Drugs

Pfizer Seeking Covid-19 Vaccine Full Approval

Pfizer says it will ask FDA by the end of the month to convert its Covid-19 vaccine’s emergency use authorization to a full BLA approval. The submission will include safety and efficacy data through six months, according to the company. In April, Pfizer and development partner BioNTech announced the six-month data from an ongoing Phase 3 study showing the vaccine was 91.3% effective against Covid-19. It was also shown to be 100% effective against severe disease, and 95.3% effective against severe Covid-19. “Safety data from the Phase 3 study has also been collected from more than 12,000 vaccinated participants who have a follow-up time of at least six months after the second dose, demonstrating a favorable safety and tolerability profile,” it says.

Additionally, Pfizer says it will conduct a study on the safety and immunogenicity of co-administration of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate with a booster dose of the Covid-19 vaccine for use as early as this fall or winter. Results of the study are expected in the third quarter and could potentially inform the government’s recommendations and guidelines surrounding the co-administration, it says.

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