MANILA, Philippines — The Food and Drug Administration (FDA) may have approved the use of Moderna vaccine among children aged six to 11, but this is not yet ready for rollout, the Department of Health (DOH) said yesterday.
There are pertinent provisions in the COVID-19 Vaccination Act of 2021 that must be followed before we can roll out any COVID-19 vaccination, said Beverly Ho, DOH director for health promotion bureau.
“We are waiting for the recommendations of the World Health Organization (WHO) on the use of Moderna for six to 11 years old,” Ho added.
She said the WHO recommendation would guide the Philippine Health Technology Assessment Council (HTAC) in its independent evaluation of the Moderna vaccine that would be given to children.
On May 20, the FDA approved the application of Zuellig Pharma Corp. to amend the emergency use authorization (EUA) of Moderna so this can be administered to children.
A copy of the FDA approval showed the agency took into consideration similar regulatory actions of the internationally recognized National Regulatory Authorities (NRA) of Canada, European Economic Area (30 member-states), Australia and other countries such as Peru and Vietnam.
It said the known and potential benefits of Moderna when used to diagnose, prevent or treat COVID-19 outweigh its known and potential risks.
“Based on totality of evidence available to date, including data from adequate and well-known controlled trials, it is reasonable to believe that Moderna may be effective in preventing, diagnosing or treating COVID-19,” the FDA said.
Case increases
Meanwhile, the DOH reported that 13 regions are currently seeing a rise in COVID cases, although nationally the country remains at low risk case classification.
Ho said these 13 regions posted a “positive two-week growth rate.”
“Despite the slow uptick in COVID cases in the past few weeks, the country remains at low risk case classification,” Ho said.
“These 13 regions also continue to be at low risk classification.”
The 13 regions are Bicol, Calabarzon, Caraga, Central Luzon, Central Visayas, the Cordilleras, Davao Region, Eastern Visayas, Ilocos, Mimaropa, Soccsksargen and Zamboanga peninsula as well as National Capital Region.
Ho said the uptick in the cases was not a cause of concern as the health care utilization rate remains low.
“The increase that we are seeing has yet to translate to an increase in admissions in hospitals,” Ho said.