FOI release

Freedom of Information request (FOI 22/1041)

Published 17 January 2024

14th November 2022

FOI 22/1041

Dear

Thank you for your email of 16th October 2022 requesting information under the Freedom of Information Act 2000 relating to testing of Covid-19 vaccines.

I can confirm under Section 1(1)(a) of the FOI Act, that the Medicines and Healthcare Products Regulatory Agency (the Agency) does hold information as requested. Some of the information is subject to exemptions under the FOI Act 2000.

Please see the responses to the individual questions below:

1-Please detail the companies used by MHRA for testing of the covid 19 vaccines to date, for vials containing products for the following manufacturers:

A-Pfizer

B-Moderna

C-AstraZeneca

Response: Samples of batches manufactured by Pfizer/BioNTech, Moderna and AZ underwent testing at the MHRA’s laboratories for biological medicines. The MHRA does not use other companies for testing.

2- Please specify number of batches from each tested?

Response: Number of batches tested and certified up until 3rd August 2022 –

A-Pfizer - 99

B-Moderna - 100

C-AstraZeneca - 118

3- Specifically what technology is used to test the vials contents ie from list below - (please be specific in your response to A to I) and detail test procedures where answered in the affirmative?

Response: The tests listed below were performed against the specifications listed in the respective marketing authorisations.

A-Visual inspection - Performed for COVID vaccines produced by Pfizer/BioNTech, Moderna and AZ

B-Mass spectrometer - N/A

C-Magnetic test for metal – N/A

D-Electron microscopy – N/A

E-Dark field microscopy – N/A

F-Chemical testing – N/A

G-Conductivity tests – N/A

H-Toxicity – N/A

I-Pharmacological – N/A

J- Other -

AZ: Potency and identity

Pfizer/BioNTech: Potency/sequence ratio, identity, RNA encapsulation, RNA content, RNA integrity

Moderna: Identity ratio, RNA encapsulation, RNA content (potency), RNA purity (integrity)

Further information about the batch testing performed by MHRA can be found at https://nibsc.org/control_testing.aspx

4- do the manufacturers provide you with full details of contents so that comparative analysis can be undertaken, ie by mole etc?

Response: In order to obtain a marketing authorisation in the UK, all manufacturers of a medicinal product need to provide batch analyses that show the product complies with an agreed finished product specification.

5- if no to question 4, how do MHRA validate tests performed and results obtained?

6- do MHRA hold GMP license details (copies of inspection certificates for services such as filtered air, pure steam, water for injection etc) for the facilities used to manufacture the vials by those companies listed (A to C) in question 1?

7- are manufacturers places of production held to the same GMP licensing standards as required in UK?

In response to 6 and 7, in order to obtain a marketing authorisation in the UK, all manufacturers of a medicinal product need to hold a valid GMP certificate from an inspection performed by MHRA or another mutually recognised regulatory authority.

8- Specifically what results were found in batches (if occurred) that were deemed unsatisfactory or unsafe for use within population?

Response: Any out of specification result is investigated as part of the ISO/IEC 17025:2017 compliant quality system that is followed to support the MHRA laboratory 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 is 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 Section 43 and Section 38 of the FOI Act 2000.

Section 43 of the FOI Act 2000 states Commercial interests

MHRA laboratory 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. Details of results found in batches that underwent independent testing or were deemed unsatisfactory is 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

vaccine manufacturing companies. This harm could ultimately undermine the confidence for manufacturers to send materials for testing to MHRA and is therefore subject to an exemption under section 43.

Application of the Public Interest Test:

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

MHRA 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. In the case of vaccine testing, the assurance provided to the public by MHRA 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.

The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

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

MHRA Customer Experience Centre