WHO approves second, affordable vaccine for malaria, Serum Institute of India takes on production challenge

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The World Health Organization has approved a new anti-malaria vaccine, which will offer countries a cheap and more accessible option to combat one of the leading causes of child deaths in Africa.

Developed by Oxford University, the R21/Matrix-M vaccine is the second such vaccine to be recommended by the WHO, it said in a statement Monday.

The recommendation, based on preclinical and clinical trial data, showed that the vaccine reduced symptomatic cases by 75 percent following a three-dose series in a year, in areas with high seasonal malaria transmission. The Phase III clinical trial results are under peer review, Oxford said in a statement.

At a cost of $2-4 per dose, R21 was a cost-effective intervention, the WHO said, adding that it expects the vaccine to be available by mid-2024.

“As a malaria researcher, I used to dream of the day we would have a safe and effective vaccine against malaria. Now we have two,” WHO Director General Tedros Adhanom Ghebreyesus said in the statement.

Malaria is a life-threatening though curable disease primarily transmitted through bites of certain mosquitoes. People who contract malaria develop fever, chills and flu-like symptoms.

Millions of cases are reported every year, and the WHO reported an estimated 619,000 deaths from malaria in 2021. Nearly all of the malaria cases occur in Africa, and children under 5 account for 80 percent of the deaths reported in the region, according to the WHO.

The United States reports about 2,000 malaria cases every year, the Centers for Disease Control and Prevention says, with the majority of them contracted abroad. Most recently, health officials in July issued a warning after a few cases were reported in Florida and Texas in people who had not traveled overseas.

The WHO approved the first vaccine for malaria, known as RTS,S, in 2021.

But while the demand for malaria vaccines is “unprecedented,” the supply of RTS,S has remained limited, hampering prevention efforts, the WHO said Monday. The WHO, UNICEF and Gavi, a global vaccine alliance, allotted 18 million doses of RTS,S to 12 African countries for 2023-2025.

The Serum Institute of India, which will manufacture the latest R21 vaccine, said it has established capacity for producing 100 million doses annually. The Institute has been a long-term partner supporting Oxford and was the main funder for the Phase III clinical trial, the university said.

The WHO said there is no evidence to suggest one vaccine performs better than the other, adding that the two have not been tested in a head-to-head trial. Last year, the Associated Press reported that the Bill and Melinda Gates Foundation ended direct financial support to RTS,S, saying it had lower efficacy than they wanted.

Public health experts lauded the breakthrough, but cautioned that a lot more needed to be done in the fight against malaria.

Gareth Jenkins, executive director of advocacy and strategy at nonprofit Malaria No More UK, said in a statement that it is vital for both vaccines to receive funding and support to reach children in need soonest.

“The reality is that malaria financing globally is far from where it needs to be and annual deaths from malaria rose during the pandemic and are still above pre-pandemic levels, so we cannot afford to be complacent as new tools are developed,” he said.