Green light for use of child vaccine outside EU

by Gary Finnegan – Emerging uses of EMA Approved Drugs –

The European Medicines Agency (EMA) has given its backing to the use of a Hexaxim outside the EU.

The approval of the product, a child vaccine made by Sanofi, is the first time the European regulator has authorised a vaccine under a special procedure designed to fast-track the international use of products considered to be of major public health interest.

Vaccines used in the WHO’s Expanded Programme on Immunisation, as well as medicines for protection against public-health-priority, neglected or WHO target diseases such as HIV/AIDS, malaria and tuberculosis, are eligible for consideration under the scheme.

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 Agency is looking forward to continuing its work with the WHO to speed up access to important medicines like this one in regions outside the EU.”

The vaccine protects against six of the World Health Organisation’s priority diseases: diphtheria, tetanus, whooping cough, Hepatitis B, poliomyelitis and serious infections caused by Haemophilus influenza type B.

The EMA said its opinion was based on the results of clinical trials carried out in children in several countries outside the European Union, which showed an adequate immune response against all six diseases across all major ethnic groups, the regulator said in a statement.

All the active substances in the vaccine have already been used in other vaccines, except the hepatitis B components.

The manufacturer says the EMA seal of approval should make it easier to roll out the product in developing countries.

“Upon licensure we intend to introduce Hexaxim in countries looking for improved and effective solutions in particular for public immunisation programmes,” Olivier Charmeil, head of Sanofi’s vaccine unit Sanofi Pasteur, said in a statement.