the risk, with
respect to potential viral and non -viral adventitious agents contamination of drug product , is
acceptable. Equipment is cleaned b y validated cleaning procedures described in 3.2.A.1
Facilit y and Equipment – Puurs. I n addition, sterility testing is performed on the final
product, as described in 3.2.P.5.1 Specifications.
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