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	First-tier Tribunal (General Regulatory Chamber)
You are here: BAILII >> Databases >> First-tier Tribunal (General Regulatory Chamber) >> Grainger v Information Commissioner & Anor [2025] UKFTT 346 (GRC) (21 March 2025) URL: http://www.bailii.org/uk/cases/UKFTT/GRC/2025/346.html Cite as: [2025] UKFTT 346 (GRC)

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First-tier Tribunal
(General Regulatory Chamber)
Information Rights

		Heard by Cloud Video Platform Heard on: 20th February 2025
		Decision Given On: 21 March 2025

Decision:

1. The Appeal is Dismissed

REASONS

Decision under appeal and background

1. This appeal is brought under section 57 of the Freedom of Information Act 2000 ("FOIA"). The appeal is against the decision of the Information Commissioner ("the Commissioner") contained in a Decision Notice dated 8^th April 2024 (reference IC-272282-Z5D1).
2. The Appellant requested from the Medicines and Healthcare Products Regulatory Agency (the "MHRA") information relating to Yellow Card Vaccination Monitor data (YCVM) on 13^th April 2023. The MHRA refused the request under section 22 of FOIA (information intended to be published in the future).
3. The Commissioner's decision was that the MHRA were entitled to rely on section 22 of FOIA to refuse to comply with the request for information. The Commissioner did not require the Council to take any steps as a result of this decision.
4. This appeal was lodged by the Appellant against the decision of the Commissioner. The appeal was opposed by the First and Second Respondents.

Background to the appeal

5. On 13^th April 2023, the Appellant made the following request for information to the MHRA:

"On 17th November 2022 you gave a recorded lecture at the All-Wales Therapeutics and Toxicology Centre at the AWMSG 20th Anniversary Conference - The Nicola Wheatley Memorial Lecture.

During that lecture you spoke of the Yellow Card Monitor as an active surveillance of specifically identified cohorts and specifically mentioned a group of 2000 pregnant women who shared their data via the monitor. You were very pleased that this specific group gives you a denominator to presumably work out more accurate data analysis. FOI Questions on active surveillance of 2000 pregnant women:

1. How were the pregnant women monitored, how often they report and how long were they followed for?

2. When were they vaccinated, in which trimester, and how often were they vaccinated and with which vaccine?

3. What was the % of the 2000 pregnancies experiencing

a. miscarriage?

b. still births?

c. spontaneous abortions?

4. What was the % of the 2000 pregnancies that delivered

a. to full-term?

b. pre-term?

5. Was there any congenital malformation?

6. What were the serious adverse side effects for:

a. Mother?

b. Baby?

7. What were the less serious adverse side effects for:

a. Mother?

b. Baby?

8. Were there any women followed up whilst breast feeding;

a. Were any AEs recorded?

b. Any breast milk discolouration, paresis, suppressed lactation, pain?

9. Did this cohort of 2000 pregnant women influence the MHRA risk/benefit analysis in pregnancy?"

6. The MHRA responded on 19^th July 2023. It refused to provide the requested information, citing section 22 of FOIA (information intended for future publication). Instead, it provided an interim report dated June 2021 that it considered may have been useful to the Appellant.
7. Unhappy with that response, the Appellant requested an internal review. On 20^th September 2023, the MHRA provided its internal review response and maintained its original position. The Appellant complained to the Commissioner on 23^rd November 2023.
8. The Commissioner considered the section 22 exemption and that MHRA must have a settled expectation that the information will be published at some future date, even if no precise date had been set. The Commissioner also confirmed that the public interest test applied to the exemption.
9. As part of the complaint investigation, MHRA had confirmed that some information was already in the public domain as part of its regular reporting and that it intended a scientific publication on the Yellow Card Vaccine Monitor (YCVM) that would consider the totality of the data collected. MHRA intended to publish the information via a peer reviewed journal and whilst there was not a confirmed date for publication, it was anticipated that it would be published in late 2023 or 2024.
10. The Commissioner considered the public interest balancing test. The Appellant said that noting the indications in the interim report of significant adverse drug reactions by pregnant women, the full report ought to be published to protect pregnant women and to update vaccine safety advice.
11. MHRA acknowledged the public interest in the safety of vaccines, indicating that the interim report and other information was available to the public and that the full report would consider the totality of the information rather than just the answers to the questions posed by the appellant in her request. The Yellow Card Vaccination Monitor was novel and it was important for the information to be reviewed by experts before release. The final publication in a journal would allow for wider peer review and that this was in line with accepted practice for the publication of a paper presenting scientific methodology. It allowed for a discussion involving experts and the public. MHRA considered that by disclosing the information in response to the request alone (many of which requires only a 'yes' or 'no' answer) may lead to misinterpretation and unnecessary concern about safety within a vulnerable population. There was already safety data available regarding the use of Covid-19 vaccines on pregnant women. The YCVM was only one source of data that had contributed to the assessment; other published studies had been considered as part of the assessment process. MHRA confirmed that it was fully committed to publishing the data from the YCVM and sharing this with the public but that it needed the time for a full analysis and commentary, as well as peer review and that the information released after this full process would serve the public interest more.
12. After considering the competing positions, the Commissioner decided that whilst there was a public interest in transparency, that there was a greater public interest in allowing MHRA to publish the information in the timeframe and with the processes that it had planned to. This would ensure that the public had all the information necessary and, reduced the risk of misinformation or unnecessary concern. The Commissioner's decision and considerations were contained within his decision notice dated 8^th April 2024.
13. It was acknowledged that MHRA had not provided a response within 20 working days as required by section 17(1) of FOIA.
14. The Appellant appealed the decision of the Commissioner on 3^rd May 2024

Appellant's grounds of appeal dated 3^rd May 2024

15. The Appellant said that -

(i) There were no pregnant women included in the Covid-19 clinical trials and known effects on fertility, pregnancy and embryo or offspring development. MHRA's remit was to protect pregnant women and delays in reporting the data kept the information from those people that MHRA are supposed to be protecting.

(ii) She said that this type of reporting was not new and had been taking place in the US; that data was published without review.

(iii) MHRA had said that reporting was expected by Q1 of 2024 but had not happened. What would happen if the full report/data was never published?

(iv) She said that the data would involve a group of 1366 which was novel. The advice about the safety of the vaccine was not underpinned by evidence.

(v) The interim report was published in June 2021 without any peer review. The public needed to see the data collected and the raw data did not need a peer review.

(vi) The raw data was required to understand the summary that had been provided. Summary data can lead to more misinterpretation than the raw data. Professor Fenton (a mathematician who is a world leading expert on risk assessment) had already reviewed this interim data; the MHRA were not the only ones who could interpret data.

(vii) She believed that the MHRA were hiding the data by delaying publication as the Monitor was not producing the results hoped for. The interim report released showed 565/1366 (41.4%) pregnant women reported adverse drug reactions (ADRs). She needed the raw data to be released in the full report so that she could ascertain the seriousness/type of ADR listed.

The Commissioner's response to the appeal dated 7^th June 2024

16. The Commissioner considered that the issue raised by the Appellant was a challenge to the public interest analysis rather than the application of the exemption itself.
17. The Commissioner opposed the appeal and relied on his observations in the decision notice. The Commissioner maintained that the public interest in disclosure was outweighed by the factors in favour of withholding the information. There was a stronger public interest in allowing the MHRA to publish the requested information in its planned schedule.

The Appellant's reply to the Commissioner's response dated 27^th June 2024

18. The Appellant said that the YCVM interim report showed that all three Covid-19 vaccines were not safe in pregnancy in June 2021. There was no long-term data about Covid-19 vaccine use, let alone for pregnant women.
19. The MHRA's Yellow Card Adverse Event has been publishing weekly reports all the way through 2021-22. The Yellow Card Vaccine Monitor data was more reliable as the MHRA know the participants' information (30,000 registered vaccinees including 1366 pregnant), who provided regular timed reports on adverse reactions. This was a monitor of real-time reactive data, provided by the public who should be able to access the results. 53% of the Monitor participants had one or more Adverse Drug Reactions (ADRs). 66% of the pregnant who received the AZ vaccine reported at least one ADR. MHRA was tasked with ensuring the safe use of medicines in pregnancy.
20. The process was not new. 10 million people participated in the V-Safe Monitor in the US. The data was not released until after a court ordered disclosure.
21. It was not reasonable to withhold the information. The use of vaccines and the effect on pregnancy was a very important issue of high public interest. The Monitor data provided evidence on whether these treatments were "safe for use" in pregnancy, as demanded by the Medicines Act 1968. It was not fair nor sensible to withhold this pregnancy data which should have been released as soon as it was known. The release of this data was in the public interest so that harm, including death and serious injury were avoided. On 12^th February 2023, the Yellow Card Data, showed one serious adverse event for every 426 doses of Covid 19 vaccine. The Yellow Card System on Covid-19 vaccines, between the 4^th January 2021 and the 26^th May 2021 showed 1,253 deaths and 888,196 ADRs (256,224 individual reports) were reported during this period. A vaccine is usually withdrawn with <50 deaths, irrespective of how many doses have been given. Up to 26^th May 2021, Yellow Card Reports appear to show a high number of Pregnancy ADRs (307 ADRs), including one maternal death, 12 stillbirths but only 3 listed as fatal, one newborn death following pre-term birth, and 150 spontaneous abortions. At the same time this information was being published and available to the public, the Monitor data was being held back. The interim report suggested the vaccine data was bad if not worse.
22. In response to the four questions posed by the Commissioner in his response - The data had still not been published even though it was indicated that it would be published in Q1 of 2024. There was a risk is cover-up. The interim report was evidence that these vaccines were harmful and that the MHRA have known about these harms but not released the full data set for three years. The public did not know when it will be published. Noting professional opinions that Covid-19 vaccines were not safe for use, the strong public interest was to provide the data to the public and to protect the public.
23. There were extremely high levels of ADR in the interim report. Of the 1366 maternal exposures there were only 8 live births as most subjects remained pregnant at the time of the report. The outcome of those pregnancies should be known. There were high levels of ADRs with all three vaccines reported in pregnant women (between 38% and 66%).

The response of MHRA dated 28^th June 2024

24. The Second Respondent submitted that the public interest favoured maintaining the exemption. Publishing the data requested in a scientific journal ensured it, and the methodology used to collect it, which was previously untested as part of safety monitoring within UK regulatory vigilance systems, underwent a rigorous peer review process prior to publication and was highlighted to a broader audience of researchers with expertise in conducting active vaccine safety monitoring. In contrast, releasing the requested information in response to the specific questions raised by the Appellant, and without a full discussion of the methods of data capture and the limitations of the data provided, risked both misinterpretation and the loss of the benefits that flowed from scientific peer review which included greater opportunity for independent external experts to inform the presentation of the data. This could lead to unfounded concerns about the safety of vaccination within a vulnerable population.
25. The MHRA maintained a "Yellow Card" website. Through the Yellow Card scheme, members of the public and healthcare professionals voluntarily submit reports of suspected side effects to the MHRA. Drug companies also submit such reports as part of their legal requirements. The "Yellow Card" website is one way in which the MHRA collects and monitors information on safety concerns such as suspected side effects or adverse incidents involving medicines and medical devices. Data can also be collected and monitored through the app, some clinical IT systems and by phone.
26. A summary report of adverse reactions to approved COVID-19 vaccines alongside MHRA's assessment of Yellow Card data, and that from other sources was published regularly across 2021-2022 on gov.uk. However, in February 2023 the Commission on Human Medicines advised that given the stable safety profile of the COVID-19 vaccines, the MHRA should transition to routine safety data publication and communication of safety concerns for COVID-19 vaccines. The MHRA continued to publish COVID-19 vaccine reports which contain a complete listing of all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme for all COVID-19 vaccines. This included all spontaneous reports received from healthcare professionals, members of the public, and pharmaceutical companies.
27. In addition to spontaneous Yellow Card reporting, as part of the MHRA's COVID-19 vaccine safety surveillance strategy, targeted active monitoring of vaccinees was introduced to enable follow-up of participants through a new platform: the Yellow Card Vaccine Monitor ("YCVM"). The strength of spontaneous reporting was to help detect new safety signals, active monitoring helped to put the frequency of common reactions into context. It also allowed collection of data on longer term outcomes of side effects as updates from individuals were received over time.
28. As part of the initiative, the MHRA invited nearly 1.3 million people to take part in YCVM and of these over 36,000 people registered. Over 2500 pregnant women registered and were followed up to capture the outcomes of their pregnancy.
29. Enrolment was sought prior to vaccination (and thereby before any suspected side effect was experienced) and vaccinees were then contacted at set intervals (for example 7 days, 14 days, 3-6 months) to ask whether they suspected that any adverse reaction had occurred.
30. The YCVM data was continuously assessed alongside other data the MHRA collected or has access to, to support signal detection activities. Specifically, the data from YCVM contributed to the MHRA's assessment position and overall conclusions that data related to COVID-19 vaccines exposure during pregnancy do not raise any particular safety concerns. The YCVM represented the first time the MHRA have operated surveillance of a vaccine through active recruitment of patients prior to exposure with repeated follow up over time.
31. The MHRA was developing a scientific publication concerning the YCVM, which would discuss the surveillance methodologies and strategies used and contain the totality of the data collected pursuant to this programme. The MHRA considered the YCVM, and associated data, should be subject to appropriate peer-review, as it was a novel technology and methodology. Submission of a scientific journal article for peer review would ensure appropriate levels of independent scientific oversight.
32. That process was ongoing. However, the MHRA had published an interim review of the YCVM, which was presented to MHRA's Pharmacovigilance Expert Advisory Group in July 2021 (the "interim report"). The MHRA sought to meet the public interest in the safety of medicines for those who are pregnant through the provision of the interim report. The MHRA also provided, to the public, information on the use of COVID-19 vaccines, including the use of vaccines on those who are pregnant. This position was based on analysis of all Yellow Card data and relevant data from other sources including YCVM and large published epidemiological studies. It was not based on the subset of data which relates to the YCVM in isolation.
33. In refusing the request for information, MHRA confirmed that it held data in relation to pregnant women based on Yellow Card data and data from other sources. MHRA explained that the YCVM data was continually assessed alongside other data and so there were not regular reviews of the YCVM data alone.
34. MHRA responded to the basis of the Appellant's appeal, namely, if it was reasonable in all the circumstances to withhold the requested information until the date of publication, and if there is a public interest in maintaining the exemption.
35. MHRA submitted that publishing within its timeline allowed for peer-review noting that this was novel methodology in UK safety monitoring activities. Peer review would allow for discussion about strengths and limitations of the process before wider publication. The conclusions would be more credible as a result. This was the same approach as that taken in the US.
36. MHRA expected that the data would be reviewed by a wider scientific audience with expertise of active surveillance of vaccines. The data collected in the YCVM was subject to limitations with missing data and failures to follow-up. The data needed to be carefully analysed to reach a robust interpretation and to ensure the data was appropriately and clearly presented.
37. There was a disbenefit of publishing the data without context. Disclosure of aggregate data, and answers to the narrow questions in the request, without a full discussion of the merits of data capture, and the limitations of the data provided could lead to misinterpretation, which could in turn lead to unnecessary concern on the safety of vaccination within a vulnerable population.
38. The requested information only concerned one aspect of the wider YCVM programme. Early disclosure could inhibit the value of the full publication.
39. The request was not seeking analysis but 'yes' or 'no' answers which condenses any analysis and lessens the public interest in disclosure. Safety information about Covid-19 vaccines has already been misinterpreted; MHRA gave an example of having to release a press release in September 2022 to combat such misinformation.
40. There would be a risk of adverse public health outcomes if the data was misinterpreted which resulted in refusal to be vaccinated.
41. The MHRA estimated that the data would be submitted to a journal for publication by the end of August 2024. Data from Yellow Card reports are routinely made available.
42. In considering the public interest in disclosure, it was appropriate to consider both the harm arising from early disclosure ahead of the scheduled release date, as well as harm arising out of the context in which information is disclosed - Queen Mary University London v Information Commissioner (EA/2012/0229) (26 September 2012) (at para.9). The MHRA maintained that the public interest plainly favoured maintaining the exemption, and making the requested information available in a way that allowed the presentation of the MHRA's research to a wide audience with appropriate peer review.

The Appellant's responses to MHRA dated 19^th July 2024 and 9^th September 2024

43. The Appellant disputed the claim that only by publishing in a scientific journal would allow the MHRA to ensure that their methodology underwent "rigorous review". She said that reputable journals typically only required three reviewers, one of which was usually recommended by the author. The interim report contained high levels of ADRs and the numbers of ADRs expected has been greatly exceeded.
44. The MHRA collected Yellow Card data since January 2021, and it was published without peer review ever since. The interim report showed serious levels of ADRs which needed to be disclosed.
45. The data in the interim report and YCVM is different with the latter being a much larger sample. The public had a right to see the raw data to assess if the decision that the vaccines were safe, was correct. The public did not know the extent of harm to pregnant women even though the percentages of pregnant women affected was high.
46. The Appellant reminded the Tribunal of the Thalidomide scandal. MGRA and PEAG knew about the harm caused by the vaccines and have not released the full data set for three years and the public did not know when it would be published.
47. It was not reasonable in all of the circumstances that the information was withheld, especially if showing harm to a vulnerable population. The subject matter, the use of vaccines and the effect on pregnancy is a very important issue of high public interest, and a very important part of the MHRA's pharmacovigilance role.
48. Queen Mary University London v Information Commissioner (EA/2012/0229) (26

September 2012) (at para.9) was a harassment case and therefore was not comparable to releasing information about safety data due to actively encouraged vaccination in a large population of people including pregnant women. The most severe adverse drug reaction could be death and therefore safety data was of paramount importance.

49. The weight of public opinion was to release the data. The public deserved to know the information, whatever it showed. Informed consent to vaccination cannot take place without the release of the information.

Procedural matters relating to the determination of the appeal and the evidence at the appeal

50. This appeal was originally listed before this Panel on 3^rd December 2024. The Appellant clarified that she was contending both the engagement of the section 22 exemption and the public interest test. The Panel had an open bundle of 154 pages and a closed bundle of 42 pages. Information appeared to be missing from the bundle and the Panel considered that the appeal could not fairly proceed for reasons outlined in the case management order of the same date. The MHRA had released a pre-print of their publication less than two weeks before the appeal and the Appellant's case was that some information was still missing notwithstanding that report. The Panel considered that a full understanding of what was missing from the pre-print with respective submissions from each party was important to determine the intention to publish. An updated bundle was directed together with a schedule itemising the respective parties' views about what information had been released by publication which the Panel considered relevant to the intent to publish.
51. For this hearing, the Tribunal considered the updated open bundle (820 pages) and a closed bundle (42 pages). The Appellant and Second Respondent had each filed a skeleton argument. All parties confirmed that we had all the necessary information to hear the appeal. The documents in the bundle can only be used for the purpose of the appeal unless the Tribunal gives permission for other uses. Individual documents within the bundle, may only be used for other purposes if the party who disclosed the document, and the person to whom the document belongs, agrees or the Tribunal gives permission - DVLA v Information Commissioner and Williams (Rule 14 Order) [2020] UKUT 310 (AAC) 3.
52. Two days before the hearing, the Panel gave notice to the parties that section 22A of FOIA may also be relevant and that they should be prepared to make submissions on section 22A, if appropriate.
53. The closed bundle was provided pursuant to rule 14 of the Tribunal Procedure (First-Tier Tribunal) (General 2 Regulatory Chamber) Rules 2009. The Tribunal directed the bundle not to be disclosed but would keep that decision under continuing review. The open bundle contained a gist of the closed materials. We were not provided with the raw data and were not hampered by not seeing the same.
54. The hearing was attended by the Appellant, her three proposed witnesses, counsel for the Second Respondent and the Second Respondent's witness.
55. The hearing took place remotely via video (CVP). There were no objections to this as a suitable method of hearing and no technical or other difficulties during the hearing. The Tribunal were satisfied that was a just and expedient way to conduct the appeal.
56. The Appellant had filed written evidence from three witnesses – Professor Fenton, Dr Chandler and Dr Wilkens.
57. Professor Norman Fenton is a mathematician and computer scientist. He had been analysing the Covid risk data since 2020. In his statement dated 3^rd November 2024, he considered the YCVM to be an important data set to evaluate risk noting the proportion of pregnant women reporting an adverse reaction and the ongoing advice to be vaccinated. He was critical of the peer review system as effective feedback and the Covid narrative. He considered that previous studies had been flawed and that there was no evidence that the vaccines were effective or saved lives. He considered that the if the release of the data confirmed the safety of the vaccine, this may reduce reluctance to have the vaccine. If the data showed otherwise, the release of the data would prevent unnecessary harm to pregnant women.
58. In his second statement dated 22^nd January 2025, he considered that the pre-print had not properly answered any of the nine questions posed by the Appellant. Whilst he commented on each question in turn, his response was not that the information had not been included in the pre-print but that the data had omissions that undermined its veracity, accuracy or was meaningless without other information. Professor Fenton gave evidence to the Tribunal broadly confirming the same. He concluded that releasing the full data was essential.
59. Dr Robert Chandler is a retired Professor of Medicine based in the US who had written extensively about the vaccines and women of reproductive age. In his statement dated 5^th November 2024, he was concerned about the effect of the vaccine on women and said that additional data was needed to understand the impact of the vaccine on reproduction. He identified the studies that taken place and he had concluded that there were significant risks with vaccinating pregnant women. He considered that the release of the YCVM data to be very important and in the public interest to be released.
60. In his second statement dated 27^th January 2025, Dr Chandler emphasised that to answer the nine questions required analysis of the full data. Dr Chandler identified flaws in the YCVM and its methodology, and the flaws in the data that would result. He identified that some data was missing and how data should have been further defined at the point of collection.
61. Whilst Dr Chandler attended the hearing, the Tribunal were unable to receive his oral evidence remotely as he was based in California and permission had not been given by the US Authorities for him to give evidence from abroad. Nonetheless his written evidence was considered by the Tribunal.
62. Dr Julia Wilkens is a consultant in obstetrics and gynaecology, involved in clinical trials and chaired the Data Monitoring and Ethics Committee. In her statement dated 4^th November 2024, she said that she was concerned about the coincidence of rising perinatal mortality and the introduction of the Covid vaccines, and the lack of investigation into this trend. She highlighted data that substantiated her concerns and that there was a lack of reliable data to confirm that the vaccines were safe for pregnant women. This is why she considered the YCVM data was important.
63. In her second statement dated January 2025, Dr Wilkens commented on the pre-print and was of the similar opinion that information was lacking or that the data without more was meaningless. She submitted that the full data was required both in her written evidence and in her short oral evidence.
64. The Second Respondent chose not to question the witnesses. Ms Thelan submitted that the Second Respondent did not accede to the evidence of the experts but the issue was not about whether the data collection was flawed but whether the exemption was properly claimed and the public interest balance. The Second Respondent had always accepted the weight of the public interest to release the information.
65. The schedule which allowed the Second Respondent to highlight where in the pre-print they had answered the questions posed by the Appellant, allowed the Appellant to identify where they had not and for the Second Respondent to comment on the alleged deficiently, was very helpful. That document crystalised the respective positions of the parties clearly.
66. We had a witness statement dated 1^st November 2024 from Philip Tregunno, the Deputy Director of Patient Safety Monitoring at MHRA. He described the four ways in which the surveillance of the vaccines would take place – voluntary reports through the yellow card scheme, surveillance of adverse events of special interest using patient data, targeted active monitoring of patients through the Yellow Card Vaccine Monitor and retrospective studies. The YCVM could not be used in isolation to identify vaccination-association risks. It was used to monitor how the tool was used and the broad safety profile of the vaccine. The YCVM was considered alongside other data. He said that the interpretation of safety data about medicines needed careful consideration. The simple summary data in the request could not give an indication of the safety of the vaccine. He described the key risks for releasing the data before it is analysed was the potential for misinterpretation and the spread of misinformation and potential for reluctance in accepting vaccination which could result in graver consequences.
67. Mr Tregunno gave evidence and emphasised that the YCVM was a single source of data that was considered in the publication. He said that weekly reports had been released by the MHRA from Yellow Card Reporting and the interim report which had been provided to the Appellant. He said that the MHRA had considered very carefully the release of the full data but after considering a number of examples where data had been misused and the potential for the data to be taken out of context, the MHRA decided to do a full analysis of all of the information gathered. He said that an early publication about the data would not have been detailed, enough. He was cross examined about the where the data was and he was able to point to where the data was in the publication; he had also completed the MHRA's responses in the Scott schedule as to where the data could be found. The Appellant had started to question Mr Tregunno about the methodology of the MHRA and why specific actions had not been taken; I reminded the Appellant that this appeal was not a forum to interrogate the MHRA on their research.
68. The evidence of the Appellant's witnesses and indeed the Appellant, highlighted the misunderstanding about the scope of the appeal. Despite reiterating numerous times that the appeal was about the exemption and the public interest, the Appellant sought to put a case that the data capture was inadequate, inchoate and not compared to other data and so was either meaningless or unreliable. The original request did not ask for the full data capture but a series of questions that could either be answered with a numeric figure or very short answer. The Appellant did not ask for the full data capture on the 2000 pregnant women. The Tribunal were unable to confirm that she would have been given the full raw data even if requested, other exemptions may have been pleaded if that were the original request.
69. Whilst there were references to another First Tier decision in the bundle, First Tier Tribunal decisions are not binding on the same level of Tribunal.

The Legal Framework

70. The Freedom of Information Act 2000 allows any person to make request of public authorities for information. The right is contained in section 1(1) as follows:

(1) Any person making a request for information to a public authority is entitled—

(a) to be informed in writing by the public authority whether it holds information of the description specified in the request, and

(b) if that is the case, to have that information communicated to him.

71. Subject to the authority requesting further information from the applicant to identify and locate the information, the Act provides for disclosure of the information (not documents) unless one or more exemptions in the Act apply.
72. An authority may rely on an exemption under Part II of the Act before the Tribunal that had not been relied upon previously, subject to the Court's case management powers.
73. Section 22 of FOIA provides a qualified exemption –

Information intended for future publication.

(1) Information is exempt information if—

(a) the information is held by the public authority with a view to its publication, by the authority or any other person, at some future date (whether determined or not),

(b) the information was already held with a view to such publication at the time when the request for information was made, and

(c) it is reasonable in all the circumstances that the information should be withheld from disclosure until the date referred to in paragraph (a).

74. Section 22A of FOIA provides a further qualified exemption –

Research

(1) Information obtained in the course of, or derived from, a programme of research is exempt information if—

(a)the programme is continuing with a view to the publication, by a public authority or any other person, of a report of the research (whether or not including a statement of that information), and

(b)disclosure of the information under this Act before the date of publication would, or would be likely to, prejudice—

(i)the programme,

(ii)the interests of any individual participating in the programme,

(iii)the interests of the authority which holds the information, or

(iv)the interests of the authority mentioned in paragraph (a) (if it is a different authority from that which holds the information).

(2) The duty to confirm or deny does not arise in relation to information which is (or if it were held by the public authority would be) exempt information by virtue of subsection (1) if, or to the extent that, compliance with section 1(1)(a) would, or would be likely to, prejudice any of the matters mentioned in subsection (1)(b)

75. The exemptions under section 22 and 22A are qualified exemptions and therefore subject to the public interest test, namely whether the public interest in maintaining the exemption is greater than the public interest in disclosing the requested information.
76. The Powers of the Tribunal are provided by section 58(1) of the 2000 Act:

If on an appeal under section 57 the Tribunal considers—

(a) that the notice against which the appeal is brought is not in accordance with the law, or

(b) to the extent that the notice involved an exercise of discretion by the Commissioner, that he ought to have exercised his discretion differently,

the Tribunal shall allow the appeal or substitute such other notice as could have been served by the Commissioner; and in any other case the Tribunal shall dismiss the appeal.

77. The powers of the Tribunal were considered by the Upper Tribunal in Information Commissioner v Malnick and the Advisory Committee on Business Appointments [2018] UKUT 72 (AAC) who confirmed that the Tribunal conducts a full merits review of the Commissioner's decision albeit the starting point was the Commissioner's decision. The Tribunal will give such weight as it considers fit to the Commissioner's views and findings; and will determine whether the Commissioner's decision was in accordance with the law. The appeal process is not adversarial, it is inquisitorial by nature.
78. In Montague v Information Commissioner and the Department of International Trade [2022] UKUT 104 (AAC), the Upper Tribunal decided that the public interest balance must be assessed on the basis of how matters stood at the time of an authority's decision on a request.

Analysis of the evidence and findings on appeal

79. The appeal raised issues about the nature of a FOIA request and the powers of the Tribunal. Section 1(1) provides the right "to be informed in writing by the public authority whether it holds information" and to have that information communicated to them. Section 84 of the Act defines information as information recorded in any form. The response, absent an exemption, should be to provide the recorded information, there is no obligation to provide the document with the information recorded, although the public authority may choose to do so. In addition, a FOIA request is not an opportunity to ask questions, seek clarification or explanations, or get into dialogue with a public authority about issues. Even if the public authority know information but it is not recorded in any format, then the information is not held for the purposes of FOIA. Public authorities are not required to create new information in order to comply with a request for information under the Act. They only need to consider information already in existence at the time a request is received. The Appellant in the schedule sought to suggest repeatedly that the information recorded does not go far enough, leads to other questions or is inchoate. The only issue for the Tribunal is whether the information is recorded (or not) and if so, whether it should be released. The Tribunal does not examine the quality of the information held.
80. Once information is provided, the FOIA request does not extend to consequential conversations about the information provided. The requester may make a further requests for information, subject to restrictions in the Act.
81. Another issue for the Tribunal that had been conflated was the scope of the original request. The original request was a series of nine questions asking for very specific data. The request was not for the full data captured from the 2000+ pregnant women who were involved in the YCVM. The witnesses and the Appellant submitted that the full data was essential. However, as repeatedly reminded by the Tribunal, this was not within the scope of the original request. Even if the appeal was successful, the Tribunal would not be able to direct the release of the full data captured in the YCVM. There was conflation between the information requested and what was sought by the Appellant at the hearing.
82. In the context of a FOIA request, the Commissioner's role is to investigate a refusal to supply recorded information and make a decision about whether the information is held and if so, whether it should be provided. The role of the Tribunal is to determine whether the Commissioner was correct and if allowing the appeal, make the decision that it considers the Commissioner should have made. The Tribunal cannot make declarations, nor require a party to take any action save to disclose recorded information or issue a fresh response, as appropriate. The Appellant has asked the Tribunal to make the full data capture from the YCVM available. The Tribunal can only direct the release of recorded information requested in the original request, which were the nine specific questions. The Appellant has also asked the Tribunal to direct the MHRA to withdraw its declaration that the vaccines are safe. The Tribunal has no power to do so. This appeal is not to determine the safety of the vaccines.
83. These misunderstandings about the FOIA regime and the powers of the Tribunal have infected some aspects of this appeal.
84. The Appellant had clarified on 3^rd December 2024 that she contended both the engagement of the exemption and the public interest were issues for the appeal. Her view was that the MHRA did not intend to publish. At the hearing on 20^th February 2025, the Appellant did not make submissions about this point, nor did she question Mr Tregunno about this issue.
85. The Appellant was concerned about the delay in publication, the insistence on peer review before public publication and that the raw data would not be published. The Tribunal considered that the exemption under section 22 did not require a fixed date for publishing. The YCVM continued until December 2022 but the report was to bring together other sources of information as well as the YCVM data. Having already highlighted the potential for misinformation by taking isolated figures, the MHRA were correct to provide the information in a way that could be understood and properly analysed.
86. There was agreement between the parties that the information requested was held at the time of the request. The Appellant had been doubtful that the MHRA intended to publish the data. The request for information was made on 13^th April 2023. The MHRA had responded to the Commissioner that the YCVM continued as follow-up information could still be received and that would be included in their safety assessments.
87. The Tribunal were satisfied that there was an intent to publish the information before the request from the Appellant but the publication date had yet to be determined. There was information in the closed material that confirmed that discussions had taken place almost 12 months before the request for information was made about publication of the data recorded to analyse the safety of the vaccines and that this was agreed in 2022. It was clear that a report analysing the data was what was envisaged rather than the full data set. The Tribunal also considered that the MHRA had published an interim report in June 2021 which had been made available and that the MHRA had committed to regular updates on Yellow Card reporting. This was not indicative of an agency seeking to conceal information. Indeed, the MHRA were set up to regulate medicines and drugs. The Appellant had read into the refusal to disclose, suspicions about the data, whether it would be released and a cover-up of safety concerns. The Tribunal were satisfied that the exemption was properly engaged at the time of the refusal.
88. A firm date for publication had not been set; indications were available some time later. It was clear that even though the YCVM ended at the end of 2022, some data was still being received. That data was going to be fully analysed against other sources. That process was going to take some time, noting that the publication was being prepared in-house. The request was made in June 2023. The publication was released in November 2024.
89. The risk of misinformation was real and significant. The bundle included information about false claims being made in videos on social media and in articles, and Advertising Standards Authority rulings about advertisements that referred to untrue information about Covid Vaccines. Mr Tregunno had concerns about information being taken in isolation and out of context being used to mislead or mis-inform with potentially harmful consequences to the public. The YCVM data was only collected from individuals who had been vaccinated, there was no comparator with unvaccinated individuals and so the data could not show in isolation the risks associated with the vaccines. He referred to flawed information which had been published which had damaged the uptake of the measles, mumps and rubella vaccines, and that the ASA had upheld complaints about misleading articles which confirmed that misleading articles had already been published. The YCVM was not the only source of information, data was being analysed from various sources and in conjunction with data from international sources.
90. The reasonableness in all the circumstances of withholding the requested information until publication is closely related to the public interest balancing test.
91. It is and always has been recognised that there is significant public interest in the vaccine information being released. The Covid pandemic impacted everyone and recognising concerns about vaccination, especially for women who were or planned to become pregnant, clear information about the efficacy and safety of the vaccination programme was important in the public interest. The MHRA and indeed the Commissioner had accepted that the public interest was weighed in favour of the release of the information.
92. But this had to be balanced against the need to have proper analysis of all of the data and a considered overview of safety. The current advice was published and there to be seen with full analysis. The publication of the raw data would only release part of the information available and could easily, as has happened before, be misused, misquoted or misunderstood. There was contemporaneous information already available to the public in the periodic updates. The full summary of the information was of greater public interest than the raw data which was likely to be of interest to the medical community. Misinformed hysteria about the vaccine may equally put lives at risk.
93. The Tribunal concluded that it was reasonable in all the circumstances for the Second Respondent to withhold the information until publication, and that the public interest in withholding the information until publication was greater than the public interest in releasing the information at the time of the refusal. As the Tribunal found the exemption in section 22 was engaged, we did not need to go on to consider section 22A.
94. In conclusion, The Tribunal were satisfied that the Commissioner's decision was correct, and the appeal is dismissed.

District Judge Moan

20^th March 2025