BARDA-supported multiplex diagnostic test for COVID-19, flu, and RSV receives FDA-clearance
MedicalCountermeasures.gov (9/7), features Becton, Dickinson and Company (BD)
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 could greenlight new Covid boosters as early as Friday
NBC News (9/6)
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.
Africa: Ghana manufactures first cholera vaccine in Africa
Ghanaian Times (9/4), features the International Vaccine Institute (IVI)
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 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.