No blood clot reports from Sisonke vaccine trial study - Sahpra

Government announced earlier this week that it had put a temporary hold on the vaccine implementation study following six reported cases of rare blood clots in women who received the Johnson & Johnson vaccine in the United States.

FILE: Nurse Zoliswa Gidi-Dyosi was the first person in South Africa to receive the Johnson & Johnson COVID-19 vaccine on Wednesday, 17 February 2021. Picture: Siya Duda.

CAPE TOWN - The South African Health Products Regulatory Authority (Sahpra) said that there were no major safety concerns arising from data submitted by Sisonke researchers.

Government announced earlier this week that it had put a temporary hold on the vaccine implementation study following six reported cases of rare blood clots in women who received the Johnson & Johnson vaccine in the United States.

READ: Zweli Mkhize: SA to temporarily suspend rollout of J&J vaccine

Sahpra CEO, Dr Boitumelo Semete-Makokotlela, said that there had been no such reports from the South African cohort that'd been vaccinated.

"Sahpra requested that the study be paused for a number of days in order for Sahpra to consider this data together with any other relevant data that we would be receiving from other regulators, such as the FDA."

The six cases all occurred in women under 50, who were among 7.2 million Americans vaccinated with the Johnson & Johnson vaccine.

Federal officials and immunology experts said that the risk was extremely low, especially when compared with COVID-19 death rates.

One of the six women has died.

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