BSACI Statement on the MHRA Guidance 10.12.2020

BSACI Statement on the MHRA Guidance managing allergic reactions following COVID-19 vaccination with the Pfizer/BioNTech vaccine

You will all be aware of the two widely-reported episodes of anaphylaxis and a further possible allergic reaction that occurred following administration of the Pfizer BioNtech COVID-19 vaccine. We were delighted to hear that the individuals are recovering well, following rapid treatment. 

The MHRA yesterday convened an expert working group that included members of the allergy and immunology community. This included an opportunity to review the potential risk of allergic reaction to polyethylene glycol (PEG), which is an excipient in the vaccine, although it is not yet clear if this was the cause.

Updated MHRA advice

Following this meeting, updated MHRA guidance was issued across the NHS last night, to all those involved in the COVID vaccination programme. You can also see their press statement on GOV.UK here. The advice rightly states that whilst allergic reactions to vaccines are rare, it is critical that immunisation centres are equipped and ready to deal with these promptly. 

I would urge you to connect with the vaccine programmes running in your areas to see where, as allergy specialists, we can offer support and advice to ensure we get this right. 

Patients with Allergy

The MHRA has also adopted a very risk-averse approach, recommending that for now the vaccine is not offered to anyone reporting a history of immediate-onset anaphylaxis to a vaccine, medicine or food. 

We acknowledge that while the cause of these reactions has not been confirmed, there is a need for such caution.  

As we develop a better understanding of the reactions that have happened it is important that the advice rapidly evolves to focus on a tighter definition of the at-risk group. 

If not, this advice would risk causing unnecessary anxiety within the allergy community.  It would result in patients who are not at an increased risk being denied access to a potentially life-saving vaccine. 

We are thus committed to continuing to work with the MHRA and NHS leadership to support their decision making, on the basis of independent and expert advice.

Adam Fox
BSACI President