The British Muslim community has been disproportionately affected by Covid-19 with excess cases and deaths. One third of those from minority backgrounds in the UK are Muslim, and these communities have had a similarly high burden from Covid-19. Despite being a relatively young population (33% under 15y and 4% over 65y), the self-reported quality of life measures and health outcomes of our communities are poor. Chronic disease is often badly managed, with higher rates of diabetes and cardiovascular disease5 – which are poor prognostic factors for Covid19, with poor patient satisfaction and access to health services.
The British Islamic Medical Association has consulted various Muslim experts in infectious diseases, pharmaceutical industry, clinical medicine, commissioning, public health, and bioethicists to produce the following statement on the Pfizer/BioNTech Covid-19 vaccine that is being rolled out in the UK, and how it relates to the Muslim community in Britain.
The statement reads:
This vaccine uses modified RNA technology which is formulated in a lipid nanoparticle. This delivers a section of genetic instruction which, once in the body, starts producing the spike protein found on the SARS-CoV-2 virus and triggers the body’s natural production of antibodies and stimulates immune cells to protect against Covid-19 disease.
It is given as 2 injections, 21 days apart. This specific method has not been used for approved vaccines before. However, RNA based treatments and drugs formulated with lipid nanoparticles have been approved by global regulators for other diseases. Phase I/II data on the safety, tolerability, and immunogenicity for this vaccine has been published in peer-review literature.
Although Phase III trial data has not yet been published publicly in the scientific literature, this data has been provided to global regulators, including the MHRA in the UK, and the protocol has been published. The lack of public scrutiny is concerning given the need for transparency and appraisal of the trial data by experts who are independent of industry and regulators.
Human trials of this vaccine involved 42,000 people globally with half receiving the vaccine and the other half given a placebo.
162 people fell ill with Covid-19 in the placebo group as did 8 in the treatment group – resulting in the quoted 95% efficacy figure.
There are legitimate concerns regarding the vaccine. More data is required regarding the ability of the vaccine to improve mortality rates and reduce transmission. Many subgroups of patients were not included in the trials or were in limited numbers.
The approval for this vaccine is based on data relating to over 2,000 persons. All trial participants will be followed for 24 months with data to be provided to regulators on an ongoing basis. Trials in other age groups who were excluded, including pregnant women, are either ongoing or planned. At present, the advice is for the vaccination to not be taken by those that are pregnant or breastfeeding, and those intending pregnancy should be delayed for two months following the second vaccination dose.
There is no content of animal origin (i.e. no gelatine) and no products are derived from foetal cell lines. The remaining excipients are not of concern.
The Medicines and Healthcare Products Regulatory Authority (MHRA) is the independent agency responsible for ensuring medicines are acceptable and safe. The MHRA approved the Pfizer/BioNTech vaccine for the UK market with a temporary authorisation for emergency use on 2 December, being the first in the world to do so. As with any regulator, the industry being monitored can play an influential role. However, we have received several reassurances, including from MHRA themselves, that corners have not been cut, processes remain robust in assuring safety, and that they have been regularly reviewing data on a rolling basis.
Despite these concerns and the influence of industry, there is currently have no reason to doubt the decision of the MHRA. In line with other childhood vaccines in the UK, the Pfizer/BioNTech vaccine has also been added to the Vaccines Damage Payment Scheme which provides financial assistance to anyone suffering a severe disability from taking the vaccine.
Despite the improvement in mortality rates since the first wave, in part due to better supportive treatment and health system preparedness, Covid-19 remains a serious condition with a significant burden on survivors and our society. Research has suggested that 1 in 20 people with Covid-19 are likely to suffer with symptoms for 8 weeks or more, and that psychiatric presentations may be more likely following Covid-19 than other illnesses.
The Joint Committee on Vaccination and Immunisation (JCVI) is an independent UK advisory body of experts who advise on vaccines. Their report on which groups in the UK population should be a priority Covid-19 vaccination outlines several cohorts of the population who should receive the vaccine.
They advise that the priority should be to prevent death from Covid-19 and then protect health and social care staff.
Accordingly, a framework has been developed which will see that there is a sequential roll down the risk groups, starting with those in care homes, individuals aged 80+, staff in the NHS and care sector, and will currently be going down to those aged 50+. It will also include individuals aged 16+ with underlying conditions that put them at higher risk of serious disease and mortality.
The chances of dying from Covid-19 increase with age: people aged 80y+ have a 20-fold increased risk of dying compared to those aged 50-59.
Deaths overall are higher this year compared to previous years. Furthermore, mental health issues have increased with social isolation, working from home, limited services, and the closure of places of worship having negatively affected the wellbeing of the nation.
The JCVI guidance does acknowledge minority communities in their recommendations, but in a webinar on 04 December stated that this is not being prioritised due to the absence of an effective way to target these communities.
A failure of effective engagement with these communities may mean that there is a lack of confidence in adhering to Government guidelines and messaging in relation to social distancing, wearing of masks, and now uptake of the Covid-19 vaccine. This has seen to be the case with historical low rates of routine immunisations in minority ethnic communities. However, to ensure maximal efficacy, a substantial proportion of the population needs to be vaccinated to achieve herd immunity. This includes those who have previously had Covid-19 and have proven antibodies to it. Thus, it is imperative individuals are given sufficient information regarding vaccination. There has been some concern that if low levels of the population take up the vaccine this may lead towards mandatory vaccination either through legislation or through exclusion from social or economic activity (e.g. events, travel, education). At present, however, there are no concrete plans for this or for “vaccine passports”, although this continues to be debated.