Highlights of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review this week of a safety signal to assess reports of thromboembolic events with low platelets in people who received the COVID-19 Vaccine Janssen.
Thromboembolic Events with J&J/Janssen Vaccine
Four serious cases of unusual blood clots with low blood platelets have been reported postvaccination with COVID-19 Vaccine Janssen, EMA reports. One case occurred in a clinical trial and three cases occurred during the vaccine rollout in the US. One of them was fatal.
COVID-19 Vaccine Janssen is currently only used in the US, under an emergency use authorization. COVID-19 Vaccine Janssen was authorized in the EU on March 11. The vaccine rollout has not started yet in any EU member state but is expected in the next few weeks.
The Janssen vaccine uses an adenovirus vector, as does the AstraZeneca vaccine.
PRAC is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information, it adds.
a lo que el doctor J, comenta:
Dr. J DR| Anesthesiology 2 hours ago
Regardless of the perceived benefits of the vaccine, these are still experimental. It’s in the vaccine paperwork and consent. These have been released under Emergency Use Authorization, which means they have not received FDA approval, and have not been studied as rigorously as usual.
And if these newer vaccines have been showing up and causing/associated with these thrombotic and thrombocytopenic episodes, some serious, who are you/we to say that the risk of the disease- for a given patient with a given set of demographics and diagnoses- is worse than the vaccine itself? That clearly smacks of medicap paternalism, a paradigm I thought we were trying to get away from. Until covid anyway…
This is why a person’s choice is paramount, and why a vaccine mandate and mandated passport is so completely wrong.
y antes, esta manana:
Dr. Stacy Orwig| Family Medicine 13 hours ago
Given the evidence existing for reduction in death, serious illness, and hospitalization from covid with vaccines, it appears to me that the benefits of covid vaccination exceed the risks for patients whose risk of severe covid infection exceeds at least 1/100 to 1/150. However, we need to consider whether the serious adverse event rates in kids whose risks of serious illness from covid are 1/400,000, especially without solid evidence on reduction of transmission.
The FDA defines a “serious adverse event” as life-threatening, and includes death, inpatient hospitalization, disability, anaphylaxis, strokes, PE, DIC, paralysis, etc. This does not include dizzines, nausea, or vagal responses. If a child won’t infect their high risk family/neighbor/teacher, it affects the benefit ratio in a public health perspective. But if the “serious” adverse event rate from a shot is 1/100, and severe covid including complications/death is 1/1000-1/400,000, the argument for benefit>risk for the individual becomes much more challenging!
a lo que responde un administrador de salud:
Michael Herron| Health Business/Administration 5 hours ago
We are also human beings who have the freedom and the absolute right to decide what is or is not injected into our bodies, regardless of risk benefit analysis.