Moderna seeks nod for vaccine for kids aged 5 and below

NEW YORK • Moderna Inc says it will ask regulators to authorise its Covid-19 vaccine for children younger than six years old based on data showing it generated a similar immune response in young children as for adults in its clinical trial.

The Omicron variant of the coronavirus was predominant during Moderna's paediatric trial, and the drugmaker said on Wednesday two doses were around 38 per cent effective in preventing infections in two-to five-year-olds and 44 per cent effective for children aged six months to two years.

Moderna said these results were consistent with the vaccine's lower effectiveness against Omicron seen in adults who had received two doses.

"People are automatically recalling the 95 per cent (vaccine efficacy) from Pfizer or Moderna early on, and I don't think those are fair comparisons because Omicron is an immune-evasive variant," said Dr Amesh Adalja, an infectious disease expert at the Johns Hopkins Centre for Health Security.

Dr Adalja said the vaccine would be especially valuable for children at high risk of severe disease.

Moderna's vaccine could become the first authorised shot for children under the age of five in the United States. The Covid-19 vaccine from Pfizer Inc and Germany's BioNTech SE is authorised for use in children aged five and older. Their trial results for two-to four-year-olds showed a weaker immune response than in adults, forcing the trial to be extended to test a third dose. Results are expected next month.

Moderna chief executive Stephane Bancel said in a statement that the company is "working with the United States Food and Drug Administration and regulators globally to submit this data as soon as possible".

Dr Jacqueline Miller, a top scientist at Moderna, told Reuters the company was "a couple of weeks away" from filing for authorisation for the age group.

Separately, Australia will partner with Moderna to manufacture tens of millions of vaccine doses domestically, including Covid-19 mRNA shots, as the country seeks to bolster its pharmaceutical supply lines.

In a deal worth almost A$2 billion (S$2.03 billion), according to a report in The Australian newspaper, Moderna finalised an agreement with the government to establish a "state-of-the-art" mRNA vaccine manufacturing facility in the state of Victoria.

It could begin operations as soon as 2024, the company said in a statement yesterday. "This means an Australian shot in the arm for our pandemic preparedness, for Australia's health but also for the future of Australian manufacturing in the medical sphere," Prime Minister Scott Morrison told reporters in Melbourne.

The facility is expected to produce about 100 million vaccine doses annually when operational, for a range of respiratory illnesses including Covid-19, seasonal influenza and other potential respiratory viruses.

Australia is the first country outside the US to reach an onshore manufacturing agreement with Moderna, the company said.

As part of the deal, Moderna said it will work with Australia's research industry to collaborate on mRNA development, including a research centre into respiratory and tropical diseases.

The Morrison government was regularly criticised throughout the pandemic for failing to move quickly enough to secure medical supplies to tackle the virus, especially vaccines in early 2021 and then testing equipment early this year.

REUTERS, BLOOMBERG