Loading ...‘Vaccine Safety Pyramid Scheme’: FDA Approves Meningococcal Vaccine for Infants Without Placebo-Controlled Trials
The FDA expanded approval of Sanofi’s MenQuadfi, a meningococcal vaccine, to include infants as young as 6 weeks old, even though 5.3% of infants who participated in clinical trials experienced a serious adverse event. The FDA approved the drug based on trials that compared MenQuadfi to a similar, previously approved vaccine, not a placebo, in what attorney Aron Siri called a “vaccine safety pyramid scheme.”
The U.S. Food and Drug Administration (FDA) has expanded its approval of Sanofi Pasteur’s MenQuadfi meningococcal vaccine to include infants as young as 6 weeks old. The vaccine, designed to protect against meningococcal disease — meningitis and meningococcal septicemia — was previously recommended for children ages 2 and older. According to the package insert, during the six months following the clinical trials, 5.3% of infants ages 6 weeks to 23 months who received the MenQuadfi shot experienced a serious adverse event.
The FDA approved MenQuadfi for the younger age group because the agency considered adverse event rates to be similar to those found to be associated with GSK’s Menveo, another approved meningococcal vaccine. In the case of Menveo, 3.6% of infants who got the shot experienced serious adverse events.
In other words, because Menveo is considered safe, and MenQuadifi’s serious adverse event rates are only slightly higher than those of Menveo, the FDA can conclude that MenQuadifi is also safe despite the high rates of serious adverse events, according to attorney Aaron Siri, who first reported the expanded approval on X.