J&J booster shots on the cards for health workers as Sisonke 2 trials set to begin
Access to the second Sisonke study trial for healthcare workers will begin soon, the SA Medical Research Council (SAMRC) and national health department said.
“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 rollout and ahead of the Delta-driven third wave” said Prof Glenda Gray, one of the conational principal investigators of the Sisonke study.
The Sisonke booster vaccinations will be offered from the week of November 8 at selected sites to be announced in all nine provinces.
The single-dose regimen has provided the backbone of campaigns for other essential workers like educators and members of the SA Police Service, and those who live in more rural locations.
“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 and some countries have decided to offer booster doses to certain high-risk populations like the elderly and health workers or other frontline workers.
“In SA, where only 30% of eligible adults have been fully vaccinated, increasing coverage of first doses to levels that would reduce hospital admissions and deaths during a fourth wave remains a top priority,” said SAMRC and the health department.
A new 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.
“Based on this new information, and to bolster the immune response of our health workers ahead of a fourth wave, the SAMRC has worked with the department of health, SAHPRA and J&J to provide early access to Janssen® (J&J) vaccine booster doses for all health workers who received a first dose of this vaccine as part of the Sisonke study.
“As before, access will be in the context of a Phase 3B study and results will be used to guide future decisions regarding boosters.”
The organisations said they are in the final stages of approvals from the regulators and ethics review committees, and vaccination will be open to all health workers, including pregnant and breastfeeding women, who received a first dose of the Janssen® (J&J) vaccine as part of the Sisonke study.