Drug manufacturer Merck misrepresented the efficacy of its mumps vaccine for years, “overfilling” the vaccine with live mumps virus to meet efficacy targets despite the lack of safety testing — and the practice may be continuing today.
Merck appears to have concealed the practice from public health agencies, which have taken no action to stop it.
Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense, joined “The Defender In-Depth” this week to discuss the revelations, which stem from a lawsuit two Merck whistleblowers filed in 2010 under the False Claims Act.
The 3rd Circuit U.S. Court of Appeals in Philadelphia heard oral arguments in the case on July 9.
According to Hooker, the Merck measles, mumps rubella vaccine, MMR II — the only mumps vaccine licensed in the U.S. and listed on the childhood vaccine schedule for 12- to 18-month-olds — may contain up to 4 times the approved concentration of live mumps virus.
A two-part deposition by Dr. David Kessler, former head of the U.S. Food and Drug Administration (FDA), also indicates that Merck, rather than informing regulators that it was “overfilling” its MMR vaccine, relied on passive surveillance — reports from parents regarding vaccine reactions in their children — to identify possible safety signals.
Hellbound and Down 