U.S. health officials have recently recommended a temporary ban on a popular vaccine against the diarrhea bug rotavirus. Doses of Rotarix are suspected to be contaminated with a benign pig virus, according to officials at the U.S. Food and Drug Administration. Other countries have instituted a full-blown Rotarix recall.
PCV1 Found in Rotarix
Independent researchers found porcine circovirus 1 (PCV1) in Rotarix, a GlaxoSmithKline drug. Though it is not known to cause illness in humans, the presence of the virus calls into question the sterility of the vaccine. According to HealthDay, FDA Commissioner Dr. Margaret Hamburg says the FDA is recommending that clinicians temporarily suspend the use of Rotarix vaccine.
"FDA is investigating how the PCV1 DNA came to be present in the vaccine," Hamburg said.
This is good news for Merck, maker of RotaTeq, the other vaccine that protects against rotavirus. Pediatricians are recommending RotaTeq for those who have started, but not yet completed, they Rotarix cycle.
"Preliminary tests on the RotaTeq vaccine by an academic research team and FDA have not shown the presence of PCV1 DNA," Hamburg said.
Pharmaceutical Response
HealthDay reported statements from Thomas Breuer, head of global clinical R&D and chief medical officer of biologicals at GlaxoSmithKline. He said that the company was working closely with regulatory agencies around the world.
“GSK is committed to patient safety and to the highest manufacturing standards for all our vaccines and medicines. GSK is now reviewing how best to replace, in a timely way, the cell bank and virus seeds used as base production material. In the meantime, and in accordance with the regulators, the company will continue to manufacture Rotarix to the existing approved production and quality standards to meet public health needs worldwide," the company added.
If Only We Had a Vaccine for the Vaccines
Last September British health officials temporarily suspended a vaccination program after a 14-year-old girl died a few hours after being vaccinated with the Cervarix vaccine, which protects against two strains of the human papilloma virus that causes cervical cancer.
Considering other cases of medication recall, we could use some guarantees. The pharmaceutical company that comes up with a wonder drug to protect us from the wonder drugs will be the winner. That’s a stock I’d like to own.