Research Roundup: Pfizer-BioNTech shot in kids, shared NIH technology, and an antiviral for high-risk patients

International Women’s Day calls for action to address biases, discrimination, and inequities that continue to impact the quality of life of women and girls, including their access to healthcare, such as malaria prevention and treatment. Pregnant women and their babies are among the most at risk from malaria, and this is exacerbated by their limited access to antimalarial medicines. According to the World Health Organization (WHO), in 2020, nearly 12 million pregnant women were exposed to malaria, and they are particularly vulnerable as pregnancy can weaken their immune system. Malaria can have devastating effects on pregnant women and infants, from mothers with severe anemia and babies born with low birth weight to, in the worst case, the death of the mother and/or baby. According to research from 2020, one in ten maternal deaths in malaria-endemic countries is the result of malaria. WHO recommends intermittent preventive treatment in pregnancy (IPTp) to prevent malaria in pregnancy. Ideally, eligible pregnant women should receive three doses of sulfadoxine-pyrimethamine (SP) to prevent malaria in their second and third trimesters for optimal protection. Due to several factors, only 32 percent of eligible pregnant women received all three recommended doses of IPTp in the 33 sub-Saharan African countries assessed by WHO’s 2021 World Malaria Report. A 2019 review that looked at determinants of IPTp uptake in 18 sub-Saharan African countries found that poor policy implementation resulting from weak coordination between national malaria control and reproductive health programs and stockout of quality SP were the main barriers. The review also mentioned the pivotal role played by health providers in delivering IPTp, highlighting the correlation between their awareness of the policy and the IPTp coverage. In sub-Saharan Africa, between 70 and 90 percent of pharmaceuticals are imported, making it difficult to ensure a steady supply of treatments like SP. To help remedy this access gap, Medicines for Malaria Venture (MMV) is currently leading a UNITAID-funded project to enable the pharmaceutical companies Universal Corporation Ltd (Kenya), Swipha/Biogaran (Nigeria) and Emzor (Nigeria) to manufacture quality SP, not only for domestic use, but also for other countries in Africa. Community IPTp (C-IPTp) is another solution to help address the access gap, in which pregnant women visit “purposely trained and supervised, easily accessible community health workers” close to their homes to receive IPTp. C-IPTp is being explored by many countries with promising results in improving SP uptake. MMV is also involved in Transforming Intermittent Preventive Treatment for Optimal Pregnancy, otherwise known as TIPTOP, a Jhpiego-led project to increase the number of women able to benefit from C-IPTp.Under the umbrella of the Roll Back Malaria Partnership, MMV is participating in a signature campaign calling for global leaders to Speed Up Scale-Up IPTp through an open letter that asks for increased funding to address malaria in pregnancy, proper training for health care workers and the removal of the previously mentioned barriers to seeking care. Beyond statistics: Surviving malaria in pregnancy The need for new options for medicines is underscored by Eileen Buxton’s experience. Eileen, a Ghanaian nurse, was already aware of the risks of malaria in pregnancy as a health care worker in an endemic country. After falling ill while pregnant herself, Eileen “was scared… I knew how being sick during pregnancy could affect the mother and the child too.” She was admitted to a hospital for treatment. After her release, however, the fever came back within a couple of days. Eileen was experiencing severe malaria and had to be admitted to the hospital again, this time for about three weeks. “It took a long time for me to recover some strength,” she recalls. Despite this harrowing experience, Eileen can be described as one of the fortunate ones: after her recovery, she gave birth to healthy twin babies. Millions of women are not so lucky. Scaling up IPTp-SP access will prevent millions of women from going through experiences like Eileen’s. While International Women’s Day highlights women’s achievements, it is also a reminder of the existing challenges they face. When it comes to health and malaria specifically, it is also a reminder that we have not yet reached equity. Ending malaria means working to provide access to antimalarial prevention and scaling up access to IPTp and other treatment methods that are effective and safe for all people—like Eileen Buxton—who are most at risk. Ultimately, that’s a win for everyone. We urge you to add your name to the open letter and help protect more mothers and babies from malaria.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Sanofi and GlaxoSmithKline (GSK) plan to submit their COVID-19 vaccine for authorization following strong phase 3 trial results, the companies announced Wednesday. The two-dose adjuvanted protein-based vaccine showed 100 percent efficacy against severe disease and hospitalization and 57.9 percent overall efficacy against symptomatic COVID-19 disease, which, while lower than rates originally reported for other vaccines, reflects efficacy expectations in an environment now dominated by variants of concern, the companies said. The vaccine can also be used as a booster, including in people who originally received an mRNA vaccine, and is stable at refrigerator temperatures, making it more suitable to reach low-resource settings than vaccines with stricter cold-chain requirements. Sanofi and GSK are submitting the vaccine for authorization from the US Food and Drug Administration and the European Medicines Agency.  An international trial will investigate COVID-19 booster shots administered at reduced dosages in an effort to increase global access to vaccines. The trial, supported by the Coalition for Epidemic Preparedness Innovations, will test boosters of the Pfizer-BioNTech, Moderna, and Oxford-AstraZeneca vaccines among up to 3,300 healthy adults across Australia, Indonesia, and Mongolia. Results are expected to provide data on the merits of vaccinating with fractional booster doses of the COVID-19 vaccines and offer information on whether fractional doses produce fewer side effects, which could guide future vaccination strategies. The three booster vaccines being tested have received emergency use listing from the World Health Organization (WHO) and are being supplied to the COVAX vaccine-sharing initiative.WHO is establishing a new global biomanufacturing training hub in South Korea to support production of biologicals, including vaccines and monoclonal antibodies, in low- and middle-income countries. The hub, to be located in a large facility outside Seoul that is already providing biomanufacturing training for companies based in the country, will provide technical and hands-on guidance to trainees from around the world and complement specific trainings developed by the mRNA vaccine technology transfer hub recently established in South Africa. The WHO Academy will work with the Korean Ministry of Health and Welfare to develop a comprehensive curriculum on general biomanufacturing. South Korea plans to start training 370 professionals from Asia, Africa, and South America in July.