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Don’t give Pfizer Covid vaccine to patients with ‘significant’ allergic reactions history, says MHRA


Anaphylaxis epipen


GPs and other health professionals should check with patients if they have previously suffered significant allergic reactions before administering the Pfizer Covid vaccine, under temporary guidance issued today.

This follows two incidents reported under the MHRA’s yellow card scheme yesterday, the first day of vaccinations against Covid-19 in England.

Both affected patients were health professionals, and NHS England said they are ‘recovering well’.

The new guidance states that:

  1. 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. 
  2. Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.

Pulse has asked the MHRA and NHS England to define what resuscitation facilities are required and what it means for vaccinations from GP sites due to begin next week, but the BMA said GPs would have the necessary equipment.

A statement issued by Pfizer said it has ‘been advised by MHRA of two yellow card reports that may be associated with allergic reaction due to administration of the COVID-19 BNT162b2 vaccine’.

It added: ‘As a precautionary measure, the MHRA has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes. Pfizer and BioNTech are supporting the MHRA in the investigation.’

An MHRA spokesperson said: ‘We are fully investigating the two reports that have been reported to us as a matter of priority. Once all the information has been reviewed we will communicate updated advice.

‘In line with existing advice we advise anyone with a history of a significant allergic reaction due to receive the Pfizer COVID vaccine to speak to your healthcare professional who is administering the vaccine.’

NHS England national medical director Professor Stephen Powis said: ‘As is common with new vaccines the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday. Both are recovering well.’

MHRA chief executive Dr June Raine told MPs on the House of Commons health and social care committee this morning that ‘last evening we were looking at two case reports of allergic reactions’.

She said that ‘from the very extensive clinical trials that this wasn’t a feature’, but added that ‘now that we’ve had this experience in the vulnerable populations – the groups that have been selected as a priority – we [will] get that advice to the field immediately’.

She stressed that the MHRA’s job does not stop ‘at the point of approving’ the vaccine, but there is ‘a proactive plan to monitor those benefits and risks in clinical use’.

She said: ‘The role is before, during and after and there is a true end to end – looking from the scientific laboratory bench through to the patient who yesterday first received the vaccine.’

Regarding the temporary guidance on resuscitation facilities, BMA GP Committee chair Dr Richard Vautrey told Pulse: ‘Practices would have the necessary equipment and experience to deal with allergic reactions that can occur in their patients.’

The MHRA approved the Covid vaccine developed by Pfizer and BioNTech last week (2 December) after final-stage trials had shown it was effective and ‘well tolerated across all populations’ with ‘no serious safety concerns observed’.

Pfizer’s statement added: ‘‘In the pivotal phase 3 clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee. The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination.’

Around 50 hospital hubs have begun vaccinating the first risk groups this week, with the first GP sites to follow next week.

In full: MHRA communication issued to health professionals

Risk of allergic reactions

Advice to Healthcare professionals

This precautionary advice is being issued following two case reports of anaphylactoid reactions associated with administration of Pfizer BioNtech COVID-19 vaccine.

New advice:

1. 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. 

2. Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.

Background

There have been two cases of anaphylactoid reactions in individuals with a strong past history of allergic reactions both of whom carried an adrenaline auto injector. These individuals developed symptoms of anaphylactoid reaction shortly after receiving the vaccine. Both recovered after appropriate treatment. We are seeking further information and will issue further advice following investigation.

Please report any suspected adverse reactions via the Yellow Card scheme. To make a report or find out more about the Yellow Card COVID-19 reporting site please visit: Coronavirus Yellow Card reporting site

Source: NHS England

READERS' COMMENTS [2]

terry sullivan 9 December, 2020 4:30 pm

gps are being dumped on–run away now

Rogue 1 9 December, 2020 6:10 pm

I wonder how many people will ‘brave’ 1 jab, and then not come back for the second?