THE Food and Drug Administration has approved amendments to the Emergency Use Authorization (EUA) of Sinovac and has given the green light to the Department of Health for the use of its vaccines for children aged 6 years old and above.
In an eight-page letter to IP Biotech Inc., FDA acting Director General Oscar Gutierrez informed the local partner of Sinovac of the granting of the amended EUA.
“After due consideration, the Food and Drug Administration (FDA) hereby revises the EUA granted to the COVID-19 Vaccine Sinovac to reflect the requested changes. This product is suitable for clinically healthy people aged 6 years old and above susceptible to virus,” Gutierrez said.
In a separate text message, National Vaccination Operations Center (NVOC) head Myrna Cabotaje confirmed the FDA approval of the EUA amendment for Sinovac jabs.
“Yes, there is already an EUA for Sinovac for 6 years old and above,” said Cabotaje.
The FDA said it has completed its review and consideration of the manufacturer’s application, including all supporting documents, and a review of local experts.
“Based on the totality of evidence available to date, including data from adequate and well-known controlled trials, it is reasonable to believe that the COVID-19 vaccine Sinovac may be effective to prevent, diagnose, or treat COVID-19,” said Gutierrez.
In addition, he said the approval comes after giving consideration to the EUAs given by counterpart National Regulatory Authorities (NRAs).
“In issuing this EUA, consideration has been given to the emergency use authorizations given by counterpart National Regulatory Authorities (NRAs), such as China, Brazil, and Indonesia,” said Gutierrez.
The FDA said the Sinovac jab for the pediatric population remains a two-dose vaccine, with the second dose to be given after four weeks from the first dose.
FDA added that each vial must contain 0.5ml per dose containing 600SU of indicated COVID-19 inactivated virus as antigen.
Cabotaje said the DOH is already discussing the guidelines for its implementation and “will be out soonest”.
The FDA has so far allowed the use of Pfizer and Moderna vaccines for 12 to 17 years old.
On the other hand, Pfizer vaccine is the only jab that has received emergency use approval for those aged 5 to 11 years old.
