The lower dose Moderna paediatric COVID-19 vaccine was just proven to be safe and effective for kids 6 months to under 6 years of age!
Here is what you need to know…
Moderna COVID-19 Vaccine Safe + Works For Kids Under 6!
On 23 March 2022, Moderna announced the interim results of the Phase 2/3 KidCOVE study, which looked at the safety and efficacy of their paediatric vaccine in children 6 months to under 6 years of age.
The interim results showed that their lower-dose paediatric vaccine delivered a “robust neutralising antibody response” with a “favourable safety profile”.
Based on these interim results, Moderna will ask regulators like the US FDA and the European Medicines Agency (EMA) to authorise this lower-dose paediatric vaccine for use by kids 6 months to under 6 years in age.
Moderna COVID-19 Vaccine For Kids Under 6 : The Interim Results
The KidCOVE trial is a randomized, observer-blind, placebo-controlled study (RCT) designed to evaluate the safety and efficacy of the lower-dose Moderna vaccine for use by kids 6 months to under 6 years in age.
The study involved approximately 11,700 children in the US and Canada, of which two groups received the vaccine :
- 2 to under 6 years in age : 4,200 kids
- 6 months to under 2 years in age : 2,500 kids
The paediatric Moderna vaccine comprised of two doses of 25 μg (micrograms), which is a quarter of the adult dose (100 μg), and half the dose for 6-11 year old children (50 μg).
The KidCOVE study (NCT04796896) was conducted in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA).
Safety + Side Effects
- Majority of adverse events* were mild or moderate
- Adverse events were more frequently reported after Dose 2
- Fever greater than 38°C was seen in 17% of the under-2 group, and 14.6% in the older group
- The study was not paused for any safety issues.
- No new safety concerns were identified.
- No deaths, myocarditis / pericarditis, or multi-system inflammatory syndrome in children (MIS-C) were reported
* Adverse events are not necessarily side effects of the vaccine.
The Omicron variant predominated during the KidCOVE study, and its ability to escape vaccine protection was confirmed.
The Moderna vaccine efficacy (against symptomatic infection) was reduced against Omicron, which is consistent with what was seen with the adult vaccine.
However, the vaccine was shown to protect against severe disease, hospitalisation and death./
- Two 25 μg doses provided similar immunogenicity to two adult doses of 100 μg.
- Efficacy vs symptomatic infection by Omicron (under 2) : 43.7%
- Efficacy vs symptomatic infection by Omicron (2 to under 6) : 37.5%
- Majority of Omicron cases were mild.
- No child in both vaccine groups developed severe COVID-19.
- No child in both vaccine groups were hospitalised for COVID-19.
- No child in both vaccine groups died from COVID-19.
Moderna will continue to monitor all participants for 12 months after their second injection to assess long-term protection and safety.
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