Why Johnson & Johnson shots were paused — and why that’s so confusing

“Both the Food and Drug Administration and the Centers for Disease Control and Prevention recommended a pause in distributing the vaccine after six reported cases of cerebral venous sinus thrombosis (CVST). These clots block blood flowing out of the brain and can quickly turn deadly.

The complications were found in women between the ages of 18 and 48, and they arose between six and 13 days after receiving the Johnson & Johnson vaccine. “Of the clots seen in the United States, one case was fatal, and one patient is in critical condition,” said Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, during a Tuesday press conference.”

“For regulators, the episode highlights the tricky challenge of balancing caution against an urgent need for a vaccine in a still-raging pandemic. And as they investigate the problem, they also have to try to maintain public confidence in the vaccination program. The pause helps show that regulators are taking potential problems seriously, but if they botch the messaging, that could make people less likely to get vaccinated.”

“there are several factors that made regulators pay close attention to the recent cases following vaccinations with the Johnson & Johnson shot. Marks explained that patients with these clots also had thrombocytopenia, a condition where platelets in the blood drop to very low levels, leading to bleeding and bruising. The combination of blood clots and low platelets means that patients cannot receive conventional blood clot therapies like heparin, a blood thinner. That’s why health officials want to wait to resume vaccinations with the Johnson & Johnson vaccine until they can investigate the concern and come up with new guidelines if necessary.

Another factor is that these cases occurred in younger women, who normally don’t face a high risk of these types of clots.” 

“when vaccines make the jump from thousands of carefully screened trial participants to millions of people in the general population, rare problems — the one-in-a-million complications — start to emerge.”

“Regulators could, then, take a similar approach with the Johnson & Johnson shot to the one they used for allergies and the mRNA vaccines, adding a screening criterion for people at highest risk of these blood clots before they receive the Johnson & Johnson vaccine.”

https://www.vox.com/2021/4/13/22381844/johnson-vaccine-pause-covid-19-clot-cerebral-venous-thrombosis

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