Monday morning, the FDA recommended that healthcare providers across the country temporarily suspend the use of the Rotarix vaccine, manufactured by GlaxoSmithKline. Switzerland, the United Kingdom, the Republic of Singapore, Saudi Arabia and several Latin American countries have also requested that this vaccine’s use be suspended pending the outcome of further investigations.
These requested suspensions are in response to the discovery of of porcine circovirus type 1(PCV1) contaminants in the vaccine by an independent research lab. This discovery was confirmed additional tests conducted by both the FDA and GlaxoSmithKline laboratories. Tests also indicated the contaminants have been present in this vaccine since the first manufacture date. Clinical trials were conducted with Rotarix that contained PCV1 contaminant particles.
Porcine circovirus type 1 is a single stranded DNA virus discovered in 1974. It is one of the smallest viruses known to have the ability to replicate autonomously. It is not known to cause any diseases in the pigs it normally infects. It is believed to have no effect on the human population.
GlaxoSmithKline officials say it is a common virus that is frequently eaten in meat products, and presents no threat to the human population. They plan to continue to produce the vaccine with the PCV1 contaminants, until they can figure out how to fix the process.
Scientists are currently trying to determine whether the contaminant is the whole virus able to replicate on its own, or just fragments of the virus.