FOI release

FOI for NIBSC five tests

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00187

Received 20 February 2026

Published 21 August 2026

Request

this is an FOI to see the five tests mentioned in this Covid Inquiry report relating to Batch EJ0553 Please also supply the Lot release protocol accomanying the batch. I note there is aleady such a protocol in existence empdicte in a Baych release certificated produced under FOIA in USA . I give the url and screen shot below. As this type of onformation is alrady in the pbilic domain I do not expect information to be witheld inder an exemption unless it is similarly redacted as below, I do note at this staghe MHRA has confirmed to me that the "agreed" contractual endotoxin limits in drug product are 12.5EU/ml and I am also aware the "agreed " limit for active substacne is also 12.5 EU/ml and so these redactions are quite useless but if you are to redact them please let me know why you are redacting them as thery are also verifiable in EMA open source documentation.

Response

See attached

Documents

• EJ0553 Corrected NIBSC Release Request (redacted).pdf (1.3 MB)
• FOI2026_00187 (redacted).pdf (2.0 MB)
• Prelimenary CoC EJ0553 with attachments _ manf comments JP 02Dec20 (1) (redacted).pdf (1.8 MB)

This is Medicines and Healthcare products Regulatory Agency's response to a freedom of information (FOI) or environmental information regulations (EIR) request.

You can browse our other responses or make a new FOI request.