The first batch of 80,000 doses of the J&J vaccine will be administered to health workers approved by the SA Health Productions Regulatory Authority (SAHPRA) under the Sinsonke Protocol. The first vaccine was given yesterday at the Khayelitsha District Hospital in Cape Town.
This approval is for the vaccine’s “open, pragmatic, real-world clinical trial” to evaluate the effectiveness of the single-dose vaccine in preventing severe COVID-19, hospitalizations and deaths among vaccinated health workers.
Sister Zoliswa Gidi-Dyosi is the first health care worker in South Africa to receive the coronavirus #vaccine at the Khayelitsha District Hospital # VacciNationpic.twitter.com / 9DwHixJ88R
– South African Government (@GovernmentZA) February 17, 2021
South Africa had planned to launch the AstraZeneca vaccine, but discontinued its use earlier this month after trial data showed reduced efficacy compared to variant B.1.351 (“South African”).
However, the Phase 3 study for the Janssen vaccine has been shown to have 57% effectiveness in preventing moderate to severe COVID-19. compared to 66% overall effectiveness. (One of the Phase 3 studies was conducted in South Africa, where almost all of the cases of COVID-19 observed in the study were due to the B.1.351 line.)
“I am delighted 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.
“Since this batch has already been approved by the SA Health Products Regulatory Authority (SAHPRA) under the Sisonke Protocol, these vaccines are being shipped quickly to all provinces.
“The Johnson & Johnson vaccine has been shown to be safe and effective in extensive studies and protects our healthcare 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 promote its uptake.
Leading by Example: President @CyrilRamaphosa has encouraged South Africans to take # COVID19 after being among the first to get vaccinated
– @SAgovnews (@SAgovnews) February 17, 2021
Marketing authorization applications in Europe and the USA.
In Europe, J&J submitted a Conditional Marketing Authorization Application to the European Medicines Agency this week. An ongoing review of the vaccine began in early December. and the EMA’s Human Medicines Committee (CHMP) could deliver an opinion by the middle of next month – “provided the company’s data on the efficacy, safety and quality of the vaccine are sufficiently comprehensive and robust”.
This is the fourth CMA filing for a COVID-19 vaccine since the pandemic began. It follows EMA’s assessment of BioNTech / Pfizer, Moderna and AstraZeneca vaccines, which are now approved in the EU.
J&J filed an application for emergency use approval in the US on January 4th. A meeting of the FDA’s Advisory Committee on Vaccines and Related Biological Products (VRBPAC) is scheduled for February 26th.