US recommends J&J vaccine pause as precaution

No cases of very rare blood clotting disorders in vaccinated SA health workers

13 April 2021 - 15:22
The US regulatory authority recommended a pause in the rollout of Johnson & Johnson's Covid-19 vaccine to investigate a very rare blood clotting disorder. File photo.
The US regulatory authority recommended a pause in the rollout of Johnson & Johnson's Covid-19 vaccine to investigate a very rare blood clotting disorder. File photo.
Image: Dado Ruvic/Reuters

No cases of very rare blood clots have been detected in around 300,000 SA health  workers who received the Johnson & Johnson (J&J) Covid-19 vaccine by Monday.

However, in the US six cases out of nearly seven million people vaccinated with the shot have been reported, prompting authorities there to recommend a pause in J&J Covid-19 vaccinations on Tuesday.

The US Food and Drug Administration on Tuesday recommended “a pause in this use of this vaccine out of an abundance of caution” while it investigated the cases of an extremely rare blood clotting disorder. One woman is critically ill and another has died of the clotting disorder, which developed within two weeks of the vaccination.

“At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine,” the company said in an e-mailed statement to Reuters.

The European Medicines Agency’s safety committee is also reviewing the J&J vaccinations and the cases of the blood clotting disorder known as cerebral venous sinus thrombosis, which typically occurs in one to two people out of a million.

Prof Glenda Gray, co-principal investigator of the Sisonke implementation study — which has been protecting health-care workers by delivering J&J vaccinations to them since mid-February — said: “We continue to monitor safety, especially with regard to thromboembolism events.

“To date we have not had any rare events. But, then again, we may need millions vaccinated before we see these rare events.”

These rare events have also been seen following Pfizer and Moderna vaccinations said Gray, president of the SA Medical Research Council.

The European Medicines Agency has also been reviewing cases of extremely rare and potentially lethal clotting disorders which could be linked to the AstraZeneca vaccine, typically picked up in women under the age of 60.

No causal link has been found to the vaccinations, and the European regulatory body recommended countries resume their AstraZeneca vaccinations while updating the packaging to reflect this potential risk.

Several European countries temporarily suspended their rollout of the AstraZeneca vaccines but resumed them as soon as the safety signals had been resolved.

Other countries, including Canada, have paused the AstraZeneca vaccine for women under 55 years while making it clear the benefits far exceed the potential risks for older citizens.

Nearly 50 million people have received the AstraZeneca shot globally, with these rare and severe side-effects reported in a few dozen people in Europe, nine of whom died.

The risk of dying of Covid-19 in SA is roughly 1,000 times higher than it would be from these potential side-effects, based on the population size and number of Covid-19 deaths at more than 53,000 by Tuesday.

By April 12, 289,787 health workers had been vaccinated in the first phase of SA’s Covid-19 vaccination programme, according to health minister Zweli Mkhize.

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