I worked R&D and manufacturing. That was no accident. That virus had help. *Deliberate* help. R&D badges don’t work at manufacturing facilities and vice versa. Unless you’re management, or an approved visitor. *Someone* deliberately took that sample from the R&D facility in this country, got on a plane, flew to europe, deplaned, managed to get INTO the manufacturing facility and INTO the room with the big giant vat and PUT that virus in there.
If that QC is so poor why should we trust their QC at all? Level 3 samples don’t just *walk out* of R&D facilities. Nor do they just *walk in* manufacturing facilities.
Yes, totally accidentally.
It's basic research. So, it probably went like this: the researchers either wrote by hand or typed out a protocol--they were NOT following a textbook protocol (new experimental vaccine does not have a defined recipe). It contains dozens of steps. More than one researcher was involved. The person opening the eggs thought the person extracting the virus would do the formalin deactivation step; the person doing the extraction thought the person opening the eggs had already added the formalin. Or someone picked up the dilute formalin bottle instead of the pure formalin bottle and diluted it (a second dilution), so that instead of using 3.7% formalin, they were using 0.37% formalin. In any case, the formalin deactivation never occurred, and all the remaining steps were performed with live virus that everyone thought was dead. The experimental vaccine was packaged and sent off (via UPS or USPO) with the usual paperwork; no one realized until the ferrets were inoculated and died that the virus was still active. Maybe such an event is newsworthy, but it's hardly an indictment of an entire company, nor is it an indication of malicious intent. It's just an accident of the type that sometimes happens in basic research labs. Usually, that kind of accident only causes experiment failure; in this case, it caused ferrets to die (which is still only an experiment failure, even though the ferrets suffered).
Experimental vaccines are not made at manufacturing facilities. They are made by scientists working in small labs on a small scale. Nor do they undergo the QC process required for licensed vaccines. The researchers probably measured the protein content of the vaccine, and made sure it was free of bacterial contamination... I doubt they did much else.
You say you worked R&D and manufacturing. That tells me that you did not work at the basic science level, which is where vaccines are developed, long before they reach the clinical trial stage. At the basic science level, there is no QC.
I know how these things happen. I *also* happen to know in Baxter's case the virus was IN a level 3-4 facility in THIS country, somehow managed to get on a plane, across a continent, an ocean and another continent to ANOTHER facility and INTO a reactor vessel.
That wasn't an accident. The facility that produced that 'contaminated' vaccine wasn't supposed to have that particular live virus at ALL.
This was NOT a 'protocol error'. This was deliberate. They mixed TWO different types of flu virus in a reactor vessel. Both live. THIS is how pandemics start.