Top News in R&D





 Global Health Technologies Coalition 


R&D News Roundup: May 8, 2023


Top News in R&D

US FDA approves first-ever RSV vaccine
Health Policy Watch (5/4)
Additional coverage from STAT (5/3) and The Washington Post (5/3)

The US Food and Drug administration (FDA) last week approved the first-ever vaccine for respiratory syncytial virus (RSV). GSK’s Arexvy vaccine is a single shot intended for use in adults aged 60 and older and could be available as soon as fall of this year, as long as the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices provides further approval. RSV, which has an annual global death toll of 160,000 people, has challenged vaccine researchers for six decades. Building on those years of efforts, GSK’s Arexvy showed strong results in an ongoing trial of nearly 25,000 adults. Further FDA approvals for RSVP vaccines developed by Pfizer, Moderna, and Bavarian Nordic could follow soon, with the decision on Pfizer’s candidate expected as soon as this month.

Gates Foundation commits $200M to develop affordable childhood vaccines
Devex (5/3), features the Bill & Melinda Gates Foundation and PATH

Last week at the 2nd Global Forum on Childhood Pneumonia in Madrid, Spain, the Bill & Melinda Gates Foundation announced a nearly US$200 million commitment, to be awarded over the next year and a half, to support the development and delivery of affordable vaccines for some of the leading causes of childhood mortality, including pneumonia, meningitis, neonatal sepsis, and RSV. This includes supporting a more affordable next-generation pneumococcal conjugate vaccine, Pneumosil, developed by the Serum Institute of India and PATH and advancing a Group B streptococcus vaccine entering phase III trials later this year. The foundation is partnering with the companies developing these vaccines to ensure they are available and affordable to Gavi and low- and middle-income countries, therefore narrowing the gap between the rollout of vaccines in high-income and Gavi-supported countries.

One dose of HPV vaccine prevents infection for at least three years
The New York Times (5/2), features the Gates Foundation

A new gold-standard clinical trial in Kenya showed that a single dose of the human papillomavirus (HPV) vaccine may be as effective as two or three doses over at least three years. Deploying a single-dose strategy could dramatically lower the rates of cervical cancer and other associated diseases, as well as extend vaccine supplies, lower costs, and simplify distribution, especially in low- and middle-income countries. At least 24 countries have already shifted to a one-dose approach, and this trial could make it a more widely adopted strategy, which the World Health Organization estimates could prevent 60 million cervical cancer cases and 45 million deaths worldwide over the next 100 years.



News from GHTC

Opinion: Time to bridge the funding gap to achieve zero malaria
Health Policy Watch (5/3), features the Gates Foundation

USPSTF maintains recommendation of latent TB infection screening for at-risk people
360Dx (5/3), features the Infectious Diseases Society of America

COVAX vaccines helped avert 2.7 million COVID deaths – but could have saved more with stable regional supplies
Health Policy Watch (5/2), features the Coalition for Epidemic Preparedness Innovations

Following Kenya, Malawi appears ready to ratify the African Medicines Agency treaty
Health Policy Watch (5/1), feature PATH



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