World’s first malaria vaccine receives positive opinion from EU regulators

A vaccine for malaria – Mosquirix – has been given a positive response from European regulators, paving the way for approval by the WHO and African regulators for use in sub-Saharan Africa and other malaria stricken areas. Mosquirix is the first vaccine for the disease to be assessed by a regulatory agency. Middle East Health reports.

In a major breakthrough in the battle against malaria, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion for RTS,S/AS01 (brand name Mosquirix) – a Plasmodium falciparum and hepatitis B vaccine – for use outside the European Union.

According to WHO, in 2013 627,000 deaths from malaria were reported globally, of which 562,000 (about 90%) occurred in the African region mostly among children under the age of 5 years (82%).

RTS,S/AS01 was submitted to EMA under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU. This means that EMA can help facilitate access to new medicines for people living outside the EU. Mosquirix was developed by GSK in partnership with the PATH Malaria Vaccine Initiative (MVI).

The vaccine is intended for use in areas where malaria is regularly found, for the active immunisation of children aged 6 weeks to 17 months against malaria caused by the Plasmodium falciparum parasite, and against hepatitis B.

The positive response comes on the back of evidence derived from a large phase III clinical trial programme involving more than 16,000 young children that was conducted by 13 African research centres in eight African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania).

Data from this trial demonstrate that over the first 18 months following three doses of RTS,S, malaria cases were reduced by almost half in children aged 5-17 months at the time of first vaccination and by 27% in infants aged 6-12 weeks. At study end, four doses of RTS,S reduced malaria cases by 39% over four years of follow-up in children, and by 27% over three years of followup in infants. In areas of the highest malaria burden, more than 6,000 clinical malaria cases were prevented over the study period for every 1,000 children vaccinated. The efficacy of RTS,S was evaluated in addition to existing malaria control measures, such as insecticide treated bed nets, which were used by approximately 80% of the children and infants in the trial.

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.

The European Medicines Agency (EMA) now issued what is called “a European scientific opinion”. This is not licensure, but provides a scientific opinion which African regulators may use to help their own regulatory processes.

Regulatory approval

EMA’s opinion was positive indicating that in their assessment the quality of the vaccine and the risk/benefit is favourable from a regulatory perspective. This does not take into account contextual elements such as the feasibility of implementation, the value of the vaccine in the context of other malaria control measures, and the likely cost-effectiveness of the intervention in different settings. The registration of vaccine will be done by African national regulatory authorities that will consider licensing the vaccine in their jurisdictions. African regulators will consider this when the manufacturer makes a regulatory submission to them, which has not yet occurred.

WHO will convene the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC)3 to review all evidence regarding RTS,S/ AS01 efficacy and safety, as well as other relevant data for global policy. SAGE/ MPAC will propose recommendations to WHO for the use of RTS,S/AS01 in October 2015. It is planned that WHO will make its official policy position available by the end of November 2015.

RTS,S/AS01 is being considered as a complementary intervention, i.e. any use of RTS,S/AS01 would be in addition to scaled-up access to and use of nonvaccine malaria preventive measures, prompt diagnostic testing and effective anti-malarial medicines.

There are many effective interventions now available that can be used to reduce the burden of malaria in Africa. These include prevention through mosquito vector control using long-lasting insecticidal bed-nets and, in some settings, indoor residual spraying with insecticides; seasonal malaria chemoprevention in some settings; intermittent preventive treatment for infants and during pregnancy; prompt diagnostic testing; and treatment of confirmed cases with effective anti-malarial medicines. These measures have dramatically lowered malaria disease burden in many African settings. The malaria disease burden can be lowered further by continuing to scale up existing WHO-recommended control measures. Available malaria control interventions represent some of the most cost-effective measures for public health.

Sir Andrew Witty, CEO of GSK said: “[The CHMP] scientific opinion represents a further important step towards making available for young children the world’s first malaria vaccine. While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions currently available such as bed nets and insecticides, would provide a very meaningful contribution to controlling the impact of malaria on children in those African communities that need it the most. 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.”

Dr David C. Kaslow, Vice President of Product Development at PATH said: “[the positive opinion of the CHMP] marks a significant scientific milestone for the long-standing partnership to develop a vaccine, yet several more steps remain before a malaria vaccine might reach the young children in Africa who most need protection against this deadly human parasite. PATH will continue to work with GSK and other partners to ensure that the evidence is available, as soon as possible, to support informed decisionmaking on those remaining steps.”

GSK has committed to a not-for-profit price for RTS,S so that, if approved, the price of RTS,S would cover the cost of manufacturing the vaccine together with a small return of around five per cent that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.

Following the WHO policy recommendation, GSK will also submit an application to the WHO for pre-qualification of RTS,S. WHO pre-qualification involves a scientific assessment of the quality, safety and efficacy of any new vaccine proposed for introduction in WHO Expanded Programme on Immunization. A prequalification decision is used by the United Nations agencies and other large scale public procurement agencies to help inform vaccine purchasing decisions.

Once a WHO pre-qualification is granted, GSK would then apply for marketing authorisation in countries in sub-Saharan Africa on a countryby- country basis. These regulatory and policy decisions would, if positive, enable countries to begin implementation of RTS,S through their universal immunisation programmes.

Both a WHO policy recommendation and WHO pre-qualification are requirements for Gavi, the Vaccine Alliance, to support eligible African countries introducing RTS,S into local immunisation programmes supported by UNICEF.

 Date of upload: 12th Sep 2015


                                               Copyright © 2015 All Rights Reserved.