Following a warning from the US Food and Drug Administration that the diarrhea vaccine Rotarix may contain a pig virus, the Drug Administration of Vietnam (DAV) March 24 sent an official query to Rotarix-maker GlaxoSmithKline (GSK) Pte. Ltd., Vietnam.
GSK recently announced the discovery of the pig virus, called PCV-1, in the oral Rotarix vaccine used to fight rotavirus in children to DAV
The DAV has now asked GSK to provide documents proving the vaccine’s safety. It has also requested information on how the US FDA and other affected countries are dealing with the problem.
An independent US academic research team first detected DNA from porcine circovirus 1 (PCV-1) in Rotarix, and follow-up tests by GSK and FDA scientists confirmed the team’s findings.
The tests also showed that viral components had been present since the early stages of the vaccine’s development, including during clinical studies.
PCV-1 does not multiply in humans and is not known to cause rotavirus-related illness in people, GSK said. The US FDA, however, has advised doctors to temporarily avoid using the vaccine.
The DAV has also asked for guidelines from Hanoi’s Department of Preventive Health and Environment, the National Institute of Hygiene and Epidemiology, and the National Institute for Control of Vaccine and Biological Products.
Children in Vietnam have had access to the rotavirus vaccine since 2007 and around 155,000 of vaccine doses have been used. Parents must pay for the vaccine, which is not covered under the National Expanded Program on Immunization.