RP FDA: No need for ban on Rotarix vaccine

Health authorities said there will be no need for a ban on Rotarix, a vaccine against rotavirus infection, at least for now. In an April 14 advisory, the Food and Drug Administration (FDA) cited findings by the manufacturer and other regulatory agencies that the virus does not pose any public health risk. “Other regulatory agencies issued statements that the virus does not pose any public health risk as it does not cause any diseases in humans. Notably the World Health Organization (WHO) Global Advisory Committee on Vaccine Safety considers the benefits of vaccination far outweigh any currently known risk associated with the use of Rotarix given the extensive clinical data supporting the safety of the said vaccine and the benefits of rotavirus vaccination for children," FDA head Nazarita Tacandong said. Citing information reaching the FDA, Tacandong said a porcine circovirus-1 (PCV-1) had been discovered in the cell bank of the Rotarix vaccine. But she said the manufacturer of the vaccine initiated extensive experiments and confirmed it. Still, she said tests conducted so far showed the benefits outweigh the risks. “Relative thereto, the FDA advises the public of its decision that there is no need to withdraw the vaccine from the RP market," Tacandong said.

But she said the FDA will continue to coordinate closely with the manufacturer and evaluate data submitted by the company and other information available from other sources. “In the meantime doctors may continue giving the vaccine to their patients based on their discretion and professional judgment," she said. GlaxoSmithKline, the manufacturer of Rotarix, said in its website there is no evidence at this time that this finding poses a safety risk. Rotarix is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9). It is approved for use in infants 6 weeks to 24 weeks of age, according to GlaxoSmithKline's website. — LBG, GMANews.TV