A COVID-19 vaccine – what we know so far

Published Date
03/12/2020
Author

Update: 22 January 2021

Visit our vaccine information page.

Since this blog was written, a second COVID-19 vaccine has now been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) after meeting required safety, quality and effectiveness standards. This means that roll-out of two vaccines is now underway.

More information on the Oxford University/AstraZeneca vaccine is available here and more information on the Pfizer/BioNTech vaccine is available here.

As set out in the blog below, access to COVID-19 vaccination is being prioritised in line with guidance produced by the Joint Committee on Vaccination and Immunisation (JCVI). People with muscle-wasting conditions who are classed as clinically extremely vulnerable are in the fourth priority group (of 11). On 4 January the Prime Minister announced that the Government expects to have offered the first vaccine dose to everyone in the four top priority groups by the middle of February. The full transcript of the speech is available online. If you are living with a muscle-wasting condition but are not classed as being clinically extremely vulnerable, your priority group will be determined by your age.

In just a few months, a COVID-19 vaccine has gone from being a distant hope to being on the cusp of roll-out. It is dominating national attention. For people living with muscle-wasting conditions, especially those of you who have been shielding for much of this year, we know you need clear information and swift access. Here, Rob Burley, our Director of Campaigns, Care and Support, explains what we’ve achieved and know so far; and what’s still left to do.

This week, you’ll have heard that the Medicines and Healthcare products Regulatory Agency (MHRA) announced its approval for use in the UK of the first COVID-19 vaccine, developed by Pfizer/BioNTech. This is a remarkable collaborative, scientific achievement, given that few of us had even heard of COVID-19 at the start of the year – and certainly didn’t realise the extent to which it would impact our lives.

Last month, when it was clear that a vaccine could soon be approved, we started getting questions about it from people living with muscle-wasting conditions. Our helpline team has been answering questions about two main issues – when will people with a muscle-wasting condition have access to a vaccine, and will it be safe?

1. When will people with muscle-wasting conditions have access to a vaccine?

As has been the case with so much of our response to COVID-19, we’ve worked in collaboration to answer these questions and to make the case for our community receiving the vaccine swiftly. We’re pleased to report that our concerns have been heard.

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. Their initial guidance, published at the end of September, highlighted age as the likely most important factor in determining priority, and recognised the need for health and social care workers to receive early access too. Under these initial proposals, it was unlikely that anyone under 65 with a muscle-wasting condition would have been higher than priority group six (out of 11).

We felt this was unfair to the many people classed as clinically extremely vulnerable to COVID-19, who have been shielding for much of the year. So we did the following:

  • sought clarity on this, working through the Shielding and High Risk Coalition
  • wrote to the JCVI, along with SMA UK, Genetic Alliance UK, Neurological Alliance, Disabled Children’s Partnership, Angelman UK and Contact
  • joined a wider group of charities on 18 November to meet with representatives of Public Health England, MHRA and the Department of Health and Social Care to raise our concerns directly with them.

On 2 December, the JCVI published its final advice on priority groups for the Pfizer/BioNTech vaccine. We warmly welcome news that our concerns were heard and that people classed as clinically extremely vulnerable have been moved up the priority order and are now in priority group four. You can see the full guidance here.

It should be noted that the JCVI has 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 to the Shielding and High Risk Coalition that “unpaid/informal adult carers” are included in priority group six.

Children

It is important to note that in the immediate term, only a limited number of children are likely to be offered the vaccine. The JCVI advises 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. The JCVI guidance does highlight that: “As trials in children and pregnant women are completed, we will also gain a better understanding of the safety and effectiveness of the vaccines in these persons.” We would hope that the precedent set with prioritising clinically extremely vulnerable adults will be mirrored in the approach to children.

2. Will the vaccine be safe?

Advice from Professor Francesco Muntoni, Professor Ros Quinlivan, Dr Adnan Manzur and Dr Chiara Marini-Bettolo who are four neuromuscular experts leading the paediatric and adult North Star and SMA Reach networks of neuromuscular health professionals:

‘We can advise that the Pfizer/BioNTech, Moderna, or Oxford/AstraZeneca vaccine should be fine to receive for those living with a neuromuscular condition including those on immunosuppression treatments. We therefore encourage you to get vaccinated at your earliest opportunity via your GP once available.

Those on immunosuppression may have a reduced immune response (i.e the vaccine will be less effective) but can still have the vaccine.

Please make every effort to avoid exposure to COVID-19. If you feel unwell then please seek a PCR-based test from the national testing centres. If this is positive please let your specialist teams know as soon as you can.

It is important to remember that the Medicines and Healthcare products Regulatory Agency (MHRA) would not have licenced the vaccine if there were any doubts as to its safety. The Joint Committee on Vaccination and Immunisation (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, and there were no clinically concerning safety observations”.

3. Next steps

There are still lots of areas where we need further clarity, and clear communication from Government. We still don’t know the schedule for the rollout of the vaccine across the priority groups. 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.

As you know, this is a very fast-moving situation, with more vaccines on the way. We’ll continue to advocate for swift access to COVID-19 vaccination for everyone with muscle-wasting conditions, and we’ll keep you updated as things become clearer and we get more answers.

If you want to get in touch, you can call our helpline on 0800 652 6352 or email us at info@musculardystrophyuk.org.

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