46 - Safety first

It’s natural for people to enquire about a new drug or vaccine. Even more so when some adverse reactions, even if very rare, attract publicity. But what our COVID-19 experience has reminded me is the gap in public knowledge about ‘routine’ drug safety and pharmacovigilance activity. We are seeing people wrongly assume that a ‘post authorisation’ safety study means a failing in clinical trials. Or that a very rare side effect means a vaccine is unsafe.

As a pharmacovigilance service, we need to do more to help the public understand our work, to show that far from being a cause for alarm, our work is a normal, planned part of the drug development process to ensure we keep people as safe as possible.
In the UK there is good take-up of the vaccine. But still, one in five Britons don’t feel the COVID-19 vaccines are safe and effective. In America, confidence in the Johnson & Johnson (J&J) vaccine is only 46%; it is expected that the figure would be similar for the AstraZeneca vaccine, which uses the same methodology to deliver the vaccine.
What’s more, the decision to pause distribution of the J&J vaccine in the US resulted in 24% of Americans saying they had lost confidence in the vaccine. Only 1% said the pause increased their confidence. Yet the pause was so researchers could assess the very latest data, check again whether the vaccine was safe. It should have been reassuring. Clearly it was not.

The fact people misunderstand our work shows we must communicate it better.
We need to show that uncovering rare side effects, studying these and working out how to minimise risks for certain affected groups is a sign our safety process is working well. It can be alarming to read about harmful side effects of new drugs or vaccines. But we must remember how rare they are. Many widely used medicines and vaccines cause very rare adverse effects, which do not stop people using them because their benefits outweigh the risks.

We need to reiterate that very rare side effects only appear when drugs are used by tens of thousands of people, something not usually possible to detect during clinical trials. And that drug safety monitoring and research after medicines have been authorised means any detected side effects, however rare, can be picked up and acted on immediately. This enhances the safety and well-being for everyone.

The recent reports of rare blood clots linked to the AstraZeneca and J&J vaccines are legitimate safety concerns. They are rightly being thoroughly investigated and risk minimisation measures, such as people aged under 40 being offered alternative vaccines, are in place in the UK. But the context is important. Contracting COVID-19 also can be associated with rare serious and fatal outcomes in people in this age group.
Air travel is considered safe. Very occasionally, it’s not. But that doesn’t stop us flying. We need to apply this kind of context to COVID-19 vaccines.

The COVID-19 vaccines are truly a success story. They’ve been highly effective in reducing the number of affected people and deaths from a terrible disease. As drug safety experts, it’s our role not only to scrupulously monitor and research any possible side effects of the vaccines but also to help people understand the process and not feel alarmed by it.