Ensuring patients receive their vaccine boosters at the correct time, must now be a priority

At the end of 2020, the UK became the first country in the world to approve the Pfizer BioNTech covid-19 vaccine. The announcement sparked great excitement in the medical community. General practice teams began at great speed to work out the logistics of how to offer the vaccine safely, in addition to maintaining core services. GP teams were given the choice to sign up to the covid-19 vaccination programme. While many felt able to offer vaccinations in addition to existing services, other GP teams do not have the facilities or staff required. NHS England has since offered guidance to GPs on non-essential services that can be paused in order to speed up vaccinations.   

On the basis of the priority order from the Joint Committee on Vaccination and Immunisation (JCVI) the patients who initially were to receive the vaccine were largely older, frail patients many of whom needed help or pre-arranged transport to attend appointments. People in this age group do not tend to use SMS services or email and were therefore largely booked in by individual phone calls. The time and effort to book in hundreds of patients at short notice cannot be overstated. Many GP teams did this over weekends and evenings, with reception and administrative teams working overtime, and the GPs taking on lists of patients to call.

After two early anaphylactoid reactions (in patients with a history of anaphylaxis), the advice changed, and all patients must now wait for 15 minutes after a Pfizer BioNtech vaccination in case of any immediate adverse reaction. This posed another huge logistical challenge and greatly slowed down the speed of vaccination clinics, as more staff time is needed. The benefits of this enforced 15 minute wait are debatable, especially as people with severe allergy were then excluded. As we gained confidence with the vaccine, this policy was revised on 30th December to only exclude any patients with a known allergy to one of the actual ingredients of the vaccine itself.

A further change to the vaccination rollout was the decision, on 30 December 2020, to delay all Pfizer BioNTech boosters until 12 weeks, to allow more people to receive their first dose. Initially the second dose was scheduled to be given up to 21 days after the first dose, following the manufacturer’s advice and trial data. The JCVI’s decision to delay the boosters has been the subject of much debate, but on a practical level it meant that GPs had to cancel thousands of patients’ appointments. These patients had given their consent and been booked in for a booster at 21 days. For each cancelled person the GP teams would have to re-book new patients in their place.

This discussion is a complex and emotionally charged. Cases of covid-19 have been rising quickly, hospital admissions have been increasing, and although we now hope that we are “past the peak,” NHS capacity has been enormously stretched to meet the demand. We have the infrastructure in place within agile and willing primary care teams to vaccinate at pace. Now supported by community pharmacy and mass vaccination centres. The limiting factor here is simply vaccine supply. We have already heard multiple reports of delayed or cancelled vaccine deliveries. [1] There are around 1250 primary care networks (PCNs) in the UK, so to reach 2 million vaccinations a week means a mere 1600 vaccinations per PCN, which would be achieved very easily. A reliable, steady, and planned supply of vaccines is now a priority, with a coherent recall system, to allow us to invite patients, and ensure that they receive their correct boosters at the correct time. We do not want to be forced into the uncomfortable position of offering a “mix and match” approach in 12 weeks’ time to an already aggrieved cohort of delayed Pfizer BioNTech patients. 

Various ethical decisions arise from the decision to delay the booster doses of the vaccine, especially as there are no guarantees that second doses will be available since “The MHRA has also updated the conditions for the authorisation for the supply of the Pfizer BioNTech vaccine to remove the requirement to hold back 50% of available doses for administration as second doses.” The immediate question arises; is it right and fair to delay those patients who had consented and already booked in for their boosters at 21 days? The BMA argued that changing appointments that are already booked was impractical and potentially distressing for patients. NHS England initially said that GPs could use their discretion in changing these appointments, but subsequently, on 11 January 2021, sent this letter stating that without exception all appointments to receive the second dose must be delayed, with recipients to be booked in for a booster in the 12th week.

Beauchamp and Childress developed a framework based on four principles, which is much used in medical ethics. We think this can be applied here: 

Autonomy—although some GPs did initially honour the second doses booked, patients have not had any autonomy from 11 January 2021. 

Beneficence—it may be considered beneficent to vaccinate more patients with their first dose rather than giving patients with appointments their boosters. This is the main argument used by the Government to justify their policy.

Confidentiality—this is maintained.  

Do no harm (”non-maleficence”)—one could argue that distress was caused to those expecting their boosters at 21 days, in accordance with the trial data, product licence, and consent to being vaccinated. However, one could also argue that by delaying boosters more patients will receive some protection more quickly.

Equality is hard to quantify in this context. Is it fair that only some of the first 700,000 patients in the UK have their Pfizer BioNTech boosters at 21 days, but others and all subsequent patients will have to wait 12 weeks and have a delayed off-licence booster?

On a simple ethical framework, it would seems fair and correct to honour those patients who consented to a booster at 21 days, and if the expert advice from the JCVI and Public Health England, supported by the four chief medical officers subsequently changed to delay all boosters to 12 weeks for the “greater good of society”, then future patients could then be asked to give their consent to this new rule. The last thing we need is any further loss of trust in the government’s pandemic response, or reduced confidence in the covid-19 vaccination programme—particularly if the correct boosters are not available at the 12 week stage.

Ben Eliad is a GPST1, based in Watford, Hertfordshire. Twitter: @BenElian

Simon Hodes has worked as a GP partner in the same Watford practice since 2001, and is also a GP trainer, appraiser, and representative on the local medical committee. The views expressed above are his own. Twitter: @DrSimonHodes.

Neena Jha is a salaried GP in Hertfordshire with an interest in emergency care and global child health. The views expressed above are her own. Twitter: @DrNeenaJha

Frances Mair is Norie Miller professor of general practice. Twitter: @FrancesMair 

Competing interests: none declared.