Australia gives a green light to Moderna’s coronavirus vaccine for children aged 6 to 11.
Australia’s medicines regulator granted provisional approval on Wednesday to Moderna’s coronavirus vaccine in children aged 6 to 11. It is the first time a national regulator has approved the vaccine for children younger than 12.
The green light by the Therapeutic Goods Administration, which regulates medicines and most other therapeutics in Australia, provides an alternative to the Pfizer-BioNTech vaccine for immunizing children against the coronavirus.
Moderna’s chief executive, Stéphane Bancel, called the authorization an “important milestone” for the company. Australia granted provisional regulatory approval last year for its use in adults and adolescents, and the company has been studying its use in younger children and infants.
The vaccination schedule authorized for children is the same as for adults — two shots, four weeks apart — but the pediatric doses are 50 micrograms, half the size of a standard adult dose. Moderna’s booster shots for adults are also 50 micrograms.
While each country’s regulatory agency for pharmaceuticals acts independently, it was likely that the data Moderna gave to the Australian regulators was also being submitted to authorities in the United States, the European Union and Britain, said Brian Ferguson, an immunologist at Cambridge University.
“If they are seeing the same data, because one regulatory agency has been convinced, then it is likely that others will be convinced,” Dr. Ferguson said in an interview. “It is good news for the vaccination of children, because it means that there will be more options available.”
Pediatric vaccines are manufactured using a different supply chain from those for adults, he said, but even so, adding Moderna pediatric doses will not make a big difference in the worldwide imbalance between the supply of effective vaccines and the demand for them.
The Food and Drug Administration granted full approval last month for use of Moderna’s coronavirus vaccine in adults in the United States, but has not yet acted on the company’s application for authorization to administer it to adolescents.
