SisonkeTrialReport-J&J-3b-Safety-PlosMedicine
Comments:
BE WARY OF CONCLUSIONS IN HEADLINES AND ABSTRACTS.
Reading the abstract of this J&J Covid-19 vaccine study among South African healthcare workers leaves one with a sense of trust and confidence. The authors claim “The single-dose Ad26.CoV2.S vaccine had an acceptable safety profile supporting the continued use of this vaccine in our setting.” AND “In conclusion, this study affirms that the single dose Ad26.COV2.S vaccine is safe and well tolerated when administered to adults in South Africa.”
However, attentive reading of the full article leaves one with areas of concern, which include:
- Definitions of the terms “safe” and “safety”, and of the concept “acceptable safety profile”, have not been provided by the authors. This failure is relevant to concerns about how many SAE (serious adverse events) and deaths these authors consider to be acceptable.
- The study had no capacity to account for medium- or long-term adverse events. The study was conducted over a short period of time, just under 4 months. Active contact with participants was only up to two-weeks post-vaccination.
- It was an open label single arm study without any placebo-controlled group. The surveillance system was primarily passive relying on self-reporting.
- The study did not include clinical laboratory tests as surrogate markers for toxicity. Deaths were excluded from the serious adverse effects analysis.
- The observed versus expected analysis for GBS (Guillain-Barre Syndrome) was a 5.09 times increased risk.
- The observed versus expected analysis for thrombotic thrombocytopenic syndrome was a 2.40 times increased risk.
- Of the reports SAEs: 34.8% had recovered, 26.1% were recovering, 32.6% were ongoing and 6.5% were deceased.