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发布日期:2021年04月21日

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Vaccination

Everything you need to know about the UK's COVID-19 vaccination programme

Now that the UK has begun its COVID-19 vaccination programme, how is it working? And are community pharmacies likely to be involved in this effort?

Open access article

The Royal Pharmaceutical Society has made this article free to access in order to help healthcare professionals stay informed about an issue of national importance.

To learn more about coronavirus, please visit: /resources/pharmacy-guides/wuhan-novel-coronavirus

Vaccination

Source: Shutterstock.com

The government is setting up mass vaccination centres as well as vaccination hubs in NHS trusts as one part of the vaccination effort

Administration of the UK’s first authorised COVID-19 vaccine began in hospitals on 8 December 2020. Mass vaccination centres and local vaccination sites — which will chiefly be led by primary care networks (PCNs), but could also be operated by pharmacies — are to follow.

Which vaccines have been approved?

On 2 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) authorised the Pfizer/BioNTech COVID-19 vaccine for widespread use in the UK. The government has already ordered 40 million doses. On 9 November 2020, BioNTech and Pfizer announced an interim efficacy analysis of their vaccine, which suggested that it is more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection.

The MHRA is also in the process of reviewing the Oxford/AstraZeneca COVID-19 vaccine, after receiving a request from the Department of Health and Social Care (DHSC) to do so on 27 November 2020.

Other vaccines, such as those manufactured by Novavax, Moderna and Janssen, are currently in phase III clinical trials. For more information on the COVID-19 vaccine candidates and trials, read our list of ten things pharmacists should know about COVID-19 vaccines.

Who will get the vaccine first?

Administration of the vaccines started on 8 December 2020, and on 21 December prime minister Boris Johnson said that more than 500,000 had received the first of two doses of the Pfizer vaccine. The Joint Committee for Vaccination and Immunisation (JCVI), which advises UK health departments on immunisation, updated its prioritisation of patients to receive the vaccine on 2 December 2020. The update from interim guidance published in September 2020 will see shielding patients vaccinated earlier than previously listed.

The ranked prioritisation is as follows:

  1. Residents in a care home for older adults and their carers
  2. All those aged 80 years and over, and frontline health and social care workers
  3. All those aged 75 years and over
  4. All those aged 70 years and over, and clinically extremely vulnerable individuals
  5. All those aged 65 years and over
  6. All individuals aged 16–64 years with underlying health conditions that put them at higher risk of serious disease and mortality
  7. All those aged 60 years and over
  8. All those aged 55 years and over
  9. All those aged 50 years and over

Simon Stevens, chief executive of the NHS, said further regulatory approval was needed before the packs of 975 doses of vaccine could be broken down into smaller packs for distribution to care homes. But NHS England said in webinar on 10 December 2020 that six PCNs would “undertake a supervised run-through of the care home vaccination model” during the week of 14 December 2020.

How is the vaccination programme organised?

At a briefing on 2 December 2020, Stevens announced that hospital hubs would start delivering the vaccine to patients aged 80 years and over and to care home staff — typically those expected to be seen in trusts for an outpatient appointment, or patients on discharge. This was then to be followed by the running of primary care network-led vaccination centres.

Centres run by community pharmacies will operate “probably from the beginning of January [2021]” as more vaccines become available, according to Stevens.

Patients will be contacted through a national call and recall programme. Once patients are notified by the service, they will be able to book an appointment at the PCN-led vaccination centre affiliated with their registered GP, or use the National Booking Service to be vaccinated by another provider, such as a community pharmacy or mass vaccination clinic. Pharmacists will be responsible for uploading clinic times to the system so that bookings can be made.

National call and recall will not apply to some of the earlier cohorts, such as care home residents and health and social care workers.

NHS England has said that there will be a “strict system for ordering based on national allocations”. The national programme will be working with designated sites when they are confirmed to start sharing information and establishing the supply chain.

In Wales, Vaughan Gething, minister for health and social services, said two sites had been identified from which health boards would be able to collect the vaccine. While he said the characteristics of the vaccine mean it cannot be delivered to care homes “at this stage”, he added that delivery will start in hospital sites and then move into community settings.

The Welsh government has developed the Welsh Immunisation System, which will create appointments and automatically schedule second doses, send appointment letters and record vaccinations for each COVID-19 vaccine given. It also began its vaccination programme on 8 December.

“Those receiving a COVID-19 vaccination will be given a credit card-sized NHS Wales immunisation card which will have the vaccine name, date of immunisation and batch number of each of the doses given handwritten on them,” he said.

Scotland started its vaccination programme on 8 December 2020 by “vaccinating first the vaccinators themselves”. Unlike England and Wales, Scotland’s health minister Jeane Freeman said supplies of the Pfizer vaccine — which are transported in pack sizes of nearly 1,000 doses — can be repackaged into smaller packs for administration in care homes from 14 December 2020.

How will pharmacists be involved?

The involvement of community pharmacists and community pharmacies in the delivery of the vaccine is still unclear. In a letter sent to community pharmacists on 27 November 2020, NHS England said it expects pharmacy-led vaccination sites to be ready to administer vaccines from “late December or early January”.

As part of an enhanced service specification, GP practices running the PCN sites can subcontract COVID-19 vaccination work to community pharmacies. Chief pharmacists at clinical commissioning groups are expected to support GPs at PCN designated sites by ensuring the safe handling and use of the vaccines.

NHS England has yet to clearly set out how community pharmacists can become involved in trust-led vaccination centres. However, Jill Loader, deputy director of pharmacy commissioning at NHS England and NHS Improvement, said this could be an opportunity for pharmacists to participate. Pharmacists can apply for an immuniser or supervisor role in the COVID-19 vaccination programme through NHS Professionals.

Hospital pharmacists working in vaccination centres will primarily be in charge of overseeing that the complex handling requirements of the COVID-19 vaccine are met “to ensure patient safety”.

Guidance published by NHS England noted that pharmacy input “must be considered in the mass vaccination sites to maintain product integrity of the vaccine” as the workforce mix of healthcare professionals and new recruits means “good pharmaceutical oversight is essential to ensure patient safety”.

In Scotland, first minister Nicola Sturgeon said vaccine deployment centres would be “overseen by pharmacy staff”, with Freeman adding that “key pharmacy staff” would be on hand to draw up vaccine doses from the vials during the first week of its administration. Freeman added that the Scottish government is in talks with pharmacy contractors “in order to secure what I would describe as their sessional time — their time in local vaccination centres”.

Can the vaccine be administered in a community pharmacy?

Possibly. Pharmacy contractors were asked to apply to NHS England for status as a designated COVID-19 vaccination site by 6 December 2020, as long as the pharmacy site meets a certain set of requirements. NHS England has said that a “limited number” of community pharmacy sites will be commissioned to administer vaccines under a local enhanced service. Pharmacies were due to be told on 18 December whether they would be operating a vaccination centre, but as of 21 December 2020 that information had not been provided.

The requirements that pharmacies need to meet to be chosen as a vaccination site are very stringent. For example, pharmacy-led sites will need to deliver 1,000 vaccines each week and have capacity to store these vaccines in fridges at 2–8°C all at once. They will also need space to store PPE and other consumables needed to administer the vaccine, as well as physical capacity to comply with social distancing and to provide 15 minutes observation if the patient will be driving. Sites will need to deliver vaccinations seven days a week, from 08:00 to 20:00, including bank holidays.

Pharmacy sites will also need the staff and the space to ‘draw up’ vaccines from multi-dose vials, if necessary.

Even if a community pharmacy does meet all of the criteria, NHS England said it does not automatically mean that the site will be designated, as other factors “such as equity of access, geographical coverage and total number of sites that can be accommodated within the COVID-19 vaccine supply chain need to be considered”.

NHS England said in its letter that it does “not expect the majority of contractors’ sites will be able to meet these requirements”. Instead, pharmacies are expected “to continue their very important role in flu vaccination”.

However, because of the strict requirements, NHS England said vaccinations would likely “take place on a site other than the registered premises”. Chosen pharmacies will also be able to subcontract with other providers for additional support.

The Scottish government has not said whether there is scope for the vaccine to be delivered in community pharmacies. Local health boards in Wales have been taking expressions of interest from community pharmacies keen to provide a vaccination service.

How much will community pharmacies be paid for participating in the delivery programme?

Pharmacies in England and Scotland will be paid £12.58 per vaccination on the completion of the final dose. So, for a vaccine with two doses, pharmacies will be paid £25.16. 

GP practices operating under PCN-led sites have been asked to put in place a COVID-19 Enhanced Service Vaccination Collaboration Agreement, which will set out how they will work with providers in the PCN to administer the vaccines. This agreement will need to cover “financial arrangements relating to other healthcare providers (such as community pharmacies) outside its PCN grouping involved in local delivery” of the vaccine. The agreement will also include subcontracting arrangements.

The NHS has established the COVID-19 Vaccination Channel (CVC), which is a dedicated supply chain to provide equipment and consumables to vaccination administration sites. The CVC will supply goods from a specified list, including aprons, eye protection, face masks and gloves. Cool box refrigeration and clinical waste bags, for example, are also listed for supply through the CVC.

Who else will be administering COVID-19 vaccines, beside GPs and pharmacists?

In October 2020, the government enacted changes to the Human Medicines Regulations, which expanded the workforce able to administer a COVID-19 vaccine. Under the amended legislation, each of the four UK nations will draw up protocols specifying eligibility for vaccine administration, including “where appropriate, requirements for the supervision of an additional experienced vaccinator”.

The NHS is setting up a team of COVID-19 vaccinators through NHS Professionals, which is recruiting registered healthcare professionals to administer vaccines and to offer clinical supervision. According to its website, non-healthcare professionals can also apply to be immunisers, as long as they have at least two A-levels. First aid training is “desirable” for this role.

In Scotland, the government is looking to recruit 2,000 vaccinators and support staff by the end of January 2021, including general practitioners, pharmacists, dentists and optometrists.

Health boards and trusts in Wales have developed their own workforce plans for vaccination that identifies training and recruitment needs. Health boards and trusts are using existing workforce to fill these roles first with additional recruitment ongoing.

What about pharmacy technicians?

The national protocol for England has yet to be published, but NHS England indicated in a letter to GPs on 1 December 2020 that this could include pharmacy technicians, as well as medical students, airline staff, lifeguards and community fire officers.

Pharmacy technicians, who are registered with the General Pharmaceutical Council, are currently not allowed to vaccinate under patient group directions, but the DHSC told The Pharmaceutical Journal in October 2020 that no options were off the table when asked whether they could be included in the protocols for eligibility to administer COVID-19 vaccinations. 

How will vaccinators be trained?

All vaccinators across the four UK nations will be asked to take the COVID-19 vaccination e-learning course developed by Public Health England (PHE), Health Education England and NHS England & Improvement. Registered healthcare professionals and some unregistered and non-healthcare vaccinators will also have to undertake additional e-learning on immunisation.

All unregistered and non-healthcare vaccinators will also be given face-to-face and practical training, according to PHE guidance, before being signed off as competent by a registered healthcare professional with experience in immunisation, using the COVID-19 vaccinator competency assessment tool.

Timeline

9 November 2020 — NHS England writes to GPs asking them to nominate one site from each primary care networks (PCN) from which COVID-19 vaccines will be delivered

20 November — NHS England to decide on designated PCN-led vaccination sites

27 November — NHS England writes to pharmacies asking for applications to be come a COVID-19 vaccination site, with a deadline of 6 December

1 December — NHS England published enhanced service specification for GPs

2 December — Medicines and Healthcare products Regulatory Agency authorises use of COVID-19 vaccine manufactured by Pfizer and BioNTech

8 December — First administration of the Pfizer/BioNTech vaccine

18 December — NHS England due to tell pharmacy contractors whether their applications for site designation have been successful

Key quotes

Health secretary Matt Hancock in a statement to the House of Commons about the Pfizer/BioNTech vaccine: “Mr Speaker, over the next few months we will see vaccines delivered in three different ways. First, we will begin vaccination in hospital hubs. Second, we will deploy through local community services, including GPs and in due course pharmacies too. And, third, we will stand up vaccination centres in conference centres and sports venues to vaccinate large numbers of people as more vaccines come on stream.”

Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies: “A small number of our members have been progressing applications to run very well-thought-through vaccination centres — the process has unfortunately proven to be not very community pharmacy-friendly and has discouraged more of our members from making an application.”

Alastair Buxton, director of NHS Services at the Pharmaceutical Services Negotiating Committee: “Site designation will only be attainable for a small number of pharmacies. Contractors will need to carefully consider whether they may be able to participate as a designated site, or if they would be better placed assisting in another way.”

Sandra Gidley, president of the Royal Pharmaceutical Society: “Pharmacists have the expertise to play a crucial role in administering COVID-19 vaccinations, having delivered on many effective flu vaccination programmes in the past. We need assurances from the NHS and governments that the programme will not disrupt our already stretched workforce, but make way for greater collaboration between health professionals and minimise the impact on routine practice.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2020.20208621

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