Thailands Food and Drug Administration Expands Authorisation of COVID-19 Vaccine Moderna for Use in Adolescents 12 to 17 years old
Thailand, 16 September 2021 – ZP Therapeutics, a division of Zuellig Pharma, a leading healthcare services provider in Asia, today announced that Thailand Food and Drug Administration (FDA) has expanded the authorisation of the COVID-19 Vaccine Moderna for use in adolescents aged 12 to 17 years old. The vaccination regimen is the same as that for adults – two doses of the vaccine to be administered 28 days apart.
"The approval of COVID-19 Vaccine Moderna for use in adolescents expands the vaccine arsenal that Thailand has to combat the pandemic. We are grateful that the Food and Drug Administration has authorised the use of the COVID-19 Vaccine Moderna for adolescents so that they can be offered protection against the coronavirus, especially in light of the highly contagious Delta variant.
We are working tirelessly to support Thailand's mass vaccination efforts. The more people we help to get vaccinated against the virus, the quicker we will reach herd immunity, and the faster we will be able to transition towards normalcy. We are very proud to have a role to play in this process," said Ms. Sunaiyanaa Kidkasetpaisal, General Manager, ZP Therapeutics, Zuellig Pharma Thailand.
In May, Moderna announced that the Phase 2/3 TeenCOVE study of COVID-19 Vaccine Moderna in adolescents met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. Two-dose primary series of COVID-19 Vaccine Moderna showed 100% efficacy in protecting adolescents aged 12 to 17 from symptomatic infection.
The vaccine was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adults. Safety data continues to accrue, and the study continues to be monitored by an independent safety monitoring committee. These data are subject to change based on ongoing data collection.