J&J vaccine data will be reviewed over a few days, no concern in SA to date

The SA Health Products Regulatory Authority (Sahpra) says no major safety concerns have been identified in the country so far with the J&J Covid-19 vaccine.

The authority, an entity of the national department of health, said it, together with its scientific expert committees, recently reviewed the data from the Sisonke phase 3b implementation study.

“Based on these data, no major safety concerns have been identified. No causal relationship between vaccination and the development of blot clots is evident at this stage.”

However, after the decision by the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to pause the use of the J&J vaccine in that country, Sahpra met with the Sisonke study team and the manufacturer Janssen Pharmaceutical on Tuesday.

Sahpra said it was provided with updated data on the Sisonke study.

It has requested further data from the manufacturer and the US FDA.

“Sahpra has requested a pause in the implementation of the Sisonke study to enable it to review the relevant data and further updates will be communicated in due course.

“It is envisaged that this process will take a few days.”

The statement follows the announcement of the temporary suspension of the vaccine rollout on Tuesday night by health minister Zweli Mkhize, who said this was a precautionary measure until the causal relationship between the development of clots and the J&J Covid-19 vaccine was sufficiently interrogated.

TimesLIVE