New Delhi: The US drug regulator has suspended the use of rotavirus vaccine Rotarix, made by UK-based drug maker GlaxoSmithKline Plc. and sold in India as well, after it was found to contain impurities.
Rotavirus is the most common cause of dehydrating diarrhoea in children.
In a statement on 22 March, the US Food and Drug Administration (FDA) said it “has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix”.
FDA, however, said there was no evidence to say the presence of PCV1 poses a safety risk and since available evidence supports the safety of Rotarix, “no medical follow-up is needed for patients who have been vaccinated with it”.
GSK said it had informed India’s regulator and will abide by any guidance it issues.
The European Medicines Agency and WHO “have issued statements confirming that the presence of the material from PCV-1 does not suggest any change to the positive balance of benefits and risks of the vaccine and have not recommended any change to the way that healthcare practitioners in Europe and the developing world use Rotarix,” GSK said in an emailed statement.
FDA said it will further investigate the safety of Rotarix before lifting the suspension, without specifying a timeframe.
It has advised the use of another rotavirus vaccine—RotaTeq, marketed by US drugmaker Merck and Co.—for children who have received one dose of Rotarix.