Biologics

HHS Nixes Moderna Bird Flu Vaccine Funding

HHS has terminated a $590 million late-stage grant award to Moderna and its development of a vaccine candidate targeting the H5 avian influenza virus subtype. The termination news comes as the company announces “positive interim data” from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018.

“After a rigorous review, we concluded that continued investment in Moderna’s H5N1 mRNA vaccine was not scientifically or ethically justifiable,” HHS communications director Andrew Nixon told FDA Webview 5/29. “This is not simply about efficacy — it’s about safety, integrity, and trust. The reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public.” HHS says there are three other avian flu contracts under the National Prepandemic Influenza Vaccine Stockpile program.

Moderna says that while HHS’s move to cancel the funding adds uncertainty, “we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program. These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.”

The Phase 1/2 study of mRNA-1018 demonstrated a rapid, potent and durable immune response, according to Moderna. “At baseline, pre-existing immunity was minimal, with only 2.1% of participants showing hemagglutination inhibition (HAI) antibody titers greater than 1:40, an HAI titer considered to correlate with protection,” it says. “At Day 43, three weeks after the second vaccination, 97.8% of participants achieved titers greater than 1:40 with a 44.5-fold increase of titers from baseline.”

Morderna notes that the vaccine was found to be generally well-tolerated, with no dose-limiting tolerability concerns observed. “Most solicited adverse reactions were Grade 1 or 2 and did not increase significantly with number of doses or between first and second doses,” it says, adding that further data will be shared at an upcoming scientific meeting.

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