Health minister Zweli Mhhize’s announcement earlier this week that the use of Johnson & Johnson’s (J&J) coronavirus vaccine would be temporarily paused pending an investigation into reports of rare blood-clotting disorders in people who received the shot was the right call.

The decision came hard on the heels of an announcement by the US Food and Drug Administration (FDA) — one of the world’s most stringent medicine regulators — that it recommended pausing administration of the shot after six women developed life-threatening clotting disorders within two weeks of receiving the jab. The women were all under 50 and developed an unusual combination of blood clots and a low platelet count, which requires specialised treatment.

The incidence of this condition appears, at this stage, to be extremely rare: there have so far been just six cases reported among 6.8-million recipients of J&J’s vaccine in the US, less than one in a million. None has been reported among the 290,000 health-care workers who received the jab in SA under the Sisonke implementation study, which got under way in mid-February.

While no causal link between J&J’s vaccine and these events has yet been established, the government and the SA Health Products Regulatory Authority need to demonstrate to the public that they take any sign of potential harm caused by Covid-19 vaccines seriously and establish exactly what risks a vaccine poses to recipients. This is important not only for individuals but also to guide doctors on the diagnosis and treatment of any serious complications that arise.

People take medicines all the time without thinking about their risks. Non-steroidal anti-inflammatory drugs used as painkillers can sometimes cause severe stomach bleeds; antibiotics may cause life-threatening Stevens-Johnson syndrome; and antidepressants can increase suicidal behaviour. But vaccines are different. They are taken by individuals who are healthy, for a future benefit not only for themselves but for society at large. And so the risk-benefit calculation conducted by regulators for vaccines is more complex and subjected to a higher level of public scrutiny.

The government is correct in calling timeout to ascertain exactly what is going on. But it has no time to lose. With the looming prospect of a third wave it cannot afford any more delays to its vaccination programme.

Every day lost in vaccinating front-line health-care workers in the Sisonke study increases their risk of illness and death from Covid-19. The country needs answers quickly, ideally within days, and once the verdict is in from the medicines regulator it cannot prevaricate. It needs to take a swift decision about whether to press ahead with administering J&J’s vaccine.

The government is in a very different position from the US, which has Pfizer and Moderna vaccines available to substitute for the J&J vaccine. SA’s tardy and drawn-out negotiations with drug manufacturers, and the unexpected blow to its original plans to roll out AstraZeneca’s shot by the emergence of a new variant, means it confronts a very different calculus from the US. It has no immediate alternative to the J&J jab since the first batch of the 30-million doses of vaccines ordered from Pfizer will arrive only in May. And even then, the shots will be trickling in in shipments of just 325,260 doses a week.

Three things are vital for a successful vaccination drive: timely supplies, an efficient distribution system and public confidence in the jabs on offer. If the government decides to put the brakes on the J&J vaccine, it will weaken all these elements.

Whatever the government decides, it has a delicate communication task on its hands. Vaccine hesitancy may be lower in SA than in some other parts of the world, but there are still plenty of people who are ambivalent or opposed to getting vaccinated. If the government gets its messaging right and convinces the public that it has sought and obtained answers to the safety questions about J&J’s vaccine, it may well bring some sceptics into the fold. But if it gets it wrong, it risks making people who are already hesitant even more unsure about getting the shot.

And the cost of that mistake will be paid in lives.


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