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Immunize.org summarizes ACIP’s June 22–23 meeting on influenza, pneumococcal, MMR, and other vaccines, and use of Moderna COVID-19 vaccine for individuals age 6 through 17 years The Advisory Committee on Immunization Practices (ACIP) met on June 22–23, 2022, and approved recommendations for influenza vaccine for the 2022–2023 season, 15-valent pneumococcal conjugate vaccine (PCV15) for children, a new formulation of measles-mumps-rubella (MMR) vaccine, and use of Moderna COVID-19 Vaccine for individuals age 6 through 17 years. ACIP also received updates on vaccines for respiratory syncytial virus (RSV) and human papillomavirus (HPV), as well as an update on the ongoing monkeypox outbreak. Presentation slides are available online and may be reviewed for details. Highlights of the meeting, focusing on the committee’s votes, are provided below.
Influenza vaccines for the 2022–2023 season: new preference for certain vaccines in older adults
The session opened with a report of the current season’s preliminary influenza vaccine effectiveness estimates from the U.S. Flu Vaccine Effectiveness (VE) Network. There was low circulation of influenza virus this season and the circulating strain was not well matched to the vaccine. Despite this mismatch, preliminary estimates showed that vaccination reduced influenza illness by about 35% overall, with clear benefit among children and young adults but no measurable benefit for adults age 50 years or older.
ACIP members concluded their multi-year deliberation of the benefits of preferring the use of higher dose or adjuvanted influenza vaccines for adults age 65 and older, compared to standard dose inactivated influenza vaccines. They concluded that, although the quality of data varied from rigorous, large randomized controlled trials (Fluzone High Dose, Sanofi), to observational, real-world evidence subject to significant limitations (Fluad, Seqirus; FluBlok, Sanofi), sufficient evidence suggested that any of these three products may be superior to standard dose influenza vaccines among adults age 65 and older. Of note, more than 3 out of 4 adults in this age group received a higher dose or adjuvanted vaccine in recent influenza seasons. ACIP members voted unanimously to approve the following language:
“ACIP recommends that adults aged >65 years preferentially receive one of the following higher dose or adjuvanted influenza vaccines: quadrivalent high-dose inactivated influenza vaccine (HD-IIV4), quadrivalent recombinant influenza vaccine (RIV4), or quadrivalent adjuvanted inactivated influenza vaccine (aIIV4). No preference is expressed for any one of these three vaccines. If none of these three vaccines is available at an opportunity for vaccine administration, then any other age-appropriate influenza vaccine should be used.”
Two additional changes to the 2022–2023 influenza vaccination recommendations include:
- All vaccines will contain four influenza strains; the A(H3N2) and the B/Victoria components will be updated from the 2021–2022 season
- The cell-culture based inactivated influenza vaccine (ccIIV, Flucelvax Quadrivalent, Seqirus) is licensed and recommended for all people age 6 months and older. All standard dose IIVs are now approved for use beginning at age 6 months.
Pneumococcal conjugate vaccine (PCV15) for children
PCV15 (Vaxneuvance, Merck) was licensed by the FDA on June 17 for use in children beginning at 6 weeks of age. PCV15 includes all serogroups in PCV13 (Prevnar 13, Pfizer), plus two additional serogroups. Its recommended schedule is the same as PCV13 and the cost per dose is estimated to be equivalent or slightly lower than PCV13, meaning that the potential additional disease prevention would come at no additional cost. PCV15 was shown to have similar safety and side effects as PCV13 in the clinical trial, with the possibility that it might produce higher fever in a small number of children. The assumptions of how well the vaccine will work are based on studies showing that PCV15 produced the same or better immune response to vaccination compared to PCV13; real-world evidence of PCV15 vaccine effectiveness is not yet available. For these reasons, ACIP members chose not to prefer PCV15 over PCV13, but to consider them equally acceptable options. No changes were made to recommendations for the use of 23-valent pneumococcal polysaccharide vaccine (PPSV23) in certain high-risk children age 2 through 18 years. ACIP voted unanimously to approve the following policy statement:
“PCV15 may be used as an option to PCV13 for children aged <19 years according to currently recommended PCV13 dosing and schedules.”
Measles-mumps-rubella (MMR) vaccine
ACIP concluded its review of a newly FDA-approved measles-mumps-rubella (MMR) vaccine, Priorix (GSK). Priorix was first licensed in Germany in 1997 and is approved in over 100 countries. Several countries consider it fully interchangeable with the long-standing U.S. product MMR II (Merck) because it contains equivalent vaccine virus strains. No significant differences in safety or side effects have been found and members noted that having a second manufacturer licensed and recommended would help ensure the stability of the supply of MMR in the United States. ACIP voted unanimously to approve the following policy statement:
“MMR vaccine (Priorix, GSK) is recommended according to currently recommended schedules and off-label uses as an option to prevent measles, mumps, and rubella.”
Moderna COVID-19 Vaccine for children and adolescents age 6 through 17 years
Epidemiology of COVID-19 infection in U.S. children and adolescents age 5 through 17 years: Since the beginning of the COVID-19 pandemic, there have been more than 10.3 million cases and over 600 deaths among U.S. children and adolescents age 5 through 17 years. As in all other age groups, children and adolescents who have received COVID-19 vaccines have better outcomes from infection than unvaccinated children, particularly against severe illness. However, 65% of children age 5 through 11 years and 30% of adolescents age 12 through 17 years remain unvaccinated.
Moderna dosing specific to age: Moderna’s vaccine is packaged in different formulations for age 6 through 11 years and age 12 years and older. A 50 mcg per 0.5 mL dose product is authorized for primary series doses given to children age 6 through 11 years and the 100 mcg per 0.5 mL dose product is authorized for primary series doses for adolescents and adults age 12 years and older. The immune response to SARS-CoV-2 produced by the age-appropriate vaccination series in each age group was equivalent to the response in young adults. As a result, it is likely that the effectiveness of the products in each group will also be similar. Because the clinical trials occurred before the emergence of the Omicron variant, real-world vaccine effectiveness cannot be predicted precisely.
Summary of Moderna COVID-19 Vaccine for age 6 through 11 years
- Schedule and dose – 2 doses (50 mcg per 0.5 mL dose) administered intramuscularly, with at least 28 days between doses 1 and 2. CDC recommends that the interval between doses 1 and 2 may be between 4 and 8 weeks. Use of an 8-week interval may substantially lower the risk of myocarditis compared to a 4-week interval. CDC recommends that children in this age group who are moderately or severely immunocompromised receive a third primary series dose administered at least 4 weeks after the second dose.
- Vaccine safety – Consistent with the safety and side effects seen in young adults who receive Moderna COVID-19 Vaccine; no new safety concerns have been identified. However, clinical trials were not large enough to detect rare adverse events such as myocarditis. More than 90% of recipients experienced pain at the injection site, mostly mild or moderate intensity, for about 3 days. Twelve to 19 percent of recipients also reported redness or swelling at the injection site or swelling and tenderness in the armpit near the injection site. Systemic symptoms were common and more likely to occur after dose 2. About 1 in 4 reported fever after dose 2.
- Booster doses – No booster dose is recommended at this time, but recommendations will be revised as necessary in coming months.
- 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 through 11 years has a purple border on the label and wording on the box.
- The vial label for this product states it is for “booster doses only,” but this is not correct. The 50 mcg per 0.5 mL dose product may be used as a booster dose in adults age 18 and older, and is also authorized for the primary series doses for children age 6 through 11 years. To reduce the confusion created by the incorrect label, FDA has included an image of the vial on the Emergency Use Authorization Fact Sheet for Healthcare Providers for Moderna COVID-19 Vaccine for age 6 through 11 years.
- Children should routinely receive the vaccine formulation recommended for their age on the day of vaccination, regardless of their size. However, CDC and FDA permit flexibility (if needed) in the choice of formulation for children who have a birthday between dose 1 and dose 2 that leads to a change in recommended formulation.
- As with all Moderna COVID-19 Vaccine presentations, no diluent is needed.
Summary of Moderna COVID-19 Vaccine for age 12 through 17 years
- Schedule and dose – 2 doses (100 mcg per 0.5 mL dose) administered intramuscularly, with at least 28 days between doses 1 and 2. CDC recommends that the interval between doses 1 and 2 may be between 4 and 8 weeks. Use of an 8-week interval has been associated with a substantially lower risk of myocarditis compared to a 4-week interval. The 8-week interval may be especially important in this age group because the risk of myocarditis after mRNA vaccination is highest among adolescent and young adult males. CDC recommends that children in this age group who are moderately or severely immunocompromised receive a third primary series dose administered at least 4 weeks after the second dose.
- Vaccine safety – Consistent with the safety and side effects seen in young adults who receive Moderna COVID-19 Vaccine; no new safety concerns have been identified. However, the clinical trial was not designed to detect rare adverse events, such as myocarditis. More than 90% of recipients experienced pain at the injection site, mostly mild or moderate intensity, for about 3 days. About 1 in 5 recipients also reported redness or swelling at the injection site or swelling and tenderness in the armpit near the injection site. Systemic symptoms were common and more likely to occur after dose 2.
- Booster doses – No booster dose is recommended at this time, but recommendations will be revised as necessary in coming months.
- Practical issues for clinicians
- This formulation of Moderna COVID-19 Vaccine has a red 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 100 mcg per 0.5 mL dose formulation of the vaccine intended for recipients age 12 through 17 years has a light blue label border and wording on the box.
- Children should receive the vaccine formulation recommended for their age on the day of vaccination, regardless of their size. However, CDC and FDA permit flexibility in the choice of formulation for children who have a birthday between dose 1 and dose 2 that leads to a change in recommended formulation.
- As with all Moderna COVID-19 Vaccine presentations, no diluent is needed.
New materials from CDC to support implementation of all new COVID-19 vaccine recommendations for age 6 months through 17 years have been or will soon be posted. All clinicians should carefully review the CDC web page Use of COVID-19 Vaccines in the United States Interim Clinical Considerations, which contains links to CDC job aids updated with the latest recommendations. The Immunize.org Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools has been updated with links to the latest versions of CDC and FDA resources. Immunize.org’s Ask the Experts COVID-19 website will be updated in coming weeks. IZ Express will highlight new materials available to support implementation as they become available.
Other vaccines discussed
RSV – The committee discussed the substantial burden of RSV disease in infants and in older adults and those with chronic health conditions. Several new products, including vaccines for adults and a long-acting (5 months or longer) single-dose monoclonal antibody (mAb) for newborns and infants are in late stages of clinical development and may be eligible for FDA licensure during 2023.
HPV - Information was provided about the recent decision by the World Health Organization’s Strategic Advisory Group of Experts (SAGE) to recommend 1-dose HPV vaccination as an option in settings where use of a single dose will allow countries to expand HPV vaccination programs to more age groups. Early evidence suggests that a single dose may be sufficient to provide a sustained, high level of protection from infection with HPV strains in the vaccine that may be close to the benefit of 2 doses; however, there is no plan at this time to consider a one-dose HPV vaccination schedule in the United States.
Monkeypox – The committee discussed the ongoing monkeypox outbreak in the United States. Two vaccines are available for post-exposure or pre-exposure prophylaxis when indicated: a live vaccine (ACAM2000, Emergent BioSolutions) and a replication-deficient live vaccine (Jynneos, Bavarian Nordic). Images in the presentation slides show how the skin lesions of monkeypox (deep-seated pustules or vesicles) in the current outbreak may differ from previous outbreaks. Clinicians who suspect monkeypox should contact their state or local public health department for consultation and assistance with specimen collection and testing. Testing is not available through commercial laboratories at this time.
Future meetings
The next scheduled ACIP meeting will be held on October 19–20, 2022, although additional emergency meetings may be announced prior to that time. Information about past and future ACIP meetings may be found on the ACIP website.
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Immunize.org updates “Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools” to include infants and young children
Immunize.org has expanded its three-page job aid, Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools, to help you keep up with changes to COVID-19 vaccine guidance and resources for all ages, now including CDC and FDA resources for the vaccination of infants and young children. The checklist includes the most recent revision dates of CDC’s primary COVID-19 vaccination websites, as well as print-ready PDF documents from CDC and FDA. Each date is hyperlinked to the original document or web page. Immunize.org updates this list at least monthly, prominently indicating when it was last updated at the top of the page.
Immunize.org updates this list at least monthly, prominently indicating when it was last updated at the top of the page. We encourage COVID-19 vaccination providers to review this checklist monthly to be sure your practices stay up to date.
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Florida meningococcal disease outbreak continues; gay and bisexual men living in Florida urged to get vaccinated
On June 22, CDC issued a press release in response to an outbreak of meningococcal disease, recommending quadrivalent meningococcal vaccine (MenACWY) vaccination for all gay, bisexual, and other men who have sex with men who live in Florida and recommending it be considered for men in these groups who are visiting Florida. CDC is also emphasizing the importance of routine MenACWY vaccination for people infected with HIV. A portion of the press release appears below.
The Centers for Disease Control and Prevention (CDC) continues its collaboration with the Florida Department of Health to investigate one of the worst outbreaks of meningococcal disease among gay and bisexual men in U.S. history. At least 24 cases and 6 deaths among gay and bisexual men have been reported....
People can find a meningococcal vaccine by contacting their doctor’s office, pharmacy, community health center, or local health department. Insurance providers should pay for meningococcal vaccination for those whom it is recommended for during an outbreak. In Florida, anyone can get a MenACWY vaccine at no cost at any county health department during the outbreak.
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Canada Day is July 1! A summary of immunization information and advocacy in Canada. O Canada! In tribute to Canada’s 154th national anniversary, July 1, we are sharing select Canadian resources for immunization information and advocacy. Best wishes to all our vaccinating friends in Canada!
Expert committees:
Advocacy groups and resources:
Helpful resources:
COVID-19 resources:
Government institutions:
These Canadian documents and resources are provided in French by clicking “Français” at the top right of the web pages.
Spotlight: Check out Immunize.org’s vaccination resources for children to help your patients get up to dateAs children come into your office for sports physicals and well visits this summer, be sure to utilize the resources available at Immunize.org.
Parent Handouts main page offers a library of handouts providing answers to parents' questions about vaccinations.
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.
CDC Schedules main page provides print PDFs of the recommended immunization schedules for children, adolescents, and adults.
Vaccine Confidence main page offers a library of handouts with information for parents who may be questioning vaccinations for their children.
Summary of Recommendations for Child/Teen Immunization is a six-page reference table summarizing ACIP recommendations on the appropriate use, scheduling, and contraindications/precautions for vaccines in children and teens.
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.
Featured Resources
HHS's "We Can Do This" campaign launches toolkit for pediatricians and physicians who communicate with parents and patients about pediatric vaccination
HHS’s public education campaign, We Can Do This, launched its Pediatricians and Family Physicians Toolkit, which includes a sample letter to parents, clinician talking points, posters and flyers that can be hung in exam and waiting rooms, as well as digital communications such as social media posts and sample text messages. The toolkit is also available in Spanish.
In addition to the new toolkit, HHS released a new PSA titled Promise (view in Spanish at Promesa), announcing the new vaccine authorization for children age 6 months and older.
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Vaccines.gov helps people of all ages find COVID-19 vaccines in communities across the United States
Vaccines.gov, powered by VaccineFinder, HHS, CDC, and Boston Children's Hospital, is a user-friendly website that helps you find locations that carry COVID-19 vaccines for people of all ages across the country. The contact information of the provider, clinic, or pharmacy is listed so that you can schedule a vaccination appointment directly at the location of your choosing. Listings include the age groups eligible for vaccination at each site, including infants and toddlers.
Participating providers who want to enroll in this directory that helps millions of people find vaccines can visit the Vaccines.gov Provider Resources main page.
ACOG offers maternal vaccination education videos and infographics, as well as new podcast, Labor of Love: Stories of Vaccines, Variants, and Parenting during COVID
American College of Obstetricians and Gynecologists' (ACOG) new podcast, Labor of Love: Stories of Vaccines, Variants, and Parenting during COVID is a five-part series in which Veronica Pimentel, MD, MS, speaks with women dealing with everything that accompanies motherhood and pregnancy during the pandemic. Dr. Pimentel also speaks with medical experts in the fields of maternal health, fertility, and mental well-being who provide evidence-based information and recommendations on how best to navigate pregnancy and motherhood during COVID-19.
The five-part podcast series can be found on the Labor of Love podcast web page, as well as on your favorite podcast streaming outlet.
In addition, ACOG's Immunization Department, through a cooperative agreement with CDC, created short maternal immunization patient education videos and infographics available to view and download on ACOG’s patient website. These videos and infographics help reach pregnant patients and help support ob-gyns and other women's healthcare practitioners in recommending and advocating that pregnant individuals receive all recommended vaccines at the appropriate time during pregnancy. ACOG encourages clinicians to use these materials on their trusted web platforms, patient portals, and social media pages associated with their practice.
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Vaccinate Your Family offers free graphics, talking points, and FAQs on COVID-19 vaccination of children younger than age 5 years in both Spanish and English Vaccinate Your Family (VYF) has gathered graphics, talking points, and FAQs on the COVID-19 recommendation for children younger than age 5 years. Available in English and Spanish, these materials are free for you to co-brand, repurpose, and use to advocate for COVID-19 protection!
VYF also posted a new animated video, How Do We Know Vaccines Are Safe?, explaining the rigorous safety testing of vaccines and the network of safety systems in place in the United States that constantly monitor for safety signals and alert at the slightest detection of a problem. You can find this and other informational videos on Vaccinate Your Family's YouTube Channel.
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Order Immunize.org’s child, adult, and lifetime immunization record cards—wallet-sized, designed to last! Immunize.org's personal immunization record cards, printed on rip-proof, smudge-proof, water-proof paper, are designed to last a lifetime. They fit in a wallet when folded. The record cards are for you to give to your patients as a permanent personal vaccination record and are sold in boxes of 250.
Make bulk purchases and receive quantity discounts. For quotes on larger quantities or customizing, or to request sample cards, call 651-647-9009 or email admininfo@immunize.org.
Explore the www.Give2MenACWY.org website to increase coverage for the MenACWY booster and other adolescent vaccinations Immunize.org's www.Give2MenACWY.org website promotes the importance of adolescent vaccination, including 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.
Materials on this colorful website for healthcare professionals incorporate the 2020 ACIP meningococcal vaccine recommendations and coverage statistics from CDC’s National Immunization Survey–Teen (NIS–Teen). One particularly popular resource on the site is the updated Algorithm for MenACWY Immunization in Adolescents 11 through 18 Years of Age.
The website is divided into five easy-to-access sections:
The site also categorizes materials according to whether they are primarily of interest to providers, to adolescents, or to parents.
Visit Give2MenACWY.org and enjoy browsing (and deploying) its bountiful resources.
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Notable Publications
“Association between COVID-19 Vaccination and Influenza Vaccination Rates" published in NEJM
On June 15, the New England Journal of Medicine published Association between COVID-19 Vaccination and Influenza Vaccination Rates. A summary appears below.
Nationally representative data from the CDC was used to calculate changes in influenza vaccine uptake at the state-population level during the pandemic, after COVID-19 vaccines became widely available (September 2021–January 2022) compared to influenza vaccination rates before the pandemic (September 2019–January 2020). The findings suggest that after the widespread availability of COVID-19 vaccines, safety concerns and mistrust of COVID-19 vaccination may have also led to lower influenza vaccination rates.
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“Maternal Vaccination and Risk of Hospitalization for COVID-19 among Infants” published in NEJM
On June 22, the New England Journal of Medicine published Maternal Vaccination and Risk of Hospitalization for COVID-19 among Infants. They estimated vaccine effectiveness by comparing the odds of full maternal vaccination (two doses of mRNA vaccine) among infants younger than 6 months of age who were hospitalized for COVID-19 (cases) and those hospitalized without COVID-19 (controls). The study occurred during circulation of the Delta variant (7/1/2021 to 12/18/2021) and the Omicron variant (12/19/2021 to 3/8/2022).
The effectiveness of maternal vaccination in preventing hospitalization for COVID-19 among infants younger than 6 months of age was
- Overall: 52%
- By variant: 80% during the Delta period and 38% during the Omicron period
- By gestation at the time of maternal vaccination: 69% when maternal vaccination occurred after 20 weeks of pregnancy and 38% during the first 20 weeks of pregnancy
The researchers conclude, “ Maternal vaccination with two doses of mRNA vaccine was associated with a reduced risk of hospitalization for Covid-19, including for critical illness, among infants younger than 6 months of age.”
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