Freedom of Information request on hearing losses related to COVID-19 vaccination (FOI 21-523)
Published 13 August 2021
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15th June 2021 FOI 21/523
Dear
Thank you for your correspondence of the 18th May 2021 regarding hearing losses related to COVID-19 vaccination.
Deafness and other hearing loss terms are not currently recognised as side effects for any of the COVID-19 vaccines currently deployed in the UK, which are the Oxford University/AstraZeneca, Pfizer/BioNTech and Moderna COVID-19 vaccines.
Since the launch of the COVID-19 immunisation campaign we have been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at population level. Our most recent adverse reaction assessment report can be found here: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions.
As of the 10th June 2021 there have been a total of 579 reports following the Oxford University/AstraZeneca vaccine, 269 reports following the Pfizer/BioNTech vaccine and 11 reports following the Moderna vaccine that reported an event term in the “Hearing Losses” category. The breakdown of the number of reports for individual terms for each vaccine is included in Table 1 below. However, it is important to note that the nature of Yellow Card reporting means that reported events are not always proven side effects. Hearing loss is a common condition, with around 1 in 6 people (approximately 11 million people) in the UK with a partial or total inability to hear from one or both ears1 , and it should be noted that these adverse reaction reports have occurred in the context of over 40 million Oxford University/AstraZeneca doses, 25 million Pfizer/BioNTech doses and 460,000 Moderna doses. It is also important to note that reports of hearing loss events do not necessarily mean that permanent hearing loss has occurred, with many of these events likely to be transient in nature. Additionally, when any vaccine is administered to very large numbers of people, some recipients will inevitably experience adverse events following vaccination, and some of these events may be due to underlying or concurrent illnesses and such events can also be coincidental. The MHRA encourage reporters to update us with the status of their recovery from hearing loss events and follows up reports when is it is considered that additional information would aid MHRA assessment of the case.
1 https://publichealthmatters.blog.gov.uk/2019/06/05/health-matters-hearing-loss-across-the-life-course/
The MHRA will continue to monitor reports of hearing loss following COVID-19 vaccination and, if there is evidence of an association with vaccination, we will take appropriate action to minimise risk to patients. I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Yours sincerely
FOI Team, Vigilance and Risk Management of Medicines Division