Sanofi's Hexaxim vax gets EMA thumbs up

The European Medicines Agency (EMA) has adopted a positive opinion for Sanofi Pasteur's hexavalent vaccine for babies and toddlers, Hexaxim, as part of a procedure designed to evaluate medicinal products intended for markets outside the European Union. This states that the benefits of the vaccine outweigh the risks, and is the first time that the EMA has given a positive scientific opinion to a vaccine following this process, which is part of a cooperation with the World Health Organization, and allows the agency's Committee for Medicinal Products for Human Use (CHMP) to give scientific opinions on human medicines that are intended for markets outside of the EU and that prevent or treat diseases of major public health interest.

Hexaxim, a combined bacterial and viral vaccine, targets diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b--all WHO priority diseases. According to the company, it is the only fully liquid, ready to use 6-in-1 pediatric vaccine covering these diseases. It's designed for use in infants and toddlers from six weeks to 24 months, and is given as three doses at least four weeks apart.

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."

The advantages of Hexaxim are that it includes an inactivated polio vaccine component, so that it contributes to the worldwide campaign for the eradication of polio, and that it is ready for use, making administration simpler. It is also six-valent, so it reduces the number of injections that young children have to undergo. Sanofi Pasteur, which is the vaccines division of Sanofi-Aventis Group, is the largest company in the world devoted entirely to human vaccines.

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- see the summary of the positive opinion from the EMA
- check out the press release from the EMA

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