Seychelles has seen rising numbers of COVID-19 cases despite 61% of its population being fully vaccinated as of May 8, calling into question the effectiveness of the COVID-19 vaccines used by the island nation.
To accelerate drug development targeting the pandemic, the FDA issued final guidance May 17 on master protocols for drugs intended to prevent or treat COVID-19 infections. Although the guidance is geared toward developing COVID-19 drugs, the FDA said it expects master protocols to continue to play an important role in addressing the public health needs in future pandemics.
LONDON – Delaying the second dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine significantly increases the antibody response in people ages 80 to 99, compared to the approved schedule of two doses three weeks apart, according to the latest data from the U.K. coronavirus immunology consortium.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Becton Dickinson, Crannmed, Labcorp, Zoll Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biotheranostics, Caregility, Diaceutics, Genetron, Halberd, Health Recovery Solutions, Hologic, Identifysensors Biologics, Osi Systems, Second Sight Medical Products, Seracare Life Sciences, Spacelabs Healthcare.
Roughly a year and a half after the start of the COVID-19 pandemic, many unknowns remain about the future of the virus. How it will mutate, how long protection from either illness or vaccination will last, when it will cease to be a pandemic and instead be endemic, even whether the worst is still ahead. And there is also an increasing acknowledgment that there remain unknowns about SARS-CoV-2’s past.
LONDON – Initial results from the U.K. randomized trial assessing mixed COVID-19 vaccine schedules show there is a significant increase in systemic side effects with one dose of Astrazeneca plc’s and one of Pfizer Inc./Biontech SE’s vaccines (in either order), compared to receiving two doses of the same vaccine.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied DNA, Bioecho Life Sciences, Desktop Health, Chordate Medical, Endologix, Johnson & Johnson Vision, Qiagen.