Approval and access to COVID19 vaccines for people living with SMA. What is happening in the European Union and the UK’s initial experience, where the first person was immunised this week.
Access to COVID19 vaccines will differ throughout Europe as approval is granted. The United Kingdom (UK) is the first to have approved BNT162b2, a COVID19 vaccine developed by Pfizer/BioNTech. Here, we describe how our member, SMA UK, is working to ensure access to people living with SMA and other muscle-wasting conditions. We also highlight a stakeholder meeting to be held by the European Medicines Agency (EMA) this Friday, 11th December, ahead of approval in the European Union.
In the United Kingdom
In the UK, a COVID-19 vaccine, developed by Pfizer/BioNTech, was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and is now being administered. SMA UK, together with a wider group of charities met with representatives of Public Health England, MHRA and the Department of Health and Social Care to raise concerns around access of people with muscle-wasting conditions and safety of the vaccine:
In the UK, the Joint Committee on Vaccination and Immunisation (JCVI) is responsible for advising UK health departments on immunisation and for setting the priority order in which people will have access to a COVID-19 vaccine. Under their initial proposal, it was unlikely that anyone under 65 with a muscle-wasting condition would have been in a high priority group.
SMA UK and partners, met with representatives of Public Health England, MHRA and the Department of Health and Social Care to raise concerns over this priority setting. The JCVI’s final advice now classes people who are clinically extremely vulnerable further up the priority ladder.
The order of priority for each group in the population corresponds with data on the number of individuals who would need to be vaccinated to prevent one death, estimated from UK data obtained from March to June 2020. The list is now as follows:
- Residents in a care home for older adults and their carers
- All those 80 years of age and over and frontline health and social care workers
- All those 75 years of age and over
- All those 70 years of age and over and clinically extremely vulnerable individuals
- All those 65 years of age and over
- All individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality
- All those 60 years of age and over
- All those 55 years of age and over
- All those 50 years of age and over
The JCVI highlighted that many individuals who are clinically extremely vulnerable will have some degree of immunosuppression or be immunocompromised and may not respond as well to the vaccine. People in this group are advised to continue to follow advice on reducing their risk of infection.
In terms of family members and carers of people who are clinically extremely vulnerable, the Department of Health and Social Care has confirmed that unpaid/informal adult carers are included in priority group six.
In the immediate term, only a limited number of children are likely to be offered the vaccine. The JCVI has advised that only those children at very high risk of exposure to and serious outcomes from COVID-19, such as older children with severe neuro-disabilities that require residential care, should be offered vaccination. This is in large part because trials so far have been undertaken only with adults. Last week, SMA UK joined other stakeholders and wrote to the JCVI expressing that clinically vulnerable children and adults as well as their families/ carers/ personal assistants should also feature as priority groups under the current early access proposals.
The JCVI guidance does highlight that as trials in children and pregnant women are completed, a better understanding of the safety and effectiveness of the vaccines in these persons will be gained. It is hoped that the precedent set with prioritising clinically extremely vulnerable adults will be mirrored in the approach to children.
The MHRA would not have licensed the vaccine if there were any doubts as to its safety. The JCVI guidance states that it has reviewed unpublished Phase I/II/III safety and efficacy data for the Pfizer BioNTech mRNA vaccine. The vaccine appears to be safe and well-tolerated, with no clinically concerning safety observations. In a meeting with representatives of Public Health England, MHRA and the Department of Health and Social Care, experts confirmed the safety of any approved vaccine and said it was highly unlikely anyone would be contra-indicated unless they had an allergy to a specific vaccine.
MDUK’s Services Development Committee, made up of senior neuromuscular clinicians as well as people living with muscle-wasting conditions, also discussed a vaccine. There was consensus among the clinical experts that there is no reason to think that COVID-19 vaccines will not be safe for people living with muscle-wasting conditions, but that if people had any concerns they should speak to their neuromuscular clinician.
- Next steps
In the UK, the schedule for the rollout of the vaccine across the priority groups is still not known. With reports that 400,000 doses will have been given by the end of the year, it is likely that access will begin in earnest in early 2021.
There are also practical issues that may affect the priority group list, particularly around how this Pfizer/BioNTech vaccine needs to be stored. It appears the initial 400,000 doses will initially be available only in hospitals, as they have the capability to store the vaccine at the required very low temperature.
This is a very fast-moving situation, with more vaccines on the way. SMA UK, together with MDUK, will continue to advocate for swift access to COVID-19 vaccination for everyone with SMA.
What is happening in the European Union?
A vaccine to prevent SARS-CoV-2 infections has not yet been approved in the European Union.
EURORDIS-Rare Diseases Europe, of which SMA Europe is a member and the European Patients’ Forum (EPF) invited the European Medicines Agency (EMA) to organise a multi-stakeholder meeting, open to the public, on the development & authorisation of safe & effective COVID-19 vaccines in the EU. This event will take place this week, on Friday 11th December between 13.00 and 16.30 CET. This public meeting will explain, to all interested parties, the processes for the development, evaluation, approval and safety monitoring of COVID-19 vaccines in the EU, including EMA’s specific role. It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, which will then be considered by EMA and the European medicines regulatory network in the decision-making process.
It is important to highlight that patients should be in close contact with their treating physician to assess their individual situation when it comes to immunisation against SARS-CoV-2
More information on EMA’s stakeholder meeting
- Link to EMA’s Stakeholder Meeting live broadcast – Friday 11th December from 13.00 to 16.30 CET
- Agenda for EMA’s Stakeholder Meeting
More information on what is happening for the EU
- Eurordis statement – 8 December 2020