Single vaccines and anaphylaxis
Recently the BBC reported on a concern about the use of single vaccines:
UK researchers have raised concerns over the monitoring of the safety of single measles and rubella vaccines.
It comes after an unexpectedly high number of cases of anaphylactic shock after single vaccines given at private clinics in south west England.
Although the figures are likely to be an anomaly, poor data on vaccines given at private clinics is preventing proper scrutiny, they warn.
I am a supporter of the use of the combined measles, mumps and rubella (MMR) vaccine. I support its use for two reasons, neither of which involve concerns about the safety of single vaccines.
1. The use of single vaccines leads to gaps in the vaccination schedule, exposes the child to more discomfort, and potentially can lead to a failure to vaccinate at all. It should be remembered that before MMR thousands of children suffered measles.
2. Providing single vaccines against the scientific evidence would be exploited as a tacit admission that there was a risk of autism attached to MMR vaccine by UK anti-vaccinators. It would undermine confidence in MMR vaccine, and the media would publish extremely confusing news stories about MMR vaccine. Wakefield’s hypothesis never explained why single vaccines might be “safer” in this regard. Anti-vaccinators would then move on to attacking single vaccines, winning by increments.
The latter point is a perhaps less of a concern. Despite some calls from politicians for the provision of single vaccines in the past, the autism-MMR vaccine hypothesis is now so discredited that I don’t think there is any possibility of caving in to the demands of a few isolated cranks. In addition, a rising awareness of the damage done to herd immunity in the UK, and outbreaks of measles, make the public health case for the combined vaccine even more compelling. So why don’t I admit a loud Whoopee about this news? MMR vaccine has less chance of causing anaphylaxis. Or does it?
The authors of the new study, which the BBC report is based upon, cite a UK national incidence of anaphylaxis for MMR vaccine as 1.4 cases per 100,000 doses from a paper by Peng et al in Arch Intern Med from 2004 [PDF]. That study is a GPRD (General Practice Research Database) study, which uses medical data from a large number of GPs (currently 450) and their patients (currently 13 million). While the GPRD has a good reputation, in terms of quality of data, even Peng et al state that “we cannot rule out the possibility that some cases of anaphylaxis may not have been recorded in the GP computer record, particularly those that occurred in hospital.” Anaphylaxis in the community may not have been recorded in patient’s notes in all cases. If a child suffered anaphylaxis in a surgery acute treatment of the child would have been a priority; the child later being admitted to a hospital where the coding would happen in a totally different system. In addition, the average of 1.4 cases per 100,000 is based on 2 cases of anaphylaxis after 143,000 administered doses of MMR vaccine. Only a small amount of cases which avoided coding would move the average up considerably.
The paper by Erlewyn-Lajueunesse et al that the BBC report is based upon used what appear to have been 4 spontaneous reports of anaphylaxis submitted to the authors in their locality, with data obtained from the MHRA on the number of imported MMR vaccine obtained nationally during the period. They argue that the incidence of anaphylaxis they found (18.9 cases per 100,000 for measles and 22.4 per 100,000 for rubella) was probably an under-estimate, since presumably more cases of anaphylaxis occurred elsewhere they were unaware of. This is probably a fair assumption. However, there are perhaps other biases at work. Perhaps the reporters were also the suppliers of the single vaccines, and are partly motivated by what they perceive as a danger of MMR vaccine. If so, they may have been more keen to report reactions to other vaccines. Alternatively, the reporters could have been those treating the anaphylaxis and may have felt strongly that side effects to the unlicensed single vaccines should be reported. So reporting rates in both studies may have been totally different in nature. It is hard to make any firm decisions on the limited data we have.
It is therefore not sensible to compare the two incidences, and to come to the conclusion that single vaccines are more prone to anaphylaxis. To be fair the authors make this point themselves at the BBC:
“We can’t think of any reason why it [anaphylaxis] would be higher for single vaccines and it’s probably an anomaly.
“The issue is that people go for these vaccines because they are uncertain about how safe the MMR is but we know how safe the MMR is because we have lots of data.”
He added that the Healthcare Commission should insist private clinics are subject to the same standards of vaccine data reporting as is expected of the NHS.
“They are more than likely safe but the issue it raises is about how that is monitored.”
Seeking to scare parents into using the combined jab on the basis of the evidence about anaphylaxis isn’t quite as dubious as the Wakefield-inspired scare story over MMR vaccine, but it is in the same ball park. David Elliman’s comments are also sensible:
Immunisation expert Dr David Elliman, a community paediatrician at Great Ormond Street Hospital also said there was “no logical reason” why the rates of anaphylaxis should be so high with the single vaccines.
“The important message is not about the rate but the fact that it does occur and this idea that the single vaccines for some magical reason are safer is nonsense.”