Pfizer-BioNTech COVID-19 Vaccine Suspension For Intramuscular Injection EY0584

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COMPLIANCE STATEMENT FOR RELEASE

The following lot of Pfizer-BioNTech COVID-19 Vaccine Suspension for


Intramuscular Injection (with 2mL diluent – 0.9% Sodium Chloride Injection,
USP) (mRNA vaccine – nucleoside modified) produced by Pharmacia & Upjohn
Company LLS, Kalamazoo Michigan, USA, whose numbers appears on the
labels of the final containers, is comparable and conform to the same quality
standard as COMIRNATY Concentrate for Dispersion for Injection registered in
Malaysia.

As a minimum, the release is based on assessment on the cold chain


requirement only.

Lot no: EY0584


Expiry date: 31 October 2021
No. of doses: 400,140
No. of doses per container: 6

Signature:

Name of authorized person: NIK JUZAIMAH BINTI JUHARI


Head of Product and Cosmetic Testing Section
for Director of National Pharmaceutical Regulatory Agency (NPRA)
Ministry of Health Malaysia

Date: 5 July 2021

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