Sahpra: All reports of severe side-effects of COVID jabs thoroughly assessed

The regulator on Thursday announced that a patient had died after developing Guillain-Barré Syndrome post vaccination with the Johnson & Johnson vaccine.

Vials and syringes of the Johnson and Johnson Janssen COVID-19 vaccine are displayed for a photograph at a Culver City Fire Department vaccination clinic on 5 August 2021, in California. Picture: Patrick T. Fallon/AFP

CAPE TOWN - THE South African Health Products Regulatory Authority (Sahpra) said that thorough assessment of all severe reported side effects following coronavirus inoculation was ongoing.

The regulator on Thursday announced that a patient had died after developing Guillain-Barré Syndrome post-vaccination with the Johnson & Johnson vaccine.

To date, more than 9.1 million doses of the J&J jab have been administered in South Africa.

Sahpra CEO Doctor Boitumelo Semete-Makokotlela said that the National Immunisation Safety Expert Committee (Nisec) conducted the cause of death.

"Nisec follows a very thorough methodology that is guided by the WHO and this is a methodology that is utilised by all regulators across the world," Semete-Makokotlela said.

Sahpra board chairperson, Professor Helen Rees, stressed that they had to inform the public about the death, even of an increased risk of a very rare side-effect following vaccination.

"... in this case, the Guillain-Barré Syndrome and that had already been noted as a risk and is in the professional information. If we see that risk, we need to let the public know. But we need to say is it risk this size or is it a tiny risk this size? What is the risk of the disease itself?"

Just over 6,200 adverse events following coronavirus vaccination, which varies from being mild to severe, have been reported to Sahpra.