Moderna: COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to ≤ 6 Years successfully meets its primary endpoint

Moderna has announced interim data from the Phase 2/3 KidCOVE COVID-19 vaccine study ahead of its submission to global regulatory bodies.

Approximately ​4,200 children aged 2 to <6 years and 2,500 children aged 6 months to <2 years were recruited across the U.S. and Canada ​with participants receiving 2 doses of 25 μg, 28 days apart (a lower dose compared with older age groups).

Moderna reports immunogenicity consistent with that seen in adults (18-25 years) receiving doses of 100mcg with a vaccine efficacy of 43.7% in those aged 6 months to <2 years and 37.5% in those aged 2 to <6 years.  Omicron was the predominant COVID-19 strain circulating during this trial.

Adverse events following vaccination were reported as mild or moderate and more frequently ​associated with dose two. No deaths, myocarditis, pericarditis, ​or cases of multisystem inflammatory syndrome in children (MIS-C) were reported. ​Independent safety monitoring ​will continue for 12 months following the second dose.

To read the press release in full, please click on the link below:
COVID-19 Vaccine Phase 2/3 Study in Children 6 Months to ≤ 6 Years successfully meets its primary endpoint


Clinical recommendations for COVID-19 vaccines- updated booster advice

The Australian Technical Advisory Group on Immunisation (ATAGI) have provided updated recommendations ​on the use of booster doses of COVID-19 vaccine​s:

  • Individuals aged 18 years and above are recommended to receive a single booster dose of either mRNA vaccine (Pfizer or Moderna), 3 months after the completion of a primary course of vaccination.
  • Individuals aged 16-17 years are recommended to receive a single dose of Comirnaty (Pfizer) as their booster, 3 months following the completion of their primary course. Alternate COVID-19 vaccine brands are not registered for use as a booster dose in this age group.
  • Whilst Nuvaxovid (Novavax) is not TGA-registered for use as a booster dose, ATAGI recommends that it may be used as a booster in individuals aged 18 years or older in circumstances where there is a contraindication to mRNA vaccines. There is limited safety and efficacy data to support the use of Nuvaxovid as a booster dose, however there are no theoretical concerns.
  • Vaxzevria (AstraZeneca) is no longer recommended for use as a booster dose. Individuals who have already received Vaxzevria (AstraZeneca) as their booster dose do not need a repeat booster dose of an alternate brand.

For further information regarding the ATAGI recommendations on the use of a booster dose of COVID-19 vaccine, please refer to the links below:

ATAGI recommendations on the use of a booster dose of COVID-19 vaccine


The Conversation: The Moderna vaccine is now available for 6 to 11 year olds. Here’s what parents need to know

The Moderna COVID-19 vaccine is now approved for use in children aged 6 to 11 years. With just under half of Australian primary-school-age children having received their first COVID vaccine dose, the approval of Moderna’s COVID vaccine provides parents with an additional opportunity to protect their children against severe disease. 

Following the KidCOVE clinical trial, this article explores the ongoing safety and efficacy as well as the considerations and administrative recommendations for the use of Moderna’s COVID-19 vaccine in the 6 to 11 years cohort. 

To read the full article, follow the link below.

The Conversation: The Moderna vaccine is now available for 6 to 11-year-olds. Here’s what parents need to know