Johnson & Johnson COVID vaccine linked to death in South Africa, health regulator reports

South Africa’s well being regulator reported on Thursday a causal hyperlink between the loss of life of a person and Johnson & Johnson’s (J&J) COVID-19 vaccine, the primary time such a direct hyperlink has been made within the nation.

The individual introduced with uncommon neurological dysfunction Guillain-Barre Syndrome quickly after being given J&J’s Janssen vaccine, after which the individual was placed on a ventilator and later died, senior scientists informed a information convention.

“On the time of sickness no different trigger for the Guillain-Barre Syndrome (GBS) might be recognized,” Professor Hannelie Meyer mentioned.

The individual’s age and different private particulars weren’t disclosed for confidentiality causes.

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J&J mentioned in an emailed assertion that GBS was related to the administration of assorted vaccines and different medicines and will also be triggered by SARS-CoV-2, the virus that causes COVID-19.

The corporate mentioned it strongly supported elevating consciousness of the indicators and signs of uncommon occasions to make sure they are often shortly recognized and successfully handled.

Final July, U.S. authorities added a warning to a factsheet for J&J’s vaccine saying information prompt there was an elevated threat of GBS within the six weeks after vaccination. On the time it famous 100 preliminary stories of GBS in vaccine recipients, together with 95 severe circumstances and one reported loss of life.

J&J mentioned on the time of the U.S. warning it was in discussions with regulators and the speed of reported circumstances of GBS in Janssen vaccine recipients exceeded the background price solely barely.

“The good thing about vaccination nonetheless far outweighs the chance,” Boitumelo Semete-Makokotlela, chief govt of the South African Well being Merchandise Regulatory Authority (SAHPRA), informed reporters.

“In our context we now have administered about 9 million (doses) of the Janssen vaccine, and that is the primary causally linked case of GBS.”

Europe’s medicines regulator final yr added GBS as a doable side-effect of AstraZeneca’s COVID vaccine which, like J&J’s, makes use of viral vector know-how.

South Africa’s Well being Minister Joe Phaahla informed Thursday’s information convention that as of mid-July there had been simply over 6,200 “opposed occasions” reported to SAHPRA out of the greater than 37 million COVID vaccine doses administered within the nation, equal to 0.017%.

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Semete-Makokotlela mentioned the regulator had assessed round 160 deaths for the reason that COVID vaccination rollout began however had not seen a causal hyperlink to vaccination till now.

South Africa has been utilizing pictures from J&J and Pfizer in its COVID vaccination marketing campaign. The rollout obtained off to a sluggish begin resulting from difficulties securing provides and protracted negotiations with pharmaceutical firms, however extra not too long ago it has been slowed by hesitancy.

Round 46% of its grownup inhabitants of 40 million is now totally vaccinated.