Freedom of Information request on defective medicinal products (FOI 21-361)
Published 28 June 2021
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5th May 2021 FOI 21/361 Dear
Thank you for your communication to the MHRA in relation to a Freedom of Information request for:
- How many Covid-19 vaccines (AstraZeneca, Pfizer, Moderna) have been spoiled (ie. have been manufactured and then deemed unfit for use and had to be discarded) within the UK.
- If you have the numbers, please also provide information on how many vaccines have been discarded due to cold chain compliance issues (refrigerator/freezer malfunctions etc).
-
Please provide any numbers you have (overall numbers of discarded vaccines/discarded vaccines in February etc).
- Please see below table, for information received by Defective Medicines Report Centre only. The information received by Defective Medicines Report Centre is from reports from healthcare professionals reported to Defective Medicines Report Centre directly or via the MHRA Yellow Card reporting tool, for issues observed at the point of vaccine reconstitution and administration.
The role of the Defective Medicines Report Centre is to protect public health by minimizing the hazard to patients arising from the distribution of defective medicinal products. Reports relating to potential defective medicines, including vaccines and other medicinal products are routinely reported to the Defective Medicines Report Centre and managed in line with our processes as detailed in The Guide to Defective Medicines: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/403210/A_guide_to_defective_medicines.pdf
| Month | Pfizer/BioNTech | AstraZeneca/Oxford | Moderna |
|---|---|---|---|
| Total Vials deemed unfit | Total Vials deemed unfit | Total Vials deemed unfit | |
| December 2020 | 76 | N/A N/A | |
| January 2021 | 379 | 0 | N/A |
| February 2021 | 241 | 3 | N/A |
| March 2021 | 105 | 59 | N/A |
| April 2021* | 15 | 0 | 0 |
*up to and including 06/04/2021 as per date of FOI request.
• To provide some context for these figures, the total number of cumulative doses (first and second doses) administered up to and including 06/04/2021 was 37,391,103. (This includes 31,707,594 first doses and 5,683,509 second doses)
Defective Medicines Report Centre have no additional data from throughout the supply chain, as indicated, these reports are from healthcare professionals at the point of reconstitution and administration and there may other incidents of vaccine wastage, prior to the reconstitution and administration stages, for which Defective Medicines Report Centre /MHRA do not hold any data as this would not be reported to us.
- The Defective Medicines Report Centre have received zero reports of vaccines discarded due to cold chain compliance issues.
- Please see the table above for reports received by the Defective Medicines Report Centre.
If you have a query about this letter, please do not hesitate to contact us at IE&SFOI@mhra.gov.uk
If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.
After that, if you remain dissatisfied, you may write to the Information Commissioner at; The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU