Merck Discloses Finding Pig-Virus DNA Fragments In Its Human Vaccines, As Glaxo Earlier Did

Tomorrow morning, an FDA Advisory Committee will meet to review the relatively-recent appearances of porcine virus DNA fragments in Glaxo's Rotarix^® -- as well as smaller amounts of such virus DNA, in Merck's RotoTeq^® vaccine.

While FDA sees no current patient safety issue here, the agency had earlier advised doctors to switch vaccines, away from Glaxo's Rotarix, in favor of Merck's RotoTeq, while it studied the implications of the PCV1 DNA appearance in the GSK product. Now what to do, eh? We probably shouldn't halt all such vaccinations of babies while the problem is studied, right?

My bet is that the Advisory Committee will tomorrow recommend that the choice of which competing branded product (GSK v. Merck) once again be left up to the treating physician. The GSK vaccine requires one fewer shot per regimen, than the Merck version. Here is the FDA Advisory Committee's blurb about tomorrow's sessions (I may find a live media-stream, and live-blog some of it -- we'll see):

. . . .FDA recently received information from Merck & Co, Inc. that its preliminary studies have identified fragments of DNA from PCV1 and from a related porcine circovirus type 2 (PCV2) in its RotaTeq vaccine. Merck’s findings suggest that the number of PCV DNA fragments in its vaccine may be smaller than what has been found in Rotarix. These preliminary findings will be included in discussions with the Committee.

FDA has been working closely with manufacturers of the two licensed rotavirus vaccines, has consulted with experts inside and outside of the federal government, and has considered issues related to the novel testing that led to the identification of PCV. . . .

Oh, and by the way, do also go read Pharmalot's on this topic, today -- including a great piglet graphic, at his joint.