More than 155,000 doses of the diarrhea vaccine Rotarix, now known to contain a pig virus, have been used in Vietnam since 2007, when it was approved for use in the country.
Following the recent announcement by the US Food and Drug Administration (FDA) that Rotarix contains the pig virus PCV-1, Vietnam temporarily halted using the vaccine from March 27.
The country has also asked Rotarix-maker GlaxoSmithKline (GSK) in Vietnam to coordinate with local importers and distributors to alert all health clinics about the directive and not to order further batches.
GSK announced the discovery of the pig virus in the oral vaccine, used to fight rotavirus in children, to the Drug Administration of Vietnam (DAV) on March 24.
Dr. Nguyen Thi Tuong Vi, GSK representative in Vietnam, said March 27 that GSK had agreed to cooperate fully with the DAV in temporarily stopping the administration of the vaccine.
GSK has already informed importers and distributors and checked the current volume of Rotarix. It will report to the DAV by March 31, she added.
Dr. Vi said GSK will not stop producing and distributing the vaccine because PCV-1 does not multiply in humans and is not known to cause rotavirus-related illness in people.
Data from clinical research shows that the vaccine is safe, she added.
However, many parents whose children have taken Rotarix are now very anxious and have asked for advice from doctors.
According to the National Institute for Control of Vaccine and Biological Products, there is no cause for public alarm as all vaccines must pass rigorous safety testing before being put into use.
The DAV has 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.
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Vietnam halts use of diarrhea vaccine Rotarix
