By Kaya 959 News
National health regulator, the South African Health Products Regulatory Authority, has recommended that the pause on SA’s COVID-19 vaccine programme be lifted.
In a statement issued yesterday ((MONDAY)) SAHPRA said it had reviewed the available data and believed the suspension on the J&J roll out should be lifted.
“SAHPRA has engaged with the Sisonke Phase 3B Implementation Study team and Janssen Pharmaceutica. The focus of the engagement was on the safety data reported from the Sisonke study, following administration of the Covid-19 vaccine Janssen, as well as the adverse events reported in the United States of America,” the regulatory body said.
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Last week, SA Health Minister Dr Zweli Mkhize announced that SA would voluntarily halt the roll out after an American woman died after experiencing blood clots. Five other women reported the same issues with blood clotting days after they were inoculated.
READ: Health Committee welcomes decision to ‘voluntarily halt’ J&J vaccine roll out
SAHPRA said they recommend the pause be lifted, provided that specific conditions are met.
“These conditions include, but are not limited to, strengthened screening and monitoring of participants who are at high risk of a blood clotting disorder. In addition, measures are to 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,” SAHPRA said.
The body explained that participants in the Sisonke study will be informed about the possible risks of developing a blood clotting disorder after vaccination.
It said they 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 study team will submit the required updated documents, procedures and study arrangements to SAHPRA for approval. Resumption of the Sisonke Phase 3B Implementation Study will also require approval from the relevant Research Ethics Committees,” SAHPRA said.
DA Shadow Minister for Health Siviwe Gwarube said the decision to halt the roll out spelled disaster for healthcare workers and the most vulnerable.
“It makes little sense to copy countries like the United States where the context is very different. The United States has the luxury of being able to temporarily suspend administration of the J&J vaccine because they have already vaccinated millions of their citizens and have various vaccines in circulation. 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,” he said.
Gwarube said the government has failed spectacularly thus far to procure a variety of vaccines in bulk, to reach the 1.2 million healthcare workers targeted, to produce a general rollout plan, and to move beyond the trial phase of the vaccine rollout.
“The rollout has been criminally slow,” he said.
READ: Dr. Zweli Mkhize calls for calm after suspending the Johnson and Johnson vaccine
He added that the only rational approach to vaccine administration is a cost-benefit analysis of the risks South Africa faces.
“Covid-19 has had a devastating impact on our country – costing thousands of lives and millions of livelihoods. The risk of adverse effects is negligible when compared to the risks associated with a possible 3rd wave of C0vid-19 infections,” he said.
Image courtesy of Pixabay.
