J&J pause ‘bound to confuse’, side-effects rare – expert

The decision to temporarily halt the roll-out of the Johnson & Johnson (J&J) Covid-19 vaccine, following six US women developing a rare blood-clotting disorder and one death, amounted to government being overly cautious after over 53 000 deaths, a medical expert said yesterday.

Health Minister Dr Zweli Mkhize has announced suspending the J&J vaccine roll-out while scientists deliberated over its use. This followed the US Food and Drug Administration’s (FDA) pausing of the vaccine “out of an abundance of caution”.

The SA Medical Research Council (SAMRC), which has been spearheading the J&J Sisonke phase three study, has expressed concern at the FDA decision.

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Said its spokesperson Dumile Mlambo: “The Sisonke investigators, in discussion with Johnson & Johnson, Sahpra [SA Health Products Regulatory Authority], the minister and the health director-general, have collectively decided to temporarily pause the study out of caution, until further information is made available by the FDA.

“We understand that this may cause alarm among people who have already received the vaccine – anxiety about Covid-19 vaccines in general.

“We wish to reassure health workers and the public that safety is our number one priority and that has guided our decision to pause the study temporarily.”

But Professor Heather Zar of the University of Cape Town’s department of paediatrics and child health at the Red Cross Children’s Hospital, said the US incident should not be a cause for panic.

“This pause is bound to confuse and not good in the context of wanting to promote vaccination.

“Except for these very rare events, side-effects occur with any vaccine, as we have seen in the case of AstraZeneca.

“Even with Pfizer and Moderna vaccines, one can expect a rare component of side-effects – but it is one in four million chance.

“It is important that we look at a bigger picture – the protection and prevention of the spread ofCovid-19, especially when we’ve lost over 50 000 people,” said Zar.

“SA needs a rapid roll-out because too many people have died and many more are going to die. “We are dealing with extremely rare side-effects at much higher risk of succumbing to Covid-19.

“AstraZeneca had side-effects – one in a million.”

Vaccinated last month, Johannesburg-based general practitioner Dr Leon Odendaal, said he was “not scared or paranoid”.

“It was about six thrombosis after two million doses were administered,” Odendaal said.

SA has already administered the vaccine to about 200 000 people without reports of side effects, he said.

brians@citizen.co.za