Yesterday, federal health officials asked that doctors stop using Rotarix, a vaccine used to protect babies from the rotavirus. Rotarix is made by GlaxoSmithKline (GSK) and received FDA approval in 2008. So far, about one million U.S. children have been given this vaccine and about 30 million children worldwide. It is not being recalled; its use is just suspended.
Rotarix was found to be contaminated by material from a pig virus. However, the FDA Commissioner, Dr. Margaret Hamburg, stated that there is no evidence of any safety risk from this pig virus. It does not affect humans. On the other hand, it should not be in the vaccine and usually is not, so how did it get there?
The academic research group that found it was using a new technique to look for viruses in a range of vaccines. The told GSK what they had found and GSK re-tested, finding the contamination in the cell bank and the seed they used to make the vaccine. That indicates that it got into the vaccine at an early stage of manufacture. GSK then told the FDA, who also confirmed the findings.
In a written statement, GSK emphasized that this pig virus “is found in everyday meat products and is frequently eaten with no resulting disease or illness.”
- “No safety issue has been identified by external agencies or GSK,” said Thomas Breuer, GSK’s Chief Medical Officer, in a written statement.
Similar Vaccine Made by Merck
Merck’s rotavirus vaccine, called RotaTeq, was FDA-approved in 2006. No contamination has been found in it, so it can be used as an alternative to Rotarix until GSK solves this puzzle. A Merck spokeswoman has said: “Obviously, we will work with the … FDA to evaluate supply needs.”
If you have received a dose of Rotarix, you can switch to Merck’s RotaTeq to finish the series.
The research group’s paper is to be published in a scientific journal shortly and until then, the group wants its name withheld from the public. Since incidence of rotavirus is relatively low in the U.S., the Rotarix suspension is only happening in this country. Other countries where incidence is higher are making their own judgment calls.