ADR that result in revision of patient information
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| Use of rotavirus vaccines resumes |
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The Department of Health (DH) has decided to approve the two rotavirus vaccines, Rotarix by GlaxoSmithKline Plc (GSK) and RotaTeq by Merck & Co, Inc (Merck) to re-enter the market today (May 17) after studying the latest evidence regarding the two vaccines.
The decision followed an examination of the latest information on the two vaccines from various sources including the US, Europe, the World Health Organization and the manufacturers, as well as the local situation. After reviewing scientific literature, it is concluded that the benefits of these vaccines outweigh the risks. DH has concluded that it is now appropriate for doctors to resume the use of the two rotavirus vaccines.
In Hong Kong, both vaccines are registered pharmaceutical products for children six weeks and older against diarrhoea and vomitting due to rotavirus infection. Both were recalled earlier on quality grounds following the identification of fragments of DNA from the pig virus in the vaccines in the US.
A DH spokesman said both manufacturers will be required to revise labellings in future stocks of the vaccines to include information about the presence of PCV type 1 (Rotarix) and DNA from PCV type 1 and PCV type 2 (RotaTeq) in the vaccines.
"The department will continue to monitor developments and work with the vaccine manufacturers concerned on the latest information," he said.
The department will keep the public informed of any further developments.
Ends/Monday, May 17, 2010 |
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