Immunization Schedules US Children: Standard vs Alternative

In the United States, the immunization schedule for children 0 to 18 years of age is based on recommendations of the Advisory Committee on Immunization Practices (ACIP), an independent group of experts housed within the Centers for Disease Control and Prevention (CDC). A total of 14 vaccines are included in the ACIP recommendations.

There are also alternative schedules that are not endorsed by any public health authority. These include schedules from pediatrician Robert Sears (a.k.a. “Dr. Bob”), cardiac surgeon Dr. Donald Miller, and others. Due to misinformation and increasing rates of vaccine hesitancy, up to one-third of children in the United States are currently on an alternative vaccine schedule.

Recommended ACIP Immunization Schedule

The Advisory Committee on Immunization Practices (ACIP) is a committee tasked with preparing recommendations for the routine vaccination of adults and children.

The committee is made up of 15 members who meet three times yearly to review data and vote on vaccine recommendations. ACIP recommendations are made with the input of the American Academy of Pediatrics (AAP), American Academy of Family Physicians (AAFP), and others.

In the United States, ACIP statements are official federal recommendations.

To ensure that parents can make an informed choice about childhood vaccinations from birth to 18 years, the National Childhood Vaccine Injury Act requires all healthcare providers to provide parents or patients with copies of vaccine information statements before administering a vaccine.

Recommended Vaccines From Birth to 15 Months

Vaccinations are scheduled at an age when they are most beneficial. Vaccinations usually are delivered in a series of doses to build durable immunity to the disease.

In the United States, the first round of vaccinations starts at the time of birth and continues every one to three months until the age of 15 months.

The 11 vaccines that will have been started (and in some cases completed) between birth and 15 months are:

• Hepatitis B (HepB) vaccine: A three-dose series given at birth, 1–2 months, and 6–18 months
• Rotavirus (RV) vaccine: Either oral Rotarix (two-dose series given at 2 months and 4 months) or oral RotaTeq (three-dose series given at 2, 4, and 6 months)
• Diphtheria, tetanus, and pertussis (DTaP) vaccine: A five-dose series given at 2, 4, 6, 15–18 months, and 4–6 years
• Haemophilus influenzae type b (Hib) vaccine: Either ActHIB or Hiberix given as a four-dose series at 2, 4, 6, and 12–15 months, or PedvaxHIB given as a three-dose series at 2, 4, and 12–15 months
• Pneumococcal vaccine: Vaxneuvance (PCV15) or Prevnar 20 (PCV20) is given as a four-dose series at 2, 4, 6, and 12–15 months. One dose of Pneumovax23 (PPSV23) may be given to children with certain conditions at age 2
• Polio vaccine (IPV): A four-dose series given at 2, 4, 6–18 months, and 4–6 years
• Measles, mumps, and rubella (MMR) vaccine: A two-dose series given at 12–15 months and 4–6 years
• Varicella (VAR) vaccine: Better known as the chickenpox vaccine, this is given in a two-dose series at 12–15 months and 4–6 years
• Hepatitis A (HepA) vaccine: A two-dose series given at 12 months and 18–23 months
• Influenza vaccine (IIV): Given annually by injection starting at the age of 6 months (two doses given at least four weeks apart for children 6 months to 8 years if it is their first flu vaccination, and one dose for everyone else)
• COVID-19 vaccine: Either authorized mRNA vaccine, given as a two-dose (Moderna) or three-dose (Pfizer) primary series, available starting at 6 months

There is also a nasal spray flu vaccine called FluMist available to healthy children 2 years of age and older. With the exception of the age restriction and the route of administration (one spray into each nostril), FluMist is given on the same schedule as the flu shot.

Recommended Vaccines From 18 Months to 18 Years

Some of the above-mentioned vaccines will continue to be given during this period. Your child will have completed all of the vaccinations they started early in life by the time they are 4 to 6 years old (with the exception of the flu vaccine, which they must get every year).

They will receive these three additional vaccines, which ideally will be completed by age 18:

• Tetanus, diphtheria, and pertussis (Tdap) vaccine: One dose given at age 11 or 12 to boost immunity to the DTaP vaccine
• Meningococcal vaccine: All children should receive either Menveo, or MenQuadfi at age 11 or 12 and again at 16 to protect against meningococcus types A, C, W, and Y; children may also receive a two-dose series of meningococcus B vaccine (Bexsero or Trumenba) at age 16-18; a combination vaccine covering all types, Penbraya, is also an option
• Human papillomavirus (HPV) vaccine: A two-dose series of Gardasil 9 given at age 11 or 12 with a second dose six to 12 months later

Combination Vaccine Options

Many of the recommended vaccines can be delivered at the same time. To further ease the vaccination burden on children, five combination vaccines have been approved for use in the United States by the Food and Drug Administration (FDA):

• Pediarix: A combination of DTaP, polio, and hepatitis B vaccines given as a three-dose series at 2, 4, and 6 months
• Pentacel: A combination of DTaP, polio, and Hib vaccines given as a four-dose series at 2, 4, 6, and 12–15 months
• ProQuad: A combination of MMR and varicella vaccines typically given as the second dose of the MMR and varicella series at ages 4–6
• Kinrix or Quadracel: A combination of DTaP and polio vaccines given at ages 4–6 to replace the fifth dose of DTaP and fourth dose of polio vaccine
• Vaxelis: A combination of DTaP, polio, Hib, and hepatitis B vaccines given as a three-dose series at 2, 4, and 6 months

State Mandated Immunizations

While the ACIP directs the federal recommendations for vaccinations (and, in turn, their coverage in health insurance), it is up to the state to determine which vaccines children are required to have to go to school or daycare. Not all of the ACIP recommendations are taken up by the states, but the majority are.

One common exception is the human papillomavirus (HPV) vaccine which is only mandated in Hawaii, Rhode Island, Virginia, and the District of Columbia.

States will allow for a varying degree of medical, religious, and philosophical exemptions, wherein parents can opt out of certain vaccines without the threat of having their child barred from participating in school, sports, or other activities.

Alternative Immunization Schedules

Alternative immunization schedules are those that veer from the ACIP recommendation, either in terms of which vaccines should be given or when they are given.

These alternative guidelines are often based on personal or anecdotal evidence and have not undergone the rigorous safety and efficacy research used by ACIP to make its recommendations. No alternative immunization schedule is endorsed by any medical association in the United States.

Many of these schedules are designed by vaccine critics or skeptics, some of whom suggest that receiving so many vaccines before the age of 2 “overburdens” a child’s immune system and is potentially harmful.

These alternative schedules are broadly categorized by four themes:

• “Shot-limiting” (not taking all doses of a vaccine)
• “Selective delaying or refusal” (choosing when and which vaccines you will or will not use)
• “Decision by visit” (deciding if the child is fit or well enough at the moment to take a vaccine)
• “Vaccine refusal” (refusing all vaccines)

Two widely published alternative schedules—called the “Donald Miller User-Friendly Schedule” and “Dr. Bob’s Alternative Vaccine Schedule”—incorporate many of these features.

Donald Miller User-Friendy Schedule

The Donald Miller User-Friendy Schedule first published in 2004 was written by a cardiac surgeon and professor of surgery at the University of Washington Seattle.

Miller’s schedule is based largely on personal observation and the foundational belief that “medicine is not a science.” In an article published in 2014, Miller argued that “populations cannot be tested to demonstrate strict regularity of outcome in every individual.”

In response to these beliefs, Miller proposed a more “user-friendly” approach that he insists is safer than ACIP recommendations despite a lack of supporting evidence.

This includes:

• No vaccinations until a child is two years old
• No vaccines that contain the preservative thimerosal (which excludes DTaP vaccines that contain thimerosal)
• No live virus vaccines
• The separation of diphtheria, tetanus, and pertussis vaccines by six months rather than giving them all at once (which requires a child to receive 18 immunizations rather than six).

Dr. Bob’s Alternative Vaccine Schedule

Developed by pediatrician Robert Sears, MD (a.k.a. “Dr. Bob”), this schedule spaces vaccines so that infants get no more than two at a time, meaning they will need almost monthly shots for the first year. Sears’ views are based on the disproven concept of “antigenic overload” in which the body is said to over-respond to vaccines and make a child unnecessarily ill.

A well-known vaccine critic, Sears stated in 2014 that “the disease danger is low enough where I think you can safely raise an unvaccinated child in today’s society.”

Sears’ 2007 best-selling book, The Vaccine Book: Making the Right Decision For Your Child, was said to have sold over 180,000 copies and garnered endorsements from many celebrities.

According to Dr. Bob’s schedule, immunizations are rolled out as follows:

• 2 months: Rotavirus and DTaP
• 3 months: PCV and Hib
• 4 months: Rotavirus (second dose) and DTaP (second dose)
• 5 months: PCV (second dose) and Hib (second dose)
• 6 months: Rotavirus (third dose) and DTaP (third dose)
• 7 months: PCV (third dose) and Hib (third dose)
• 9 months: Polio and Influenza (and given every year until at least 19 years old)
• 12 months: Polio (second dose) and mumps (separated from MMR)
• 15 months: PCV (fourth dose), Hib (fourth dose)
• 18 months: DTaP (fourth dose) and varicella
• 2 years: Rubella (separated from MMR) and polio (third dose)t
• 2 1/2 years: Hep B Hep A
• 3 1/2 years: Hep B (second dose) and measles (separated from MMR)
• 4 years: DTaP (fifth dose) and polio (fourth dose)
• 5 years: MMR (second dose of each vaccine)
• 6 years: Varicella (second dose)

How Alternative Schedules Affect Healthcare and Health

A national survey conducted by the AAP reported that 87% of pediatricians received requests from parents for an alternative immunization schedule with the primary concern being the “overburdening” of the immune system.

While vaccine hesitancy and vaccine complacency are hardly new phenomena, the rise in social media disinformation has led to a rise in the number of under-vaccinated children in the United States.

In 2016, 69.7% of children in the U.S. completed the vaccine series recommended by ACIP by age 24 months. By 2021, that number had dropped to 35.6%.

Despite this, many pediatricians are accommodating parent’s requests for adjustment to the ACIP schedule. According to a 2017 survey in Clinical Pediatrics, 58% of pediatricians reported frequent alternative immunization schedule requests and 24% reported feeling comfortable using them.

And this, despite the fact that low vaccination rates have given rise to vaccine-preventable diseases in the United States and abroad, including measles, varicella, and rotavirus.

According to a statement issued by ACIP, “any changes in the immunization schedule that leads to an increase in exposure to preventable disease will increase the spread of the pathogens responsible for these diseases.”

Summary

Vaccine schedules are designed to ensure that a child is protected from preventable diseases. The recommended schedule from the Advisory Committee on Immunization Practices (ACIP) helps prevent diseases that, in the past, caused large numbers of children to become sick, disabled, paralyzed, or die.

Despite these gains, vaccine hesitancy and misinformation have fueled the rise of alternative immunization schedules which remain unsupported by research and unendorsed by any major health organization.