FDA branded ‘shameful’ over infant meningococcal vaccine approval
Regulator under fire for expanding infant use of meningococcal vaccine—1 in 20 reported suffering a serious adverse event in the study period.
“It’s shameful,” said attorney Aaron Siri of Siri & Glimstad LLP, criticising the FDA’s decision to expand use of the meningococcal vaccine MenQuadfi to infants as young as six weeks.
Previously licensed for children over two, the vaccine is now approved for babies aged 6 weeks to 23 months, based on trials in which infants received up to four doses.
Siri, who has represented families affected by vaccine injury, says the move reflects a broader pattern of weak oversight—where flawed trial designs and circular assumptions are used to justify approvals despite serious safety concerns.
