Health body urges resumption of J&J vaccine roll-out
The SA Health Products Regulatory Authority (Sahpra) has recommended that the government lift the pause on administering Johnson & Johnson’s (J&J) Covid-19 vaccines, provided that certain conditions are met.
Health Minister Zweli Mkhize announced on Tuesday that the country would voluntarily suspend the roll-out of J&J’s Covid-19 vaccine in the “implementation study”.
This came after the Food and Drug Administration (FDA) and the Center for Disease Control and Prevention (CDC) in the US advised the temporary suspension of the J&J vaccine roll-out in the US based on reports of six females who developed unusual blood clots with low platelets. More than 6.6 million US citizens have received the J&J vaccine jab.
Mkhize said that in South Africa, there were no reports of clots that have formed after vaccination. This comes after about 289 787 health-care workers had been inoculated under the J&J local research study, Sisonke Protocol.
“Based on their advice, we have determined to voluntarily suspend our roll-out until the causal relationship between the development of clots and the Johnson and Johnson vaccine is sufficiently interrogated,” the minister said.
Mkhize added that South Africa’s scientists were confident that the FDA’s decision was precautionary and the department expected that this will not result in the complete withdrawal of the vaccine from the vaccination armament.
Sahpra said on Wednesday that it, together with its scientific expert committees, recently reviewed the data from J&J’s local research study immunising health-care workers and found no major safety concerns.
“No causal relationship between vaccination and the development of blot clots is evident at this stage,” Sahpra said.
The minister and Sahpra said that a decision on the J&J vaccine would be made within a few days.
In a statement on Saturday evening, Sahpra said that it had engaged with the Sisonke study team and the J&J vaccine manufacturer, Janssen Pharmaceutical.
“Based on their review of the available data, Sahpra has recommended that the pause in the Sisonke study be lifted, provided that specific conditions are met,” the regulatory authority said.
The conditions for the lifting of the pause include, but are not limited to, the strengthening of screening and monitoring of participants who are at high risk of a blood clotting disorder.
Sahpra further recommended that, in addition, measures be implemented to ensure the safe management of any participants who develop vaccine-induced thrombosis and thrombocytopenia (VITT).
“The participant information sheets and informed consent forms will be updated to include the newly identified adverse events. Participants ... will be informed about the possible risks of developing a blood clotting disorder after vaccination,” the regulator said.
Sahpra added that participants in the Sisonke study will also be advised to seek immediate medical assistance if they develop early signs and symptoms associated with blood clots or low platelet counts.
The J&J study team will also submit the required updated documents, procedures and study arrangements to Sahpra for approval, before the study can be resumed. The relevant research ethics committees will also be required to approve the resumption of the study.