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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. The Pfizer-BioNTech COVID-19 vaccine’s effectiveness among children ages 5 to 11 wanes over time but continues to protect against the most severe outcomes, according to new real-world evidence released last week. Analysis from the US Centers for Disease Control and Prevention, summarizing data from ten states, suggested that while vaccine effectiveness faded during omicron and generally decreases relative to the time since vaccination, the vaccine was protective against hospitalization and death in 5-to-17-year-olds, even after omicron emerged. A preprint study by the New York State Department of Health, also published last week, showed a substantial decline in protection among the younger age group in the state, including a significant decline in protection against hospitalizations. The new data comes amid developments involving vaccines for children under 5, which the US Food and Drug Administration plans to wait to review until data on third doses is available.The Biden administration plans to share government-backed COVID-19 technology with the World Health Organization (WHO) to help bolster access to medicines in low- and middle-income countries. The technologies, developed by the National Institutes of Health (NIH), would be licensed to the WHO’s COVID-19 Technology Access Pool as well as sublicensed through the United Nations-backed Medicines Patent Pool. Details on which technologies would be made available through the deal are still being determined, but the policy is not intended to apply to vaccines and therapeutics in the US market developed by private companies. Sharing NIH-devised technologies is meant to allow other countries to replicate the manufacturing process and therefore more quickly boost the global stockpile of pandemic supplies.On Wednesday, a WHO panel backed the use of Merck & Co., Inc.’s COVID-19 antiviral pill for high-risk patients. The recommendation, based on new data from six clinical trials involving 4,796 patients, conditionally endorses the pill, molnupiravir, for use among patients with non-severe disease who are at high risk of hospitalization. This could include immunocompromised individuals, the unvaccinated, older people, and those with chronic diseases. No recommendation has been made for use of the pill among patients with severe or critical illness, as there is no trial data for the group. The WHO panel is also preparing recommendations for Pfizer’s COVID-19 antiviral pill, Paxlovid.

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.

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. A third person appears to have been cured of HIV, scientists announced last week, using a new treatment method involving umbilical cord blood. Cord blood is more widely available than the adult stem cells used in bone marrow transplants—the method used for the previous two patients cured of HIV—and does not need to be matched as closely to the recipient. The patient, a mixed-race woman who also had leukemia, received the cord blood to treat her cancer in August 2017. She discontinued antiretroviral therapy 37 months after the transplant, and now, more than 14 months later, shows no signs of HIV in blood tests and does not seem to have detectable antibodies to the virus. The news opens up the possibility of curing more people of diverse racial backgrounds than was previously possible, scientists said.BioNTech plans to set up modular mRNA vaccine facilities to produce its COVID-19 vaccine, codeveloped with Pfizer, in Rwanda and Senegal, with a fill-and-finish collaboration in Ghana. The initiative involves modular factories, dubbed “BioNTainers,” that consist of one drug substance and one formulation module, each of which is built from six standard shipping containers fitted with the necessary equipment. The first containers will be delivered in mid-2022, and the first vaccine batches will be produced in the following months. The facilities will be equipped to manufacture a range of mRNA-based vaccines, including BioNTech’s investigational malaria and tuberculosis vaccines if successfully developed and authorized by regulatory authorities.Dr. Robert Califf was officially confirmed as commissioner of the US Food and Drug Administration (FDA) last week after a 50–46 Senate vote, the narrowest confirmation in the history of votes to lead the agency. The FDA has been without a permanent leader for nearly 400 days, instead being led by an acting commissioner, Janet Woodcock, who will now serve as principal deputy commissioner under Califf. Califf, a cardiologist and researcher, was nominated for the role by President Joe Biden in November and will take the helm at the FDA for the second time, having previously held the role during the final year of the Obama administration. Califf was officially sworn in as commissioner on Thursday.