Q&A: Six things you should know about the Sisonke Covid-19 vaccine study

6 Apr 2021

How do Sisonke study researchers decide which hospital is a Covid vaccination site and will these venues also be used for our wider, national vaccine roll-out? Bhekisisa breaks it down and explains how sites store the vaccines.

In early March, about two weeks after South Africa’s Sisonke Covid vaccine trial started, Bhekisisa published interactive map with the 18 sites where health workers could get their vaccines from. The implementation study will give half a million health workers access to Johnson & Johnson’s (J&J) Covid vaccine (just over half of them have been vaccinated so far).

As the sites expanded, we updated the map — but we soon ran out of steam. Sites, ranging from large city hospitals to rural areas such as Namakwa in the Northern Cape, opened and closed all the time and four lists were being circulated simultaneously, all with a different selection of venues.

So we started phoning sites directly to find out if they were operating and we also contacted the researchers directly — but this didn’t help much either; everyone gave us a different answer.

Readers would email or contact us on social media and tell us that a site indicated as open on our map, was closed. Or that a venue that we thought had closed down, was in fact up and running. In the week of 22 March alone the presidency announced 54 sites, the Sisonke researchers told us there were 51 venues and the South African Medical Research Council (SAMRC) told parliament there were 72 places of vaccination.

This prompted us to investigate who decides on the sites, how they do it and how the vaccines are stored and administered. Here’s what we found.

Things get, well, complicated with so many partners

The first set of venues we had doubts about were in KwaZulu-Natal, so that’s where our search for answers began. In mid-March, Albert Luthuli Central Hospital in Durban was, for instance, indicated as open on some site lists and closed on others.

The reasons for this are complicated.

The Sisonke study is spearheaded by the SAMRC in partnership with the national health department, Desmond Tutu Health Foundation, Centre for the Aids Programme of Research (Caprisa) and the drug company Janssen Pharmaceuticals that is owned by Johnson & Johnson.

In addition to this, provincial health departments and several researchers — each of them responsible for a province or provinces — are involved.

That’s a lot of partners.

And although the national health department and research team ultimately decide on where sites will be, the process is complex, because everyone has to be consulted.

Nigel Garrett, an infectious diseases specialist from Caprisa who coordinates vaccinations in KwaZulu-Natal and the Free State, says his days start with calls among the provincial health department, private hospital representatives and general practitioners to discuss the hospitals where vaccines are available.

If a new site is due to open on a particular day, the hospital’s CEO first needs to be consulted, and the provincial team needs to ask the national health department to activate the site on the government’s online registration platform, the electronic vaccination data system (EVDS). If all these things don’t happen, the vouchers that the EVDS issues to health workers who register on the system, won’t correspond with the actual venues (so no one would be referred to a new venue if the site hadn’t been processed by the EVDS).

“The provincial team needs to submit a form with the site name and the names of catchment sites to the national team … [and] that can [only] be implemented within a day or two,” explains Garrett.

This means there may be delays between venues opening or closing and removing the facilities from or adding them to site lists, because they can only be removed or added once the EVDS has been updated. And because there are frequent vaccine deliveries, and all districts need to be served, new requests are submitted regularly — the requests can therefore be at different approval stages on the EVDS, which can then result in site lists being in different stages of being updated.

But there’s even more to it, explains the SAMRC’s president and co-lead investigator of the Sisonke study.

“A successful vaccine roll-out has to be nimble and flexible,” Gray says. “The same model simply doesn’t work everywhere. That means plans change all the time.”

An example would be upcoming plans to vaccinate the staff of the South African Military Health Service. “We’ve just heard that we need to vaccinate the military and there are 8,000 people. We now have to decide whether we should send a team to a military hospital such as 1 Military Hospital or if we should have the military staff travel to one of our research sites and vaccinate them there,” explains Gray.

“It’s always better to keep sites open and move people there to get vaccinated, because every time we open a new site, we lose a day and a half with setting it up. But this doesn’t work for all situations. In the case of the military, it might work for some categories of health staff, but not for others.

“So things change all the time, as vaccinations move forward. I can give you our plan, but when new issues arrive, we’ll suddenly change it, so that we can vaccinate people as fast as possible. And that essentially means that any list we give you will only be 80% correct at any given time.”

Bhekisisa has consulted with all the different roleplayers for the latest update (the latest available data is for the week of 29 March) of the sites where health workers can access Covid vaccines. We’ll continue to update the map as new site data becomes available.

How does a health facility become a site?

Between October 2020 and February 2021 another J&J vaccine trial, called the Ensemble study, was conducted. It took place in eight countries, including South Africa. That study measured the efficacy of the J&J vaccine (it provided 64% protection against Covid-19 in South Africa).

The Sisonke study builds on the Ensemble trial and started in mid-February — once the Ensemble study’s results had been announced.

In order to get access to the study vaccine, at this stage still termed an investigational product, the Sisonke searchers were bound to use the Ensemble study’s research sites to vaccinate health workers.

“Everything happened at rapid speed. Therefore, the national health department team and Sisonke researchers decided to start with big hospitals with large numbers of healthcare workers,” says Garrett.

“Those hospitals were mostly located close to the research sites, where the vaccines would be stored. As we moved on and gained more experience, it became more of a consultative process where the provinces and private providers would suggest hospitals, and we would activate new sites ahead of time.”

But any hospital can’t just become a vaccination site — a facility needs to be Covid compliant and have enough fridges to store vaccines at the correct temperature during the day. Sites, for instance, need to be large enough or have big enough outside spaces, to allow health workers coming for vaccines to practice social distancing. That’s why the Netcare St Augustine’s Hospital in Durban (the hospital that saw South Africa’s first large Covid-19 outbreak among healthcare workers in May) set up a vaccination centre in its parking lot where 800 people are getting vaccinated per day.

Venues must also have waste disposal systems so that the syringes and needles that were used to inject vaccines into people’s arms, can be done away with safely. Moreover, the health department’s guidelines require sites to have a “computer or other device” with “appropriate connectivity [WiFi] to submit data” to the EVDS system.

In the Sisonke study, the researchers are responsible for the storage of vaccines at the vaccination sites. They also have to supervise the preparation of shots at the vaccination venues. The J&J vaccines are stored at research sites in -20℃ freezers and are then thawed overnight and transported to all the other vaccination centres. At the centres, the vaccines are prepared and drawn up into syringes under the supervision of trained pharmacists.

Vaccination sites must have WHO-approved temperature monitoring devices so that staff know the temperature of the vials at all times. The J&J vaccines can be stored in fridges at between 2℃ and 8℃ at facilities for up to three months.

Lastly, venues must have alternative power sources such as generators, so that they are able to maintain cold storage requirements in the case of power failures or scheduled load shedding. They’re also expected to have back-up plans for alternative storage “if the cold storage unit fails”.

How are rural sites selected?

The Sisonke study team tries to serve all health districts, including those with rural hospitals. “In addition to adhering to the health department’s vaccination site readiness guidelines, rural sites have to be accessible to the team”, Garrett says.

Vaccination venues that are more than two hours away from an Ensemble research site can be harder to manage and more costly to run, because the vaccination team has to sleep over. Garrett says it can also be more difficult to “achieve high volumes of vaccinations” at such sites.

But the research team has found ways around this.

For example, researchers now conduct scouting visits before a new rural site is opened to ensure that sites are set up properly before pharmacists and study staff arrive. “We’ve done that in Ixopo [in the southern KwaZulu-Natal Midlands], and booked people into hotels for a week and managed to complete all vaccinations within that week,” says Garrett.

In the next three weeks, the Sisonke team is planning to cover many areas of the rural Eastern Cape. This will include mobile outreach teams that can serve smaller hospitals and clinics in more remote areas.

For how long can jabs be used after they’ve been opened?

William Brumskine from the Aurum Institute is a clinical research site leader for the Sisonke study in Rustenburg. He travels to hospital vaccination venues in the area to make sure the rules of the study are followed and that trial participants are adequately monitored.

Brumskine says the J&J vials are delivered to Sisonke sites in frozen vials. Each research vial contains two doses, but the commercial vaccines that will be used in our national roll-out and of which South Africa has bought 31-million doses, will come in vials that contain five 0.5 ml doses each.

The vials for a day’s use are thawed overnight at fridge temperatures of between 2°C to 8°C — unpunctured vials can be stored at this temperature for up to three months.

But once the vials have been thawed, they cannot be refrozen again, according to J&J’s storage guidelines. And “if you then draw them into syringes… you have to administer it within about six hours”, says Brumskine.

The J&J guidelines stipulate that a punctured vial will only last for six hours if it’s kept in a fridge at between 2°C to 8°C. If it’s kept at room temperature, the vial’s contents can be used for up to two hours. So if there are doses in punctured vials left by the end of the day, they cannot be used the next day, and have to be thrown away.

The day to day running of a site, therefore, needs researchers, pharmacists, clinic floor and vaccination coordinators to all speak to each other so that the opening of vials are coordinated and jabs aren’t wasted. Brumskine says larger sites can prepare 100 doses (50 vials) in a go while smaller sites may choose to ready batches of 10 doses (five vials) every 30 minutes to make sure there is no wastage.

What do sites do when people miss appointments or a venue runs out of jabs?

The EVDS is linked to a scheduling system that vaccination sites may or may not use. This can be activated centrally, and can also be linked to the voucher ticketing system. To ensure that prepared jabs aren’t wasted, some sites only allocate part of a day’s vaccinations to appointments scheduled via the EVDS.

For example, at Brumskine’s site, only 70% of the doses for a particular day are allocated to vaccinations that have been booked on the EVDS. The remaining 30% of the doses are used for walk-in vaccinations and to accommodate people who had missed their appointments for personal reasons or due to a site running out of jabs on the day of their scheduled appointment.

If there are punctured vials left after all scheduled and walk-in vaccinations have been done, health workers working at a site who haven’t yet been vaccinated, are called in for unscheduled appointments and get vaccinated with the left-over stock.

Will the Sisonke sites be used for our national roll-out?

Yes, according to Garrett, Brumskine and the Western Cape health department, the Sisonke sites may also be used for South Africa’s wider, national roll-out. The roll-out is scheduled to start soon after the country’s first batch of commercial jabs arrives in the second half of April. According to Health Minister Zweli Mkhize, one million J&J shots are scheduled to touch down in the third or fourth week of April.

The national health department’s director for affordable medicine, Khadija Jamaloodien, says there will be 1,500 small, 200 medium/large and 50 mass vaccination sites that will do between 250,000 and 300,000 vaccinations per day, depending on how many doses the country has access to during a specific time period (the Sisonke study does about 12,000 vaccinations per day). Small sites will have two vaccinators each and do about 80 vaccinations per day, medium/large sites will have 6-16 vaccinators and vaccinate about 300-500 people a day, and mass vaccination sites will have 50 or more vaccinators that will do about 2,000 daily vaccinations.

Sites will range from public and private health facilities to pharmacies, GP practices, retail stores, gyms, hotels, conference centres and stadiums.

Mark van der Heever, the deputy director for communications at the Western Cape health department, says how vaccines will be distributed across the different sites, will be determined by the rate of infections when the roll-out starts. “This will all depend on where we find ourselves during those specific circumstances. We could be where we are now or in the third wave, which would mean we would have to de-escalate clients from our health facilities because those facilities would need to be opened up again for testing.” DM/MC

This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.

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