Rare side-effects under spotlight

The death of a 26-year-old Dunedin man linked to the Pfizer Covid-19 vaccine will have shocked and saddened many.

It will be no comfort to those who mourn him that his affliction, vaccine-related myocarditis, is a heart condition which is a rare side-effect from the vaccine, occurring in about three in 100,000 vaccinations in New Zealand.

An earlier death in New Zealand, that of a woman, is also believed to be as a result of vaccine-related myocarditis.

Myocarditis causes inflammation of the heart, often due to a virus. Indeed, the risk of getting it from Covid-19 is much greater than the likelihood of a vaccination-related onset.

However, the vaccine-related illness is likely to be under reported because the onset of symptoms occurs in the first few days.

Data gathered by the Centre for Adverse Reactions Monitoring in New Zealand shows that myocarditis/pericarditis which have been clinically validated in the first 30 days after the vaccine, occur about equally in men and women, over a wide age range, with a median age in the mid-30s. They occur about equally after dose one or two.

Most commonly, the symptoms are chest heaviness, discomfort, tightness or pain, difficulty breathing, shortness of breath, feeling dizzy, light-headed or faint, or a racing or fluttering heart, or a feeling of skipped beats.

The onset of such symptoms, if they occur, is usually in the first few days following the vaccine but can occur in the weeks later.

In the case of the Dunedin man, it appears that he began experiencing symptoms soon after his first vaccine, symptoms which continued and which he put down to stress before he died 12 days later.

His bereft fiancee has questioned whether he was made fully aware of potential side-effects of the vaccine.

The Ministry of Health moved urgently to reinforce the need for those involved with the vaccination programme to provide good information to patients about rare side-effects and what symptoms they might experience if they were unlucky enough to have them.

Has there been too much emphasis on common and mild side-effects so as not to unnecessarily alarm patients or deter them from going ahead? Informed consent should involve patients being as fully informed as they can be.

We agree with the ministry that it is crucial people are informed of the rare and serious potential side-effects, such as anaphylaxis, myocarditis, and pericarditis (also a heart condition).

If people know about how such conditions may present, then they can also be advised to seek medical help should these symptoms occur.

The ministry advice says there is an expectation that this information is provided in both written and verbal form. This is essential. Providing only written material assumes everyone can and will read and understand such information.

Healthcare providers have also been asked to review their clinical investigation and management of myocarditis/pericarditis and ensure everyone knows the drill.

Understanding risk is not something we are necessarily very good at, and, confronted with a tragedy like the young man’s death, we expect some people will be more than usually worried and will be seeking reassurance from those involved with the vaccination programme

We trust that reassurance about the value of the vaccination programme will be forthcoming, along with comprehensive advice on possible after-effects of the vaccine, with the message on symptom worries, "if in doubt, check it out", coming through loud and clear.

And another thing

Maori will have high hopes the vaccination programmes for boosters and children work better for them than the vaccination strategy has so far.

In a damning report this week, the Waitangi Tribunal criticised the Government’s failure to prioritise Maori in the vaccination rollout, saying this and the shift to the traffic light protection framework had put Maori , who have well known poor health status, at a disproportionate risk from Covid-19.

The Government must do better.