Biologics

J&J Juggling Several Covid Vaccine Issues

Georgia, North Carolina, Iowa and Colorado health officials have reported adverse reactions observed at vaccination sites after administering Johnson & Johnson’s Covid-19 vaccine. In Georgia, one individual was evaluated at a hospital and then released, and seven others were monitored and then sent home. In North Carolina, health officials said that multiple people fainted after receiving the vaccine. The Centers for Disease Control and Prevention is investigating the incidents, according to health officials.

On Friday (4/9), the European Medicines Agency (EMA) said it was investigating thromboembolic events that occurred after vaccination with the J&J vaccine. “Four serious cases of unusual blood clots with low blood platelets have been reported post-vaccination with Covid-19 Vaccine Janssen,” it said. “One case occurred in a clinical trial and three cases occurred during the vaccine rollout in the USA. One of them was fatal.”

The vaccine was authorized in the EU on 3/11 and the rollout is expected in the next few weeks. “The reports point to a ‘safety signal’, but it is currently not clear whether there is a causal association between vaccination with Covid-19 Vaccine Janssen and these conditions,” the EMA says.

Meanwhile, after an incident at J&J’s contract manufacturer Emergent BioSolutions’ facility in Baltimore last week, which saw workers accidentally mixing ingredients of vaccines from AstraZeneca and J&J, the U.S. is allocating only 785,000 doses of the J&J vaccine next week to states, down from 4.95 million doses this week.

Johnson & Johnson says it still expects to fulfill its contract for 100 million doses delivered to the U.S. government by the end of May.

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