Biologics

Revoke Children’s Covid Vaccine EUA: ICAN

The Informed Consent Action Network (ICAN) is petitioning FDA to revoke the 5/10/21 reissuance of an emergency use authorization (EUA) for Pfizer/BioNTech’s Covid-19 vaccine in children ages 12 through 15. ICAN also asks FDA not to authorize Moderna’s request for EUA of its Covid-19 vaccine in children ages 12 to 17.

The petition says FDA lacked the legal authority and had no need to issue an EUA for Pfizer’s vaccine for youths ages 12-15 for numerous reasons, including that there is no health emergency for children.

ICAN says it also was improper to issue an EUA for the youths when:

the data do not demonstrate that the known benefits outweigh the known risks;
the trial was underpowered; and
there are serious concerns regarding how the trials were conducted.

“Even if FDA had the legal authority or purported need at the time of issuance, it no longer does as additional data since authorization clearly show the known benefits do not outweigh the known and potential risks,” ICAN says. “Because there is no health emergency for children, FDA likewise lacks the legal authority to issue an EUA for Moderna’s vaccine for 12- to 17-year-old children.”

In addition to actions on the Pfizer and Moderna vaccines, the petition asks that FDA require T-cell assessment from Covid-19 vaccine developers as a measure of evaluating vaccine efficacy.

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