Biologics

Pfizer/BioNTech Studying Next Gen Covid Vaccine

Pfizer and BioNTech have begun a Phase 1 study of their next-generation Covid-19 vaccine that they say is designed to “enhance SARS-CoV-2 T cell responses and potentially broaden protection against Covid-19.” The study is part of the companies’ strategy to generate more robust, longer-lasting, and broader immune responses against Covid infections and severe illness. “As part of this approach the companies are developing multiple vaccine candidates with the aim of delivering a potential pan-SARS-CoV-2 vaccine,” they say in a news release.

The investigational vaccine, BNT162b4, comprises a “T cell antigen mRNA encoding for SARS-CoV-2 non-spike proteins that are highly conserved across a broad range of SARS-CoV-2 variants and will be evaluated in combination with the companies’ Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine,” they explain. “These non-spike proteins have been chosen based on BioNTech's proprietary target prioritization platform and were designed into a vaccine candidate with the purpose of enhancing and broadening T cell immunity and potentially extending durability of protection against Covid-19.”

The U.S. study (NCT05541861) is enrolling about 180 healthy individuals between 18 and 55 years of age, who have received at least three doses of an mRNA-based CoviD-19 vaccine. The trial will analyze different vaccine dose levels of the new vaccine administered in combination with a 30-µg dose of the companies’ Omicron BA.4/BA.5-adapted bivalent CoviD-19 vaccine and will be compared to the bivalent Covid-19 vaccine as a booster.

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

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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