FOI release

Freedom of Information request on the specification results for two batches of COVID-19 vaccines (FOI 22/587)

Published 14 June 2022

FOI 22/587

27th April 2022

Dear

Thank you for your information request dated 30th March 2022 where you asked for information following a response to a previous FOI 22/554 related to out of specification results for two batches of COVID-19 vaccine products.

We have provided a response to your questions below. Unfortunately, some of the information is exempt from release and this is explained further below.

1) Regarding: “We have obtained out of specification results for an individual test for two batches of a vaccine.”

a) Please confirm that these were COVID-19 vaccine products.

Response - Yes, we can confirm these were COVID-19 vaccine products.

b) Please state the batch numbers.

Response – We cannot provide the batch numbers for these vaccines as this information is subject to exemptions under the FOI Act 2000 (see later)

c) Please state the specification that failed for each batch.

Response – The specification that failed in both cases was for level of RNA concentration which was outside the specification criteria.

d) Please release documents which constitute evidence that the batches did not conform to specification. Response – We cannot provide documents related to non-conformance to specification as this information is subject to exemptions under the FOI Act 2000 (see later)

e) Please release a copy of MHRA/NIBSC’s internal nonconformance report.

Response – We cannot provide a copy of the internal nonconformance report as this information is subject to exemptions under the FOI Act 2000 (see later)

2) Regarding: “The relevant manufacturer was notified on each occasion.”

a) Please release the emails sent by MHRA/NIBSC to the “relevant manufacturer[s]” which informed them of the nonconformances.

3) Regarding: “In each case, the manufacturer withdrew their request for release of the batch, and it was not necessary for NIBSC to formally reject the batch.”

a) Please release emails and/or other documentation that constitute evidence that this happened.

b) Please release emails and/or other documentation relating to CAPA processes that took place as a result of these nonconformances.

Response to questions 2 and 3 - the out of specification result was investigated as part of the ISO/IEC 17025:2017 compliant quality system that is followed to support the MHRA/NIBSC core function as the United Kingdom’s Medicines Control Laboratory for biological products, performing independent laboratory testing and certification of batches of licensed blood products, vaccines and other biotherapeutics. As part of this process, all testing and reporting was subject to the strict requirements for out of specification results. – Documentation related to the testing and notification to the manufacturer is subject to exemptions under the FOI Act 2000 (see later)

The following exemptions apply to areas of your request:

Section 41 of the FOI Act 2000 - Information provided in confidence

The documentation requested includes information that has been provided in confidence by the manufacturer. In addition, the documentation generated within the work by MHRA/NIBSC includes information provided in confidence.

Section 43 of the FOI Act 2000 states Commercial interests

MHRA/NIBSC carries out independent batch testing of vaccines, which is a regulatory activity carried out on behalf of the Department of Health and Social Care under the Health and Social Care Act 2012, Functions 56 and 57. This is a commercial activity, with any testing data or correspondence generated through this activity being confidential data relevant to a particular customer. This request relates to a specific COVID-19 product that underwent independent testing and the information produced in relation to these products is therefore subject to this exemption.

We have applied a prejudice test to the use of exemption under Section 43. We would argue that data generated, if disclosed, would be likely to, prejudice or harm our commercial interests with this company, and other vaccine manufacturing companies. This harm could ultimately undermine the confidence for manufacturers to send materials for testing to MHRA/NIBSC and is therefore subject to an exemption under section 43. 4) Should S.43 be invoked on any part of this request, please release evidence that a public interest assessment took place.

Application of the Public Interest Test:

We have considered if the public interest in applying the exemption outweighs the public interest in its disclosure.

NIBSC carries out a regulatory function in its testing of vaccines and as such holds commercially sensitive information obtained via these regulatory activities that are carried out to ensure independent assurance for the quality and safety of medicines, in this case with reference to a specific vaccine.

There is arguably a strong public interest in allowing access to information which helps protect the public from unsafe products or dubious practices. In the case of vaccine testing, the assurance provided to the public by MHRA (NIBSC) is that testing is carried out on all batches of vaccines against agreed specifications to ensure the safety of the public. Disclosure of detailed information about different vaccines could in our view lead to a loss of public confidence and result in a risk to current and future adherence to vaccine programmes by the public.

The COVID-19 pandemic is the subject of heightened public interest and therefore, issuing of information that might allow comparison between individual types of vaccines could result in loss of confidence in any particular vaccine and may have a detrimental effect on a vaccination programme that is essential for the protection of the UK public.

The outcome of the public interest test therefore recognises that Section 38 of the FOI Act 2000 for Health and Safety is also applicable to this request where disclosure might have an effect on public health.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email.

Yours sincerely

FOI Lead, NIBSC, on behalf of

MHRA Customer Experience Centre