Metro Manila (CNN Philippines, December 1) — The Food and Drug Administration (FDA) is not processing any application for the emergency use of COVID-19 vaccines for age 11 and younger as of Wednesday.
FDA Director General Eric Domingo said Pfizer already signified its intention to apply for emergency use of its vaccine on five to 11 years old, but it has yet to submit the requirements. He said the government is expecting Pfizer to send an application this December.
“Yung sa Pfizer, nag-signify sila ng intention and nagtanong na sila anong requirements. They have been informed and we expect na mag-apply na sila soon kasi narollout na sa ibang countries ang kanilang vaccine for aged 5 to 11. So, that means they will be able to share with us not only clinical trial results, but also real-world data on 5 to 11. So, hinihintay natin yan,” Domingo told CNN Philippines in an interview on Wednesday.
[Translation: Pfizer signified its intention and asked for requirements. They have been informed and we expect them to apply soon because their vaccine for aged five to 11 has already been rolled out in other countries. That means they will be able to share with us not only clinical trial results, but also real-world data on 5 to 11. We are waiting for that.]
Sinovac, on the other hand, initially applied for the use of its vaccine on kids aged three to 17 years old. But Domingo said the vaccine experts did not approve its initial application because the data the company submitted was limited. Sinovac was asked to provide additional information on the safety and efficacy of its vaccine for children.
“‘Yung initial application niya ang decision was to disapprove. Sabi lang namin, kapag kumpleto ang data n’yo, mag-apply kayo and re-evaluate namin,” Domingo said.
[Translation: The [vaccine experts] decided to disapprove Sinovac’s initial application. We told the company to apply again when their data is complete, then we will re-evaluate it.]
Domingo said Sinovac initially submitted its “very early data” on its vaccine’s immunogenicity, referring to the vaccinated children’s production of immune response against the virus.
“Ang gusto kasi natin makita yung compared sa hindi binigyan, sino ba ang nagkaroon ng sakit? Ilan ba ang na-prevent na COVID-19? Kasi ‘yun ang basis ng EUAs natin sa adults… Check nila ang antibodies, at the end of three months, six months. Titingnan nila kung sino nagkaroon ng COVID sa hindi nabakunahan. Ilan ang nagka-COVID sa nabakunahan and then you compare ilan ang na-prevent mo? ‘Yun lang ang kulang pa– actual preventing ng disease,” he added.
[Translation: We want to see the comparative outcomes between those who were vaccinated (with Sinovac) and those who were not vaccinated. How many got sick? How many COVID-19 cases were prevented? Because these are also the basis of giving emergency use authorizations for COVID-19 vaccines for adults. They have to check the antibody levels at the end of three months, six months. They need to see how many unvaccinated got COVID. Among the vaccinated — how many caught COVID-19? Then you have to compare — how many infections have been prevented? That is what is lacking in their data — actual [prevention] of disease.]
The FDA chief said vaccine experts are extra cautious in approving COVID-19 vaccines for children as they might need a different dose than the adults.
“Siyempre ‘pag five to 11, unang una ang experts natin mas mabusisi sila kasi maliliit na ang bata…May possibility kasi rin na iba ang dosage, unlike adolescents 12 to 17 who are mostly adult size naman. So, ‘yung five to 11, we just have to make sure ang dosage na gagamitin kaya medyo mas maingat lang tayo,” Domingo said.
[Translation: Our experts are meticulous when it comes to vaccines for five to 11 years old because small kids are involved…It is also possible that the dosage will be different for them, unlike the vaccines for adolescents aged 12 to 17 who are mostly adult size. So, for the five to 11, we just have to make sure we use the right dosage that’s why we are more careful.]
Domingo said the FDA hopes application for emergency use of vaccines for children will be submitted within the month as the government aims to begin inoculation of 11 years old and younger early next year. A specific vaccine brand for this age group will not be given until the FDA approves its emergency use.
