Yes, it seems statistically insignificant and outright ridiculous. However, I feel like half the shit I do for my job is guided by the edge cases. About issues that MAYBE a few dozen out of hundreds of thousands/millions of customers have. Because if we don't the FDA is on our asses, auditing the shit of out of us, wondering how we missed it and/or didn't take action sooner, and, if we REALLY screw up, fining the shit out of it/taking our product off market.

Also, liability is probably the main guiding principal here. God forbid some anti-vaxxer/anti-government shithead was one of the six people. They'd sue J&J, their county, their states, and the government for millions, if not billions.