Biologics

FDA Moving to Annual Covid Strain Selection Like Flu

FDA is proposing to move to a flu vaccine-type model to have its vaccines advisory committee annually select Covid-19 strains in June for immunizations beginning no later than September each year. The agency says that if a serious “pathogenic vaccine-escape variant” begins circulating then an ad-hoc strain selection advisory committee meeting would be held to determine whether to adjust the current Covid vaccine. An advisory committee meeting 1/26 will discuss the new strategy, in addition to whether it recommends using the same vaccine strain composition for the primary vaccination series and booster doses, and how to simplify Covid-19 immunization schedules.

“Given the evolution of SARS-CoV-2 variants and associated changes in the epidemiology, susceptibility to reinfection, and waning of vaccine-induced immunity, barring development of a significantly improved vaccine, periodic future updates to the S protein sequence(s) contained or encoded in Covid-19 vaccines and revaccination will likely be needed to induce and maintain vaccine effectiveness (VE), respectively,” FDA says in a briefing document released in advance of the meeting.

Additionally, the agency says current data on prior exposure to and vaccination against SARS-CoV-2 suggest that most people may only need to receive one vaccine dose annually to restore Covid-19 immunity protection. However, it says, two doses “may be needed to induce the expected protective immunity for those who have a low likelihood of prior exposure (the very young) or those who may not generate a protective immune response (older and immunocompromised individuals).”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome