Breakthroughs Blog: FDA

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 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.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.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.

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, a US Food and Drug Administration (FDA) advisory panel recommended approval of two vaccines for respiratory syncytial virus (RSV) for adults 60 and older, one by Pfizer and one by GlaxoSmithKline. The agency could grant formal approval to the vaccines in the coming months, making them the first shots available against RSV, a disease responsible for significant deaths and hospitalizations among older adults and young children. Other vaccines, as well as monoclonal antibody treatments, also in the pipeline could additionally address the yearly burden of RSV.The US Centers for Disease Control and Prevention (CDC) has issued a warning about a rise in extensively drug-resistant cases of Shigella, especially in gay and bisexual men, in the United States and other countries. Shigella is a highly infectious bacterial infection that causes an inflammatory diarrheal condition and is spread when infected fecal matter enters the mouth or nose. The European Centre for Disease Prevention and Control also released an alert about possible cases among recent travelers. Doctors have faced major challenges in identifying viable alternative antibiotics to treat these cases, underlining the need for greater focus on the research and development of new antibiotics.This year’s Conference on Retroviruses and Opportunistic Infections saw a myriad of presentations on how best to expand global access to the cabotegravir, or CAB-LA, which is a long acting, injectable form of preexposure prophylaxis (PrEP) used to prevent HIV infection. CAB-LA joins oral PrEP and the recently approved dapivirine vaginal ring as a third safe and effective biomedical HIV prevention option, for the first time allowing people an authentic choice among products. However, to ensure access and availability of these products, there remains a need for additional research on the use of CAB-LA in certain patient populations, including among people who inject drugs, and further research on effective delivery methods to expand uptake of oral PrEP.

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 World malaria report 2022, published last Thursday, found that progress in the fight against malaria has been steady, despite setbacks due to the COVID-19 pandemic. In order to strengthen the global response to malaria, investment is needed to close the funding gap and ensure money is available for the research and development (R&D) of new tools. There is a robust R&D pipeline of innovative technologies for malaria control including new long-lasting bednets, diagnostic tests, next-generation medicines, and other vaccines that will be essential to address the growing challenges of antimicrobial resistance and the spread of the Anopheles stephensi malaria vector in urban areas.Despite rising COVID-19 cases in the United States, no monoclonal antibodies treatments are available for use as the US Food and Drug Administration paused the emergency authorization for the last remaining antibody treatment developed by Eli Lilly because it is not as effective against newer variants. There are other medications aimed at preventing COVID-19 that are currently authorized, including Evusheld and Paxlovid, but these treatments may not be as effective against new variants and may not be available for everyone. New antiviral treatments are in development, including one drug developed by researchers at the Dana-Farber Cancer Institute and another by Shionogi, which has received emergency authorization in Japan.The spread of Sudan ebolavirus in Uganda has slowed dramatically, raising questions about whether the trial testing vaccine efficacy that was expected to begin shortly can go on due to reduced numbers of potential participants. A cancelled trial would be considered by many a loss given the incredible amount of effort that has gone into securing the vaccines, permissions, and funding for the trial, as well as the interest in testing new vaccines that could be effective against Sudan ebolavirus. Looking forward, stockpiling experimental vaccines and pre-agreed trial protocols could ensure readiness for any future Sudan outbreaks.

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, Pfizer announced promising results from their late-stage clinical trial for an experimental vaccine candidate for respiratory syncytial virus (RSV), which has been causing serious concern in recent weeks. The vaccine was administered to pregnant individuals with the goal of protecting infants upon their birth. The trial found that the vaccine candidate was 82 percent effective against severe illness for infants in their first 90 days and 69 percent effective through their first six months. The Pfizer vaccine is one of several candidates that are expected to undergo review from the US Food and Drug Administration later this year.As the Ebola outbreak in Uganda continues, three experimental vaccine candidates aimed at protecting against the Sudan strain of the virus (for which there are no approved vaccines) have been sent to Uganda to be administered to people and to help generate more data for clinical trials. The candidates include one vaccine developed by Oxford University and manufactured by the Serum Institute, one developed by the National Institute of Allergy and Infectious Diseases and licensed to the Sabin Vaccine Institute, and one candidate from Merck. Doses of all three vaccines will be deployed to Uganda through a joint effort with the World Health Organization and the United States Centers for Disease Control and Prevention in the coming weeks and months.A new study conducted in Mali showed that a single dose of monoclonal antibodies provided protection from malaria infection for up to six months. While monoclonal antibodies are notoriously expensive to produce and complex to administrate, the lab-made antibodies employed in the study could prove to be a key tool to protect children and pregnant individuals in the fight against malaria, at least in the short-to-medium term. This study follows another last year, which showed that intravenous administration of the antibody prevented infection in all nine participants.