This marks the start of South Africa’s new, adjusted vaccine roll-out plan where jabs will be given as part of an implementation study conducted by the South African Medical Research Council and the Department of Health. The study will focus on “real-life” environment roll-out issues and gather additional data on side-effects and the protection the shot offers against severe Covid-19 disease caused by the new SARS-CoV-2 (the virus that causes Covid-19) variant, 501Y.V2, that is now dominant in South Africa.

We break down everything you need to know about the Johnson & Johnson vaccine – how well it works against the new variant, how many doses will be going to which sites (see our interactive map), and how many more vaccines will be arriving and when. 

1. How well does the J&J vaccine work?

The Johnson & Johnson vaccine is the only jab, at least so far, for which we have clinical trial data on the kind of protection it provides against severe Covid-19 disease caused by the new variant.

Why are we interested in protection against severe disease? Because that’s the type of Covid that leads to people ending up in hospital or dying. Reducing these cases means our health system doesn’t get overwhelmed, and the impact of the pandemic on our economy when breadwinners, for instance, die, is alleviated. In the case of health workers, who are on the frontline taking care of people with severe Covid and are most vulnerable to infection, we’d want to protect them as much as possible.

Johnson & Johnson tested its vaccine in eight countries – the US, Argentina, Brazil, Chile, Columbia, Mexico, Peru and South Africa. Fifteen percent, or 6,567 of the study’s 43,783 participants, were from South Africa.

Most participants were older than 60 (33.5% over 60, 19.6% over 65, 3.5% over 75, 1% over 80). This helped the researchers to get better data on how the vaccine fared against severe Covid (because people above 60 are more likely to get severe disease than those who are younger than 60).

The study showed the jab was 85% effective in preventing severe disease in people who were 18 years and older in all the countries that were studied. The protection kicked in 28 days after the shot was given. And the protection the jab provided against severe disease increased over time – 49 days after a jab was given, not a single case of severe Covid was reported in people who had been vaccinated.

Moreover, the jab demonstrated 100% protection against Covid-related death: 28 days post-vaccination, no trial participant had died.

How do the study’s investigators know that the Covid cases in the South African arm of the trial were caused by 501Y.V2? They sent a sample of the cases for genomic sequencing, which allowed them to decode the genes of the virus and establish which variant it was. The results showed that about 94% of the Covid cases from South Africa were caused by the variant, one of the two co-principal investigators of the local Johnson & Johnson trial, Glenda Gray, said in a presentation on 7 February. Gray is also the president of the South African Medical Research Council.

But the trial data also showed the Johnson & Johnson vaccine offers less protection against moderate to severe Covid caused by 501Y.V2 than against severe Covid. It offered 57% protection against moderate to severe disease, which was lower than the protection provided in countries where the 501Y.V2 variant was not dominant. However, the 57% is, so far, the best protection we have in a vaccine against moderate to severe disease caused by 501Y.V2 – the Novavax and AstraZeneca jabs showed less than 50% protection, which is the World Health Organisation’s threshold for a Covid jab to be considered effective.

2. Have the data been peer reviewed?

Before a scientific study can be accepted for publication in a reputable academic journal, the research goes through a process called peer review: a committee of “peers” (other academics or researchers) examine the data and methodology of the study to make sure it is sound. This can take months.

During the Covid pandemic, research moved considerably faster than usual because of the need to find treatments and vaccines fast. This means study results are often released in the form of preprint studies (not peer reviewed) or press releases.

In the case of the Johnson & Johnson vaccine, the study results have not been peer reviewed. The data were released in the form of a press release on 29 January. This means there are limited data available about the exact numbers being looked at and we don’t yet know how many of the Covid cases recorded during the trial occurred in which of the eight countries that the trial was done.

3. How many shots do you need?

So far, the Johnson & Johnson jab is the only Covid vaccine that requires one shot. All the other jabs that are available require two. This makes the Johnson & Johnson vaccine considerably easier to administer because health workers don’t have to spend time and resources on ensuring that people return for their second shot.

Potentially, down the line, researchers could test if a second “booster shot” designed against the 501Y.V2 variant could increase the protection.

4. How many Johnson & Johnson doses are we getting – and when?

For now, we’ll be receiving four batches of vaccines once every two weeks, says Linda-Gail Bekker, the other co-principal investigator of the Johnson & Johnson study. The first three batches will consist of 80,000 doses and the fourth will have 60,000. Once we’ve received 300,000 doses and shown that we were able to administer all of them, we will have the option of asking Johnson & Johnson for another 200,000.

All these doses (500,000) will be provided to South Africa for free by Johnson & Johnson. Why? Partly solidarity and partly because they come from research stock the company won’t be using, says Bekker.

In addition to the free vaccines, South Africa has procured nine million doses from Johnson & Johnson, which, according to a January presentation by President Cyril Ramaphosa, are expected to arrive in the second quarter of 2021. Media reports on 9 February stated that an additional 20 million doses are under negotiation, but this has not been officially confirmed.

South African will need to pay for these doses. And when we get them will depend on when Johnson & Johnson has stock available and when the South African Health Products Regulatory Authority (SAHPRA), is able to conclude the firm’s application for approval to use the vaccine for a wider roll-out (the approval for the first 500,000 doses is for use in research, which is different from the type of approval required for wider use, and is a much simpler and quicker process).

5. When will the roll-out start?

Bekker says “if all goes well, we’ll start with the first vaccinations by midday on Wednesday, 17 February”.

6. Who is getting the vaccine?

Only healthcare workers can get vaccinated for now – until all of the country’s estimated 1.25 million health workers have been covered. They are considered the most vulnerable to infection because they deal with infected patients daily. That is why they are the only group targeted in Phase 1 of South Africa’s vaccine roll-out.

The first batch of 80,000 vaccines will be distributed to 17 sites across nine provinces, says Bekker, who is also the director of the Desmond Tutu HIV Centre at the University of Cape Town.

Each province will have two vaccination sites – all are public hospitals. One site (Pelonomi Hospital in the Free State), is not ready to vaccinate and will be phased in later, Health Department spokesperson Popo Maja told Bhekisisa.

How many of the 80,000 doses will each site get?

Bekker says the numbers will be calculated based on the number of trained staff available at a site and the burden of disease (the number of infections in the area). “Additional training will also be done to increase the amount of people able to administer the jab beyond just healthcare workers.”

For the second consignment of 80,000 doses, some of the vaccines will be distributed to private healthcare sector sites, which will then be added to the list of 17 vaccination sites. As more vaccines arrive, the sites will increase further. 

Bhekisisa obtained a list from the Health Department with the names of the 16 vaccination sites that are ready to operate and the number of doses they will receive. We’ve turned it into an interactive map to make it easy to understand.

7. How do you let the Health Department know you’d like to be vaccinated?

Everyone who wants to get vaccinated needs to register on the online electronic vaccination data system (EVDS), which will record your name, ID number, address, whether you have medical aid, and other details and let you know if you’re eligible. Once identified as eligible you will receive a text message saying where and when you will be vaccinated. You will also receive a unique code you must give to the vaccinator, along with your ID. Once you’ve had your jab you will receive an electronic vaccination certificate.

Registration for health workers on the EVDS has started. By 1pm on 15 February, 351,213 (28%) of the country’s 1.25 million health workers had registered, according to Health Department data.

8. Why are we doing a research study with Johnson & Johnson’s vaccine if we already have data that show it works against 501Y.V2? 

The short answer: Getting a vaccine approved for use in a research setting is considerably quicker than for wider use, and if we have to wait for the latter, we’re likely to only start the roll-out in about two months.

The long answer: Johnson & Johnson has submitted a rolling application with SAHPRA to enable it to roll-out its vaccine on a large scale. But, according to Gray, the approval process is likely to only conclude in about three months.

This is because SAHPRA has to review loads of data to ensure the vaccine is safe and as effective as Johnson & Johnson says it is. Another complicating factor is that, in order to speed up this process during a pandemic, SAHPRA uses a reliance mechanism. This means it leans heavily on the findings of other large regulators, such as the US Food and Drug Administration (FDA)  and the European Medicine Agency. But the Johnson & Jonson vaccine is new, so no other country has yet approved it. The FDA has scheduled an independent review for 26 February.

So, while Johnson & Johnson awaits approval for wider use of its vaccine, it’s doing an implementation study – because it’s the only way health workers can get earlier access to Covid vaccinations with this jab. It will also provide more data.

This study will show “how an intervention performs under real-world conditions”, Gray says. “By doing the roll-out in the form of an implementation study, additional information can be gathered to confirm the findings of the phase three study that this vaccine protected against hospitalisation and death.”

While there are trial data showing the vaccine’s safety, certain groups like pregnant women are not able to take part in clinical trials. They can now participate in the implementation study and provide information on how the vaccine performs, while the jab’s safety can be monitored in a wider roll-out.

Bekker concludes: “Additionally, this approach to roll-out can provide insight into vaccine uptake among the population.” MC/DM

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

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