Coronavirus (COVID-19) advice for people on the Highest Risk List: evidence review

Annex C - Removal of groups from the Highest Risk List

The majority of those previously identified as highest risk do not face the same level of risk of severe illness or death from COVID-19 following the vaccination roll out and introduction of therapeutic treatments. This is reflected in the following conclusion and summary information:

17. Children

17.1 In Winter 2021, the NHS England Children and Young People National Clinical Director was commissioned by the Department of Health and Social Care to undertake an evidence review, to understand which children and young people are at highest risk from COVID-19 based on data and clinical intelligence^[13].

17.2 On 15 July 2021, the 4 Chief Medical Officers reviewed evidence presented by the UK Government on risk to children and young people from COVID-19. They decided that all children and young people under 16 should be removed from the Highest Risk List, on the basis of extremely low rates of serious disease or mortality in this age group.

17.3 The evidence shows that a small number of children could still be advised by their GP or hospital clinician to follow stricter precautionary measures, as they would have been pre-pandemic, but there would no longer be any central shielding advice for children and young people, and they should be removed from the Shielding List.

17.4 The decision to remove children and young people from the List in Scotland was delayed as a precautionary measure, due to increases in the prevalence of the virus among younger age groups, and the severity of Delta at the time we proposed to remove them.

17.5 On 22 December 2022 the Joint Committee of Vaccination and Immunisation (JCVI) advised of primary vaccination of 5 to 11 year olds in a clinical risk group, which provides a further layer of protection^[14] and supports the recommendation to remove children and young people from the Highest Risk List in Scotland. In a clinical trial, vaccine efficacy against COVID-19 in 5 to 11 year olds was 90.7%^[15].

17.6 Booster vaccinations are also being offered to children and young people aged 12-15 who are in a clinical risk group, and those who are severely immunosuppressed and who have had a third primary dose.

17.7 As at 21 February 2022, there were 1,384 people under 16 on the Highest Risk List in Scotland, making up less than 1% of the overall list.

18. Group 1 – Solid organ transplant recipients

18.1 These are people who have had a transplant of the kidney, liver, pancreas, islet cell, heart, lung, stomach or other part of the intestine who are considered to be at higher risk due to the immunosuppression medication these individuals are required to take to stop rejection of transplanted organs.

18.2 A statement from NHS Blood and Transplant recommended vaccination as the best protection from severe disease, risk of hospitalisation and death from COVID-19.^[16]

18.3 Data from Public Health Scotland showed that in January 2022 the transplant group had a COVID-related mortality rate 9 times higher than that of the non-highest risk population. This fell from a high of 59 times higher in June 2021.

18.4 The REACT-Scot study^[17] recommended an option of passive immunisation therapies for solid organ transplant recipients for prevention in "those who have a medical condition making them unlikely to respond to or be protected by vaccination".

18.5 The COVID-19 Statistical Report^[18] published in March 2022 by Public Health Scotland showed a decrease in the percentage of COVID-related deaths following a positive test in the transplant group from 17% in January 2021 to 2% in January 2022.

18.6 We will continue to review vaccine efficacy evidence and consider what future support would benefit this group of people.

18.7 As at 21 February 2022, there were 6,666 people within the transplant group on the HRL in Scotland, making up 4% of the overall list.

19. Group 2 – People with specific cancers

19.1 You are in this group if you:

• have cancer and are undergoing active chemotherapy, or have had radical radiotherapy for lung cancer
• have cancer of the blood or bone marrow and are at any stage of treatment. This includes cancers such as leukaemia, lymphoma or myeloma
• have cancer and are having immunotherapy or other continuing antibody treatments
• have cancer and are having specialised treatments that can affect the immune system. This includes protein kinase inhibitors or PARP inhibitors
• have had a bone marrow or stem cell transplant in the last 6 months, or if you are still taking immunosuppression drugs

19.2 The cancer group had a COVID-related mortality rate 12 times higher than that of the non-highest risk population in January 2022. This group had the highest relative COVID-related mortality rate in January 2022, the same as the rare diseases and clinician identified groups (Figure 9).

19.3 The COVID-19 Statistical Report^[19] published in March 2022 by Public Health Scotland showed a decrease in the percentage of COVID-related deaths following a positive test in the cancer group from 19% in January 2021 to 3% in January 2022.

19.4 We will continue to review vaccine efficacy evidence and consider what future support would benefit this group of people.

19.5 As at 21 February 2022, there were 25,630 people within the cancer group on the HRL in Scotland, making up 14% of the overall list.

20. Group 3 – People with severe respiratory conditions

20.1 You are in this group if you have:

• cystic fibrosis
• lung conditions which require home oxygen
• severe asthma requiring regular inhaler use and long-term steroid tablets to control your asthma – for example, Prednisolone or regular injections
• severe non-cystic fibrosis bronchiectasis
• pulmonary hypertension
• severe COPD. This usually means being on several different inhaler medications in the last year. This must include two long acting preventers as well as a steroid inhaler, for example, Long Acting Beta Agonists and Long Acting Anti-Muscarinic Antagonists. Severe COPD means that:
• o you are too breathless to walk 100 yards;
• o you have 2 or more lung infections a year, or;
• o you require oxygen to help with your breathing

20.2 The respiratory group had a COVID-related mortality rate 9 times higher than that of the non-highest risk population in January 2022. This was similar to those in the transplant group (Figure 9).

20.3 The number of COVID-related deaths remains highest for those in the respiratory and clinician identified groups in January 2022.

20.4 The COVID-19 Statistical Report published in March 2022 by Public Health Scotland showed a decrease in the percentage of COVID-related deaths following a positive test in the respiratory group from 23% in January 2021 to 1% in January 2022.

20.5 As at 21 February 2022, there were 70,049 people within the respiratory group on the HRL in Scotland, making up 39% of the overall list.

21. Group 4 – People with rare diseases

21.1 You are in this group if you have:

• An inborn error of metabolism which increases your risk of infection. Examples include Severe Combined Immunodeficiency (SCID) and homozygous sickle cell disease
• Interstitial Lung Disease (ILD)
• Sarcoidosis
• Down's syndrome, and you are aged 18 or over

There are many conditions classed as a rare disease but not everyone with a rare disease would be considered to be at a higher risk of COVID-19.

21.2 The rare diseases group had generally low relative mortality rates ranging from 0 to 9 times higher than that of the non-highest risk population between April and August 2021, however there was an increase in September 2021 to a relative mortality rate of 20 times higher. This reduced to a mortality rate of 12 times higher than that of the non-highest risk population in January 2022 (Figure 9).

21.3 This group had the highest relative COVID-related mortality rate in January 2022, same as the cancer and clinician identified groups. (Figure 9).

21.4 The COVID-19 Statistical Report^[20] published in March 2022 by Public Health Scotland showed a decrease in the percentage of COVID-related deaths following a positive test in the rare diseases group from 25% in January 2021 to 2% in January 2022.

21.5 As at 21 February 2022, there were 10,647 people within the rare diseases group on the HRL in Scotland, making up 6% of the overall list.

22. Group 5 – People on immunosuppression therapies which increase risk of infection

22.1 These are people who:

• may also belong to other groups, for example, because they are on immunosuppressive therapy for organ transplants
• may be on a high dose of corticosteroids (equal to Prednisolone 20 mg or more per day) for more than 4 weeks, or on a lower dose of corticosteroids for more than 4 weeks, combined with other disease modifying medications
• are on specific single therapies, for example Cyclophosphamide (usually prescribed by hospital specialists), and those on disease modifying medications who also have other chronic medical conditions

22.2 The immunosuppressed group had a COVID-related mortality rate 6 times higher than that of the non-highest risk population in January 2022 (Figure 9).

22.3 In August 2021 initial data published from the OCTAVE study^[21] into vaccine responses in patients with impaired immune systems found the following:

• For the majority the immune response to the COVID-19 vaccine was equitable to that of someone with a full immune system
• 40% mounted a low response following two doses of the vaccine
• 11% failed to generate any antibodies four weeks after two doses of the vaccine

22.4 This study contributed as significant evidence supporting a third dose of vaccine to those who are severely immunosuppressed.

22.5 In September 2021 the JCVI defined the criteria for severe immunosuppression^[22] and recommended a third primary dose be offered to individuals aged 12 years and over who were severely immunosuppressed around the time of their first or second COVID-19 vaccine.

22.6 As at 10 March 2022, 91% of those identified for a third COVID-19 vaccination dose because they are severely immunosuppressed have received it.

22.7 It's important to note individuals within this group who have conditions that reduce their vaccine response, or who take medication that has a similar effect, have always been at risk of infectious disease, andcontinue to take precautionary measures based on their individual circumstance and the advice of their own GP and clinician, just as they would have prior to COVID. However, those who are newly diagnosed may not have previous experience of taking precautionary measures.

22.8 Consideration should be given to findings from the Octave study, which advised the level of antibodies required for protection from COVID-19 is still not known. These findings therefore do not provide a conclusive assessment of the protection vaccines offer people with weakened immune systems.

22.9 The COVID-19 Statistical Report^[23] published in March 2022 by Public Health Scotland showed a decrease in the percentage of COVID-related deaths following a positive test in the immunosuppression group from 12% in January 2021 to 1% in January 2022.

22.10 We will continue to review vaccine efficacy evidence and consider what future support would benefit this group of people.

22.11 As at 21 February 2022, there were 36,268 people within the immunosuppressed group on the HRL in Scotland, making up 20% of the overall list.

23. Group 6 – People who are pregnant and have significant heart disease.

23.1 There have been no COVID-related deaths in this group at any point throughout the pandemic.

23.2 There was initially much reluctance among people who were pregnant to receive vaccinations because of mixed reports of side-effects, however clinicians and advisers are clear it is safe to get the vaccine if you are pregnant. This was confirmed in the Royal College of Obstetricians and Gynaecologist's Coronavirus (COVID-19) Infections in Pregnancy report^[24], published March 2022.

23.3 There is a lack of research specifically into this particular highest risk category.

23.4 Finally, this is a small group and data is not published due to the sample size, but for the reasons outlined there is a strong argument that this group could be deemed as no longer considered highest risk.

24. Group 7 – Clinical judgement, people receiving renal dialysis treatment, people with chronic kidney disease stage 5, people who have liver cirrhosis (Child-Pugh Class B and C) and people who have had their spleen removed

24.1 These are people who have been identified by their clinician or patient groups who were considered to be at highest risk after the original shielding criteria was defined.

24.2 The clinician identified group had a COVID-related mortality rate 12 times higher than that of the non-highest risk population in January 2022 (Figure 9).

24.3 This group had the highest relative COVID-related mortality rate in January 2022, same as the cancer and rare diseases groups. (Figure 9)

24.4 Due to the range of conditions within this group, little research has been carried out on this specific group.

24.5 The COVID-19 Statistical Report^[25] published in March 2022 by Public Health Scotland showed a decrease in the percentage of COVID-related deaths following a positive test in the clinician identified group from 21% in January 2021 to 2% in January 2022.

24.6 As at 21 February 2022, there were 50,778 people within the clinician identified group on the HRL in Scotland, making up 29% of the overall list.