Drugs

Positive Data on AstraZeneca Covid-19 Vaccine Trial

AstraZenca is reporting positive interim data from an the ongoing Phase 1-2 COV001 trial, which showed that its AZD1222 vaccine was tolerated and generated “robust immune responses against the SARS-CoV-2 virus in all evaluated participants.” Led by Oxford University, the trial involves 1,077 healthy adult participants and confirms that a single dose of AZD1222 resulted in a “four-fold increase in antibodies to the coronavirus spike protein in 95% of participants one month after injection,” the company says. The data also showed that a T-cell response was induced, peaking by day 14, and maintained two months after injection, it adds.

“Neutralizing activity against SARS-CoV-2 (as assessed by the MNA80 assay) was seen in 91% of participants one month after vaccination and in 100% of participants who received a second dose,” a company release says. Neutralizing antibody levels seen in participants receiving either one or two doses were in a similar range to those seen in convalescent Covid-19 patients, it says.

On the safety side, responses confirmed that transient local and systemic reactions were common in the AZD1222 group and were comparable to previous trials and other adenoviral vector vaccines, the company says. They included injection site pain and tenderness, mild-to-moderate headache, fatigue, chills, feverishness, malaise and muscle aches.

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