Breakthroughs Blog: CDC

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) has given 510(k) clearance to the BD Respiratory Viral Panel, an automated, multiplexed, and real-time PCR test that can be used to detect COVID-19, influenza A and B, and respiratory syncytial virus (RSV) from only one sample, which was developed with support from the Biomedical Advanced Research and Development Authority (BARDA). The panel runs on a BD system widely used by hospitals and labs across the United States that can process hundreds of samples a day and deliver results in two hours. By reducing the need for multiple tests to distinguish the cause of respiratory infections, the test will help patients receive appropriate care faster and reduce burdens on the health system, which is important as the United States faces the rising threat of these viruses over the coming months.FDA is expected shortly to approve updated versions of the COVID-19 boosters, which although originally designed to target the XBB.1.5. omicron subvariant should still protect against the currently circulating subvariants, as cases and hospitalizations linked to the new variants rise. While it remains unclear whether the agency will grant emergency use authorizations or full approval licenses, either will trigger the Centers for Disease Control and Prevention to make its recommendations for who should receive the shots, allowing vaccinations to likely begin soon in the United States.Ghana recently became the first country in Africa to manufacture a cholera vaccine. The private-sector pharmaceutical consortium DEK Vaccines Limited produced the vaccine, as well as six others, including against malaria, HPV, pneumonia, and rotavirus, which are expected to be available by 2026. This was made possible through a licensing and technology transfer agreement with the International Vaccine Institute (IVI). Scaling up local production of vaccines is seen as an important step toward enabling Ghana, the West African region, and the continent at large to reduce the critical shortage of vaccines and reliance on foreign countries and companies and to ensure greater access to vaccines that protect against endemic diseases.

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 landmark study published in The Lancet Infectious Diseases confirmed that the benefits of combining the RTS,S malaria vaccine with preventative antimalarial drugs in settings of high seasonable malaria transmission continue over five years. Specifically, the study found that the vaccine-drug combination reduced severe malaria cases and deaths in young children by nearly two-thirds compared to either RTS,S vaccination or seasonal malaria chemoprevention alone and that the efficacy of RTS,S in preventing malaria in highly seasonal settings was similar to seasonal malaria chemoprevention. These results underscore the importance of integrating multiple prevention tools into existing malaria control efforts to alleviate the remaining burden of malaria.The US Department of Health and Human Services (HHS) announced recipients for the first $1.4 billion round of funding for Project NextGen, the successor to Operation Warp Speed, which includes awards to develop more effective and longer-lasting COVID-19 vaccines, a new monoclonal antibody, and technologies to streamline manufacturing. Regeneron, the Global Health Investment Corporation, and Johnson & Johnson Innovation are among the first group of recipients. HHS said these awards are a catalyst to kick staff research and anticipates announcing additional awards for the $5 billion program by the end of the year.  The US Food and Drug Administration (FDA) last week approved Abrysvo, Pfizer’s respiratory syncytial virus (RSV) vaccine for pregnant people, which is aimed at protecting newborns from the virus in their first six months of life. The announcement follows the agency’s approval of Abrysvo for adults 60 and older. The US Centers for Disease Control and Prevention is expected to recommend the vaccine soon, hopefully setting the country up for a healthier fall and winter season ahead with AstraZeneca and Sanofi’s Beyfortus RSV monoclonal antibody for infants also approved earlier this summer and updated COVID-19 shots expected in the coming weeks. 

In recognition of World Mosquito Day on August 20, 2023, GHTC is testing our readers’ knowledge of mosquito-borne diseases and ongoing efforts to develop treatments, vaccines, vector-control innovations, and other tools to outsmart the world's deadliest animal. Test your knowledge by taking the quiz below!

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.