Johnson and Johnson Vaccine Update (johnson and johnson vaccine)

Johnson and Johnson Covid Vaccine Update

6 similar and rare adverse events (cerebral sinus venous thrombosis i.e. blood clots in the veins of the brain) within 6-13 days in young-middle age women were reported after emergency release of the J&J covid vaccine used on 6.8m people so far (FDA Announcement)

Serious, Unexpected Adverse Event Case Study: Johnson and Johnson Vaccine

These JnJ covid vaccine adverse events were:

1) unexpected (not listed in the Johnson and Johnson vaccine trial/Janssen ENSEMBLE Clinical Trial Protocol or 2/21 Briefing document)

2) serious (resulting in death, hospitalization, etc)

What is Clinical Trials doing to protect patient safety?

3) The trial has paused so that causality can be found in order to determine if

a) the protocol needs to be amended to list this as an “expected” rare side effect

b) they need to discontinue the trial (to all or to specific demographics) if risk is greater than harm.

4) Causality is determined by physicians and researchers by assessing multiple factors including time of onset, biological possibility, confounders (i.e. patients predisposing conditions cause hypercoag state) strength of association (i.e. others getting higher rate of leg clots, etc), dechallenge (hyper-coagulability risk decreases after time).

5) After this, a root cause analysis to see if there are any confounders that could have caused these adverse events.

6) Then, a corrective action plan (CAPA) needs to be be created to help prevent this from happening again.

7) Last, documents like protocols would need to list this as an “expected’ event, however rare, and see if specific demographics (young to middle age women) are at risk and thus should not take it.

8) At this point, COVID itself still has a much higher risk of blood clots and thus getting an available vaccination (Pfizer, moderna) until more information regarding the Janssen Vaccine Adverse Event Causality is available is still key to protecting patient safety.

How do people report Vaccine Adverse Reactions?

9) Anyone is allowed to report vaccine adverse reactions online to VAERS (VAERS online reporting form; guide to reactions to report).

10) Anyone is allowed to view VAERS reports in excel format (2021 VAERS reports; search “Janssen” “covid vaccine” etc)

Share your thoughts below with us and let’s start a discussion to keep this article updated on the changes and new reports that come out regarding the ENSEMBLE trial.