SA suspends J&J vaccine roll-out over blood clot concerns

THE JOHNSON and Johnson vaccine roll-out in South Africa has been temporarily suspended. This comes after six women in the US, between the ages of 18 and 48, developed a rare blood-clotting disorder after receiving the vaccine. One case was fatal and one remains in critical care.

SA Health Minister Dr Zweli Mkhize made the announcement during an online media briefing on Tuesday evening that the roll-out part of the Sisonke implementation study would be halted.

Mkhize's announcement comes after the US Centers for Disease Control (CDC), and the Food and Drug Administration (FDA) recommended a pause on the issuing of the vaccine over “potentially dangerous'” blood clotting concerns.

The FDA said it would investigate these cases, however, until the process was completed, it has recommended a pause in the use of this vaccine out of an “abundance of caution”.

Mkhize said the Department of Health has noted the decision taken by the FDA to advise the temporary suspension of the J&J roll-out in the US.

“We have determined to voluntarily suspend our roll-out ... I humbly call for calm and patience as we ensure that you will continue to be properly guided by science and ensure the safety of our people as we roll-out the vaccine campaign. We hope that the deliberations will only take a few days.

More than 6.8 million doses of the J&J vaccine have been administered in the US.

The J&J vaccine is part of the Sisonke implementation study roll-out in South Africa and close to 290,000 health care workers have received the shot.

South Africa has procured 31 million shots of the J&J one-dose vaccine.

The company meanwhile said in a statement it would delay the roll-out of the vaccine in Europe.

“We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our Covid-19 vaccine.”

Mhkize said meetings will be held with the SA Health Products Regulatory Authority (Sahpra), the Ministerial Advisory Committee (MAC) and the Africa Center for Disease Control (CDC)

Meanwhile, the Northern Cape Department of Health had earlier on Tuesday noted that a further consignment of 4,000 J&J vaccine doses has been allocated to the Province.

Department spokesperson Lebogang Majaha said that the vaccines were intended for provincial health care workers.

“As part of government’s efforts to curb the effects of the looming Covid-19 third wave that is expected in the country, the Northern Cape MEC for Health, Maruping Lekwene welcomed a further consignment of 4,000 Johnson and Johnson vaccine doses for the Sisonke Early Access Programme in the Province. This brings the total number of vaccines delivered to the Province to 10,600, which are towards the planned target of 14,000 health care workers to be vaccinated in Phase 1 (of the country’s vaccine roll-out),” said Majaha.

“The total number of health care workers vaccinated in the Province currently stands at 5,844 since the vaccination campaign started on February 17, 2021. More than 12,000 health care workers have registered on the electronic vaccine data system (EVDS) in the Province.”

Majaha said that the vaccines were set to be distributed among the different districts in the Province. As the J&J vaccine roll-out has now been temporarily suspended in South Africa, an update on the situation in the Northern Cape is awaited from the provincial department.

“The Sisonke team, supported by the department’s clinical team, agreed to prioritise 1,000 doses for health care workers at Robert Mangaliso Sobukwe Hospital (in Kimberley) in the Frances Baard District, 2,000 doses for health care workers at Kathu LenMed and Kuruman hospitals in the John Taolo Gaetsewe District, and a further 1,000 doses for health care workers at Dr Harry Surtie Hospital in Upington in the ZF Mgcawu District,” Majaha said earlier today.

He added that the department would also embark on a campaign to educate communities in the Province on the benefits of Covid-19 vaccines, while also dealing with any misinformation and misconceptions.

“The department will roll out a major awareness campaign throughout the Province to reduce vaccine hesitancy and resistance that may arise from misunderstandings around vaccine safety and efficacy. This campaign also seeks to dispel rumours, myths, conspiracies and misconceptions created through mistrust. The dates and venues for this campaign drive will be communicated by the end of this week.”

Majaha went on to say that the Province had recorded an increase in the number of Covid-19 infections over the Easter weekend.

“We have noted a sharp increase in new Covid-19 infections after the Easter weekend. We did caution members of the public that there is a potential for increased risk of exposure due to non-adherence to Covid-19 regulations.

“The total hospital admissions due to Covid-19 has slightly increased by 14%.”

“The total provincial deaths reached 840 since the start of the pandemic. Three-hundred and 20 of the fatalities were recorded since January 1, 2021. That includes 26 health care workers.

“The MEC is calling on all members of the community to heed the clarion call on the importance of wearing masks, sanitising hands and maintaining physical distancing at all times to lower the rate of Covid-19 transmission. This approach will assist in delaying the third wave and reducing the number of infected people,” Majaha concluded.