The U.S. Food and Drug Administration (FDA) expanded its approval of Merck’s pneumococcal vaccine Capvaxive for use in children ages 2 and up who are considered at increased risk for the disease.
The drug was specifically designed for adults, Merck said in a statement, but “may” offer additional protection for high-risk kids.
Critics pointed out that the vaccine adds to the list of childhood vaccines not tested against a placebo, and that it contains an ingredient linked to high rates of adverse events.
Children and teens with chronic conditions, including pneumonia, meningitis and bloodstream infections, can get the vaccine in addition to the pneumococcal conjugate vaccine (PCV) they already get as part of routine pediatric shots recommended by the Centers for Disease Control and Prevention (CDC).
The decision makes Capvaxive the only PCV approved as an extra vaccine for this group.
The vaccine protects against Streptococcus pneumoniae, which causes a wide range of bacterial infections, including pneumonia, bacterial meningitis and middle ear infections. The illnesses are typically treated with antibiotics.
CRM197: a questionable platform for childhood vaccines
The FDA based its expanded approval of the drug on results from a Phase 3 trial that enrolled 882 children and adolescents with chronic conditions.
The trial compared Capvaxive against PPSV23 (pneumococcal 23-valent polysaccharide vaccine), another vaccine that protects against pneumococcal illness — meaning it was not tested against an inert placebo.
Capvaxive contains CRM197, a protein. It is a mutant of the diphtheria toxin used to boost the immune response in some vaccines. In Capvaxive, bacterial sugars from 21 strains of pneumococcus are individually linked, or conjugated, to the CRM197, which enhances the body’s immune response to each of the bacteria.
Children’s Health Defense (CHD) Chief Scientific Officer Brian Hooker warned that giving a vaccine containing CRM197 to at-risk kids will be “another train wreck for children, but a boon for Merck as it opens up a fresh new market of children.”
That’s because research has found that other vaccines using the platform have high rates of adverse events.
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