They considered all two current vaccinations and these were their findings.
The committee reviewed published and unpublished phase one, two and three safety and efficacy data for the Pfizer BioNTech mRNA vaccine. They found that the vaccine appeared to be safe and well tolerated and there were no clinically concerning safety observations. The data indicated high efficacy in all age groups, 16 years and over, including protection against severe disease and encouraging results in older adults. The committee advised that this vaccine be used in the first phase of the programme, according to the priority order set out below. While there is some evidence indicating high levels of short term protection from a single dose of vaccine, a two dose vaccination schedule was currently advised as this was likely to offer longer lasting protection.
The AstraZeneca Vaccine
The committee reviewed published and unpublished phase one, two and three safety and efficacy data for the AstraZeneca vaccine. The vaccine appeared to have a good safety profile and the data indicated high efficacy in adults aged 18 years or over, indicating protection against severe disease and encouraging results in older adults. Existing data was consistent with high levels of short term protection following the first dose of vaccine, with further protection obtained following the second dose of vaccine, which may be given between 4 and 12 weeks after the first dose. The committee advised that this vaccine be used the first phase of the programme, according to the priority order set out below and a two dose vaccination schedule was currently advised as this was likely to offer longer lasting protection.
There have been no clinical trials directly comparing the Pfizer BioNTech and AstraZeneca vaccine. In phase three trials of the respective vaccines, efficacy against symptomatic disease for the Pfizer BioNTech vaccine was higher than for the AstraZeneca vaccine. Study setting, study design, study population, age, ethnicity, social demographics, etc. and efficacy endpoints may have accounted for these observed differences. The committee suggested that both vaccines gave a very high protection against severe disease, which was the primary aim for the first phase of the vaccination programmes and that both vaccines had good safety profiles.
The committee did not advise a preference for either vaccine in any specific population.
Given the current epidemiological situation in the United Kingdom, the committee felt the best option for preventing morbidity and mortality in the initial phase of the programme was to directly protect persons most at risk of morbidity and mortality. Therefore, the prioritisation was as follows.
Current evidence strongly indicated that the single greatest risk of mortality from COVID-19 was increasing age and that the risk increased exponentially with age. Mathematical modelling indicated that the optimal strategy for minimising further deaths or quality adjusted life years losses was to offer vaccination to older age groups first. Models assumed that an available vaccine was both safe and effective in older adults. Data also indicated that the absolute risk of mortality was higher in those over 65 years and that is even the majority of younger adults with an underlying health condition. Accordingly, the committee’s advice largely prioritised patients based on age.
2. Older adults, residents in care homes
There was clear evidence that those living in residential care homes for older adults have been disproportionately affected by COVID-19 as they had a higher risk of exposure to infection and a higher clinical risk of severe disease and mortality. Given the increased risk of outbreaks, morbidity and mortality in these close settings, these adults were considered to be at a very high risk. The committee advised that this group should be the highest priority for vaccination. They also considered that vaccination of staff and residents at the same time was considered to be a highly efficient strategy within a mass vaccination programme.
3. Health and social care workers
Frontline health and social care workers were considered to be at an increased personal risk of exposure to infection with COVID-19 and transmitting that infection to susceptible and vulnerable patients in health and social care settings. The committee therefore considered frontline health and social care workers who provided care to vulnerable people a high priority for vaccination.
4. Clinically extremely vulnerable patients, those who were shielding
Individuals considered extremely clinically vulnerable have been shielding for much of the pandemic. This means that any available data is likely to underestimate the risk in this group. Of those who are clinically extremely vulnerable and the oldest age groups and will be among the first to receive the vaccine. Considering data from the first wave in the United Kingdom, the overall risk of mortality for clinically extremely vulnerable younger adults is estimated to be roughly the same as the risk of persons aged 70 to 74 years.
Given this level of risk seen in this group as a whole, the committee advised that persons aged less than 70 years who are clinically extremely vulnerable should be offered vaccine alongside those aged 70 to 74. There were two key exceptions to this, pregnant women with heart disease and children. The committee also expressed the fact that many individuals who are clinically extremely vulnerable will have some degree of immunosuppression and be immunocompromised and may not respond as well to the vaccine. Therefore, those who are clinically extremely vulnerable should continue to follow government advice on reducing their risk of infection. Consideration has been given to vaccination of household contacts of immunosuppressed individuals. However, at this time, there was no data on the size of the effect of the COVID 19 vaccine on transmission.
5. Women who are pregnant
There is no known risk associated with giving non live vaccine during pregnancy. These vaccines cannot replicate, so they cannot cause infection in either the woman or the unborn child. Although available data does not indicate any safety concern or harm to pregnancy, there is insufficient evidence to recommend routine use of COVID-19 vaccine during pregnancy. The committee has advised that for women who are offering vaccination with either Pfizer or AstraZeneca COVID-19 vaccine, should consider whether the risk of exposure to SARS-CoV-2 infection is high and cannot be avoided, or where the woman has underlying conditions that put them at a very high risk of serious complications of COVID-19. In these circumstances, it is recommended that clinicians should discuss the risks and benefits of vaccination with a woman who should be told about the absence of safety data for the vaccine in pregnant women. The committee did not advise routine pregnancy testing before receipt of the COVID-19 vaccine. Those who are trying to become pregnant do not need to avoid pregnancy after vaccination.
6. Women who are breastfeeding
There is no known risk associated with giving non live vaccines whilst breastfeeding. The committee advised that breastfeeding women may be offered vaccination with either the Pfizer or AstraZeneca COVID-19 vaccines. The developmental and health benefits of breastfeeding should be considered along with the women’s clinical need for immunisation against COVID-19, and the woman should be informed about the accident and safety data for the vaccine in breastfeeding women.
7. Children less than 16 years of age.
Following infection, almost all children will have asymptomatic infection or only mild disease. There is very limited data on vaccination in adolescents, with no data on vaccination in younger children at this present time. The committee advised that only those children are at very high risk of exposure and serious outcomes, such as older children with severe neuro disabilities that require
residential care, should be offered vaccination with either the Pfizer or AstraZeneca vaccine. They suggested that clinicians should discuss the risks and benefits of vaccination with a person with parental responsibility, who should be told about the paucity of safety data for the vaccine in children aged under 16.
8. Persons with underlying health conditions.
There is good evidence with certain underlying health conditions increase the risk of morbidity and mortality from COVID-19. This is when compared to persons without underlying health conditions. The absolute increased risk in those with underlying health conditions is considered generally to be lower than the increased risk in persons over the age of 65 with the exception of the clinically extremely vulnerable. The committee’s advice was to offer vaccination to those aged 65 years and over followed by those in clinical risk groups age 16 and over. The main risk groups identified by the committee are as below.
- Chronic respiratory disease, including chronic obstructive pulmonary disease, cystic fibrosis and severe asthma.
- Chronic heart disease and vascular disease.
- Chronic kidney disease.
- Chronic liver disease.
- Chronic urological disease including epilepsy
- Down’s syndrome.
- Severe and profound learning disability.
- Solid organ, bone marrow and stem cell transplant recipients.
- People with specific cancers.
- Immunosuppression due to disease or treatment.
- Spleen or splenic dysfunction.
- Morbid obesity.
- Severe mental illness.
Other groups are at high risk, including those who are in receipt of a carers allowance or those who are the main carer of an elderly or disabled person whose welfare may be at risk if the carer falls ill should also be offered vaccination alongside these groups.
Multiple social and social drivers are recognised to contribute towards increased risk from COVID-19. The committee considered it important to understand the factors underlying health equality in COVID-19, giving due consideration to relevant scientific evidence.
Ethical principles and vaccine programme deliverability
Good vaccine coverage in the black Asian and minority ethnic groups is considered to be the most important factor within a vaccine program in reducing inequalities for this group and prioritisation of persons with underlying health conditions will also provide for greater vaccination of the BAME community who are disproportionally affected by such health conditions.
So, the vaccine priority groups as based on advice from 30 December 2020 are phase 1:
- 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 over 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 age 16 years to 64 with underlying health conditions which put them at a 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.
It is considered that this group represents around 99% of preventable mortality from COVID-19.
The London General Practice looks forward to this programme being implemented and the population being fully vaccinated.
Dr Paul Ettlinger
BM, DRCOG, FRCGP, FRIPH, DOccMed