Malaria Vaccine: Current Status – Drug and Device Digest

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Malaria occurs in nearly 100 countries worldwide, exacting a huge toll on human health and imposing a heavy social and economic burden in developing countries, particularly in Sub-Saharan Africa and South Asia. An estimated 207 million people suffered from the disease in 2012, and about 627,000 died. About 90 percent of the deaths were in Sub-Saharan Africa, and 77 percent were among children under age 5.

It is transmitted among humans by female mosquitoes of the genus Anopheles. Female mosquitoes take blood meals to carry out egg production, and such blood meals are the link between the human and the mosquito hosts in the parasite life cycle.  The parasite Plasmodium, a single-celled organism that has multiple life stages and requires more than one host for its survival. Five species of the parasite cause disease in humans – Plasmodium falciparum, P. vivax, P. ovale, P. malariae, and P. knowlelsi. Plasmodium falciparum is the most dangerous strain in humans and the target of most scientific research today.

Malaria symptoms are high fever, chills, flu-like symptoms, and severe anemia. These symptoms can be especially dangerous for pregnant women and young children who are experiencing the disease for the first time. Severe malaria can cause lifelong intellectual disabilities in children, and malaria’s economic impact is estimated to cost billions of dollars in lost productivity every year.

Calling the Ebola epidemic a “critical moment in the history of global health,” Bill Gates, Co-chair of the Bill & Melinda Gates Foundation (PATH Malaria Vaccine Initiative), urged greater investment in scientific innovation to ensure that the world stays ahead of rapidly evolving disease threats such as drug-resistant malaria and dengue fever.

Addressing the annual meeting of the American Society of Tropical Medicine and Hygiene, Gates announced that the foundation is committing more than $500 million to reduce the burden of malaria, pneumonia, diarrheal diseases, and an array of parasitic infections that are leading causes of death and disability in developing countries. Gates also announced that the foundation has boosted its annual funding for malaria by 30 percent, and he laid out a vision for how malaria can be eradicated by the middle of the 21st century.

World’s first malaria vaccine, backed by Bill Gates, received a green light for future use in babies in sub-Saharan Africa. GlaxoSmithKline worked with the PATH Malaria Vaccine Initiative to develop the vaccine, which was called RTS,S when it was experimental and which now has the brand name Mosquirix. The European Medicines Agency has OK’d it for use in children 6 weeks to 17 months old.Jul 24, 2015.

Mosquirix. is the most advanced vaccine candidate against the most deadly form of human malaria, Plasmodium falciparum. A Phase III trial began in May 2009 and has completed enrolment with 15 460 children in the following seven countries in sub-Saharan Africa: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and the United Republic of Tanzania. The World Health Organization lists malaria as the fifth biggest killer in sub-Saharan Africa.

There are two age groups in the trial: 1) children aged 5-17 months at first dose receiving only the RTS,S/AS01 vaccine; and 2) children aged 6-12 weeks at first dose who receive the same malaria vaccine co-administered with pentavalent vaccines in the routine immunization schedule. Both groups receive 3 doses of Mosquirix. vaccine at 1 month intervals.

The final Phase III results were published in April 2015. The vaccine will be evaluated as an addition to, not a replacement for, existing preventive, diagnostic and treatment measures. The need for long-lasting insecticidal nets, rapid diagnostic tests and artemisinin-based combination therapies will continue if Mosquirix. becomes available and is used. It prevented a substantial number of cases of clinical malaria over a 3–4 year period in young infants and children when administered with or without a booster dose. Efficacy was enhanced by the administration of a booster dose in both age categories. Thus, the vaccine has the potential to make a substantial contribution to malaria control when used in combination with other effective control measures, especially in areas of high transmission.

STORYLINE:  Drug-resistant malaria is viewed as an epidemic in developing countries. Vaccines being developed and approved to curb the spread of malaria. Vaccines will complement the existing therapies and preventive measures.

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