COVID-19 vaccines and tinnitus

We know that people with tinnitus have concerns about the Covid-19 so we have put together some information to help you

Updated 19 September 2023

This article is for information purposes only and is not a substitute for medical advice. You should always see your doctor or medical professional if you have any questions or concerns about the suitability of the coronavirus vaccine/s for you.

The Autumn coronavirus booster vaccination programme has begun, and numbers of people are being invited to have their vaccine.

We know that people with tinnitus have concerns about the impact of the vaccine and of Covid-19 on their condition, and we have put together some information to help you decide if vaccination is right for you.

Types of coronavirus vaccines

There are six vaccines that are being used, or have been used, in the UK. These vaccines have been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA).

Pfizer/BioNTech vaccine

The results from the clinical trial showed the vaccine to be 95% effective at protecting people against developing Covid-19 after two doses [1], and suggested it is 52% effective in the period between doses.

Oxford University/AstraZeneca vaccine

The results from the latest study, where the two doses were given 12 weeks apart, show that this vaccine is 76% effective after three weeks, and 82% effective after the second dose [2][3].

Moderna

Results from the clinical trial showed the vaccine to be 94% effective at protecting people against developing Covid-19 after two doses [4].

Novavax

Novavax was evaluated in clinical trials involving more than 30,000 participants. This showed the vaccine to be 91% effective at protecting people against developing symptomatic Covid-19 and gave 100% protection against moderate and severe disease [5].

The Moderna bivalent vaccine and the Pfizer/BioNTech bivalent vaccine have been approved by the MHRA as booster vaccines.[6]

Are the vaccines safe?

The MHRA is responsible for making sure that all medicines and medical devices – including vaccines – used in the UK are safe and effective. They have to approve any new treatment or vaccine before they can be used on the public in the UK.

Although the coronavirus vaccines were developed more quickly than normal, no stages of development and testing have been rushed or missed out. The speed was due to international effort and collaboration in the face of the unprecedented threat from Covid-19.

The MHRA will also continue to monitor the vaccines ‘robustly’ over time and provide updated safety information when needed [6].

The Yellow Card scheme

The Yellow Card scheme is the system for recording any suspected side effects from medicines, vaccines or medical devices. It is a vital part of helping the MHRA monitor the safety of all healthcare products in the UK.

Reports do not have to prove that a medicine, vaccine or medical device caused the side effect, there just has to be a suspicion that it may have. Sometimes these symptoms may occur naturally.

Do the coronavirus vaccines cause tinnitus or make it worse?

In the trials prior to release, no mention was made of the onset of tinnitus or worsening tinnitus for any of the available vaccines [3] [7] [8].

A summary of the Yellow Card reporting on the coronavirus vaccine was published in March 2023. This estimates that 53 million first doses of the vaccines had been given, 50 million second doses, and 40.6 million third or further booster doses [6].

As of August 2023, a total of 481,987 Yellow Cards reporting adverse effects had been received. Overall reporting rates have fallen as the reporting rates for third or booster doses of the vaccines are lower than those observed for the first and second doses. [9 – 15]

A total of 8,078 reports of tinnitus were made.

This means that around 1 in 6,560 people who have been vaccinated are affected which classifies this side effect as ‘rare’ [16].

Does Covid-19 cause tinnitus or make tinnitus worse?

A study by audiologists at the University of Manchester found that a significant number of patients reported a deterioration in their hearing after hospitalisation for Covid-19, with 6.6% developing tinnitus [17].

A global study found that 40% who had Covid-19 symptoms reported that their tinnitus was more bothersome [18].

Tinnitus has been recognised as a symptom of long-Covid by the National Institute for Health and Care Excellence (NICE) [19].

What should I do?

The evidence appears to show that both coronavirus vaccines are safe, and that any side effects are likely to be mild. The likelihood of the vaccines causing or making tinnitus worse appears to be very low [20].

The MHRA state that:

‘Vaccines are the best way to protect people from Covid-19 and have already saved tens of thousands of lives. Everyone should continue to get their vaccination when invited to do so unless specifically advised otherwise’.

‘The expected benefits of the vaccines in preventing Covid-19 and serious complications associated with Covid-19 far outweigh any currently known side effects in the majority of patients’ [6].

We are happy to follow the MHRA lead on this situation.

However, if you are concerned, please discuss your worries with your GP as they will be able to advise you.

If you do experience any side effects, they can be reported using the Yellow Card scheme [21].

More questions about tinnitus and Covid-19?

If you have other questions about tinnitus and Covid-19, you may find our FAQ page of interest. And if you need to talk to someone about tinnitus, please get in touch with our Tinnitus Support Team.

 

[1] Centers for Disease Control and Prevention. Information about the Pfizer-BioNTech COVID-19 Vaccine. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Pfizer-BioNTech.html [accessed 8 March 2021]

[2] Voysey M et al. Single Dose Administration, And The Influence Of The Timing Of The Booster Dose On Immunogenicity and Efficacy Of ChAdOx1 nCoV-19 (AZD1222) Vaccine. The Lancet (pre-print). https://ssrn.com/abstract=3777268 [accessed 8 March 2021]

[3] Voysey M et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. The Lancet. 397 (10269). DOI: https://doi.org/10.1016/S0140-6736(20)32661-1

[4] Oliver S, Gargano J, Marin M, et al. The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020. MMWR Morb Mortal Wkly Rep 2021;69:1653-1656.[online] DOI: http://dx.doi.org/10.15585/mmwr.mm695152e1 [accessed 4 May 2021]

[5] Heath PT et al. (2021) Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. New England Journal of Medicine; 385:1172-1183 DOI: 10.1056/NEJMoa2107659

[6] Medicines and Healthcare Products Regulatory Agency. Coronavirus vaccine –summary of Yellow Card reporting. https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#summary[accessed 19 September 2023]

[7] Centers for Disease Control and Prevention. Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events: Pfizer-BioNTech COVID-19 Vaccine. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html [accessed 8 March 2021]

[8] Baden LR et al. (2021) Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. New England Journal of Medicine; 384:403-416 DOI: 10.1056/NEJMoa2035389

[9] Medicines and Healthcare Products Regulatory Agency. COVID-19 Vaccine Pfizer/BioNTech monovalent https://yellowcard.mhra.gov.uk/idaps/TOZINAMERAN [accessed 19 September 2023]

[10] Medicines and Healthcare Products Regulatory Agency. COVID-19 Vaccine Pfizer/BioNTech bivalent https://yellowcard.mhra.gov.uk/idaps/RILTOZINAMERAN%20AND%20TOZINAMERAN [accessed 19 September 2023]

[11] Medicines and Healthcare Products Regulatory Agency. COVID-19 Vaccine AstraZeneca https://yellowcard.mhra.gov.uk/idaps/CHADOX1%20NCOV-19 [accessed 19 September 2023]

[12] Medicines and Healthcare Products Regulatory Agency. COVID-19 Vaccine Moderna monovalent https://yellowcard.mhra.gov.uk/idaps/ELASOMERAN [accessed 19 September 2023]

[13] Medicines and Healthcare Products Regulatory Agency. COVID-19 Vaccine Moderna bivalent https://yellowcard.mhra.gov.uk/idaps/ELASOMERAN%20AND%20IMELASOMERAN [accessed 19 September 2023]

[14] Medicines and Healthcare Products Regulatory Agency. COVID-19 Vaccine – brand unspecified or not in routine use in the UK https://yellowcard.mhra.gov.uk/idaps/SARS-COV-2%20VIRUS [accessed 19 September 2023]

[15] Medicines and Healthcare Products Regulatory Agency. COVID-19 Vaccine Novavax https://yellowcard.mhra.gov.uk/idaps/SARS-COV-2%20RS [accessed 19 September 2023]

[16] NHS Scotland. Incidence rates of ADRs http://www.knowledge.scot.nhs.uk/ecomscormplayer/ADRmodule1//8-incidence.html [accessed 20 January 2022]

[17] Munro K et al. Persistent self-reported changes in hearing and tinnitus in post-hospitalisation COVID-19 cases. International Journal of Audiology. 59 (12). DOI: https://doi.org/10.1080/14992027.2020.1798519

[18] Beukes EW, Baguley DM, Jacquemin L, Lourenco MPCG, Allen PM, Onozuka J, Stockdale D, Kaldo V, Andersson G and Manchaiah V (2020). Changes in tinnitus experiences during the Covid-19 pandemic. Frontiers in Public Health 8:592878. doi: 10.3389/fpubh.2020.592878

[19] National Institute for Health and Care Excellence. Long-term effects of coronavirus (long COVID). https://cks.nice.org.uk/topics/long-term-effects-of-coronavirus-long-covid/ [accessed 19 September 2023]

[20] Dorney I, Bobak L, Otteson T and Kaelber DC (2022), Prevalence of New-Onset Tinnitus after COVID-19 Vaccination with Comparison to Other Vaccinations. The Laryngoscope. https://doi.org/10.1002/lary.30395 [accessed 27 September 2022]

[21] Medicines and Healthcare Products Regulatory Agency. Yellow Card. https://yellowcard.mhra.gov.uk/ [accessed 19 September 2023]