FDA approves new malaria vaccine for children under 3 years

The Food and Drugs Authority (FDA) has approved a new malaria vaccine for children between the ages of 5 months to 36 months. Named R21, the new vaccine was produced by Oxford University and is being developed by Serum Institute of India.

Though the World Health Organization (WHO) is yet to recommend the drug for widespread use, the R21/Matrix-M vaccine exceeds the WHO 75% efficacy target. It is the first to do so.

According to Professor Adrian Hill, the director of the Jenner Institute, a part of the Nuffield Department of Medicine at Oxford University, said it “…marks a culmination of 30 years of malaria vaccine research at Oxford with the design and provision of a high efficacy vaccine that can be supplied at adequate scale to the countries who need it most”.

Phase 3 trial of the vaccine is ongoing, however, earlier trials produced a 77% efficacy.

Meanwhile, the CEO of Serum Insitute, Adar Poonawalla, has described Ghana’s decision to approve the vaccine as a big step forward. “Developing a vaccine to greatly impact this huge disease burden has been extraordinarily difficult. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” the Guardian reported.

Dr Delese Darko, CEO of the FDA said “The vaccine has been approved for use for the immunization of children between five months to thirty-six months. It is a colourless to mild turbid solution for injection, and it is supposed to be stored in a refrigerator and has a shelf life of twenty-four months. Our evaluation indicated that the vaccine has the potential to reduce infant mortality caused by malaria in Africa.”

He explained that Ghana was picked to start using the vaccine because of the country’s regulatory maturity and also its “extensive competencies”.

“Ghana was chosen because the FDA is a level three maturity national regulatory authority for medicines and vaccines and regulatory oversights and has extensive competencies in evaluating the quality of clinical and non-clinical parts of a product. We are also a regional centre of regulatory excellence with clinical trial oversights,” Dr Darko explained.

In Ghana where the disease is endemic, about 12,500 people died from it in 2021 from 5.3 million cases. Over 619,000 people died from the disease in 2021 with a larger portion of that coming from sub-Saharan Africa.