Addressing Misconceptions About ACIP, Childhood Vaccines, and Placebo Controls

Medical, public health, and advocacy experts united this week to express extreme alarm after the U.S. Department of Health and Human Services (HHS) announced the dismissal of all 17 independent experts serving on the CDC’s Advisory Committee on Immunization Practices (ACIP).

HHS’ communications about this abrupt move may create confusion and raise questions—they warrant correction and further explanation.

Below are some of the most common misconceptions circulating in the wake of the ACIP dismissals – along with facts to clarify the science, context, and standards behind vaccine development and policy.

Claim: ACIP has never recommended against any vaccine, including those withdrawn for safety concerns.

Reality:  The committee reviews FDA approved vaccines and determines which should be recommended for specific patient populations based on the latest data and research. 

It’s far from a blanket, vaccine-for-all approach.

During the committee’s last meeting in April, ACIP recommended a precaution on a chikungunya vaccine’s usage for Americans age 60 and older, pending additional safety review. The committee has also recommended withdrawing a rotavirus vaccine in 1999 after reports of intussusception, and revised or paused recommendations based on new evidence, including for a nasal flu vaccine in 2016.

Claim: Children now receive 25 vaccine injections by age 1, and they receive between 69 and 92 routine vaccines by age 18 – up from 11 in 1986.

Reality: Prior to vaccinations, 1 in 5 children didn’t live until their 5th birthday. The vaccination schedule protects children from once common illnesses and has resulted in far fewer childhood deaths. That said, this count appears inflated by including brand variations, doses, and potentially non-routine vaccines.

By age 1, a child typically receives around seven to nine injections, not 25. Combination vaccines such as DTaP-IPV-HepB reduce the number of actual injections. By age 6, most children receive around 10 to 14 distinct vaccines, including combination shots.

Children are exposed to far more antigens by crawling around the house, eating, and breathing than they are from vaccinations. In fact, every day, children are exposed to about 2,000 to 6,000 antigens. The small number of vaccines they receive safely protect them against the worst pathogens that can cause severe illness and even death.   

HHS is right to recognize immunization practices have evolved since the 1980s. The U.S. has powered global advancements in science, innovation, and reliable vaccine protections. ACIP’s work to evaluate the safety, efficacy, and population needs on a case-by-case basis demonstrates the vaccine landscape has become increasingly successful at safeguarding Americans from preventable disease. Overall, vaccinations are one of the most important public health developments in history.

Claim: No routine childhood vaccine has been licensed based on a placebo-controlled trial.

Reality: Many routine vaccines, including varicella, HPV, and early polio, were licensed based on trials that used inert placebos or appropriate comparators. Traditionally, placebo-controlled trials are ethically restricted once effective vaccines exist, and active comparators are standard.

It would not be ethical to compare a new cancer treatment to placebo when an existing treatment is on the market and effective. In the same way, when an effective vaccine is on the market, a placebo-controlled trial would be unethical.

Claim: CNN falsely cited 257 placebo-controlled vaccine studies.

Reality: CNN’s reporting included scientific studies where vaccines were tested either with placebos or with other approved vaccines, which is how the FDA recommends these trials these trials to be conducted. HHS’ claim that none of these studies were used to approve vaccines is wrong – many of them were part of the evidence used to approve vaccines or to keep monitoring their safety after approval.

Claim: Vaccine manufacturers are not liable for vaccine injury due to the 1986 National Childhood Vaccine Injury Act (NCVIA).

Reality: NCVIA established a compensation program but does not grant blanket immunity to drug manufacturers. They can still be sued in a civil court if they commit fraud or willful misconduct, fail to comply with manufacturing standards, or engage in deceptive practices. The law was designed to stabilize the vaccine supply and maintain accountability through a centralized process.