Healthcare workers who participated in the Sisonke study earlier this year will be offered a booster shot of the Johnson & Johnson (J&J) vaccine from Monday, November 8.
By receiving their booster jab, Sisonke 2 participants will be taking part in Africa’s first large study of Covid-19 booster vaccines.
How the Sisonke booster application will work
Eligible health workers will receive an invitation by SMS, on the number they used to enrol for the first part of the study.
As before, enrolment will be through the Electronic Vaccination Data System (EVDS) and will include an informed consent form which will need to be completed online.
Sisonke booster vaccinations will be offered at selected sites to be announced in all nine provinces.
Safety monitoring and evaluation of the outcomes will be led by the SAMRC.
Health workers who wish to take up this offer and have changed their cellphone numbers are advised to call the national hotline on 0800 029 999 so that staff can update their contact details on the EVDS. They should not simply reregister on EVDS.
The booster shot is only available to those who received a first dose of J&J through the Sisonke study, and has been deemed safe for women who are pregnant or breastfeeding.
However, health workers will not be eligible for the booster shot if their first dose of J&J was received outside the Sisonke study, or if they have already accessed a booster vaccination through other means.
A summary of the process
- You will receive an SMS invitation to participate in Sisonke 2.
- This will take you to a link for informed consent. Read it carefully and complete the form, should you wish to take part.
- You will receive a new vaccination voucher number starting with the letters BD- (booster dose).
- Ask your manager or watch the press and social media for details of your closest vaccination site. Sites will be available in all sub-districts.
Booster vaccinations explained
Booster vaccinations are becoming available in many parts of the world. Scientific evidence on waning (progressive decrease of immunity) and the need for booster doses is evolving. Several countries have now decided to offer booster doses to certain high-risk populations, including the elderly, health workers and other frontline workers.
Evidence of increased protection from booster vaccines
A new J&J trial, ENSEMBLE 2, evaluated a booster dose given at least two months after the first dose in 31 300 participants from more than nine countries. Studies showed the booster vaccine substantially increases protection, especially against symptomatic and severe/critical Covid-19.
At a global level, vaccine efficacy was 100% against severe disease and critical disease. Two doses were found to be safe and the usual vaccine safe effects (‘reactogenicity’) were reduced, following the second dose.
Sisonke boost study
Based on this new information, and to bolster the immune response of health workers ahead of the predicted fourth wave, the South African Medical Research Council (SAMRC) has worked with the National Department of Health (DoH), the South African Health Products Regulatory Authority and J&J to provide early access to the booster doses for all health workers who received a first dose of this vaccine as part of the Sisonke study.
The results from the study will be used to guide future decisions regarding boosters.
Health workers who received unauthorised booster doses of the Pfizer-BioNTech vaccine after their J&J vaccine, are strongly encouraged not to accept an additional booster J&J vaccine as there is insufficient safety data for such a schedule.
Overview of Sisonke
Between February 17 and May 17, the SAMRC worked with the DoH and other partners (Desmond Tutu Health Foundation, CAPRISA and J&J) to provide healthcare workers with early access to the J&J vaccine, ahead of the third wave.
The initiative also enabled the gathering of data for the evaluation of the vaccine’s effectiveness in the country, at a time when there were concerns as to whether vaccines work well against certain variants. In total, 496 424 health workers were vaccinated.
“By rolling out the Sisonke study, we bought valuable time for healthcare workers, and were able to protect them four months ahead of the national roll-out and ahead of the Delta-driven third wave,” says Professor Glenda Gray, one of the co-national principal investigators of the Sisonke study.
Getting ahead of the fourth wave
In South Africa, where only 30% of eligible adults have been fully vaccinated, it is critical that people who have not yet received their first vaccines, do so as soon as possible. This will help reduce hospital admissions and deaths during the predicated fourth wave.
Equally critical is encouraging people who have not gone for their second scheduled Pfizer vaccine, to go to any vaccination site for their jab. This will increase their level of protection.
Acting Director-General of Health Dr Nicholas Crisp says: “Vaccines remain our most powerful weapon in the fight against the Covid-19 pandemic and our priority remains the most vulnerable groups, especially senior citizens or adults who live with compromised immunity in majority, ahead of a fourth wave.
“It is our collective responsibility as individuals, families and communities to protect ourselves and loved ones, including those who we spend most of our time with. Vaccines save lives and bring us one step closer to ending the pandemic”.