The South African Health Products Regulatory Authority (SAHPRA) says it expects government to lift the pause on the rollout of the Johnson and Johnson COVID-19 vaccine in the country later this week.
SAHPRA has recommended that the suspension be lifted provided certain conditions are met. It says they include strengthening the screening and monitoring of participants who are at high risk of blood clotting disorders.
SAHPRA says measures are to be implemented to ensure the safe management of any participants who develop vaccine-induced blood clots.
The regulator says it recently reviewed data from the Sisonke Research Study under which healthcare workers are immunised and found no major safety concerns.
Chairperson of SAHPRA Professor Helen Rees says, “The research team is putting together what we call the Informed Consent Sheet that people will sign and it has a lot of information, including giving people guidance of these suggestive symptoms. But in addition to that, SAHPRA is saying that this is ok, the ethics committee that also approves these different sites around the country, also has to say, ‘yes, it’s fine to get going.’ Everyone recognises that it’s very, very urgent that we get going, not only because we need to protect healthcare workers, but we also want to get public confidence.”
Last week, Health Minister Dr Zweli Mkhize announced the temporary halt of the rollout of the Johnson and Johnson vaccine, while investigations into reports of rare blood clotting continue. This after the United States Food and Drug Administration (FDA) and Centres for Disease Control and Prevention recommended a pause in the J&J single shot in the US.
Nearly 300 000 healthcare workers have already received the one-shot COVID-19 vaccine in South Africa.
Rees said last week that the decision to halt the Johnson & Johnson COVID-19 vaccine rollout was due to extreme safety precautions in the country.
SAHPRA’s Prof Rees speaks to the SABC about the decision to halt J&J vaccine rollout: