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World first as CHMP backs GSK malaria vaccine Mosquirix

The EMA's scientific advisers recommend its useoutside Europe

Malaria mosquito

GlaxoSmithKline's malaria vaccine Mosquirix has the backing of key advisors at the EMA, putting it inline to become the world's first approved vaccine for malaria.

The European regulator's Committee for Medicinal Products for Human Use (CHMP) gave Mosquirix a positive opinion for use outside the EU in young children alongside established antimalarial interventions. 

Sir Andrew Witty, CEO of GSK, said: “Today's scientific opinion represents a further important step towards making available for young children the world's first malaria vaccine.

“The work doesn't stop here and GSK remains committed to investing in R&D for malaria vaccines and treatments to find more ways to tackle this devastating disease.”

Formerly known as RTS,S/ASO1, Mosquirix (Plasmodium falciparumand hepatitis B vaccine) was assessed under EMA rules that  allow it to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, even though it will not be marketed in the EU.

Mosquirix is meant for use in areas where malaria is regularly found, such as large parts of Africa and South Asia, as a treatment for children aged 6 weeks to 17 months.

Mosquirix was backed by the CHMP for use in line forthcoming recommendations on the disease's risk and use of available treatment options from the World Health Organization (WHO) and regulators in the non-EU countries where the vaccine would be used.

In a large clinical trial that took place in seven African countries Mosquirix was found to provide modest protection against Plasmodium falciparum malaria in children in the 12 months following vaccination. 

Although efficacy  decreased after one year, the vaccine also found to be effective at preventing a first or only clinical malaria episode in 56% of children aged between 5-17 months and in 31% of children aged 6-12 weeks. 

The EMA said: “Based on the results of the trial the CHMP concluded that despite its limited efficacy, the benefits of Mosquirix outweigh the risks in both age groups studied.

“The CHMP considered that the benefits of vaccination may be particularly important among children in high-transmission areas in which mortality is very high.”

Nonetheless, the vaccine won't reduce the need for established protection measures such as insecticide-treated bed nets, because Mosquirix does not offer complete protection from the disease and the protection it provides decreases in the longer term.

The CHMP and GSK's biologics unit agreed measures to ensure the safety and effectiveness of Mosquirix is continuously monitored under a risk management plan.

Article by
Dominic Tyer

24th July 2015

From: Regulatory



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