It took decades, but vaccines for Respiratory Syncytial Virus (RSV), a common respiratory virus that can be serious or deadly in infants and older people, are finally becoming available. On May 3, the US Food and Drug Administration (FDA) approved Arexvy, the first RSV vaccine for adults aged 60 or older, made by GSK.
A second candidate follows closely: Made by Pfizer, it would cover older people and pregnant ones, functioning as a maternal vaccination that would cover children in the first months of life when RSV is most dangerous. The vaccine is expected to be approved in the US by August and become available in Europe a few months after that.
But, despite Pfizer’s promises to do better with regard to vaccine equity after covid, it increasingly looks like the vaccine won’t be available in low- and middle-income countries in the near future. The vast majority of the yearly 100,000 to 200,000 global infant deaths due to RSV occur in the Global South, making the virus the second leading cause of deaths in children below five, after malaria. Yet it may take as long as seven years for the maternal vaccines to be available there.
Pfizer’s long delay
Pfizer expects the global market for its RSV vaccine to be about $2 billion. It received a $27.5 million grant from the Gates Foundation to support the vaccine distribution in low- and middle-income countries, for purchase by governments and international organizations.
Yet it will likely take years for that to happen. In order to be distributed outside rich countries, the vaccines need adjustments—multi-dose vials, for instance, which are cheaper and more efficient to distribute in areas where transportation may be a challenge. The vials require preservatives, so there is a need for specific trials to ensure efficacy and safety are maintained.
Pfizer, Reuters reports, is only starting to plan for its low-income country distribution now. When contacted by Quartz, the company declined to provide a timeline for making RSV vaccines available in the Global South, but pointed out that it launched a program in August 2022 to make all its vaccines available in 45 lower-income countries on a not-for-profit basis. The program doesn’t have a specific timeline attached to RSV.
Too little too late
The challenges of distribution in lower-income countries are real, but in no way new. Nor are they new for Pfizer. Since 2010, the company has been sitting on the board of the Gavi, the international organization that subsidizes vaccine distribution for low- and middle-income countries, so it is definitely aware of what’s required. Further, Pfizer is currently facing the same hurdles it encountered a decade ago with its pneumococcal vaccine. First approved by the FDA in 2010, the vaccine took several years to be distributed in the Global South. One would hope Pfizer learned lessons about faster vaccine delivery from that process.
“They should have started planning this from day one when they thought that vaccine was successful,” says Nina Schwalbe, a professor at the Mailman School of Public Health at Columbia University. The high mortality rate of RSV in low-income countries should have made it a priority, she says.
Pfizer likely started planning RSV vaccine introduction in the US as soon as the candidate showed promise, and should have done the same when it comes to the Global South, starting trials for multi-dose vials, cold chain stability, and other needs long before it received the Gates Foundation grant, says Schwalbe.
“It’s an issue of priorities and incentives within the company about what matters—and what matters is prioritizing profit again,” she says.