Updated on 25 June 2012
The vaccine offers protection against diphtheria, tetanus, pertussis, hepatitis B, polio and invasive disease caused by Haemophilus influenzae type B bacterium
Singapore: The European Medicines Agency has issued a scientific opinion recommending that the benefits of the vaccine Hexaxim outweigh its risks and that it can be used in regions outside the European Union (EU). This is the first such opinion on a vaccine.
The vaccine, developed by Sanofi Pasteur, offers protection against six World Health Organization (WHO) priority diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, polio and invasive disease caused by the bacterium Haemophilus influenzae type B, including meningitis. It is given to children between six weeks and two years of age.
The Agency's Committee for Medicinal Products for Human Use (CHMP) can give scientific opinions in cooperation with the WHO on human medicines that are intended for markets outside of the EU and that prevent or treat diseases of major public health interest. They may include vaccines used in the WHO's Expanded Programme on Immunization, as well as medicines for protection against public-health-priority, neglected or WHO target diseases such as HIV/AIDS, malaria and tuberculosis.
The CHMP bases its opinions on these medicines on the same standards of quality, safety and efficacy as for medicines for use within the EU.
Dr Tomas Salmonson, acting Chair of the CHMP, said, "We are delighted to issue a positive opinion on this vaccine, which promises to relieve the burden of these six diseases. All of these diseases continue to cause unacceptable levels of illness and death across the globe.