Are you ready to support the public to sort fact from fiction? This article aims to provide the current guidance and advice available regarding the administration of the COVID-19 vaccine in the UK and was correct at time of publishing (December 8) – for more updates see our COVID-19 hub.
When does the service begin?
The first consignment of the Pfizer/BioNTech coronavirus vaccine arrived in the UK in the first week of December and the vaccination programme is due to begin from today (December 8).(1) The Moderna vaccine is also on order but is due to arrive in the UK in spring 2021.
Who will be administering the vaccine?
The initial vaccinations will take place in 50 hospital-based vaccination hubs, with those over 80 years of age and care home workers being called in first for appointments on a booking system.(1)
From December 14, further local vaccination sites will include some GP-led primary care networks.(2) A phased increase in administration sites will occur over the month. Further plans to provide vaccination centres in sporting venues and conference centres will be used once further supplies of vaccinations are available. Pharmacies will also be asked to deliver a COVID-19 vaccination service from late December.(3)
The Pfizer/BioNTech COVID-19 vaccine necessitates the administration of a second dose, requiring a call back for all those receiving their first dose, at least 21 days later.(4) For operational purposes, it is likely that this second dose will be set at 28 days for all the vaccines because this is the advised gap for the second dose of the Moderna and AstraZeneca/Oxford vaccines.
All Pfizer/BioNTech COVID-19 vaccination providers will need to offer the service seven days a week due to the short shelf life of vaccine and storage issues.(5)
Who cannot have the vaccine?
As part of the vaccination process, patients will need to consent to the vaccine and will need to answer some questions. These will help to rule out those who are contraindicated to receive the vaccine:(4)
- Pregnant women or those planning to become pregnant in the next three months should not be vaccinated. It is not necessary to complete a pregnancy test before administering the vaccine.(6) Women should be advised to avoid becoming pregnant for two months following administration of the second dose of the vaccine.(4) If they discover they are pregnant during the course of vaccination, then the second dose should only be administered after the baby is born.
- Breastfeeding women.
- Anyone under the age of 16.
- Anyone with previous allergies or reactions to the vaccine.
- Anyone with a history of significant allergic reactions to vaccines, medicines or food.*
- Individuals with a bleeding disorder or taking anticoagulants should only be given the vaccine if the potential benefit outweighs the risk of bleeding at the injection site.
- Individuals who are unwell or have a raised temperature on the day of injection should postpone their appointment.
It is important to emphasise the message to the public that the vaccine is not considered a risk in those who are pregnant, breastfeeding or younger than 16 years, but that it has not yet been licensed due to the lack of available evidence of either risk or benefit, as these groups were not included in the trials of the vaccine. It is likely that trials and evidence will follow in the future.
Who can have the vaccine?
- The vaccine is egg-free so may be used by those with an egg allergy. There are also no animal products or preservatives in the vaccine.(4)
- The vaccine is administered from vial with a synthetic rubber (bromobutyl) that does not contain latex so is safe in those with latex allergies.(4)
- Immunosuppressed patients or those with human immunodeficiency virus are encouraged to have the vaccine. Although there is a chance of a reduced immune response effect, it is not harmful to administer it.(4)
- Patients who have previously had the COVID-19 virus, whether suspected or confirmed. There is no evidence it is harmful to receive a vaccine following natural infection. It is hoped that it should boost the pre-existing antibodies.(4)
Who gets the vaccine first?
The order of priority of those who are eligible for the vaccine has been decided by the Joint Committee on Vaccination and Immunisation (JCVI) and is available here:(7)
- Residents in a care home for older adults and their carers
- Individuals ≥ 80 years of age and frontline health and social care workers
- Individuals ≥ 75 years of age
- Individuals ≥ 70 years of age and clinically extremely vulnerable individuals
- Individuals ≥ 65 years of age
- Individuals aged 16 to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality
- Individuals ≥ 60 years of age
- Individuals ≥ 55 years of age
- Individuals ≥ 50 years of age
Ultimately, the aim of the priority approach advised by JCVI is to “reduce mortality and serious disease and to protect the NHS and social care system” as the main priority. With a secondary priority of those at “risk of hospitalisation and at increased risk of exposure, and to maintain resilience in essential public services”.(7)
Why are two doses necessary?
The Pfizer vaccine trials showed greatest efficacy after two doses. The vaccine is an RNA vaccine, which triggers the production of antibodies and T-cells by injecting part of the virus's genetic code in order to provoke an immune response.(4) It stimulates the production of viral proteins, but not the whole virus. This is enough to train the immune system to fight the full virus on future exposure but will not cause a COVID-19 infection.
After exposure to the virus in the first dose, a slight immune response develops, however the vaccine is shown to be most effective seven days after the second dose and is therefore essential to have both doses as a full course to provide protection against COVID-19.
The Moderna vaccine is also an RNA vaccine and also requires a second dose 28 days later.
If the course is interrupted for any reason, there is no need to repeat the first dose, but to try and ensure the patient receives the same vaccine as there is currently no evidence of interchangeability of the vaccines, even though they have a similar mechanism of action – further studies are underway.(8) If the individual attends a different vaccination site for their second dose and the original vaccine that they received is not available, it is reasonable to provide the alternative vaccine as a single dose follow up, rather than not providing a dose at all.(8)
What is the advice for shielded patients?
Those who are clinically extremely vulnerable are also likely to have some degree of immunosuppression.(7) This may mean that they do not respond as well to the vaccine as hoped. Until there is sufficient data gathered following the roll out of the vaccine, this population should continue to follow the government advice on reducing their risk of exposure to the virus, even after their vaccination has taken place.(7)
The JCVI decided to increase priority of this group, for receiving their vaccine, in line with the ≥ 70 age group, as the evidence of risk was not accurate due to the protective measures this group has taken to reduce their exposure.
How will the vaccines be administered?
The Pfizer trials were all completed using the intramuscular route of administration of the vaccine. The emergency registration of the vaccine by the Medicines and Healthcare products Regulatory Agency (MHRA), under regulation 174 of the Human Medicines Regulations of 2012, has been authorised by the MHRA licensing this route only. The temporary supply licensing only allows the vaccine to be administered into the deltoid muscle of the arm.(4)
The manufacturer advises that it should not be injected intravascularly, subcutaneously or intradermally.(4) Intramuscular administration has the benefit of a better immune response to the vaccine, as the appropriate cells are present in the muscle tissue to initiate the immune response.(9) Subcutaneous injections can result in a local reaction and this is less likely intramuscularly, making it the preferred route.
It is vital not to inject too high up the arm into the shoulder capsule, which could result in inflammation and pain, such as frozen shoulder, or too low into the axillary or radial nerve, resulting in pain during the administration and possible nerve damage.(9)
Flu and other vaccinations at the same time
The population that are being encouraged to receive a COVID-19 vaccine will also be in the groups recommended for flu vaccinations. It is recommended that the COVID-19 vaccine is not given within seven days of a flu vaccination or any other vaccinations.(9)
The COVID-19 vaccination is not a live vaccine and the vaccine was well tolerated in the trials.
Very common side effects shown in trials for the Pfizer vaccine include: headache, injection site pain, fatigue, chills, arthralgia, myalgia. Common side effects include: redness and swelling at the injection site and nausea. Uncommon side effects include: malaise and lymphadenopathy.(4)
Although rare, anaphylaxis is a known side effect of any vaccine. Vaccine recipients should be monitored for 15 minutes after vaccination, with a longer observation period when indicated after clinical assessment. An anaphylaxis pack (containing 0.5mg intramuscular adrenaline) must always be available during administration of the vaccine, and those overseeing the immunisation service must be trained to recognise an anaphylactic reaction and be familiar with techniques for resuscitation of a patient with anaphylaxis. The MHRA have confirmed (December 9)* that a second dose of the Pfizer/BioNTech vaccine should not be given to those who have experienced anaphylaxis to the first dose of the vaccine.
The vaccine has no or negligible effect on the ability to drive or operate machinery, however it is worth noting that some of the side effects listed may temporarily affect the ability to drive or use machines.(4)
The yellow card reporting site from the MHRA is important to direct patients to should they experience any adverse effects in addition to those listed.(10)
Vaccine storage and preparation
The Pfizer/BioNTech coronavirus vaccine has the most difficult storage requirements of all the COVID-19 vaccine candidates currently undergoing trials. Currently, it needs to be stored between -80 to -60°C and has a six-month expiry. Over time and with more data being collected this may change.(4)
The vaccine needs to be thawed (for approximately three hours in the fridge or 30 minutes at room temperature) before use and may be stored undiluted at 2–8°C for five days, or for two hours at 25°C prior to use.(4) To prepare the vaccine, it should be diluted using 0.8 mL of sodium chloride 0.9% solution for injection, marked with the date and time, and can then be stored between 2 to 25°C. It must be used within six hours or the remainder discarded.(4)
To equalise the pressure in the prepared vial, 1.8 mL of air should be withdrawn using the same syringe for preparation, after which it can be mixed by gently inverting 10 times, producing an off-white solution that is ready to be administered. The vaccines are available in packs of 195. There are five 0.3 mL doses within each vial.
In comparison, the Moderna vaccine can be stored at -20°C for up to six months, 30 days at 2 to 8°C and up to 12 hours at 25°C. Each vial contains 10 doses.
The AstraZeneca/Oxford vaccine is much simpler than both options, with storage allowance of 2 to 8°C for up to six months. Once open, the vials should be used within six hours if stored at room temperature or 48 hours in a fridge. They are delivered in packs of 10 vials with each vial containing eight or 10 doses of vaccine.
Where can patients be signposted to find more information if they are concerned on safety?
Patients can be signposted to the NHS website or to the gov.uk website for the latest news including the MHRA video on their standards for approving the vaccine. They can read the information leaflet for UK recipients for further understanding of the manufacturer advice.
Essential resources for pharmacists:
- Green book - chapter 14a: COVID-19 vaccination
- E-learning for healthcare - COVID-19 vaccination
- Yellow card reporting for COVID-19 adverse effects
- Monthly vaccination updates
- COVID-19 training resources, leaflets and posters
- Pfizer/BioNTech COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection MHRA authorisation for temporary supply product information:
- Gov.uk: COVID-19 vaccinations and care homes programme launch
- NHS England: Wave 1 mobilisation of the primary care COVID-19 vaccination programme 2020/21 letter to GPs from Dr Nikita Kanani
- Chemist + Druggist news: Limited number of pharmacies to give 1000 COVID-19 vaccinations per week
- Medicines and Healthcare products Regulatory Agency (2020) Product information for HCPs and recipients
- British Medical Association (2020) COVID-19 vaccination programme
- The Green Book (2020) Chapter 14a COVID-19
- Gov.uk (2020) JCVI priority groups advice for COVID-19 vaccination
- Public Health England (2020) COVID-19 vaccination programme
- e-Learning for healthcare (2020) COVID-19 vaccination training
- Medicines and Healthcare products Regulatory Agency (2020) Yellow card reporting
*This article has been updated to reflect a warning issued by the MHRA on December 9.