South Africa health regulator recommends resuming Johnson & Johnson vaccinations

South Africa’s health regulator has recommended resuming use of the Johnson & Johnson coronavirus vaccine, days after the country followed the US with a pause to assess the risk of blood clotting with the single-dose shot.

Lifting the pause should be conditional on “strengthened screening and monitoring of participants who are at high risk of a blood clotting disorder”, and on updated plans to treat any vaccine-related clots, the South African Health Products Regulatory Authority said this weekend. Expert ethics committees must also give approval before the country can restart.

The J&J vaccine was the only one rolled out in South Africa, until the country suspended it on Tuesday, risking further disruption to vaccinations in Africa’s most industrial economy.

The US Centers for Disease Control and Prevention and the US Food and Drug Administration recommended an indefinite suspension after six cases of a rare blood clotting disorder out of nearly 7m doses administered in the US. Use of the J&J vaccine in the US remains on hold after experts said this week that they lacked enough evidence to change their stance.

No blood-clotting cases have been recorded among the nearly 300,000 health workers who were vaccinated in South Africa before the suspension.

“The reason it is important to recognise this extremely rare side effect is because management differs from the usual way in which clots are treated, and these serious complications could be mitigated with rapid and effective treatments,” South Africa’s medical research council said this week.

President Cyril Ramaphosa’s government was under pressure to speed up the sluggish pace of vaccinations even before the US pause interrupted its plans. 

South Africa has recorded more than 1.5m cases to date, the worst-hit African country in the pandemic especially after an intense second wave struck over the new year. Daily counts of new cases have since fallen markedly but a third wave is widely feared to be around the corner.

South Africa switched to J&J at the last minute in February, after an original plan to use the Oxford/AstraZeneca vaccine foundered over evidence that it fails to protect against milder illness in cases of a variant that has become dominant in the country. 

South Africa’s supplies of the J&J vaccine have been limited to date because the initial rollout among health workers took the form of a research study rather than commercially ordered deliveries.

Larger deliveries from J&J are due from the end of this month and will be used in the second phase of the rollout, prioritising elderly and vulnerable South Africans.

Ramaphosa’s government has ordered 31m J&J shots and 30m of Pfizer’s two-dose vaccine to reach its goal of vaccinating 40m people. Online registration of those aged 60 and over began on Friday.

This week the main opposition Democratic Alliance said that unlike South Africa, the US had the “luxury” of being able to suspend the J&J vaccine as millions of Americans have already received shots made by other drugmakers.

“Halting the administering of one vaccine does not impact them as much as it could impact South Africa, since we currently only have tiny quantities of this single vaccine available to us,” the party said.