South African Health Workers To Get J&J Vaccine As Part of Implementation Trial – AstraZeneca Vaccines Will Be Offered To African Union 

Cape Town – The first South African health workers will be vaccinated against SARS-CoV2 on Wednesday with the Johnson & Johnson vaccine, instead of the AstraZeneca vaccine, which was recently shown to be unable to stop mild or moderate infection against the B.1351 (501Y.V2) variant dominant in South Africa.

In a hastily assembled Plan B, President Cyril Ramaphosa announced last week that 500,000 J&J vaccines would be arriving in batches over the next month, starting with 80 000 doses this week. J&J has made these available as a research donation.

The health workers’ vaccination programme is being run as a phase 3.b, open-label implementation trial to get around the fact that the J&J vaccine is not (yet) licensed by the South African Health Products Regulatory Authority (SAHPRA).

South Africa will meanwhile make the 1 million doses of the AstraZeneca vaccine, which it has already, received available to the African Union.  At a press briefing last week, the head of the African Centers For Disease Control said that countries where the B.1351 variant is not dominant should still roll out the AstraZeneca vaccine.  

“It did shock everyone that the AstraZeneca did not have the desired effect in South Africa,” said South African Health Minister Zweli Mkhize, explaining the country’s decision to fast-track  its switch to the J&J vaccine at a media briefing last week.

The country was initially considering running a trial to test whether the AstraZeneca vaccine could prevent severe infection in the face of the B1.351 variant but it has since decided to focus on the J&J vaccine, which has proven to work against the variant.

Global Trial Found J&J Vaccine 57% Efficacious In Preventing SA Infection – 85% In Preventing Severe Disease

Professor Linda-Gail Bekker, one of the national protocol chairs of the J&J healthworkers vaccination study, which is being called Sisonke (meaning “together” in isiZulu), told a media briefing last week that the J&J vaccine had been proven to be safe and efficacious in a large global study involving over 44,000 people in the USA, Latin America and South Africa. 

It is a follow-on to the Ensemble study which found the vaccine to be 72% efficacious in preventing infection in the US; 57% efficacious in South Africa, and 85% effective overall in preventing severe infection. A  third of the study was made up of people of the age of 60, and it included those with co-morbidities including diabetes and HIV. Fifteen percent of participants came from South Africa.

“This high vaccine efficacy was consistent across countries and regions, including South Africa where almost all cases were due to the new variant of SARS-CoV-2, B.1.351,” said Bekker.

Professor Glenda Gray, president of the SA Medical Research Council (SAMRC) and the principal investigator of the Ensemble study in South Africa, said that J&J had a “rolling” application with SAHPRA but that the regulatory agency was only likely to decide on an emergency use license for the vaccine in late March or April. 

The SAMRC and the Department of Health will co-host the Sisonke study, which starts on Wednesday at 16 hospitals countrywide, including those that have been hardest-hit by the pandemic. It aims to reach the country’s 1.25 million health workers. By mid-Tuesday, 28% of healthworkers had registered to receive theJ&J vaccine, which only requires a single dose.

Sisonke is described on the SAMRC website as an “open label, single-arm Phase 3b vaccine implementation study of the investigational single-dose Janssen COVID-19 vaccine candidate [that] aims to monitor the effectiveness of the investigational single-dose Janssen vaccine candidate at preventing severe COVID-19, hospitalizations and deaths among healthcare workers as compared to the general unvaccinated population in South Africa.”

South Africa Also Waiting For Pfizer Vaccine Doses To Arrive Next Month

South Africa has also bought 20 million Pfizer doses directly from the pharma manufacturer – but these are only expected to arrive in the latter part of the year. In the meantime, it has been allocated 117 000 Pfizer doses from COVAX according to its interim distribution forecast. These are expected within the next month or so and, as the WHO has granted an emergency use license for this vaccine, that will enable a fast-tracked approval process by SAHPRA.

South Africa has been the hardest hit country on the continent, accounting for over 55% of cases and an accumulated caseload of almost 1.5 million. 

In a race to vaccinate health workers before a third wave of COIVID-19 infections – predicted to hit the country in late May – the South African government bought 1.5 million doses of the AstraZeneca vaccine directly from the Serum Institute of India.

One million AstraZeneca doses arrived in the country on 1  February to much fanfare. However, within a matter of days, the country’s optimism was shattered by the results of a small study of the AstraZeneca vaccine, which showed that it did not protect against mild or moderate infection of the B.1351 variant.

“South Africa could not delay the receipt of the vaccine batches to await the results of the efficacy studies by our scientists. If we had done this, it would have relegated our country to the back of the line, due to the global shortage of supplies,” added Mkhize at last week’s briefing. 

Image Credits: Janssen.

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