Philippine FDA grants approval for Spikevax Covid-19 vaccine for children

The Philippine FDA has approved the Moderna Covid-19 Vaccine, Spikevax, for 6 to 11-year-olds.

The Manila Times claimed that the current approval is an update to Zuellig Pharma's emergency use authorization.

Two 50g vaccination doses showed an acceptable safety profile and elicited a robust immunological response in children ages 6 to 11.

Children had the same efficacy and safety as adults.

Zuellig Pharma medical director Philip Nakpil said the permission from the Philippine regulatory authorities adds to the latest affirmations from Canada, the EEA, Australia, and other nations on the vaccine for use in children.

Unless cancelled or until a marketing authorization or product registration certificate is received, the EUA is only valid during the declared Covid-19 public health emergency.

ZP Therapeutics Philippines general manager Jeff Folland said the updated EUA for the Moderna Covid-19 Vaccine will encourage parents to immunize their children and safeguard them from serious disease impacts.

Moderna requested a change to the European Medicines Agency's conditional marketing authorization for assessing a 25g two-dose regimen of Spikevax in children aged six months to below six years.