Australian infants and young children may soon be eligible for COVID-19 protection after a vaccination received preliminary approval from the drugs authority.
For children aged six months to six years old, the Moderna vaccine has received preliminary approval from the Therapeutic Goods Administration.
It is the first time in Australia that a vaccination for the age range has been granted provisional approval.
The SPIKEVAX vaccine for children is administered in two doses, spaced 28 days apart.
The TGA considered data from clinical trials in Canada and the United States, which included more than 6000 participants aged from six months to six years.
The study found the immune response to the vaccine in children was similar to that seen in young adults aged 18 to 25 years and had similar safety levels.
The FDA explained in a statement that the first step was temporary approval, and the decision showed “that the vaccine has met high safety, quality, and efficacy standards.”
Now that the regulator has given its permission, Australia’s immunization expert advisory body ATAGI will evaluate it and advise the government on whether kids in the relevant age group should be eligible.