ANALYSIS | Vaccination rollout is underway, but pitfalls still remain

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Time is of the essence in our vaccination campaign, writes the author.
Time is of the essence in our vaccination campaign, writes the author.
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While South Africa may have been lucky to get access to the Johnson & Johnson vaccine quickly, some issues remain, writes Neil Stacey. 


South Africa’s vaccine rollout got underway last week, using the single-dose Johnson & Johnson vaccine, just three weeks after the release of Phase 3 efficacy trial results for that vaccine, a truly remarkable turnaround time.

South Africa had previously ordered nine million doses of the J&J vaccine to be delivered later in the year, but after the AstraZeneca vaccine’s apparent failure against the 501Y.V2 variant, Johnson & Johnson agreed to supply 500 000 doses out of their research stock, free of charge and delivered right away.

It would be an understatement to say that it is fortuitous that we got access to an alternative vaccine so quickly and at no charge, and the stroke of luck is rendered all the more remarkable when one considers that, besides the failure of AstraZeneca’s vaccine against our variant specifically, many promising vaccine candidates have failed altogether, including those of global pharmaceutical giants Merck and GlaxoSmithKline.

As lucky as we have gotten with the Johnson & Johnson arrangement, some issues remain.

Scientific trial 

The vaccine is currently being rolled out without full regulatory approval, and the first 500 000 doses are to be administered under the guise of a scientific trial instead.

It is not entirely clear that the J&J vaccine will in fact obtain full clearance.

According to Johnson & Johnson press releases, the South African arm of their Phase 3 trials showed 57% efficacy at preventing moderate-to-severe illness, but the current SAHPRA guide-line for regulatory approval is a minimum of 50% efficacy at preventing all symptomatic infections, including mild cases.

The AstraZeneca vaccine, a million doses of which arrived in the country to great fanfare three weeks ago and are going unused, had a reported efficacy of 22% at preventing all symptomatic infections in the South African arm of their Phase 3 trials.

This figure can’t be directly compared to the 57% reported by Johnson & Johnson, because they measure quite different things.

READ | Analysis: Astrazeneca in South Africa: To rollout or not to rollout

Across the board, vaccine trials have shown considerably higher efficacy at preventing more severe degrees of illness and so it is very likely that 57% efficacy for moderate-to-severe infections will correspond to overall efficacy for all symptomatic infections that is somewhere below 50%.

Essentially, by reporting on efficacy against higher severities of illness, Johnson & Johnson have measured themselves against different goalposts than AstraZeneca did.

This places us in the rather strange position of having abandoned one vaccine on the basis that in the South African context it does not meet SAHPRA’s efficacy requirements, in favour of another vaccine which is itself unlikely to meet those same requirements.

While it still appears likely that the Johnson & Johnson vaccine will outperform the AstraZeneca one, the balance of probability is that both will fall into the category of providing demonstrable protective value, but not meeting SAHPRA’s current regulatory criteria.

There is no particular reason that the same regulatory loopholes used to fast-track the Johnson & Johnson vaccine could not have similarly facilitated earlier rollout of some of the AstraZeneca doses we already had in hand.

Moreover, amendments of SAHPRA’s regulatory criteria do merit consideration, lest the AstraZeneca situation repeat itself on a grander scale – we have since ordered an additional 20 milllion doses from Johnson & Johnson and we must ensure that red tape does not prevent or delay their use. 

Have no doubt that time is of the essence in our vaccination campaign.

Winter season

It is well established that the transmissibility of Covid-19 is considerably higher in cold weather and so it is widely expected that we will have a resurgence of cases beginning at the change of season in April, which happens to coincide with Easter Weekend. 

The more healthcare workers are protected by then, the less impact Covid infections will have on our over-stretched healthcare capacity.

The cumulative effects of the Covid-19 pandemic on our healthcare system are steadily mounting, with burnout and exhaustion becoming commonplace among doctors and nurses, many of whom are themselves suffering the long-term effects of Covid-19, along with PTSD.

The addition of the vaccination effort to an already-excessive workload will further stretch the healthcare sector’s limited capacity, which is particularly concerning with the change of season now less than two months away, with a possibility of another severe wave of infections looming.

The first 16 vaccination sites that were announced are all hospitals, many of which had difficulty coping with previous waves of Covid-19 infections, and are likely to be similarly afflicted this winter.  

Veterinarians

The UK created a programme of Non-Healthcare Vaccinators from other sectors who had the technical skillset to administer vaccines or otherwise participate in the inoculation campaign.

South Africa must implement similar measures or run the risk of our vaccination campaign grinding to a halt as facilities and personnel become overwhelmed with a surge of Covid-19 cases.

READ | Covid-19 vaccination chaos at Tshwane's Steve Biko hospital as doctors queue for jabs

Veterinarians feature prominently in the UK’s programme, for example, and could be a key contributor in South Africa’s campaign.

Veterinary practices routinely administer vaccines, albeit to other species, making them an ideal parallel structure, already possessing all of the associated skills, as well as storage facilities and existing distribution channels.

It is critical that the Health Department urgently explore this and all other possible avenues for shifting the burden off of a conventional healthcare system that simply cannot be expected to have any excess capacity available if the widely-expected third wave turns out to be comparable to the second wave that we have just emerged from.

- Dr Neil Stacey is a lecturer in Biomedical Engineering and Chemical Reactor Design at Wits University, and since 2020 has been a key member of a multi-institutional, multidisciplinary research collaboration developing cost-effective new treatments for critically ill Covid-19 patients.


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