Chief Medical Officer: “Covid vaccine roll-out across Wales will start within a matter of days”

The first COVID-19 vaccine has been given the go-ahead and the roll-out across Wales will start within a matter of days, the Chief Medical Officer has announced today.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has now authorised the first vaccine as safe and effective on the basis of detailed independent expert review of evidence from large scale clinical trials.

The Pfizer Biontech vaccine has become the first to receive MHRA clearance in the UK and 40 million doses of the vaccine will shortly be available for delivery across the UK, with Wales getting its allocation based on population.

The vaccine – which needs to be administered in two doses – will initially be prioritised and available for those aged 80 and over, care home staff and residents and those working within health and social care.

Approval from the MHRA is the first step of Wales’ roll-out plan, which has seen preparations on-going since May, the Welsh Government has said.

There are still a number of stages which need to happen before the vaccine reaches those in highest need and is ready for use, but this process is expected to happen over the next week. These stages include;

• The Joint Committee on Vaccination and Immunisation (JCVI) finalising and publishing their guidance for the whole of the UK;
• Finalising training materials for staff and patient information leaflets;
• Training of experienced immunisers for this particular vaccine;
• Final legal frameworks to allow registered health professionals to administer the vaccine to patients need to be authorised by each Health Board in Wales.

The Welsh Government say that further supplies become available and additional vaccines receive MHRA approval, a staged approach will see other groups be offered the vaccine, based on risk of serious complications and deaths.

Individuals in the priority groups for a COVID-19 vaccine will receive an invitation from their employer or Health Board providing information about the COVID-19 vaccines, telling them where to go and what to do on the day of their appointment.

People are urged to wait to be invited, which will happen through NHS systems. Please do not ask your pharmacist or GP.

There are plans in place for people who are housebound and for care homes to be vaccinated as soon as safely possible, with the approved vaccine being safely taken to them using a mobile service, once cleared for this purpose.

The Chief Medical Officer for Wales, Dr Frank Atherton, said: “It is fantastic to finally say that the first COVID-19 vaccine has been given the green light. We know now that we have a safe and effective vaccine for use across the UK – this is the positive news I and so many across the country have been waiting for.

“All our NHS organisations across Wales have embraced the challenge presented to them and are at the advanced stages of planning for the arrival of a vaccine. We have tested distribution and storage arrangements to ensure we can get vaccine safely to every part of Wales.

“There’s still a few stages we need to work through but once all these safeguards are in place, vaccination can begin. There will only be relatively small amounts of the vaccine at first, those who have been advised as most needing the vaccine first, through approved delivery mechanisms. A full announcement around the timetable for roll-out in Wales will follow in the next few days.”

Pfizer Biontech vaccine needs to be stored at ultra-low temperatures and two centres in Wales have been decided by Health Boards, they are in the process of being “stood-up.”

The Welsh government said: “Individuals in the priority groups for a COVID-19 vaccine will receive an invitation from their employer or Health Board providing information about the COVID-19 vaccines, telling them where to go and what to do on the day of their appointment.”

“People are urged to wait to be invited, which will happen through NHS systems. Please do not ask your pharmacist or GP.”

“There are plans in place for people who are housebound and for care homes to be vaccinated as soon as safely possible, with the approved vaccine being safely taken to them using a mobile service, once cleared for this purpose.”

The First Minister, Mark Drakeford, said: “Today’s news is a small glimmer of light at the end of what has been a long and dark tunnel.

“We know some people within our communities are much more at risk than others from the serious complications of COVID-19, which is why the new vaccine is being prioritised to protect them first.

“Whilst these first doses are given at fixed sites and occupational settings, and to protect our NHS and social care services, we must all continue to do our bit to prevent the spread of coronavirus: regular hand washing, social distancing, and wearing a face covering where required to protect yourself and others.”

The development process for coronavirus vaccines has been “as stringent as any other but the process in the face of the pandemic has been sped up by prompt, world-wide funding and a reduction in paperwork. The length of the trials have not been shortened, and the usual safety measures remain in place.” The Welsh government has said.

The vaccine will not be mandatory and people will be able to choose whether they take up the vaccine or not.

A written statement was issued by Welsh Government via the Health Minister, copied in full below:

This year has seen huge challenges for us all. The constraints placed on our everyday lives have been difficult to bear and it is with great anticipation that we welcome the news that vaccines are now beginning to become available, to save lives, protect the clinically vulnerable and enable us to begin to return to normality.

We have been closely engaged in a Four Nation approach across the UK in monitoring progress on the development of vaccines since May and the health and social care sectors in Wales have been planning in earnest in readiness for the first vaccine being available. Now all this hard work is coming into fruition. Our intent is to vaccinate as many eligible people as possible, as swiftly as possible, safely, and with minimal vaccine waste. We will start with those groups most at risk of serious illness or death from COVID-19 infection, together with front line health and social care workers.

Today we received the welcome news that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Pfizer/BioNTech vaccine temporary authorisation for use based on evidence of safety and effectiveness. 40 million doses of the Pfizer/BioNTech vaccine have been secured by the UK Government on behalf of the UK. Wales, like the other UK nations will now begin to receive its share and we will start deployment, based on advice from the Joint Committee on Vaccination and Immunisation (JCVI).

The UK Government has also pre-ordered 100 million doses of the Oxford / AstraZeneca vaccine, and having submitted its Phase III data, a decision from the MHRA is awaited for this vaccine. If approved as safe and effective for use, we are told to prepare for readiness for delivery later in December.

Both these vaccines consist of a 2 dose schedule with 4 weeks between doses. Protection is achieved by 7 days following second dose, although some protection will begin from 7 to 14 days following first dose. We will be vaccinating people who are most at-risk of catching coronavirus and developing serious illnesses first, based on the recommendations from the JCVI. They have recommended the vaccine be offered to in the first instance to care home residents and health and social care workers, alongside people aged 80 and over.

From our ongoing discussions with UK Government and the manufacturer, and from understanding the conditions under which the vaccine trials have been conducted, we are aware of the challenges of storing, distributing and handling the Pfizer/BioNTech vaccine. In particular its need for storage at very low temperatures of below minus -75ºC +/- 15ºC. Two specialist sites have been identified as appropriate delivery sites for the vaccine and local Health Boards will collect the vaccines directly from the two sites. We have been exploring suitable options for initial deployment of this vaccine, in line with the JCVI advice, bearing in mind the constraints associated its characteristics and the implications for delivery to all groups. In practical terms at this stage that we cannot deliver this vaccine to care homes.

For each candidate vaccine final deployment models will be similar across the UK. It is crucial that we all continue to work towards a Four Nations joint approach.

All NHS organisations in Wales have undertaken Wales-wide simulation exercises to test our distribution and storage arrangements and to ensure we can get effective vaccine safely to every part of Wales. On 26 November, the end to end logistics for the Pfizer vaccine from ultra-low temperature central storage to receipt by the end user was tested across NHS Wales as part of a “dummy simulation exercise”. This exercise was a follow up arrangement to an initial test on the 12 November, expanding the logistics to include multiple delivery sites and aligning all the necessary consumables required to undertake a vaccination clinic.

All key stakeholders from the seven Health Boards took part along with partners and key pharmacy leads. Cold chain maintenance was maintained throughout the distribution exercise with no temperature excursions or delays. All deliveries were received at the correct locations and receipt of deliveries recorded electronically on the Welsh Immunisation System.

Wales is ready to deploy the vaccine in phases, starting with hospital sites and then community settings. People will be sent appointments with details of the location where they will receive the vaccination, dependent on where they are on the schedule and risk. There will be no need to apply for or ask GPs or pharmacists for the vaccination, as invitation will be done automatically.

The Welsh Immunisation System has been developed in Wales and can create appointments and automatically schedule second doses, send appointment letters and record vaccinations for every COVID-19 vaccine given.

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. These will act as a reminder for a second dose and for the type of vaccine, and it will also give information about how to report side effects.

Heath Boards and Trusts, with input from primary care advisers, have developed and tested comprehensive plans for the safe delivery of vaccination in a variety of settings. This will includes using community venues and mobile teams to make the vaccine as accessible as possible for everyone who needs it. This has been done so that primary care services can continue to provide services and deliver the flu vaccine programme at the same time as the COVID-19 vaccine programme is rolled out.

Health Boards and Trusts in Wales have developed workforce deployment plans that will support their local planning and delivery requirements. This includes and identifies training and recruitment needs, how they can utilise volunteers to help with the roll out and ensuring there are enough trained and experience immunisers to vaccinate the required numbers of people, when each vaccination is safe and ready to be deployed. Health Boards and Trusts are utilising the existing workforce to fill these roles first as the early stages of the campaign, with a novel vaccine, should be initiated with experienced, trained immunisers. Additional recruitment is ongoing. The WCVA is working at local level with Health Boards and Trusts existing Volunteer Coordinators, who have established processes for volunteer deployment, to support the vaccination campaign with targeted recruitment and training of volunteers. Offers of support from St John Cymru and British Red Cross and others are being followed up.

Public Health Wales participated in a Four Nations expert training group to develop COVID 19 vaccination training materials and recommendations for all staff, including registered, non-registered, experienced, inexperienced and new staff. The training includes e-learning modules and assessments for core knowledge, Basic Life Support, anaphylaxis, guidance on work based competencies and vaccine specific data. Training and assessment of completion and competence will be also be carried out locally by Health Boards and Trusts. This will be supported by training webinars. Experienced staff and new staff have been advised to complete existing core training in advance to be ready. These training measures are a consideration for all UK nations.

Materials to provide the public and professionals with information about COVID-19 vaccines have been developed by Public Health Wales, in close collaboration with Public Health England. Guidance materials to ensure safely administration of the vaccine have also been developed, in collaboration with other public health agencies across the four nations.

The vaccine will not be mandatory and people will be able to choose whether they take up the vaccine or not. Information will be provided to people before vaccination to reassure them about patient safety and robust consent processes will be in place. As we get closer to deployment we will continue to provide clear information to the public and urge people to seek NHS advice so they have the right information to make an informed choice.