Telephone Icon

020 7650 1200

Allergic reactions to COVID-19 vaccine

Zahra Nanji discusses the latest development in the roll-out of the Pfizer-BioNtech vaccine against COVID-19.

Posted on 09 December 2020

NHS England have confirmed that two NHS staff members who received the Pfizer/BioNTech vaccine on the first day of the national vaccination programme on 8 November 2020 have suffered an allergic reaction.
 
It is understood that both the individuals had a significant history of allergic reactions, to the extent where they need to carry an adrenaline auto injector with them. Both individuals developed symptoms of "anaphylactoid reaction" shortly after receiving the vaccine and both have recovered after the appropriate treatment. An anaphylactoid reaction tends to involve a skin rash, breathlessness and sometimes a drop in blood pressure and is not the same as anaphylaxis which can be fatal.
 
GP online have reported to their readers that the Medicines and Healthcare Regulatory Authority (MHRA) has issued the following advice:
  • 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.
  • “Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.”
 
The MHRA has said it is 'seeking further information and will issue further advice following investigation' – and have highlighted that suspected adverse reactions should be reported to them via the coronavirus yellow card scheme website.
 
As I have previously expressed, the roll out of a vaccine brings with it the hope of a return to our pre-COVID world. However, for the vaccination programme to succeed, it requires the confidence of the public in taking the vaccine.
 
Amendments to the Human Medicine Regulations made in October 2020, has allowed a speedier licensing process and the extension of immunity from civil liability to companies producing the vaccine, rather than just protecting healthcare workers and manufacturers.
 
Commentators, including myself have highlighted that, there could be some resistance to the uptake of the vaccine due to the potential long-term effects of the vaccine being unknown as a result of there not being longitudinal studies (research that involves subjects being followed over time with continuous or repeated monitoring of risk factors or health outcomes, or both). The two cases of anaphylactoid reaction reported are an indicator that without longitudinal studies some side effects of the vaccine are unknown.
 
Although the MHRA have set out guidelines as to who should and should not receive the vaccine in their guidance to practitioners, without longitudinal studies, risk groups may be unknown.  For example, the MHRA have set out that although the currently available data does not indicate any safety concerns or harm to pregnancy, there is currently insufficient evidence to recommend the use of COVID-19 vaccines during pregnancy. Given the lack of evidence, it is recommended that COVID-19 vaccine is not given in pregnancy and women should be advised not to attend for vaccination if they are, or may be pregnant, or are planning a pregnancy within three months of the first dose. 
 
One way to counterbalance the concerns people may have regarding receiving the vaccine when there are no longitudinal studies, is if they can be made to feel safe in the knowledge that should they be one of the vanishingly small number of people who may suffer a serious adverse reaction to the vaccine, that they will be looked after via a suitable vaccine damages compensation scheme.
 
The Government have confirmed that COVID-19 will be added to the current vaccine damages payment scheme (VDPS).  The VDPS is a  no-fault scheme covering people who have been severely disabled as a result of vaccination. However, the scheme has for many years been criticised for its numerous problems, including that the severe disablement threshold requires a 60 per cent disability and the maximum payment under the scheme is £120,000.  This payment is very low and not comparable to likely compensation which would be awarded in court a case of serious injury.
 
Given the recommendations made in the recent Cumberledge review, which among its key recommendations was the establishment of a ‘no fault’ Redress Agency that mirrors the level of awards made by the courts in equivalent circumstances; and given that the vaccine is only going to be effective if sufficient numbers of people take it; and given that we are asking the public to take the vaccine not only to protect themselves but also their communities, I consider that the government should establish such a scheme as a matter of urgency.  Such a scheme is likely to invoke confidence in people taking the vaccine, that should they find themselves seriously injured as a result of taking the vaccine, that they will not be left to deal with the consequences alone.

Author

Profile
Zahra Nanji
Medical devices Medicines

Zahra Nanji

Zahra Nanji is an associate solicitor in the consumer law team.