Metro Manila (CNN Philippines, August 16) — The Philippines’ Food and Drug Administration has yet to approve Sinovac’s push for a vaccine trial in children ages 3 and 17 years old, a health authority said Monday.
Although the clinical trial results in China showed that Sinovac’s COVID-19 vaccine is safe, and triggers a strong antibody response for children, Philippine health officials still seek to hold local data.
“Ang Sinovac ay nag-apply for clinical trial sa children 3-17 years old, na-rekomenda na namin ang approval ng clinical trial,” Dr. Nina Gloriani, chairperson of the vaccine expert panel, said during a virtual briefing.
[Translation: Sinovac has applied for a clinical trial in children 3-17 years old, we have already recommended the approval of the clinical trial.]
The recommendation has been forwarded to the FDA for its final approval, Dr. Gloriani said.
“Ongoing ang evaluation sa FDA for final approval. Gusto natin ng local data. Although maganda ang data nila in terms of safety, antibody responses sa mga bata, pero kailangan natin ng local data bago natin payagan ang pag-deploy widely,” she said.
[Translation: The evaluation of FDA for final approval is ongoing. We want local data. Although their data is good, in terms of safety, antibody responses in children, but we need local data before we allow it to be widely deployed.]
In July, the FDA said Sinovac applied for the amendment of its emergency use authorization in the country to cover children 3-17-year-olds.
Calls to include children in the Philippines’ vaccination drive have been stressed following the growing fears of the highly transmissible Delta variant.
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Last month, Vaccine czar Carlito Galvez, Jr. said the government may inoculate children with Pfizer in the second half of 2021.
Earlier in June, the FDA approved the emergency use of Pfizer’s COVID-19 vaccines for minors aged 12 to 15 after the US FDA expanded Pfizer’s use to include that age group. The initial EUA of Pfizer covered those aged 16 and above.
