The first batch of 80,000 doses of the J&J vaccine is being administered to health workers, having been approved by the SA Health Productions Regulatory Authority (SAHPRA) under the Sinsonke protocol. The first vaccine was administered yesterday at Khayelitsha District Hospital in Cape Town.
This authorization is for the ‘open label, pragmatic, real world Phase 3b clinical trial’ of the vaccine, which will investigate the effectiveness of the single-dose vaccine in preventing severe COVID-19, hospitalizations and deaths among vaccinated health workers.
South Africa had been set to roll out the AstraZeneca vaccine, but halted its use earlier this month after trial data showed reduced efficacy against the B.1.351 (‘South African’) variant.
The Phase 3 trial for the Janssen vaccine, however, was showed to have 57% efficacy in preventing moderate to severe COVID-19; compared to 66% efficacy overall. (One of the Phase 3 trials was conducted in South Africa, where nearly all the cases of COVID-19 observed in the trial were due to the B.1.351 lineage).
“It gives me great pleasure to announce that the first batch of 80,000 doses of the Johnson & Johnson vaccine is being prepared for distribution across South Africa with immediate effect,” said President Cyril Ramaphosa yesterday.
“As this batch has already been approved by the SA Health Products Regulatory Authority (SAHPRA) under the Sisonke protocol, these vaccines will be rapidly dispatched to all provinces.
“The Johnson & Johnson vaccine has been shown in extensive trials to be safe and efficacious and will protect our health care workers from illness and death from COVID-19.”
President Cyril Ramaphosa and Minister of Health Zweli Mkhize were among the first to receive the vaccine to help promote its uptake.
Applications for authorization in Europe and the US
In Europe, J&J has this week submitted an application for Conditional Marketing Authorization to the European Medicines Agency. A rolling review for the vaccine was started at the beginning of December; and the EMA’s human medicines committee (CHMP) could issue an opinion by the middle of next month – ‘provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust’.
This is the fourth CMA application for a COVID-19 vaccine since the start of the pandemic. It comes after EMA’s evaluation of vaccines from BioNTech/Pfizer, Moderna and AstraZeneca: which are now authorised in the EU.
J&J submitted an application for Emergency Use Authorization in the US on January 4. A meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled for February 26.