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May 31, 2022

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

Two 50μg doses of the vaccine showed to stimulate a robust immune response for children aged six to 11 years.

The Philippine Food and Drug Administration (FDA) has granted approval for the Moderna Covid-19 Vaccine, Spikevax, for use in children who are aged six to 11 years.

The Manila Times reported that the latest approval from the regulatory agency is an amendment to Zuellig Pharma’s emergency use authorization (EUA), which was filed through its marketing arm ZP Therapeutics.

According to published and peer-reviewed clinical findings, two 50μg vaccine doses demonstrated an acceptable safety profile and stimulated a robust immune response for children of the age six to 11 years. 

The vaccine’s efficacy and safety in children were also in line with those in adults.

Zuellig Pharma medical director Philip Nakpil was quoted by the newspaper as saying that the approval from the Philippine regulatory authority is an addition to the latest affirmations by the National Regulatory Authorities of Canada, European Economic Area, Australia, and other countries on the vaccine for use in paediatric individuals.

The EUA is valid only for the periods of the declared Covid-19 public health emergency unless revoked or until a marketing authorisation or product registration certificate is issued.

ZP Therapeutics Philippines general manager Jeff Folland noted that with the approval of the amended EUA for the Moderna Covid-19 Vaccine, parents will be further encouraged to inoculate their children and protect them from the severe disease effects.

Earlier this month, Moderna sought a variation to the conditional marketing authorisation from the European Medicines Agency for evaluating a 25µg two-dose regimen of Spikevax in children aged six months to below six years.

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