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All medicines have risks; consumers trust that the benefits outweigh the hazards. This should be the context for the debate over the potential link between rare blood clots and the Oxford/AstraZeneca coronavirus vaccine. With millions of doses given, the evidence suggests this is a highly effective vaccine, estimated to have saved over 6,000 lives in the UK alone. It would be highly unfortunate if regulatory actions to minimise risks, based on abundant caution, unnecessarily undermined confidence in a vaccine that has already attracted more than its fair share of controversy — especially in poorer countries that may rely on it.
There are questions over why it took UK authorities longer to acknowledge and act on the potential risks than several EU countries, even if some overreacted. An answer may be that Britain’s vaccines rollout began with mostly BioNTech/Pfizer jabs for the elderly, so unusual clots only showed up as the AstraZeneca jab went to younger people.
Overall, however, the monitoring and regulatory process has functioned as it should. Britain’s regulator and its EU counterpart, the European Medicines Agency, gave identical verdicts: unusual clots should be listed as very rare side-effects, but the AstraZeneca jab’s pros far outweigh the cons. The two watchdogs deserve credit for co-operation, even after Brexit forced the EMA to relocate from London to Amsterdam.
It was not the UK regulator but an expert advisory committee on vaccinations — charged with operational decisions — that recommended offering alternative jabs to the under-30s. The reasoning looks sound: potential serious harms are higher in younger people, and benefits of the jab lower. But the guidance also happens to fit the profile of Britain’s vaccine rollout; some Pfizer and Moderna jabs can be earmarked for younger people, ministers say, while leaving the UK on track to offer all adults a first dose by July 31. Some other nations, with different rollout schemes, have restricted the AstraZeneca jab to other age groups.
It is vital that vaccine plans are tailored to reflect any possible side-effects, however rare, and these are fully communicated to recipients and medical staff so any adverse reactions can be acted on fast. Given the apparently much higher prevalence of unusual thromboses among women, there may be a case for further differentiation on grounds of gender, not just age.
There is a danger, however, that younger people, the vaccine-hesitant and even governments start to lose faith in a vaccine that is still able to save countless lives. The risk is greatest in lower income countries, which may not have alternatives and where AstraZeneca’s price and portability makes it the workhorse of immunisation plans.
The African Union made clear on Thursday a decision to drop plans to secure AstraZeneca jabs from India’s Serum Institute and seek supplies from Johnson & Johnson was related to supply questions, not safety; African countries would still receive AstraZeneca vaccines through the global Covax initiative. It would make little sense for countries to halt AstraZeneca jabs in favour of a J&J vaccine, based on similar adenovirus technology, that is only starting to be rolled out. Many nations are also buying Chinese or Russian adenovirus-based vaccines that have not received EU and US approval.
Western regulators must therefore ensure announcements are as precise and transparent as possible; AstraZeneca’s own communications need improvement. Despite all efforts, a small number of deaths may result from use of the jab. But the evidence is still that an immensely greater number would result from curtailing its use.
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