In September 2022 the Bill & Melinda Gates Foundation announced its investment in the “development and accessibility” of vaccines for Group B Streptococcus (GBS) and Respiratory Syncytial Virus (RSV). GBS and RSV are “two of the leading causes of death” among new-borns and young children across lower-income countries.
The Gates Foundation reports that “more than 45% of all deaths in children under 5 occur within the first 4 weeks of life”. GBS causes around 90,000 new-born deaths and 46,000 stillbirths a year. RSV causes “at least 100,000 infant deaths” each year. Most of these happen in low- and middle-income countries. This is because there are no vaccines available and “treatment is too often out of reach in lower-income settings”. GBS “strikes” just before birth or in the first 3 months of a child’s life. RSV is most dangerous in the first 6 months of life.
“GBS and RSV are particularly devastating in lower-income countries where access to timely and effective medical care can be a challenge.”
Thus, vaccines are in development to immunise the mother so that she can share her antibodies with the baby before birth. Professor Shabir Madhi is director of the SAMRC Vaccines and Infectious Diseases Analytics Research Unit at the University of the Witwatersrand. He has first-hand experience of the effect that maternal immunisation can have in reducing infant mortality.
“Without multisectoral collaborations like these, advancement of vaccines that could help end preventable new-born and early-infant deaths in low- and middle-income countries simply would not happen.”
Pfizer accepts the challenge
As there are currently no vaccines for these infections, the need to develop some is pressing. Pfizer is hoping to advance this. If successful, a GBS vaccine could also be the “first vaccine developed with a primary purpose for use during pregnancy to prevent infections in new-borns and young infants”. Previous vaccines for use during pregnancy have demonstrated safety and efficacy. The hope is that the development and efforts to increase access to GBS and RSV vaccines could “contribute towards the global goal of ending preventable deaths” by 2030.
Dr Annaliesa Anderson of Pfizer remarked on the “profound impact” that these vaccines could have if they are successful and approved. Pfizer’s Accord for a Healthier World programme is “focused on establishing access” to their life-saving medicines and vaccines. The Gates Foundation support will “enable faster and more equitable deployment” to the regions that need the vaccines most.
The Gates Foundation reported that a $100 million grant will “support the manufacturing of Pfizer’s GBS vaccine for Phase III clinical trials”. If this is successful it will further contribute to WHO prequalification.
“It will also help fund the development of an affordable multidose vial for delivery of the vaccine in lower-income countries via public-sector purchases, including Gavi”.
The grant builds on a previous $17 million investment to support Phase I/II trials exploring whether protective antibodies could be transferred from immunised mothers to babies.
The grants are “anchored” in the Gates Foundation’s principles of the Global Access Policy. This “ensures that knowledge generated from these efforts can be promptly and broadly disseminated and any resulting products can be made available and accessible at an affordable price”.
Dr Keith Klugman of the Gates Foundation believes maternal immunisation is a “powerful way to reduce new-born and infant mortality”. Unfortunately, innovation has too long been “underprioritized and underfunded”.
“We are hopeful our investments in this promising pipeline of new maternal vaccines, including these two grants, will help infants in low-income settings have the best chance at life.”
For more on an experimental RSV vaccine click here.
To hear more about efforts to reduce the effects of RSV come to the World Vaccine Congress in Europe 2022.