Unfortunate Adult Hep B Vaccine News Update: GSK Now Out Of Commission, Too…
August 10, 2017

A bit ago, we mentioned that Merck would be stocked out on adult Hep B vaccine, for quite a while. We even speculated that the “Not Petya” hack (locking out critical systems for monitoring batch integrity, entirely) may have been part of the problem, for Merck. But at the time, US CDC was advising that Glaxo could cover the shortfall.

No more. This is disconcerting — but to be expected, in biologics — as I’ve often said, producing a vaccine in quantity — is not unlike baking a perfect souffle — light and airy — but the size of. . . Wyoming. In sum it is very difficult bio-chemistry. That is why CDC always wants two independent sources. But at the moment (per FiercePharma‘s Manufacturing beat), both are unable to deliver viable, good vaccine stock out of the end of the pipe. GSK’s operation is in Belguim; Merck’s is in Durham, North Carolina and Westpoint, if memory serves. Continents apart, but both are stocked out.

Here’s a bit, but do go read it all:

. . . .While GSK has been able to cover for shortages in the past, a spokeswoman said the company is currently dealing with manufacturing issues of its own.

“GSK has a global shortage of hepatitis A, hepatitis B and combination hepatitis A and B vaccines. This is due to reduced manufacturing capacity for hepatitis A and B antigens, which we are working hard to return to normal supply,” the company said in an emailed statement.

The drugmaker said vaccines are produced at a plant in Belgium but wouldn’t say specifically what has caused the manufacturing bottleneck. . . .

This is, in truth, an unfortunate piece of news. And not likely to be fully resolved, before mid-2018. But as ever, onward, just the same. . . we have much for which to be thankful. Now. . . you know.