ATAGI recommendations on first booster dose in adolescents aged 12

Recommendations

• ATAGI recommends that a first booster dose of the Comirnaty (Pfizer) COVID-19 vaccine may be given to the following adolescents aged 12-15 years who have completed a primary course of vaccination 3 or more months ago:
  • those who are severely immunocompromised
  • those who have a disability with significant or complex health needs
  • those who have complex and/or multiple health conditions that increase the risk of severe COVID-19
• Currently, Spikevax (Moderna) and Nuvaxovid (Novavax) are not licensed for use as a first booster dose in this age group.
• ATAGI continues to recommend a 3-month interval between a recent confirmed SARS CoV-2 infection and a scheduled dose of COVID-19 vaccine.
• ATAGI does not recommend that a first booster dose of COVID-19 vaccine be given to all adolescents aged 12-15 years. There is insufficient evidence of severe disease 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 complete 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 those who are severely immunocompromised.
• ATAGI also recommends that all Australians, including adolescents aged 12-15 years, receive a dose of influenza vaccine as soon as practical. All COVID-19 vaccines can be

  co-administered (given on the same day) with an influenza vaccine.

Rationale

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

Adolescents aged 12-15 years who are at an increased risk of severe disease may receive a first booster dose

From first principles, ATAGI have identified three groups of adolescents aged 12-15 years who may be at greater risk of severe disease from COVID-19 compared to their peers:

• those who are severely immunocompromised
• those who have a disability with significant or complex health needs
• those who have complex and/or or multiple health conditions

A first booster dose of COVID-19 vaccine may offer additional protection against severe disease, noting the overall risk of admission to an intensive care unit 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 years during the period of Omicron predominance.^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 concurrent SARS-CoV-2 since February 1, 2022, and do not necessarily attribute cause of death to COVID-19.

Myocarditis following vaccination remains rare. Data from the United States and Israel suggest the risk of myocarditis following 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 probably lower than the rate after dose 2 and higher than the rate after dose 1.^4-5 There have currently been no reports of myocarditis following a first booster dose in female adolescents aged 12-15 years. Although female adolescents aged 12-15 years appear to have a lower risk of developing vaccine-associated myocarditis after any dose of the Pfizer COVID-19 vaccine compared to males, cases have been reported after doses 1 and 2. ⁴ See the ATAGI clinical guidance on myocarditis and pericarditis for details.

A third primary dose from 2 months after dose 2 is recommended for adolescents 12-15 years who are severely immunocompromised. The first booster dose for this cohort will be their 4^th dose of a COVID-19 vaccine. The effectiveness and safety of a 4^th dose in this age group is unknown, but the benefits are likely to 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 the current time, there is insufficient evidence that a first booster dose of a COVID-19 vaccine provides additional protection against severe disease for the majority of adolescents aged 12-15 years.

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

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

Advice may change as evidence emerges

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

References

1. Paediatric Active Enhanced Disease Surveillance (PAEDS). Interim analysis of PAEDS surveillance data. Westmead: National Centre for Immunisation 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 Centre (ANZIC-RC). SPRINT-SARI: Short period incidence study of severe acute respiratory infection. 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 Children's Surveillance Report #18. 9 May 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 meeting slides. 20 April 2022. Updates on safety of COVID-19 booster dose. 2022. Available from: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-04-20/03-COVID-Klein-Shimabukuro-508.pdf (Accessed 25/5/2022)
5. Israel 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 Jan 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 Among Persons 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 Mar 30. PMID: 35353976; PMCID: PMC9006785. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2202826