Did the FDA Just Approve a New Vaccine for Infants Without Placebo Controlled Trials?

Why do some people think that the FDA just approved a new vaccine for infants without using any placebo controlled trials?

Is it terrible that high risk infants and toddlers can now be vaccinated against a life-threatening infection???

The usual suspects…

Did the FDA Just Approve a New Vaccine for Infants Without Placebo Controlled Trials?

The first thing to understand about the MenQuadfi meningococcal vaccine, is that it is not a new vaccine.

It was approved by the FDA in 2020 for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y in individuals 2 years of age and older.

The only change, is that MenQuadfi is now FDA approved for infants as young as six weeks of age.

“ACIP recommends routine administration of a MenACWY vaccine for all persons aged 11–18 years”

Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020

A change that won’t affect most kids, as this vaccine is typically given to pre-teens and teenagers!

But with the new age indication, MenQuadfi can be given to high-risk infants and toddlers who need it.

This includes children who travel to or live in countries in which meningococcal disease is hyperendemic or epidemic and those with certain medical conditions, including:

• anatomic or functional asplenia

• complement component deficiencies (e.g., C3, C5-C9, properdin, factor H, or factor D)

• complement inhibitor use (e.g., eculizumab [Soliris] or ravulizumab [Ultomiris])

• human immunodeficiency virus infection.

Medical conditions that put these children at high risk for meningococcal meningitis, bacteremia, or both, all life-threatening infections.

RFK Jr neither torched CNN for lying nor dismantled CNN’s claim about placebos. His ideas about the use of saline placebos in vaccine studies are still wrong.

And the idea that they didn’t use a placebo is silly.

Like all vaccines, MenQuadfi was appropriately studied for safety and effectiveness.

After initial FDA approval of MenQuadfi, further post-marketing studies were done in infants and toddlers to show that it was safe and effective, allowing the expanded indication.

Since previous vaccines had used saline placebos, it was totally appropriate to use a control vaccine when it was studied. Otherwise, you continue to put kids at risk to get meningococcal disease by giving them a saline placebo!

Now that would be terrible, as would having fewer options to prevent vaccine-preventable disease in high risk kids.

References

Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020 https://www.cdc.gov/mmwr/volumes/69/rr/rr6909a1.htm

Approval History, Letters, Reviews, and Related Documents - MenQuadfi https://www.fda.gov/vaccines-blood-biologics/menquadfi

Meningococcal (Groups A, C, Y, and W) Conjugate Vaccine (MenQuadfi ®) Extension of use to include infants from 6 weeks of age https://www.cdc.gov/acip/downloads/slides-2025-04-15-16/05-Dawson-Mening-508.pdf