Thread by @Bhekisisa_MG

[THREAD] Wondering what to make of the @US_FDA’s new rules about the J&J vaccine? Here’s what you need to know.

America’s medicines regulator announced that the J&J jab should only be given to adults in 3 scenarios: bit.ly/3lfRb5p

1. They don’t have access to other #COVID jabs.
2. They can’t take other #COVID #vaccines for medical reasons.
3. They choose the J&J jab because it’s the only vaccine available.

Why the change? The regulator says it restricted the use of the jab because of an extremely rare but potentially life-threatening effect of J&J vaccine that causes blood clots alongside a condition that has the opposite effect – stopping the blood’s ability to get thicker.

This condition is called TSS and it affects people a week or two after they’ve taken the J&J jab. Learn more about it here. bit.ly/3qe8MMq

Despite this update, the J&J jab still had a role to play in the US and the global #COVID response, said the @US_FDA’s director of biologics evaluation and research.

What does this mean for SA? @SAHPRA1 says it its ruling on this vaccine hasn't changed. The local regulator says the benefits of this vaccine still outweigh the risks. bit.ly/3ljR9JK

SA has only detected four cases of TSS that could be officially linked to the J&J lab and one other was being investigated.

That’s just 0.000046% of 8 700 571 J&J doses that were administered by 18 May 2022. Here’s how @SAHPRA1 links adverse events to vaccines for sure. bit.ly/3iXfYdT

Is this a shocking move? No. “It’s not unusual for different countries and regulators to take different stances on particular medicines, according to the circumstances in their country,” senior pharmacology lecturer at @UZKN Andy Gray wrote in his regular list-serv this week.

South Africa made a similar decision recently. Do you remember when @HealthZA decided not to use the #AstraZeneca vaccine?

.@HealthZA made the call because earlier studies had shown that people who had been exposed to one of the components inside the vaccine before they were immunised could be more likely to contract #HIV. bit.ly/3w5wOf6

Given SA’s high number of #HIV cases, scientists believed the risk to the HIV-negative community was too high to use the AstraZeneca vaccine in South Africa. Get all the details here.bit.ly/3yFsmYr

Still, @SAHPRA1 and @HealthZA have different roles. So even if the regulator doesn’t change it’s ruling, the health department still has the power to change its treatment guidelines, as was the case of the #AstraZeneca vaccine. No such decision has been made by the department.

Would you still get the J&J jab? New results from the @MRCza’s @Sisonke study show the vaccine is a great tool in anyone’s #COVID19 arsenal.

#Sisonke researchers found the J&J jab was good at protecting people from being admitted to hospital (about 64.5%) and from dying from COVID (about 84%).

These results were measured during the country’s second wave (driven by the #beta variant) and the third wave (driven by the #delta variant). bit.ly/3aaeA61