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- Moderna has shared interim data from the Moderna COVID-19 vaccine (mRNA-1273) Phase 2/3 KidCOVE research.
- Moderna is also preparing to assess the potential of a booster dose
- Australian government has also inked a deal with Moderna to manufacture mRNA vaccines.
In a significant development, Biotech firm Moderna has shared interim data from its COVID-19 vaccine (mRNA-1273) Phase 2/3 KidCOVE research in children aged 6 months to under 2 years and 2 years to under 6 years.
After a 25 μg two-dose primary series of mRNA-1273, the interim analysis revealed a significant neutralising antibody response in both age groups and a satisfactory safety profile, the company said in a press release.
Moderna is set to submit a request to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global regulators for approval of a 25 μg two-dose primary series of mRNA-1273 for children aged six months to under six years.
KidCOVE is a randomised, double-blind, placebo-controlled trial which will help the scientists in assessing the safety, tolerability, and immunogenicity of two doses of mRNA-1273. The KidCOVE is given to children at a gap of 28 days. The participants in the study are separated into three age groups: 6-12 years old, 2-6 years old, and 6 months-2 years old.
If enough cases were collected, the study's efficacy could be assessed. The company has enrolled approximately 11,700 paediatric participants in the United States and Canada trials, including 4,200 children (aged 2-6 years) and 2,500 children (aged 6 months-2 years).
Booster dosages of mRNA-1273 and its bivalent booster candidate (mRNA-1273.214), which comprises Omicron variant booster and mRNA-1273, are being evaluated by the company.
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The KidCOVE study is being carried out in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. NCT04796896 is the ClinicalTrials.gov identifier.
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BARDA is reimbursing Moderna in full for all allowed expenditures spent by the company in carrying out the BARDA contract's programme. The US government has approved the purchase of mRNA-1273 under the US Department of defence contract number W911QY-20-C-0100.
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When completed, the facility will give Australians an access to a domestically made portfolio of mRNA vaccines against respiratory viruses such as COVID-19, respiratory syncytial virus (RSV), seasonal influenza, and other prospective respiratory viruses pending licence.
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Australian Federal Government has also finalised a deal with biotech firm Moderna Inc (NASDAQ:MRNA) to manufacture mRNA vaccines in Melbourne, Australia. This is in the follow-up of an agreement announced in December 2021.
Moderna expects to support Australia's mRNA research, development, and industry ecosystem as part of the strategic partnership, including collaborative research partnerships with Australian institutions and establishing a regional research centre for respiratory medicines and tropical diseases.
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