FDA approves Moderna vaccine for 6-11 year-olds
Taiwan’s Food and Drug Administration (FDA) has authorised the use of Moderna's Covid-19 vaccine in children aged from 6 to 11.
Moderna is the first coronavirus jab in Taiwan to be made available to children under the age of 12.
FDA Director-General Wu Shou-mei says a team of experts recommended authorisation after determining that the vaccine met the necessary safety and efficacy requirements.
Wu says the decision was based on Phase 2 and Phase 3 clinical trial data, which shows that the vaccine generated virus-neutralizing antibodies in children aged 6-11.
That's similar to levels seen in adult and young adult control groups.
Wu says although children are slightly more likely to develop a fever after vaccination, they also experienced other side effects at similar rates as adults, the vast majority of which were mild and temporary.
Approval has now been sent to the Advisory Committee on Immunization Practices, which will meet this Wednesday to review the move.