ATAGI Recommendations for the First Booster Dose in Adolescents 12-15 Years

Recommendations

• ATAGI recommends that a first booster dose of Comirnaty (Pfizer) COVID-19 vaccine be given to the following adolescents, ages 12-15, who completed a primary course of vaccination 3 or more months ago:
  • the ones that are severely immunocompromised
  • people with disabilities with significant or complex health needs
  • those with complex and/or multiple health conditions that increase the risk of severe COVID-19
• Currently, Spikevax (Moderna) and Nuvaxovid (Novavax) are not approved for use as the first booster dose in this age group.
• ATAGI continues to recommend a 3-month interval between a recently confirmed SARS CoV-2 infection and a scheduled dose of COVID-19 vaccine.
• ATAGI does not recommend giving a first booster dose of the COVID-19 vaccine to all adolescents aged 12-15 years. There is insufficient evidence of serious illness in otherwise healthy adolescents in this age group who have already received two primary doses of a COVID-19 vaccine. ATAGI continues to recommend that all adolescents aged 12-15 years receive a primary vaccine course of 2 doses of COVID-19 vaccine, 8 weeks apart. A third primary dose from 2 months after dose 2 is recommended for people who are severely immunocompromised.
• ATAGI also recommends that all Australians, including adolescents aged 12-15, receive a dose of the flu vaccine as soon as possible. All COVID-19 vaccines can be
  co-administered (given on the same day) with a flu vaccine.

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The current primary goal of Australia’s COVID-19 vaccination program is to prevent serious illness, including hospitalization and death. Early Australian and international data suggest that adolescents aged 12-15 years have a very low risk of serious illness or death from the Omicron variant of SARS-CoV-2, especially if they have completed a primary vaccination course.^1-3 There is currently insufficient evidence that a first booster dose provides additional protection against serious illness for most children and adolescents in this age group.

Adolescents aged 12-15 at increased risk of serious illness can receive a first booster dose

Based on first principles, ATAGI has identified three groups of adolescents aged 12-15 years who may be at greater risk of serious illness from COVID-19 compared to their peers:

• the ones that are severely immunocompromised
• people with disabilities with significant or complex health needs
• those with complex and/or multiple health problems

An initial booster dose of the COVID-19 vaccine may provide additional protection against serious illness, as the overall risk of intensive care unit admission and death in this age group remains very low.^1-3 There have been no confirmed deaths from COVID-19 in Australian adolescents aged 12-15 during the period of Omicron rule.^1.2 Most European and North American countries have also recorded no deaths, except for England (1), Denmark (5) and the United States (17).³ These data reflect deaths in adolescents aged 12-15 years with concomitant SARS-CoV-2 since February 1, 2022, and do not necessarily attribute the cause of death to COVID-19.

Myocarditis after vaccination remains rare. Data from the United States and Israel suggest that the risk of myocarditis after a third dose of the Pfizer COVID-19 vaccine in male adolescents aged 12-15 years ranges from 1 in 11,000-58,000 doses. This is likely to be lower than the rate after dose 2 and higher than the rate after dose 1.^4-5 There are currently no reports of myocarditis following a first booster dose in adolescent females aged 12-15 years. Although female adolescents aged 12-15 years appear to have a lower risk of developing vaccine-associated myocarditis after each dose of Pfizer COVID-19 vaccine compared to males, cases have been reported after doses 1 and 2. ⁴ See ATAGI’s clinical guidelines at: myocarditis and pericarditis for details.

A third primary dose from 2 months after dose 2 is recommended for adolescents aged 12-15 years who are severely immunocompromised. The first booster dose for this cohort is their 4^e dose of a COVID-19 vaccine. The effectiveness and safety of a 4^e dose in this age group is unknown, but the benefits likely outweigh the risks. There have been no safety concerns in severely immunocompromised people in older age groups.

A first booster dose is not recommended for all adolescents aged 12-15 years

At present, there is insufficient evidence that a first booster dose of a COVID-19 vaccine provides additional protection against serious illness for the majority of adolescents aged 12-15 years.

Adolescents 12-15 years of age who are not severely immunocompromised should receive 2 doses of an approved COVID-19 vaccine as a primary series, 8 weeks apart.

Early evidence suggests that two doses provide protection against serious illness, including intensive care unit admission and the development of multisystem inflammatory syndrome in children, and this protection lasts for at least several months after a primary course of vaccination in adolescents over the age of 18 years. 12-18 years.^6-8 This is supported by Australian data showing that unvaccinated adolescents aged 12-15 years are more likely to be admitted to an intensive care unit compared to those who received a primary series of COVID-19 vaccination .^1-2

Opinion may change if evidence emerges

This advice may change as new evidence or vaccines emerge or the objectives of the vaccination program respond to local epidemiology (e.g. a new variant of SARS-CoV-2 becomes predominant). ATAGI will continue to regularly assess the role of first booster doses in all adolescents aged 12-15 years.

References

1. Pediatric Active Enhanced Disease Surveillance (PAEDS). Interim analysis of PAEDS surveillance data. Westmead: National Center for Immunization Research and Surveillance of Vaccine Preventable Diseases, PAEDS; 2022. Available from: https://www.ncirs.org.au/our-work/paediatric-active-enhanced-disease-surveillance-paeds
2. Australian and New Zealand Intensive Care Research Center (ANZIC-RC). SPRINT-SARI: Investigating the short-term incidence of severe acute respiratory infections. Melbourne: Monash University, ANZIC-RC; 2022. Available from: https://www.monash.edu/medicine/sphpm/anzicrc/research/sprint-sari
3. Murdoch Children’s Research Institute. COVID-19 and Child Monitoring Report #18. May 9, 2022. Available from: https://www.mcri.edu.au/sites/default/files/media/documents/covid-19_and_childrens_surveillance_report_18_090522.pdf
4. Klein N, Shimabukuro T. ACIP slides for meetings. April 20, 2022. Updates on the safety of the booster dose COVID-19. 2022. Available from: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-04-20/03-COVID-Klein-Shimabukuro-508.pdf (Access until 25/5/2022)
5. Israeli Ministry of Health. Protection by 4th dose of BNT162b2 against Omicron in Israel. FDA Vaccines and Related Biological Products Advisory Committee Meeting; 2022. Available from: https://www.fda.gov/media/157492/download (Accessed 19/05/2022).
6. Olson SM, Newhams MM, Halasa NB, et al. Effectiveness of BNT162b2 vaccine against critical Covid-19 in adolescents. N Engl J Med. 2022 Feb 24;386(8):713-723. doi:10.1056/NEJMoa2117995. Epub 2022 January 12. PMID: 35021004; PMCID: PMC8781318. Available at: https://www.nejm.org/doi/10.1056/NEJMoa2117995
7. Zambrano LD, Newhams MM, Olson SM et al. Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA vaccination against multisystem inflammatory syndrome in children aged 12-18 years – United States, July-December 2021. MMWR Morb Mortal Wkly Rep. 2022 Jan 14;71(2):52-58 . doi: 10.15585/mmwr.mm7102e1. PMID: 35025852; PMCID: PMC8757620. Available at: https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e1.htm?s_cid=mm7102e1_w
8. Price AM, Olson SM, Newhams MM et al. BNT162b2 Protection against the Omicron variant in children and adolescents. N Engl J Med. 2022 May 19;386(20):1899-1909. doi:10.1056/NEJMoa2202826. Epub 2022 March 30. PMID: 35353976; PMCID: PMC9006785. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2202826