Immunize.org summarizes ACIP’s May 19 meeting recommending COVID-19 booster dose for children age 5 through 11 years
The Advisory Committee on Immunization Practices (ACIP) met on May 19, 2022, to discuss FDA’s May 17 amendment of its Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine to authorize a booster dose for children age 5 through 11 years. At the meeting, ACIP voted to recommend a single booster dose of Pfizer-BioNTech vaccine for children age 5 through 11 years at least 5 months* after completing the primary series. Presentation slides from the meeting are available online, and highlights of ACIP’s discussion are provided below.
* Note: After the meeting, the published recommended interval between completion of the primary series and the booster was clarified to be at least 5 months for immunocompetent children (a total of 3 doses) and at least 3 months for children who are moderately to severely immunocompromised (a total of 4 doses).
COVID-19 epidemiology and overall vaccine effectiveness – As of mid-May 2022, over 82 million COVID-19 cases and over 1 million COVID-19 related deaths have been reported in the United States. Data from 25 U.S. jurisdictions from April 2021 through February 2022 show unvaccinated people age 5 years and older had a 10 times greater risk of dying from COVID-19 when compared to people vaccinated with at least the primary series. Additionally, a new analysis indicates that vaccines could have prevented at least 318,000 U.S. COVID-19 deaths between January 2021 and April 2022.
Since March 2020, almost 5 million cases of COVID-19 have been reported among children age 5 through 11 years. More than 15,000 children required hospitalization, and 189 died. Almost 90% of children hospitalized for COVID-19 during the Omicron surge were unvaccinated, and over half of hospitalized children were Black or Hispanic. One-third of hospitalized children had no underlying medical conditions, and 27% required ICU admission. Despite clear benefits of vaccination, only 28.8% of U.S. children age 5 through 11 years have completed their primary series. Wide disparities in primary-series vaccination were noted, particularly between children living in rural and urban areas, with 14.4% of rural children in this age group having received at least one dose of COVID-19 vaccine as of April 27, 2022, compared to 39.8% of children in large urban areas.
ACIP reviewed data from multiple sources indicating 2-dose vaccine efficacy (VE) against infection declines quickly in children and adolescents, following a similar pattern to that seen in adults. A booster dose in adolescents significantly improved VE. Data were insufficient to assess waning immunity in children age 5 through 11 years or the impact of a booster against hospitalization and severe disease in children age 12 through 15 years.
Vaccine safety – CDC monitors the safety of COVID-19 vaccines in all age groups through its extensive network of surveillance systems, including the Vaccine Safety Datalink (VSD), v-safe, and the Vaccine Adverse Event Reporting System (VAERS). Updated reports from these systems and safety monitoring from Pfizer-BioNTech did not identify any new safety concerns among children age 5 through 11 years. The vast majority of VAERS reports were classified as non-serious. No link has been seen between COVID-19 vaccination and multisystem inflammatory syndrome in children (MIS-C), a severe complication of COVID-19 infection. Within VAERS, just 20 cases of myocarditis/pericarditis post-vaccination have been identified in children age 5 through 11 years. Rates of myocarditis after vaccination in children age 5 through 11 years are lower than in adolescents. All reported instances of myocarditis were within 7 days of vaccination. The risk of myocarditis caused by COVID-19 infection is greater than the risk of vaccine-associated myocarditis.
Pfizer-BioNTech presented data on the safety and immunogenicity of a 10-mcg booster dose of its vaccine in children age 5 through 11. Reactogenicity after a booster dose was mostly mild to moderate and short lived, comparable to that seen after the second dose in the primary series. The booster dose elicited a strong immune response in recipients, and the response is expected to last at least 6 months.
Vaccine acceptance – As noted above, fewer than one in three children age 5 through 11 years has been fully vaccinated against COVID-19. CDC surveys indicate about one-half of parents are worried about rare and serious side effects of COVID-19 vaccines, but many also are concerned about how new variants of the SARS-CoV-2 virus will affect children. Ultimately, 63% of parents of children in this age group report they intend to vaccinate their children at some point. ACIP members emphasized that efforts to reach unvaccinated children should not be compromised by the new booster dose recommendations.
The next scheduled ACIP meeting will be held June 22–23, 2022. However, additional meeting(s) are anticipated before then to discuss COVID-19 vaccines for children younger than age 5 years, if these are authorized by FDA. Information about past and future ACIP meetings may be found on the ACIP website.
CDC issues statement expanding eligibility for COVID-19 booster shots and strengthening second booster dose recommendations
In addition to decisions made at the May 19 ACIP meeting to provide a booster dose of Pfizer-BioNTech COVID-19 vaccine for children age 5 through 11 years, CDC strengthened its previous recommendation for an mRNA COVID-19 vaccine as a second booster dose in certain populations. On March 30, 2022, CDC recommended that certain individuals may be given a second booster dose at least 4 months after their first booster dose. In light of the recent surge in COVID-19 cases around the country, on May 19, 2022, CDC strengthened this recommendation to state that some of these individuals should routinely be given a second booster dose. The current recommendations for a second booster dose of an mRNA COVID-19 vaccine are as follows:
- Immunocompromised people age 12 years and older should receive a second booster dose at least 4 months after the first booster dose
- All adults age 50 and older should receive a second booster dose at least 4 months after the first booster dose
- Adults age 18 through 49 years who received 2 doses of Janssen COVID-19 Vaccine as their primary and booster doses may receive a second booster dose of mRNA COVID-19 vaccine at least 4 months after the first booster.
This guidance has been incorporated into CDC’s updated (May 20, 2022) Use of COVID-19 Vaccines in the United States: Interim Clinical Considerations.
In addition to this update, readers should review all of the May 20 updates to CDC’s interim clinical considerations for the use of COVID-19 vaccines, such as considerations for delaying booster doses up to 3 months following confirmed SARS CoV-2 infection.
CDC issues national monkeypox health advisory. Contact health department or CDC if you suspect a patient may have monkeypox.
On May 20, CDC issued a Health Alert Network (HAN) message on Monkeypox Virus Infection in the United States and Other Non-endemic Countries—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, Bavarian Nordic, and ACAM2000, Emergent). A portion of the summary appears below.
The Massachusetts Department of Public Health and the Centers for Disease Control and Prevention (CDC) are investigating a confirmed case of monkeypox in the United States. On May 17, 2022, skin lesions that had several features suspicious for monkeypox—firm, well circumscribed, deep-seated, and umbilicated lesions—on a Massachusetts resident prompted specialized Laboratory Response Network (LRN) testing of swab specimens collected from the resident …. Testing at CDC on May 18 confirmed the patient was infected with a West African strain of monkeypox virus. The patient is currently isolated and does not pose a risk to the public.
Cases of monkeypox have previously been identified in travelers from, or residents of, West African or Central African countries where monkeypox is considered to be endemic. CDC is issuing this Health Alert Network (HAN) Health Advisory to ask clinicians in the United States to be vigilant to the characteristic rash associated with monkeypox. Suspicion for monkeypox should be heightened if the rash occurs in people who 1) traveled to countries with recently confirmed cases of monkeypox, 2) report having had contact with a person or people who have a similar appearing rash or received a diagnosis of confirmed or suspected monkeypox, or 3) is a man who regularly has close or intimate in-person contact with other men, including those met through an online website, digital application (“app”), or at a bar or party. Lesions may be disseminated or located on the genital or perianal area alone. Some patients may present with proctitis, and their illness could be clinically confused with a sexually transmitted infection (STI) like syphilis or herpes, or with varicella zoster virus infection.
Contact your state or local health department if you have any questions or suspect a patient may have monkeypox. Health departments should consult CDC through the CDC Emergency Operations Center (770-488-7100) or contact CDC Poxvirus and Rabies Branch (firstname.lastname@example.org).
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Immunize.org’s "Ask the Experts: COVID-19" web page updated on May 15
Immunize.org published a thoroughly updated version of its popular Ask the Experts: COVID-19 web page on May 15. This extensive list of clinical questions and answers addresses COVID-19 recommendations and clinical considerations, including use of a second booster dose and new restrictions on the FDA authorization of Janssen vaccine. Readers should note that Ask the Experts does not yet reflect the changes to recommendations and clinical considerations recommended by ACIP on May 19 or the changes to clinical considerations published by CDC on May 20.
Immunize.org's Ask the Experts main page leads you to 30 distinct web pages on a variety of topics with more than 1,100 common or challenging questions and answers about vaccines and their administration. Immunize.org's team of experts includes Kelly L. Moore, MD, MPH (team lead), Carolyn B. Bridges, MD, FACP, and Iyabode Beysolow, MD, MPH.
Influenza activity continues to increase in parts of the country. Influenza vaccination still recommended.
For week 19, ending on May 14, CDC's Weekly U.S. Influenza Surveillance Report, FluView summary reports that seasonal influenza activity continues to increase in some parts of the country. The number of hospital admissions with laboratory-confirmed influenza that were reported to HHS Protect increased slightly compared with the previous week.
CDC continues to recommend influenza vaccination as long as influenza viruses are circulating. Vaccination may still prevent serious outcomes in people who are vaccinated but get sick.
In other influenza news, CDC continues to monitor the expanding avian influenza outbreak now confirmed among wild birds in 38 U.S. states and among domestic poultry in 35 states. There has been no change to CDC’s assessment that the risk to human health remains low. CDC has published avian influenza communication resources (view in Spanish).
VaccineFinder at “Vaccines.gov”
If you don’t provide influenza vaccine at your site, please strongly recommend vaccination and 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. Participating providers can update their vaccine inventory estimates on VaccineFinder by contacting email@example.com.
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Spotlight! “Ask the Experts” answers more than 1,100 questions on vaccines and vaccinations.
In this week's Spotlight, we highlight the Ask the Experts main page at Immunize.org.
Our Ask the Experts main page offers more than a thousand timely questions on vaccines and vaccine administration answered by our experts. Topics include specific diseases and their vaccines as well as vaccine delivery guidance (e.g., administration, billing, documenting).
The main page is one of the most visited destinations on Immunize.org. You'll likely find what you're looking for on one of the 30 topic links.
New and updated Ask the Experts Q&As are published in special editions of IZ Express five times per year. If you have a question that you think may be of interest to our readers, please send it to us using our online form.
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!
Click here for "Vaccines Save Lives" pin pricing and ordering information.
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’re sized to fit in a wallet when folded. The record cards are for you to give to your patients as a permanent and 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 firstname.lastname@example.org.
"Human Papillomavirus Vaccine Impact and Effectiveness through 12 Years after Vaccine Introduction in the United States, 2003 to 2018" published in Annals of Internal Medicine
In the May 17 issue, Annals of Internal Medicine published Human Papillomavirus Vaccine Impact and Effectiveness through 12 Years after Vaccine Introduction in the United States, 2003 to 2018. The results section appears below.
Among sexually experienced females aged 14 to 24 years, the impact on 4vHPV-type prevalence in 2015 to 2018 was 85% overall, 90% among vaccinated females, and 74% among unvaccinated females. No significant declines were found in non–4vHPV-type prevalence. Vaccine effectiveness ranged from 60% to 84% during vaccine eras for females and was 51% during 2013 to 2016 for males.
Note: Use of 9-valent HPV vaccine in the United States did not begin until 2014, so population-level effects for its five additional types will take longer to detect.
"Risk for Shoulder Conditions after Vaccination: A Population-Based Study Using Real-World Data" published in Annals of Internal Medicine
In the May 2022 issue, Annals of Internal Medicine published Risk for Shoulder Conditions after Vaccination: A Population-Based Study Using Real-World Data. The study found an incidence of approximately one shoulder condition diagnosis per 10,000 vaccinations. Excerpts from the abstract appear below.
In the adult vaccinated population, advanced age, female sex, an increased number of outpatient visits in the 6 months before vaccination, lower Charlson Comorbidity Index, and pneumococcal conjugate vaccine were associated with a higher risk for shoulder conditions. Among influenza vaccines, quadrivalent vaccines were associated with an increased risk for shoulder conditions. Simultaneous administration of vaccines was associated with a higher risk for shoulder conditions among elderly persons.…
These population-based data suggest a small absolute risk for shoulder conditions after vaccination. Given the high burden of shoulder conditions, clinicians should pay attention to any factors that may further increase risks.
Immunize.org and CDC offer multiple teaching materials to aid proper injection technique. See the Related Links below.
"Public Health Impact of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) in the First Year of Rollout in the United States" published in Journal of Medical Economics
In the May 15 issue, Journal of Medical Economics published Public Health Impact of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) in the First Year of Rollout in the United States. The results section appears below.
It was estimated that, in 2021, the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) contributed to averting almost 9 million symptomatic cases, close to 700,000 hospitalizations, and over 110,000 deaths, resulting in an estimated $30.4 billion direct healthcare cost savings, $43.7 billion indirect cost savings related to productivity loss, as well as discounted gains of 1.1 million QALYs. Scenario analyses showed that these results were robust; the use of alternative plausible ranges of parameters did not change the interpretation of the findings.
"Trajectory of Long COVID Symptoms after COVID-19 Vaccination: Community Based Cohort Study" published in BMJ
In the May 18 issue, BMJ published Trajectory of Long COVID Symptoms after COVID-19 Vaccination: Community Based Cohort Study. The study included adults age 18—69 years who received at least one dose of a COVID-19 vaccine after testing positive for SARS-CoV-2 infection. The conclusion appears below.
The likelihood of long covid symptoms was observed to decrease after covid-19 vaccination and evidence suggested sustained improvement after a second dose, at least over the median follow-up of 67 days. Vaccination may contribute to a reduction in the population health burden of long covid, although longer follow-up is needed.