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Please consider this a freedom of information request, in regards to own label suppliers. Could you please share which own label suppliers are applied to marketing authorisations in the UK. Other associated linking meta data that would also be useful to reference the OLS please; 1. PL number 2. OLS applied to the license 3. Pack size 4. Manufacturing batch release site on the leaflet
Published: 6 July 2025
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This is a Freedom of Information request regarding the delivery of Covid vaccines from the Serum Institute, Pune , India, to the UK. Three batches of the Oxford/Astra Zeneca vaccine, batch numbers 4120Z001/002/003 were manufactured in India in October 2020, prior to authorisation. They were subsequently supplied to different countries under the brand name Covishield. On March 5th 2021 4.5. millions doses were delivered by air to the UK and deployed within a week. Prior to that, the MHRA had expressed concerns about aspects of manufacturing at the Serum Institute; as a consequence the SII provided " a robust corrective action plan" according to Dame June Raine's evidence to the Hallett Inquiry. Dame June also told the inquiry that inspectors had been sent to India. My questions are as follows: 1 Exactly when were these inspectors sent to the SII? 2 How was MHRA convinced by SII's action plan? 3 Given that the three aforementioned batches were manufactured in October 2020 and were nearing their expiry dates, how could the action plan be applied, retrospectively, to them? 4 How and where were these batches tested for efficacy and safety? 5 What were the contents of a letter to Dame June from Professor Van Tam and Antonia Williams mentioned at the inquiry (INQ000400201) which have not yet been made public, even though this is a public inquiry?
Published: 6 July 2025
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FOIA Request: Full Disclosure of Plasmid DNA Backbone Sequences and Related Studies for Pfizer and Moderna COVID-19 Vaccines Date: April 7 2025 To Whom It May Concern, Under the Freedom of Information Act, I am requesting detailed information regarding the full genetic sequence of the plasmid DNA backbone used in the manufacturing process for Pfizer-BioNTech and Moderna COVID-19 vaccines. Specifically, I seek: 1 Complete Plasmid DNA Backbone Sequence Data: The full genome of any and all plasmid DNA backbones used in the production of mRNA for these vaccines, including: ◦ SV40 promoter/enhancer sequences. ◦ Any additional regulatory elements (e.g., origins of replication, antibiotic resistance genes). ◦ The spike protein gene sequence and any modifications made to stabilize or enhance its expression. ◦ All other genetic elements intentionally included in the plasmid DNA backbone. 2 Purpose and Function of Genetic Elements: Documentation explaining the function and purpose of each genetic element within the plasmid DNA backbone design, including why specific sequences (such as SV40 regulatory elements) were chosen. 3 Safety Assessments on the Full Plasmid DNA Backbone: All studies or analyses conducted to evaluate whether the plasmid DNA backbone is associated with: ◦ Carcinogenesis: Risks of cancer development due to genomic integration or other mechanisms. ◦ Mutagenesis: Risks of inducing mutations in human genomic DNA. ◦ Impairment of Fertility: Effects on male and female reproductive health, including germline cells. ◦ Teratogenicity: Risks of congenital malformations or developmental abnormalities. 4 Batch-Specific Variations: Information on whether different batches of Pfizer and Moderna vaccines used distinct plasmid DNA backbone designs or sequences, particularly between clinical trial materials and commercial production batches. This request is made because it is already known that Pfizer’s COVID-19 vaccine contains residual plasmid DNA, including SV40 promoter/enhancer sequences within its plasmid backbone. However, the full genome of this plasmid DNA backbone has not been disclosed, nor have the results of any studies evaluating its safety. Americans were not informed that these vaccines contain plasmid DNA capable of integrating into human genomic DNA. Such integration could theoretically lead to permanent mutations, genomic instability, activation of oncogenes, or heritable genetic changes. Additionally, Pfizer has documented over 1,200 diseases linked to adverse events following vaccination. Despite this alarming list, these vaccines continue to be widely promoted without full transparency about their contents or risks. Understanding the complete composition of the plasmid DNA backbone and reviewing related safety studies are critical for ensuring public trust in vaccine safety. If any portion of this request cannot be fulfilled due to exemptions under FOIA, please provide a detailed explanation. I look forward to your prompt response.
Published: 6 July 2025
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The below is referenced in the green guide "Rules and Guidance for Pharmaceutical distributors 2022"; Appendix 3 - Sources of useful information Can you share the WHO's "List of globally identified websites of medicines regulatory authorities" The link provided in the green guide is not working: http://www.who.int/medicines/areas/quality_safety/regulation_legislation/list_mra_websites_nov2012.pdf?ua=1 Or likewise send a different resource for covering the same topic;
Published: 6 July 2025
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I'm a neurologist in the UK planning to do some research on PML and wanted to check if you're able to provide some up to date information on figures for the UK based on yellow card reporting? I noticed that on the Gov UK site they had figures up to 2008 (Info on progressive multifocal leukoencephalopathy (PML) from Yellow Card reports - GOV.UK), and case reporting for the years following on would be very helpful.
Published: 6 July 2025
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I'd like to know what adverse reactions have been reported for vaccinations given in the UK for hepatitis A, Typhoid and the combined tetanus/poilo/diptheria vaccines.
Published: 6 July 2025
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1. Please confirm whether the attached non-technical summary (NTS), titled "Pharmacology and physiology of CNS neurotransmission", which was originally granted between January and June 2022, is the NTS for a project licence that is or was held by your institution. 2. If this NTS is for a project licence that is or was held by your institution, please provide a redacted copy of the license. 3. If the NTS is for a project licence held by your institution, please confirm whether the Forced Swim Test (FST) or forced swimming procedures have been conducted under it. 4. If the Forced Swim Test has been conducted under the project licence, please confirm: a. How many animals were used in the FST b. Which species was used in the FST c. The purpose for which the animals were used in the FST Thank you.
Published: 6 July 2025
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We are inquiring in relation to recall EL(25)A/16 for Synalar Gel 30g and 60g; If a wholesaler has exported this stock and the advice in the recall notification states to return back to the supplier; does the exporter/wholesaler from UK need to get the exported(now recalled) batch back into UK to return it to it's manufacturer/supplier in UK? or can ask the customer to quarantine and share destruction record, as it is exported.
Published: 6 July 2025
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Please could you tell me the total number of adverse drug reactions (ADRs) reported to you through the Yellow Card scheme in the 2024 calendar year? In relation to the figures for 2024 could you also provide (i) the number of UK suspected ADR reports received with a fatal outcome, (ii) number of ADR reports received which resulted in prolonged hospitalisation and (iii) the number of reports received which resulted in prolonged hospitalisation AND had a fatal outcome? In relation to the fatal outcomes could you please provide a table showing the ten drugs that were most frequently recorded as having caused such a reaction along with the number of times each one was recorded as having a fatal outcome.
Published: 6 July 2025
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I am drafting a hospital policy and require detailed information regarding any incidents involving patients, staff members, or members of the public who have a heart valve and have interacted with the MRI department. This includes any safety concerns, adverse events, or protocol deviations related to the presence of a cardiac stent in the MRI environment.
Published: 6 July 2025
