This marks the start of South Africa’s new, adjusted vaccine roll-out plan, in which vaccinations will be given as part of an implementation study conducted by the South African Medical Research Council (SAMRC) and the department of health.
The implementation study will focus on “real-life” environment roll-out issues and also gather additional data on side effects and the protection the jab offers against severe Covid-19 disease caused by the new SARS-CoV-2 (the virus that causes Covid-19) variant, 501Y.V2, which 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 (check out 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, 501Y.V2.
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 effect 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 most vulnerable to infection, we want to protect them as much as possible.
Johnson & Johnson tested its vaccine in eight countries — the United States, 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 trial participants were older than 60 years (33.5% over 60, 19.6% over 65, 3.5% over 75, 1% over 80). This helped the researchers to obtain better data on how the vaccine fared against severe Covid (because people who are older than 60 years are more likely to develop severe Covid disease than those who are younger than 60).
The study showed that 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. What is more, 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.
So, 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 took a sample of the cases and sent them 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 SAMRC.
But the trial data also showed the study’s researchers that the Johnson & Johnson vaccine offers less protection against moderate to severe Covid caused by 501Y.V2 than against severe Covid.
The jab offered 57% protection against moderate to severe disease, which was lower than the protection provided in countries in which the 501Y.V2 variant was not dominant. The 57% is, so far, however, the best protection we’ve got in a vaccine against moderate to severe disease caused by 501Y.V2 — both the Novavax and AstraZeneca jabs showed less than 50% protection, which is the World Health Organisation’s threshold for a Covid vaccine to be considered effective.
2. Has 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. This means a committee of “peers” — in other words, other academics or researchers — examine the data and methodology of the study, to make sure it is sound.
This process can take months to complete.
During the Covid pandemic, research moved considerably faster than usual, because of the need to find treatments and vaccines fast. This means that study results are often released in the form of preprint studies (that have not been peer-reviewed) or press releases.
In the case of the Johnson & Johnson vaccine, the study results have not been peer-reviewed. The data was released as a press release on 29 January. This means there is limited data available about the exact numbers being looked at and we don’t yet know how many of the Covid cases that were recorded during the trial occurred in which of the eight countries where the trial was conducted.
3. How many shots do you need?
So far, the Johnson & Johnson jab is the only Covid vaccine that requires just one shot. All the other jabs that are currently available require two shots. 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, later down the line, researchers could test if a second “booster shot”, designed to protect against the 501Y.V2 variant, could increase the protection provided.
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 of 60 000 doses. When we’ve received 300 000 doses (the total of the first four batches) and showed that we were able to administer all of them, we will have the option of asking Johnson & Johnson for another 200 000 doses.
All these doses (500 000 in total) will be provided to South Africa free of charge by Johnson & Johnson. Why? Partly solidarity, and partly because they come from research stock that Johnson & Johnson won’t be using, Bekker says.
In addition to the free vaccines, South Africa has procured a batch of nine-million doses from Johnson & Johnson, which, according to a January presentation by President Cyril Ramaphosa, is expected to arrive in the second quarter of this year.
Media reports on 9 February stated that an additional 20-million doses are under negotiation, but this has not been officially confirmed.
For these doses, South Africa, will, however, need to pay. And when we receive these will depend on two things: when Johnson & Johnson has stock available, and when our medicine regulator, the South African Health Products Regulatory Authority (Sahpra), is able to conclude Johnson & Johnson’s application for approval to use the vaccine for a wider roll-out (the approval we received for the first 500 000 doses is for use in a research setting, which is different from the type of approval required for wider use, and also 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 receiving 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. Health workers 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 one 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 however, not yet ready to vaccinate, and will, therefore, be phased in later, health department spokesperson Popo Maja told Bhekisisa.
So how many doses of the 80 000 doses will each site receive?
Bekker says the numbers will be calculated based on the number of trained staff available at a site and the burden of disease (that is, 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,” she says.
For the second consignment of 80 000 doses, some of the vaccines will be distributed to private-sector healthcare sites, which will then be added to expand the list of 17 vaccination sites. As more vaccines arrive, the number of sites will further increase.
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 each 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 be vaccinated needs to register on an online system called the electronic vaccination data system (EVDS). This system will record your name, ID number, address, whether you have medical aid, and a few other details, and then let you know if you’re eligible to be vaccinated. When you’ve been identified as eligible, you will receive a text message that will tell you where to go, and then you will be vaccinated. You will also receive a unique code, which you will have to give to the vaccinator, together with your ID. When you’ve received your jab, you will receive an electronic vaccination certificate.
Registration for health workers on the EVDS has started. By 1 pm on 15 February, 351 213 (28%) of the country’s 1.25-million health workers had registered on the platform, according to health department data.
8. So why are we doing a research study on the J&J vaccine if we already have data that shows it works against 501Y.V2?
The short answer: because getting a vaccine approved for use in a research setting is considerably faster than getting it approved for wider use and, if we have to wait for the latter, we’re likely to start with roll-out only in about two months.
The long answer: Johnson & Johnson has submitted a rolling application with Sahpra to enable it to roll-out the vaccine on a large scale. But, according to Gray, the approval process is likely to conclude only 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, to speed up this process during a pandemic, Sahpra makes use of a strategy called a reliance mechanism. This means it leans heavily on the findings of other large regulators, such as the United States 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 is waiting for approval for wider use of its vaccine, the company is conducting an implementation study — because it’s the only way that health workers can get earlier access to Covid vaccinations with this jab. But it will also provide the pharmaceutical manufacturer with more data.
“This type of research is called an implementation study — where you study 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.”
Although there is existing trial data showing the vaccines’ safety, certain groups like pregnant women are not able to participate in clinical trials. Groups like these that were previously excluded from trials can now participate in the implementation study and provide information on how the vaccine performs and to continue monitoring the jabs’ safety in a wider roll-out.
Bekker concludes: “Additionally, this approach to roll-out can provide insight into vaccine uptake among the population.”
Article by Bhekisisa Journalism Health Center
