Biologics

ICAN Wants Tougher Covid Vaccine Efficacy Standards

The Informed Consent Action Network (ICAN), generally cited as a leading anti-vaccination organization, is petitioning FDA to require changes in the study design for four Covid vaccines now in development to add additional efficacy requirements. The group’s 11/6 petition says the Phase 3 trial designs for the Moderna, Pfizer, AstraZeneca, and Johnson & Johnson vaccines should be amended to provide that:

reduction in severe Covid-19 (hospital admissions, ICU admissions, and death) be a primary endpoint;
PCR tests used to qualify an event of Covid-19 for a trial’s endpoint use a maximum of 24 amplification cycles;
interruption of transmission (person-to-person spread) be a primary endpoint; and
participants be tested for T-cell reactivity to SARS-CoV-2 pre-vaccination and post-vaccination.

ICAN says the current trial designs for the four vaccines “are inadequate to assess efficacy.” It says it will suffer irreparable harm if the actions it requests are not granted because once FDA licenses a Covid-19 vaccine, states are expected to make it mandatory.

“Hence, without FDA assuring proper efficacy trials of the vaccine now,” the petition says, “the petitioner will not have the opportunity to object to receiving the vaccine based on deficient clinical trials later. Furthermore, if the vaccine is licensed without an appropriate efficacy review, then any potential acceptance or mandate of these vaccines are likely to be based on inaccurate beliefs about the vaccine, namely that it will stop transmission of the virus from the vaccine recipient to others or that it will reduce severe Covid-19 disease and deaths. The trial protocols are not currently designed to determine whether either of those objectives can be met.”

ICAN asks that FDA act on its petition by 11/20 to allow it an opportunity to seek emergency judicial relief if the petition is denied.

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