GIF has decided to recall a series of Rotarix rotavirus vaccines. The reason is that anomalies in the manufacturing process have been detected.
The Main Pharmaceutical Inspectorate issued a decision to withdraw the Rotarix vaccine from the market, batch number: AROLC214AE, expiry date: 02.2021, MAH: GlaxoSmithKline Biologicals SA, Belgium, representative of the MAH: GSK Services.
The reason for the GIF decision is the detection of anomalies during the manufacture of the drug. These may have caused the last 50 oral applicators of this Rotarix series to be insufficiently refilled. As a result, the vaccine does not meet the quality requirements for this batch of drug in terms of the volume parameter.
Rotarix is a viral vaccine that contains live attenuated human rotavirus that helps protect your baby against gastroenteritis (diarrhea and vomiting) caused by rotavirus infection, the most common cause of severe diarrhea in infants and young children. The greatest risk of infection is dehydration, which often requires hospitalization.
In Poland, the incidence of rotavirus is high. Annually, it reaches 172 thousand. cases of illness.