Over the coming months, the Government will be able to rely less on economic and social restrictions and more on solutions provided by scientific progress. This shift will not happen overnight. But recent developments on testing make it possible to reduce cases in the highest prevalence areas alongside the tiers. Together with the prospect of effective vaccines, these advances provide confidence that as we approach spring, life can begin to return closer to normal.
VACCINES
Vaccines that provide durable and effective immunity to COVID-19 will substantially reduce the mortality rate of the virus and may limit its transmission. The deployment of vaccines therefore offers the opportunity to manage the epidemic while gradually lifting many of the restrictions which currently apply.
The Government is supporting efforts to research and produce an effective, safe and widely available vaccine as early as possible. The Government has announced agreements with seven separate vaccine developers. In total, the Government has secured access to over 350 million doses between now and the end of 2021.
The Government will make vaccines available for all of the UK, plus the Crown Dependencies and Overseas Territories. There have been positive recent announcements on vaccine development:
a. On 9 November, Pfizer/BioNTech announced interim conclusions of the phase II study of their COVID-19 vaccine candidate, reporting an efficacy of 90%.
b. On 17 November, Moderna announced the conclusion of the phase III study of their COVID-19 vaccine candidate, with a 94.5% vaccine efficacy.
c. On 18 November, Pfizer/BioNTech announced the conclusion of the phase III study of their COVID-19 vaccine candidate, with an efficacy of 95% after two doses.9 They have formally applied for a license in the United States.
d. On 19 November, Oxford/AstraZeneca announced interim results from the ongoing Phase II/III trial in which strong immune responses were demonstrated across all age groups, and boosted after a second dose.
e. On 20 November, the Secretary of State for Health and Social Care announced that the Government has formally asked the MHRA to assess the Pfizer vaccine for its suitability for authorisation.
The safety of the public will always come first. A COVID-19 vaccine will only be approved for use if it has met robust standards on safety, effectiveness and quality through clinical trials. The MHRA will apply the key criteria of safety, quality and efficacy before authorising the use of a vaccine. This means that, once the data is submitted, MHRA scientists and clinicians will carefully and scientifically review the safety, quality and effectiveness data, how it protects people from COVID-19 and the level of protection it provides. The data will include: a. results from the lab and clinical trials in humans; b. manufacturing and quality controls; c. product sampling; and d. testing of the final product.
The Joint Committee on Vaccination and Immunisation (JCVI) is the independent medical and scientific expert body that advises the Government on prioritisation for all vaccines. The Committee has been considering COVID-19 vaccine prioritisation for several months and has already provided provisional advice. The purpose of this provisional advice is to support planning for the deployment of any safe and effective vaccines as soon as they are authorised by the MHRA for use across the UK. As with the influenza vaccine, the underlying principles of the advice are to concentrate first on reducing mortality, improving population health by reducing serious disease and protecting the NHS and social care system. It is by achieving these goals that the Government can begin to lift the current restrictions safely.
It is also important to remember that the exact strength and duration of immunity provided via vaccination is not yet known. Protection by vaccination takes time to build, requires a full course, and it is unknown how well the first vaccines will stop the virus passing between individuals.
The JCVI has found that the risk of serious disease and death from COVID-19 increases sharply with age and is also increased in those with a number of underlying health conditions. They have advised that as long as an available vaccine is both safe and effective in older adults, they should be a high priority for vaccination. The Committee’s provisional advice, therefore, largely prioritises vaccination based on age. The provisional JCVI prioritisation has been published, but will continue to be updated.
The JCVI will finalise advice on prioritisation of any vaccine based on consideration of the final phase 3 clinical trial data. The characteristics of the different vaccines are key considerations in the delivery methodology which may necessarily affect prioritisation. As understanding of the clinical characteristics of a vaccine is increased following rollout, the merits and prioritisation of vaccinating lower risk adults throughout the UK will be considered, and the UK’s system of pharmacovigilance will conduct ongoing monitoring of the safety and effectiveness of all vaccines.
The urgent work that the NHS is doing will ensure that it will be ready to deploy the vaccine as soon as it is ready and licensed by the MHRA for use in England, Scotland, Wales and Northern Ireland. This work includes having service locations and staff secured, delivery models operational and an active supply chain in place so that when a vaccine does become available, it is set to mobilise. Depending upon their final characteristics, some vaccines may be better suited to differing models of delivery. The NHS delivery programme may need to be adapted from the JCVI priority list to avoid unnecessary wastage. The NHS is in the process of establishing mass vaccination centres across the country that can manage the logistical challenge of needing to store the Pfizer vaccine at minus 70 degrees Celsius. In addition, it is establishing vaccination hubs in hospitals for NHS staff. There will also be a community rollout, which will encompass those who find it difficult to travel.
