Update on MHRA decision re: Pfizer COVID-19 Vaccination 30.12.20

I am pleased to be able to update you with regards to the recent MHRA decision to advise that patients with a history of anaphylaxis to vaccines, drugs or food should not receive the Pfizer COVID-19 vaccination. This decision was made following two severe allergic reactions in the very early stages of the vaccine programme. It is still unclear as to the exact cause of these reactions but between the UK and North America, more than one million further doses of the vaccine have now been given. The enhanced surveillance since the initial precautionary advice was issued, has found no evidence of an increased risk of anaphylaxis in those with prior severe allergic reactions. This includes data from outside of the UK where the restrictions on those with a history of anaphylaxis, unless it was to a vaccine component, were not in place. Following advice from a number of BSACI members, as part of an MHRA Expert Working Group, supported by a larger number of members from the rapidly established BSACI expert vaccine allergy group, the MHRA has issued new advice. The MHRA is no longer advising that individuals with a history of anaphylaxis to any vaccine, medicine or food do not get the vaccine. However, the MHRA advice remains that individuals should not receive the vaccine if they have a history of allergic reactions to any of the vaccine ingredients or if they experience anaphylaxis after the first dose. Individuals should be closely observed for at least 15 minutes following vaccination.

You can read the full statement here (https://www.gov.uk/government/news/oxford-universityastrazeneca-covid-19-vaccine-approved).

Public Health England, again supported by BSACI, are also updating the ‘Green Book’ with regards to COVID-19 vaccinations and the risks relating to allergy. Dr Shuaib Nasser, who has led our Drug Allergy expert group, will be following up this email with some additional reflections in the coming days.

This is very welcome news and ensures that patients with allergy are not unnecessarily prevented from receiving the vaccine and will help reduce confusion around who should and shouldn’t receive it. This is coupled with the excellent news about the regulatory approval of the Oxford/Astra-Zeneca vaccine. This new vaccine does not contain PEG, the key suspect allergen in the Pfizer vaccine, and we will await clarity as to whether there will be any restrictions on this beyond those relating to previous vaccine or vaccine component reactions. We will update you accordingly and continue to stay in close contact with our colleagues in other countries where these vaccines are in use.

I would like to take the opportunity to thank the many members who have been involved in the BSACI response to this issue and wish you all a happy New Year,

With best wishes,

Adam Fox, BSACI President