Biologics

Pfizer/BioNTech Covid Vaccine Begins Study

Pfizer and BioNTech have announced that the first participants have been dosed in the U.S. in a Phase 1/2 clinical trial for their BNT162 vaccine program to prevent Covid-19. As part of their global development program, the first cohort in Germany were dosed last week.

The Phase 1/2 study is designed to evaluate four mRNA vaccine candidates evaluated in a single, continuous study, according to the companies. Each candidate represents a different combination of mRNA format and target antigen. “The novel design of the trial allows for the evaluation of the various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious candidate in a greater number of volunteers, in a manner that will facilitate the sharing of data with regulatory authorities in real time,” they say. The dose level escalation portion (Stage 1) of the trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age), the companies say.

Pfizer and BioNTech also say they are working to scale up production for global supply. “Pfizer plans to activate its extensive manufacturing network and invest at risk in an effort to produce an approved Covid-19 vaccine as quickly as possible for those most in need around the world,” they say. Millions of vaccine doses could be available before the end of the year and awaiting regulatory approvals. The manufacturing volume can be scaled up produce hundreds of millions of doses in 2021. Pfizer-owned sites in three U.S. states (Massachusetts, Michigan and Missouri) and Puurs, Belgium have been identified as manufacturing centers for Covid-19 vaccine production, with more sites to be selected.

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