Biologics

FDA May Nix Pfizer EUA for Covid Jab in Young Kids

The emergency use authorization for Pfizer’s Covid-19 vaccine for children under five may not be renewed by FDA this fall, according to The Guardian. An internal email obtained by The Guardian indicates that Moderna may be asked to step in to fill the gap.

If the agency action proceeds, it would remove the only Covid vaccine currently authorized for all children aged six months to four years. Moderna’s pediatric shot is only approved for children with certain underlying health conditions, while Novavax’s pediatric vaccine is limited to children 12 and older who have health conditions.

“It certainly would create a hole in the availability of vaccines,” American Public Health Association executive director Georges Benjamin told The Guardian. “And to do it this late in the season – clearly it’s inappropriate.”

The email, sent 8/8 by the National Center for Immunization and Respiratory Diseases to state and local vaccine coordinators, said FDA had informed Pfizer that its emergency use authorization for the under-five shot might not be renewed for the 2025 respiratory season. Pfizer’s vaccine for children aged five to 11 is still expected to receive full FDA approval this fall.

The Centers for Disease Control and Prevention (CDC) is now in talks with Moderna about ramping up production for younger children, including discussions about supply timing and possible shortages, the report says. Moderna received FDA approval in July for its pediatric Covid vaccine, but only for children with higher medical risk. Critics warn this could further limit access, especially given low vaccination rates — only 5.6% of children six months to four years old, and about 15% of children aged five to 17, have received the Covid shot, according to the CDC.

Although severe illness is rarer in children than in older adults, pediatric Covid hospitalization rates remain similar to those seen in 2020 and 2021, The Guardian says. Experts also warn about the potential long-term risks, including multisystem inflammatory syndrome and long Covid in children. Covid cases are once again rising in parts of the U.S., heightening concern over vaccine access as respiratory virus season approaches.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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