GPs will have to observe all patients for at least 15 minutes following their injection with the Pfizer Covid vaccine, in light of reports it can cause anaphylaxis.
Vaccine sites will also need an anaphylaxis management protocol in place and an anaphylaxis pack including intramuscular adrenaline. Staff will also require training in resuscitation techniques.
The MHRA convened an expert group of the Commission on Human Medicines, attended by experts in allergy and clinical immunology, to decide the guidance yesterday, following news that two healthcare professionals that were vaccinated on Tuesday suffered an allergic reaction.
The updated guidance, says:
- Vaccine recipients should be monitored for 15 minutes after vaccination, with a longer observation period when indicated after clinical assessment.
- A protocol for the management of anaphylaxis and an anaphylaxis pack must always be available whenever the Pfizer/BioNTech vaccine is given. Immediate treatment should include early treatment with 0.5mg intramuscular adrenaline (0.5ml of 1:1000 or 1mg/ml adrenaline), with an early call for help and further IM adrenaline every 5 minutes. The health professionals overseeing the immunisation service must be trained to recognise an anaphylactic reaction and be familiar with techniques for resuscitation of a patient with anaphylaxis.
This reinstates previous advice around observations, with the draft plans for the Covid vaccine enhanced service for GPs originally suggesting patients may need to be observed for 15 minutes following their vaccination.
At the time – in a bid to allay GP concerns – NHS England later said that GP sites administering Covid vaccinations would only need to observe patients for any immediate negative reactions, or for 15 minutes if they are driving.
Meanwhile, an email circulated yesterday afternoon to GPs by NHS England regional teams, seen by Pulse, said the standard operating procedures (SOP) for Covid vaccinations will be updated with details of what resus trolley contents are required, to include oxygen, a single-use nebuliser, and intramuscular adrenaline.
But GPs said that the lengthy anaphylaxis observation period would make it difficult for some sites to fulfil the requirement to administer 975 doses of the Pfizer Covid vaccine in 3.5 days.
Dr Kyle Roys, a GP in Bristol, told Pulse: ‘This makes doing the amount of vaccinations in the time frame far more difficult. Which means it is almost certain that more support is required from NHSE to staff this. I fear some will not have facilities [that are] appropriate either.’
Temporary advice to trusts earlier this week had said that ‘any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer BioNtech vaccine’.
It also said that ‘vaccination should only be carried out in facilities where resuscitation measures are available’.
The MHRA’s updated advice further confirmed that ‘any person with a history of immediate-onset anaphylaxis to a vaccine, medicine or food should not receive the Pfizer/BioNTech vaccine’.
And it stressed that ‘a second dose of the Pfizer/BioNTech vaccine should not be given to those who have experienced anaphylaxis to the first dose of Pfizer/BioNTech vaccination’.
The two individuals who suffered anaphylaxis on Tuesday ‘received prompt treatment and are recovering well’, the MHRA added.
MHRA chief executive Dr June Raine said: ‘Anaphylaxis is a known, although very rare, side effect with any vaccine. Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks.
‘Anyone due to receive their vaccine should continue with their appointment and discuss any questions or medical history of serious allergies with the healthcare professional prior to getting the jab.’
According to Dr Raine, ‘the fact that these incidents were picked up and reviewed’ is testament to the MHRA’s ‘robust and proactive safety monitoring strategy for Covid-19 vaccines’.
She added: ‘You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness. The safety data has also been critically assessed by the government’s independent advisory body, the Commission on Human Medicines.
‘No vaccine would be approved unless it meets these stringent standards – on that you can be sure.’