Biologics

Pull IPOL Polio Vaccine Until Better Trial Held: ICAN

The Informed Consent Action Network (ICAN) is petitioning FDA to withdraw or suspend approval for the polio vaccine IPOL for infants, toddlers, and children “until a properly controlled and properly powered double-blind trial of sufficient duration is conducted to assess the safety of this product.” The petition says the clinical trials the agency relied on to license the vaccine did not include a control group and only assessed safety for up to three days after injection.

ICAN says the IPOL trials did not comply with the applicable federal statutory and regulatory requirements necessary to prove the product was safe prior to licensure.

The petition says the only standalone vaccine for polio used in the U.S. is Poliovirus Vaccine Inactivated (monkey kidney cell), trade named IPOL, licensed in 1965. IPOL is unlike the Salk inactivated polio vaccine or the Sabin oral polio vaccine, it says.

“Clinical trials that only review safety for up to three days after administration, even assuming a proper control group, cannot support the safety of this product,” the petition concludes. “As such, FDA could not have fulfilled its statutory duty to assure the safety of IPOL prior to licensing it for injection into infants, toddlers, and children.

ICAN also asks FDA to order an IPOL label change to note that “IPOL does not prevent intestinal infection and therefore does not prevent poliovirus transmission.”

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