By Jennifer Rigby
LONDON (Reuters) - African countries are lining up to approve a new vaccine for malaria, with 20 million doses available for them to buy this year, the shot’s manufacturer told Reuters.
This week, Nigeria's medicines regulator followed Ghana's, with the two nations becoming the first countries in the world to back the new R21 vaccine, developed by scientists at Oxford University and manufactured by the Serum Institute of India and Novavax (NASDAQ:NVAX).
The move was unusual as it came before the World Health Organization's approval. African countries that do not have extensive resources for drug regulation have previously relied on the U.N. agency to initially review new medicines. Detailed data on the malaria vaccine from large-scale trials are not yet publicly available, and it is not clear how the poorest nations will pay for the shot.
But the urgency of addressing a disease that kills more than 600,000 people annually, most of them children under age 5 in Africa south of the Sahara, and recent efforts to enhance drug oversight in the region, are changing the process.
At least 10 other African countries' regulatory authorities are reviewing trial data to assess the shot and more of them are expected to approve it in the coming weeks, the WHO said at a high-level meeting this week.
"We expect many more countries to come through," Mary Hamel, the WHO's malaria vaccine implementation head, told the expert meeting on Tuesday. "They are sovereign countries that can make their own decisions for their vaccines.”
She did not name which countries may be next, although Tanzania and Kenya have strong regulators and among the highest rates of the disease.
Oxford scientist Adrian Hill, a lead developer of the vaccine, said the shot has remained around 70%-80% effective in late-stage trials. A malaria shot from GSK Plc, which has been authorized by WHO but has yet to become widely available due to lack of funding, is thought to be somewhat less effective.
Serum Institute Chief Executive Adar Poonawalla told Reuters his company will produce 20 million doses of the Oxford shot "at-risk" in the next two months. That means they do not yet have a buyer lined up among African governments or nonprofit organizations that often procure for poorer countries.
“We are committed to making the R21 vaccine available to people who need it most,” Poonawalla said.
The supply would be enough to inoculate 5 million children with the vaccine's 4-dose regimen and would be available in time for the upcoming malaria season, Poonawalla said, which begins in June depending on the country.
At $3 per dose, the supply is worth around $60 million. Serum declined to comment further on negotiations for the shot.
FUNDING DOUBTS
The moves are a further sign that African countries want to exert their own pharmaceutical oversight after COVID-19 exposed inequity in vaccine supply. They also want to reduce reliance on Western governments and companies by manufacturing life-saving drugs on the continent.
Serum, which produced the bulk of the COVID vaccine developed by AstraZeneca (NASDAQ:AZN) and Oxford, are in talks with a Ghanian producer, DEK Vaccines Ltd, to make some doses of R21 in Ghana in the long term.
Short-term, however, there are questions around funding the purchase and roll-out of the new malaria vaccine, which has a two-year shelf life, in poorer countries in Africa.
The two biggest buyers of childhood vaccines worldwide - Gavi, the Vaccine Alliance and UNICEF - want WHO approval for the shot before they will fund campaigns.
WHO said on Thursday that it had been given the final dossier of data on R21 last week and begun its assessment, which can take months.
WHO Director-General Tedros Adhanom Ghebreyesus told reporters in Cape Town on Thursday the process would be “expedited”.
“We will not waste even a day,” he said.
Senior health officials in Ghana and Nigeria have said there are additional hurdles to clear before the shots become available.
For example, Nigeria seeks further clinical trials before a wider rollout. Serum has in the past donated doses for such trials.