7 May 2010
The Department of Health (DH) has today (May 7) ordered a recall from the shelves, hospitals and doctors of a registered rotavirus vaccine, RotaTeq, on quality grounds.
The DH came into the decision after assessing a United States Food and Drug Administration (FDA) announcement made on May 6 (US time) concerning information received from Merck & Co, Inc. that its preliminary studies had identified fragments of DNA from porcine circovirus type 1 (PCV1) and from a related porcine circovirus type 2 (PCV2) in its RotaTeq vaccine.
The above preliminary findings together with the previous findings of PCV1 in Rotarix, another vaccine against rotavirus infection, would be discussed in FDA’s Vaccines and Related Biological Products Advisory Committee meeting on May 7 (US time).
The DH will continue to monitor future developments.
In Hong Kong, RotaTeq is a registered pharmaceutical product manufactured by Merck & Co., Inc. It is given by mouth to children six weeks and older against diarrhoea and vomiting due to rotavirus infection.
PCV1 and PCV2 are both small, circular viruses composed of a single strand of DNA. Although common in pigs, PCV1 and PCV2 are not known to cause illness in humans. However, PCV2 may cause illness in pigs.
A spokesman for the DH said as a precautionary measure, the quality defect of RotaTeq warrants the product recall. The manufacturer in Hong Kong has set up a hotline (3971 2930) during office hours for public enquiries.
To prevent rotavirus infection, members of the public are advised to take the following precautions:
1. Maintain high standard of personal, food and environmental hygiene.
2. Wash hands thoroughly before handling food, eating and after going to toilets and handling vomitus or faecal matter.
3. Wear gloves while disposing of vomitus, faeces and diapers, and wash hands afterwards.
4. Place overalls over diapers to prevent leakage
5. Clean and disinfect contaminated articles and surfaces promptly and thoroughly with 1:49 diluted household bleach (1 part of household bleach in 49 parts of water).
6. Children developing vomiting or diarrhoea should refrain from school and seek medical advice.