The Pfizer/BioNTech’s Covid-19 vaccine will be made available across the UK from next week after the Medicines and Healthcare products Regulatory Agency (MHRA) recommended its approval.
The approval follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.
The Joint Committee on Vaccinations and Immunisations (JCVI) will shortly publish its final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.
Matt Hancock said that older people, those in care homes and some NHS staff will be prioritised first but people should wait to be contacted by the NHS.
Efficacy in older populations
Observed efficacy of the Pfizer/BioNTech mRNA-based Covid-19 vaccine candidate in adults over 65 years of age was over 94% and results show older adults tended to report fewer and milder solicited adverse events following vaccination.
The primary efficacy analysis indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose.
Data demonstrate that the vaccine was well tolerated across all populations with over 43,000 participants enrolled. No serious safety concerns were observed and the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%.
Covid-19 vaccine and BAME groups
The Royal College of GPs is calling on Secretary of State for Health and Social Care, Matt Hancock, for a more detailed rationale for not including people from Black, Asian, and minority ethnic communities on the initial prioritisation list for a Covid-19 vaccination.
The initial list, devised by the Joint Committee on Vaccinations Immunisations (JCVI), does not specifically include people from Black, Asian and minority ethnic communities, despite data showing that death rates from Covid-19 are amongst the highest in patients from these groups. The list currently takes an age-based approach to prioritisation, also specifically including care home residents and staff, health and social care workers, and high and moderate-risk adults – for example, those with underlying health conditions.
In a letter to the Health Secretary, RCGP Chair Professor Martin Marshall writes: “Throughout the pandemic the RCGP has raised significant concerns about the extent to which GPs, their practice staff, and patients from Black, Asian and minority ethnic communities are disproportionately affected by Covid-19…yet we note that they are not included on the initial JCVI prioritisation list ahead of roll-out of the vaccines.
“It is important that GPs and their patients are aware of the rationale for the decisions made, particularly as data clearly indicates that patients from ethnic minority backgrounds are more susceptible to contracting and dying from the virus. While some of this may be due to the higher prevalence of pre-existing conditions within the BAME communities, a recent study by the Office of National Statistics suggested that is not sufficient to explain the disparity in mortality rates from Covid-19, and emphasises the importance of demographic and socio-economic factors, such as place of residence and occupational exposure.”