SAWT BEIRUT INTERNATIONAL

| 29 March 2024, Friday |

South African regulator says no major safety concerns from local J&J study

South Africa’s drugs regulator SAHPRA announced on Wednesday that it had recently reviewed data from Johnson & Johnson’s (J&J) local research study immunizing healthcare workers and found no major safety concerns.

SAHPRA added that it was waiting for more data from J&J and the U.S. Food and Drug Administration.

South Africa suspended the rollout of the J&J vaccine in the “implementation study” on Tuesday, after U.S. health agencies recommended pausing its use because of rare cases of blood clots in six people inoculated with it.

Johnson & Johnson said it would delay rollout of the vaccine to Europe, a week after regulators there said they were reviewing rare blood clots in four recipients of the shot in the United States.

Acting U.S. Food and Drug Administration Commissioner Janet Woodcock said the agency expected the pause to be a matter of days, and was aimed at providing information to healthcare providers on how to diagnose and treat the clots.

The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca’s COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.

FDA official Peter Marks said it was “plainly obvious” the J&J cases were “very similar” to the AstraZeneca ones. He said there had been no similar blood clot cases reported among recipients of the Moderna or Pfizer/BioNTech vaccines, which use a different technology and accounted for the vast majority of U.S. vaccinations so far.

    Source:
  • Reuters