Biologics

More European Countries Temporarily Suspend Vaccine

There is a growing list of European countries that have temporarily suspended administering AstraZeneca’s Covid-19 vaccine due to concerns about reports of blood clots in people who received it. Denmark, Iceland, and Norway had earlier indicated a temporary hold on administering the two-dose vaccine. By Monday (3/15), Ireland, France, Germany, and Italy had made similar moves.

The suspension will likely last until 3/18, when the EMA is expected to release a review of the vaccine following reports of thrombosis among some recipients in Europe. A World Health Organization expert advisory committee is also looking into the matter. AstraZeneca said late Sunday that there is no scientific evidence of a causal link between the vaccine and recent deaths in Europe from blood clots.

A statement from EMA said the adverse events involving blood clots, some with unusual features such as low numbers of platelets, “have occurred in a very small number of people who received the vaccine. Many thousands of people develop blood clots annually in the EU for different reasons. The number of thromboembolic events overall in vaccinated people seems not to be higher than that seen in the general population.”

Last week, AstraZeneca said it was planning to seek an FDA emergency use authorization for the vaccine by early April after determining that it has met FDA data requirements. The company’s 32,000-person study has accumulated data on at least 150 cases of Covid-19, according to a Reuters report. As with the currently marketed Covid vaccines in the U.S., the number of Covid-19 cases among those who got the AstraZeneca vaccine compared with infections in those who received a placebo will determine how effective the vaccine is at preventing illness.

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