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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. Last week, an advisory committee to the US Centers for Disease Control and Prevention (CDC) recommended that Pfizer’s COVID-19 vaccine be offered to adolescents between the ages of 12 and 15, following the vaccine’s authorization for this age group by the US Food and Drug Administration earlier in the week. CDC Director Rochelle Walensky adopted the recommendation later Wednesday, clearing the way for vaccine clinics to begin to vaccinate 12-to-15-year-olds. The recommendation was based on data indicating the vaccine was protective for this age group; in a trial of 2,260 adolescents, there were 18 confirmed cases of COVID-19 among those who received a placebo and no confirmed cases among those who received the vaccine.A newly established COVAX Supply Chain and Manufacturing Task Force will seek to jump-start global vaccine manufacturing capacity with a three-stage plan to enhance existing production capacity, as well as develop a new vaccine manufacturing group to bolster production in the long term. The plan seeks to address immediate manufacturing bottlenecks by identifying and matching “fill and finish” manufacturers with producers of active ingredient, accelerating approvals of export permits and customs clearances, and facilitating partnerships for the supply of vital vaccine inputs. The longer-term goals will include developing a manufacturing workforce to maximize more production using existing systems and expanding production capacity in low- and middle-income countries.Adults over 50 who received mixed types of COVID-19 vaccines for their first and second doses were more likely to report mild and moderate side effects, according to early results from a trial in the United Kingdom. The trial is evaluating whether mixing doses of the AstraZeneca and Pfizer vaccines might provide longer-lasting immunity or better protection against new variants. The findings showed more reports of chills, fatigue, headache, joint pain, malaise, and muscle aches among participants who received two different vaccines than those receiving two doses of the same vaccine, but no other safety issues were identified. Further data, including on whether and how the immune response is affected, could be released in the coming months as the studies continue.

GHTC delivered the following statement, on the 74th World Health Assembly (WHA) agenda item 13.5, antimicrobial resistance (AMR), on May 13, 2021 at the US Department of Health and Human Services (HHS) WHA stakeholder listening session:The Global Health Technologies Coalition appreciates the opportunity to comment on the antimicrobial resistance agenda item ahead of the World Health Assembly. The pandemic has exacerbated the fight against AMR, as COVID-19 and other competing global priorities are reducing activities aimed to address AMR while increasing the use of antibiotics. Secondary infections further complicate treatment for patients with COVID-19, particularly those with severe illness. Health services including treatment and immunization campaigns have been disrupted, research and clinical trials have stalled, and investments have been reallocated. This has increased the risk of greater antimicrobial misuse and resistance globally, with fewer tools to address this growing threat.The WHO director-general’s report highlights that there is a critical need for additional financing to strengthen country and regional office technical capacities to control the emergence and spread of AMR and to invest in global research and development (R&D). More resources are needed to strengthen access and stewardship of existing and new health technologies in countries with high AMR burdens.We call on all on the US to increase investment and innovation in quality-assured, new, and improved antimicrobials, novel compounds, diagnostics, vaccines, and other health technologies to fight AMR. There are few new antibiotics in clinical development and waning private investment, and we must take urgent action to support the fragile antibiotic pipeline. Innovations should be developed with the most vulnerable populations in mind and be appropriate and accessible to all who need them, including for those in low-resource settings.To increase investment in the clinical development of antimicrobial treatments and diagnostic tools, we also urge the US and other stakeholders to advance policies necessary to revitalize discovery and product development. Incentives for R&D that secure both stewardship and returns and public investments should be conditioned upon the accessibility of novel technologies to fight AMR.

GHTC delivered the following statement, on the 74th World Health Assembly (WHA) agenda item 13.4, global strategy and plan of action on public health, innovation, and intellectual property (GSPOA), on May 13, 2021 at the US Department of Health and Human Services (HHS) WHA stakeholder listening session:The Global Health Technologies Coalition appreciates the opportunity to comment on the global strategy and plan of action on public health, innovation and intellectual property (GSPOA) ahead of the World Health Assembly. As outlined in the WHO review panel’s report, although progress has been made in certain aspects of both innovation and access, many of the challenges that motivated formulation of the GSPOA remain, and the COVID-19 pandemic has exposed both long-standing shortcomings as well as new challenges. These include a lack of new health products in areas of need, the unaffordability of many new medicines and other health technologies, ineffective delivery and supply chain infrastructure, and the absence of robust regulatory frameworks, primarily but not exclusively in low-income countries. To address these challenges, and to ensure faster access for patients to safe and effective products, we urge the US to continue to support the World Health Organization (WHO) and bolster the organization’s ability to strengthen the capacity of national and regional regulatory functions and systems, including improving late-stage clinical trial regulatory review and oversight. Promoting global and regional harmonization of regulatory functions could also be instrumental in ensuring regional resources are coalesced toward meeting shared goals in this area, and hopefully speeding up regulatory approval processes.We also urge the US delegation to support the efforts being advanced to strengthen the local production of medicines and health technologies. The COVID-19 pandemic has underscored the risk of overreliance on international health supply chains, imported medicines and other health technologies and donor support. The current draft resolution being co-sponsored by multiple African countries calls for member states to support regulatory systems strengthening, access to sustainable and affordable financing, and development of skilled human resources. We urge the US to work with other WHO member states and partners to promote sustainable local production to improve access to quality, safe, effective and affordable medicines and other health technologies.Lastly, we support the recommendation outlined by the review panel calling on WHO to develop target product profiles for missing antibiotics, diagnostics tools for priority pathogens, and medical devices including personal protective equipment.