The Pennsylvania company that makes Ebola vaccines at the Maryland plant recently supplied vaccine to a lab run by Johnson & Johnson, one of the biggest makers of medical supplies, and the Maryland federal lab discovered that the vaccine — created by Emergent BioSolutions — contained E. coli bacteria, which can produce deadly pathogens in eggs.
Another immune system vaccine, for Zika, was also found in the freezer at the plant, and officials at that company plan to have the vaccine isolated from the freezer and tested, perhaps even in one of the Federal Centers for Disease Control laboratories, according to the FDA documents.
The documents do not identify the laboratory, which also does work on the Ebola vaccine. However, the records indicate the same lab is responsible for working on the Zika vaccine. Both flu vaccines, for H1N1 and H5N1 viruses, were located in the same freezer as the Ebola and Zika vaccines, the documents said.
Photos of the room showed it was sealed off with a blue tarp and discarded autoclaves, both of which are used to sterilize samples.
The company has been under an FDA inquiry since Sept. 1, when the Maryland lab found E. coli in the vaccine. That same month, at FDA requests, the company informed state health officials in Maryland and Virginia that its plant, which employs about 40 people, was on “furlough” at the time, the documents say.
The company is expected to tell state health officials in Maryland when it intends to resume production and at what rate, though it is unlikely to restart at all, after the latest outbreak of Ebola in West Africa.