Immunize.org summarizes ACIP’s June 17–18 meeting recommending COVID-19 vaccines for children age 6 months through 5 or 6 years
The Advisory Committee on Immunization Practices (ACIP) met on June 17–18, 2022 to discuss FDA’s Emergency Use Authorizations (EUAs)* issued on June 17 for use of Moderna and Pfizer-BioNTech mRNA COVID-19 vaccines in infants and young children. On June 18, ACIP voted unanimously to recommend the following:
- Moderna – A two-dose series (25 mcg per dose) for children age 6 months through 5 years
- Pfizer-BioNTech – A three-dose series (3 mcg per dose) for children age 6 months through 4 years
*On June 17, FDA also authorized Moderna mRNA vaccine as a two-dose series (50 mcg per dose) for children age 6 through 11 years and as a two-dose series (100 mcg per dose) for children age 12 through 17 years. ACIP will discuss proposed recommendations for these options during their regular meeting on June 22–23. In addition, FDA authorized a third dose of Moderna COVID-19 vaccine for all children age 6 months through 17 years with immunocompromising conditions; this third dose will be added to the immunocompromised patient schedule as part of CDC’s clinical considerations.
Expansion of vaccine recommendations down to 6 months of age allows 18.7 million children to receive a primary COVID-19 vaccine series. The following information discussed at the ACIP meeting describes the need for these vaccines and provides highlights on the use of both formulations.
Epidemiology of COVID-19 infection in young children
Since the beginning of the COVID-19 pandemic, there have been more than 2.5 million cases, 20,000 hospitalizations, and 200 deaths among U.S. children age 6 months through 4 years. Serologic surveys indicate that more than 71% of children age 6 months through 4 years have antibodies to COVID-19 indicating past infection. Additional information further characterizes the burden on young children and their families:
- Hospitalization – Compared to other diseases before they were routinely prevented by vaccines, COVID-19 infection is much more likely to result in hospitalization of young children. More than half of children age 6 months through 4 years with COVID-19-associated hospitalization had no underlying medical conditions.
- Mortality – From January 2020 through May 2022, 202 children age 6 months through 4 years died from COVID-19, accounting for 1.7% of all deaths in this age group.
- Indirect impacts – Almost half of parents of children younger than age 5 years say they have needed to leave a job or change their work schedules to care for an infected child.
Summary of Moderna COVID-19 Vaccine for age 6 months through 5 years
- Schedule and dose – 2 doses (25 mcg per dose) administered intramuscularly, with at least 28 days between dose 1 and 2. CDC recommends that the interval between dose 1 and 2 may be between 4 and 8 weeks. A third primary series dose administered at least 4 weeks after the second dose is recommended for children in this age group who are moderately or severely immunocompromised.
- Immune response – The immune response (measured by neutralizing antibodies) to the Omicron variant of SARS-CoV-2 produced by the vaccination series in this age group was equivalent to the immune response to Omicron produced by Moderna COVID-19 Vaccine in young adults. As a result, it is likely that the vaccine effectiveness in this group also will be similar. Because of the short follow-up time after vaccination and the emergence of the Omicron variant during the clinical trial, real-world vaccine effectiveness cannot be predicted precisely.
- Vaccine safety – There were no deaths, severe allergic reactions (e.g., anaphylaxis), or myocarditis/pericarditis reported in the approximately 4,800 children age 6 months through 5 years who received the mRNA vaccines in the clinical trials; however, the clinical trial was not designed to detect rare adverse events such as myocarditis. Injection-site reactions (mostly pain) within 7 days of vaccination were common, usually mild, and resolved after 2–3 days. Fever was common, with 22–23% of children in this age group experiencing fever of at least 100.4°F (38°C), with more fevers reported after dose 2 than dose 1. Fever greater than 104°F was rare (occurring in 0.4% of young children age 2 through 5 years and 0.2% of infants and toddlers age 6 months through 23 months). One child had a febrile seizure considered related to dose 1 of vaccine and later received dose 2 without event.
- Booster doses – Moderna representatives indicated the company hopes to submit information concerning safety and immune response to a third dose in this age group by late summer.
- Practical issues for clinicians
- More than one formulation of Moderna COVID-19 Vaccine has a dark blue vial cap; the distinguishing feature of the different formulations is the color on the box and the color of the border on the label. The vaccine intended for recipients age 6 months through 4 years has a magenta (hot pink) label and wording on the box.
- As with all Moderna COVID-19 Vaccines, no diluent is needed.
Summary of Pfizer-BioNTech COVID-19 Vaccine for age 6 months through 4 years
- Schedule and dose – 3 doses (3 mcg per dose) administered intramuscularly, with at least 21 days between dose 1 and 2 and at least 8 weeks between dose 2 and 3. CDC recommends that the interval between dose 1 and 2 may be between 3 and 8 weeks. Children age 6 months through 4 years who are moderately or severely immunocompromised are recommended to receive the same 3-dose primary series as other children in this age group.
- Immune response – The immune response (measured by neutralizing antibodies) to the Omicron variant of SARS-CoV-2 produced by the three-dose vaccination series in this age group was equivalent to the immune response to Omicron produced by the two-dose series of Pfizer COVID-19 Vaccine in adults age 16 through 25 years. As a result, it is likely that the vaccine effectiveness in this group also will be similar. Because of the short follow-up time after vaccination and the emergence of the Omicron variant during the clinical trial, real-world vaccine effectiveness cannot be predicted precisely.
- Vaccine safety – More than 4,700 children age 6 months through 4 years were included in the vaccine trials, and approximately 1,000 of these children were followed for at least 2 months after receipt of the third dose of vaccine. No serious local reactions, anaphylaxis, myocarditis/pericarditis, Bell’s palsy, or MIS-C were reported. Reactions were mostly mild to moderate, with pain and tenderness at the injection site reported in about 3 out of 10 recipients following each dose. Fever was not commonly reported, occurring after each dose in approximately 5% of children age 2 through 4 years and 7% of children age 6 through 23 months.
- Practical issues for clinicians
- The vial cap for the Pfizer-BioNTech vaccine formulation designed for age 6 months through 11 years is maroon.
- This vaccine requires a saline diluent. Although the total injection volume (0.2 mL) for the 6 months through 4 years “maroon cap” formulation is the same as the Pfizer-BioNTech “orange cap” (5 through 11 years) formulation, the maroon cap requires a larger 2.2 mL dilution injection volume (compared to 1.3 mL for the orange cap).
- Because some lots of the Pfizer-BioNTech vaccine were manufactured several months before the final FDA authorization, some packages and vial labels contain two statements that are not correct. First, the vial label may state that the vaccine is for age 2 through <5 years; however, FDA has authorized this product and CDC has recommended it for children age 6 months through 4 years. Second, the vial label may state that the vaccine may be used for only 6 hours after dilution; however, FDA has authorized the vaccine to be used for 12 hours after dilution. A “Dear Healthcare Provider” letter specifying that the FDA has authorized the use of this formulation beginning at age 6 months has been posted on the FDA website and will be widely distributed to vaccine providers.
Clinical Considerations
Following the ACIP meeting, CDC updated its Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States. All healthcare professionals preparing to administer these vaccines should read this carefully for specific guidance on use of these new vaccines. As with the primary series of mRNA vaccinations for other age groups, clinicians should use the same product for all primary series doses. In exceptional circumstances where a child must be given a different product because the earlier product is unknown or not accessible, CDC has provided guidance for series completion. CDC has also provided guidance on criteria for choosing between the two vaccine products, timing of vaccination in specific situations (e.g., when a child transitions from a younger to older age group or vaccination following SARS-CoV-2 infection), considerations for when to extend the interval between doses 1 and 2, allowance for coadministration of COVID-19 vaccines with other routine childhood vaccines, and other information critical to clinicians administering these vaccines. Additional guidance documents will be added or updated on the CDC website in coming days.
Implementation
In recently conducted surveys, half of parents of children age 6 months through 4 years stated they would definitely or probably vaccinate their children, although many stated that they would prefer to wait before initiating the series. At least one-third indicated they definitely or probably would not vaccinate. For many parents, a key factor in their decision is having a conversation with a trusted healthcare provider. CDC has developed many resources to assist providers in discussing these important vaccines with their patients.
ACIP meeting participants also discussed the fact that healthcare providers have expressed concerns about wasting vaccine doses in a multidose vial if only one or two eligible children were present. CDC staff responded that their message to clinicians is that there is ample supply of vaccine for this age group. In this situation, vaccination providers are encouraged to shift their typical rule of “don’t waste a dose” to “don’t waste the opportunity to vaccinate a child.”
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CDC and FDA
Moderna
Pfizer-BioNTech
Today! Virtual: Watch June 22–23 routine ACIP meeting including discussion on multiple non-COVID-19 vaccines. CDC convenes its Advisory Committee on Immunization Practices (ACIP) June 22 from 10:00 a.m.–5:00 p.m. (ET) and June 23, 2022, from 10:00 a.m.–5:00 p.m. (ET). The agenda includes discussions on influenza vaccines, pneumococcal vaccines, human papillomavirus vaccine, measles-mumps-rubella (MMR) vaccines, respiratory syncytial virus vaccine, rotavirus vaccine, and chikungunya vaccine. Votes on proposed recommendations for 2022–2023 seasonal influenza vaccines, a new pediatric pneumococcal vaccine, and a new MMR vaccine are scheduled.
No registration is required to watch webcasts of live ACIP meetings or listen via telephone. Opportunities for public comment are described at the website.
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CDC issues “Updated Case-Finding Guidance: Monkeypox Outbreak—United States, 2022” On June 14, CDC issued a Health Alert Network (HAN) message on Updated Case-Finding Guidance: Monkeypox Outbreak—United States, 2022. Monkeypox is an orthopoxvirus related to smallpox that may be prevented by vaccination. The Strategic National Stockpile contains two licensed vaccines effective against monkeypox (Jynneos from Bavarian Nordic and ACAM2000 from Emergent). A portion of the summary appears below.
This Health Alert Network (HAN) Health Update serves to alert clinicians to clinical presentations of monkeypox seen so far in the United States and to provide updated and expanded case definitions intended to encourage testing for monkeypox among persons presenting for care with relevant history, signs, and symptoms. In addition, this Health Update provides an update to a HAN Health Advisory that the Centers for Disease Control and Prevention (CDC) issued May 20, 2022 titled Monkeypox Virus Infection in the United States and Other Non-endemic Countries—2022. In people with epidemiologic risk factors, rashes initially considered characteristic of more common infections (e.g., varicella zoster, herpes, syphilis) should be carefully evaluated for concurrent characteristic monkeypox rash…and considered for testing.
The HAN messages contain images of cases from the current outbreak and useful links.
Contact your state or local health department if you have questions or suspect a patient may have monkeypox. Health departments should consult CDC through the CDC Emergency Operations Center or contact CDC Poxvirus and Rabies Branch ([email protected]).
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Influenza virus continues to circulate in parts of the country; 2021–22 vaccine formulation expires on June 30 Influenza Surveillance
For week 23, ending on June 11, CDC's Weekly U.S. Influenza Surveillance Report, FluView summary reports seasonal influenza continues to circulate in some parts of the country. The levels of outpatient visits due to acute respiratory illness are below baseline nationally, although levels are high in three jurisdictions. One new pediatric influenza-related death was reported for week 23. CDC continues to recommend influenza vaccination as long as influenza viruses are circulating.
This week is the last full FluView report of the 2021–22 season. An abbreviated report will be published during the summer, and the first full report of the 2022–23 season will be published on October 14, 2022.
Influenza vaccines for the Northern Hemisphere are clearly marked with expiration dates of June 30 each year. These products should not be used after that date. The formulation for the 2022–23 influenza season in the Northern Hemisphere will begin shipping later this summer. The FDA licenses a specific formulation of Afluria Quadrivalent (Seqirus) for travelers to the Southern Hemisphere during its 2022 influenza season. That formulation has a longer expiration date.
VaccineFinder at “Vaccines.gov”
If you don’t provide influenza vaccine at your site, refer people to sites that do vaccinate. “Vaccines.gov” is powered by VaccineFinder, a service of Boston Children’s Hospital, to help people find influenza, COVID-19, and other vaccines for any age group. To be listed as a provider by VaccineFinder, see the information at this CDC website.
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Spotlight: Expedite vaccination by using Immunize.org's screening checklists Immunize.org's Screening Checklist main page links to forms for patients to fill out, simplifying assessment of vaccination needs and contraindications. The back of each screening checklist provides detailed guidance to help healthcare personnel interpret patient answers to know if a vaccine is contraindicated or can be given with confidence. Several checklists are available in multiple languages.
Screening checklists are especially useful in settings where standing orders or batched orders are used, as well as in settings where the patient’s full medical record is not readily available.
 
Immunize.org offers nine screening checklists, including:
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Journalists interview Immunize.org experts Journalists seek out Immunize.org experts to help explain vaccines to the public and policy makers. We help the media understand and communicate the complex work vaccinators do. Here is a recent citation.
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
Recognize colleagues and students with Immunize.org's elegantly designed "Vaccines Save Lives" black enamel pins
Immunize.org’s elegantly designed “Vaccines Save Lives” pins are meaningful gifts for people who care about vaccination. The pin makes a refined statement in hard black enamel with gold lettering and edges, measuring 1.125" x 0.75".
The pin is a stick-through-post variety with the back end covered by a round rubber cap that holds the pin securely. A gold metal spring-lock clasp is also provided.
Wear these pins on clothing, uniforms, and white coats to show that you value vaccines!
 
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Prepare now for back-to-school season! Check out Immunize.org’s adolescent vaccination resources and ensure adolescents who visit your office are up to date. As pre-teens and adolescents come into your office for sports physicals and well visits this summer, be sure to utilize the resources available at Immunize.org that focus on adolescent vaccination.
Our Resources for Adolescent Vaccination main page offers all the adolescent educational materials from Immunize.org and partner organizations.
Our Adolescent Vaccination main page contains the handouts that pertain to adolescent vaccinations.
Our CDC Schedules main page provides print-ready PDFs of the recommended immunization schedules for adolescents, as well as for children and adults.
Our Screening Checklists about Vaccine Contraindications and Precautions main page links you to forms that patients can fill out to expedite assessment of vaccination needs and contraindications.
Our Give2MenACWY website promotes the importance of adolescent vaccination, including administering the recommended MenACWY vaccine booster dose at age 16. Many teens are behind on vaccines because of the pandemic, so vaccination is more important than ever.
The website is divided into five easy-to-access sections:
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Worldwide measles cases up 79% in first two months of 2022 compared to same period in 2021, according to WHO and UNICEF
The World Health Organization (WHO) and UNICEF reported a 79% increase in reported measles cases in January and February 2022 compared to the same period in 2021. The public health groups called it “a worrying sign of a heightened risk for the spread of vaccine-preventable diseases and could trigger larger outbreaks….” Portions of the report appear below.
The risk for large outbreaks has increased as communities relax social distancing practices and other preventive measures for COVID-19 implemented during the height of the pandemic. In addition, with millions of people being displaced due to conflicts and crises including in Ukraine, Ethiopia, Somalia and Afghanistan, disruptions in routine immunization and COVID-19 vaccination services, lack of clean water and sanitation, and overcrowding increase the risk of vaccine-preventable disease outbreaks.
Almost 17 338 measles cases were reported worldwide in January and February 2022, compared to 9665 during the first two months of 2021. As measles is very contagious, cases tend to show up quickly when vaccination levels decline. The agencies are concerned that outbreaks of measles could also forewarn outbreaks of other diseases that do not spread as rapidly.…
“Measles is more than a dangerous and potentially deadly disease. It is also an early indication that there are gaps in our global immunization coverage, gaps vulnerable children cannot afford,” said Catherine Russell, UNICEF Executive Director. “It is encouraging that people in many communities are beginning to feel protected enough from COVID-19 to return to more social activities. But doing so in places where children are not receiving routine vaccination creates the perfect storm for the spread of a disease like measles.”
Virtual: NFID hosts webinar “Protecting Immunocompromised Patients through Effective Prevention and Treatment” on June 27
The National Foundation for Infectious Diseases (NFID) will offer a webinar titled Protecting Immunocompromised Patients through Effective Prevention and Treatment on June 27 at 1:00 p.m. (ET). During this program, speakers will address current recommendations to protect adult immunocompromised patients through effective prevention and treatment. Discussion topics will include current U.S. vaccination recommendations, gaps in immunization coverage among immunocompromised adult patients, and strategies to overcome challenges.
NFID Medical Director William Schaffner, MD, will moderate the discussion with Kathleen Dooling, MD, MPH, Medical Officer in the CDC Division of Viral Diseases and Camille Kotton, MD, Clinical Director of Transplant Infectious Disease and Immunocompromised Host Program at Massachusetts General Hospital. Participation is limited to the first 500 attendees. On-demand recording will be available beginning on June 28, 2022. Speakers will also address questions submitted by participants, as time allows.
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