Freedom of Information request on VAED/VAERD included as an important potential risk in the Risk Management Plan for the COVID-19 vaccines (FOI 21/917)
Published 25 February 2022
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9th September 2021
FOI 21/917
Dear
Thank you for your enquiry of 11th August. VAED/VAERD is included as an important potential risk in the Risk Management Plan (RMP) for each of the COVID-19 vaccines. It is a theoretical risk only, and is included because cellular immunopathology has been demonstrated after viral challenge in some animal models administered betacoronaviruses related to SARS-CoV-2 (SARS-CoV-1 or MERS-CoV vaccines) and historically, disease enhancement in vaccinated children following infection with natural virus has been seen with an inactivated respiratory syncytial virus (RSV) vaccine. However, it is important to note that animal models of SARS-CoV-2 infection have not shown evidence of VAED after immunisation and it has not been reported from any other late phase clinical trial of other human vaccine.
The Risk Management Plan (RMP) for each of the vaccines provide details of the post-authorisation studies which are planned or ongoing for the vaccine to which it refers. This include details of the study design, study objectives and safety concerns addressed. The RMPs are available on the European Medicines Agency (EMA) website at the following links:
Pfizer/BioNTech COVID-19 vaccine (brand name Comirnaty): https://www.ema.europa.eu/en/documents/rmp-summary/comirnaty-epar-risk-management-plan_en.pdf
COVID-19 vaccine AstraZeneca (brand name Vaxzevria): https://www.ema.europa.eu/en/documents/rmp-summary/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-risk-management-plan_en.pdf
Spikevax (previously known as COVID-19 vaccine Moderna): https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax-previously-covid-19-vaccine-moderna
All of the studies listed in the RMPs for the COVID-19 vaccines which are relevant to VAED/VAERD are ongoing, therefore we are unable to provide any information on the results of these studies at this time.
Public Health England (PHE) are also closely monitoring vaccine effectiveness and we are working closely with PHE to monitor the impact of the COVID-19 vaccination programme.
All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.
For all COVID-19 vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as ‘flu-like’ illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.
These types of reactions reflect the normal immune response triggered by the body to the vaccines. They are typically seen with most types of vaccine and tend to resolve within a day or two.
As with any vaccine or medicine, COVID-19 vaccines require continuous safety monitoring and that the benefits in protecting people against COVID-19 outweigh any side effects or potential risks. This is a process known as safety monitoring (pharmacovigilance). This ensures that any potential medium and long term safety issues, which it is not possible to evaluate in clinical trials are promptly and adequately evaluated. As part of our signal detection processes, all adverse reaction reports received are individually assessed and cumulative information reviewed at regular intervals. Be reassured that the MHRA is working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division