DOST to wait for ‘acceptable efficacy, safety data’ before expanding vaccine trials to minors

Published June 10, 2021, 11:01 PM

by Merlina Hernando-Malipot

The Department of Science and Technology (DOST) on Thursday, June 10, maintained that only individuals aged 18 years old and above are allowed to participate in the vaccine trials in the country – noting that getting preliminary data is very crucial before expanding it to the younger age group.

(ALI VICOY / MANILA BULLETIN)

Issuing an official statement, DOST Undersecretary for Research and Development (R&D) Rowena Cristina l. Guevara said that to date, individuals who are 17 years old and below are not yet allowed to participate in any coronavirus disease (COVID-19) vaccine trials in the Philippines for several reasons.

“There are two main reasons why the Task Group on Vaccine Evaluation (TG VES) and Selection has so far not included children aged 17 and under in vaccine trials,” Guevara said in Filipino.

The foremost reason, Guevara said, is that vaccine developers are only inviting adults 18 to 60 years old to participate in the vaccine trials.

The reason being, she explained, is that adults have more developed physique compared to children which is the main basis for evaluating vaccine efficacy and safety.

“Gamit ang datos mula sa adult population, ay saka pa lamang masusuri ang tama at ligtas na dosage para sa mga bata (Using data from the adult population, only then can the correct and safe dosage for children be evaluated),” Guevara explained.

Guevara said that only persons 18 years of age and older may give “ethical and legal consent” for their own participation in vaccine trials.

“Kailangan ng karagdagang permiso ng mga magulang o legal guardian para sa mga may edad 17 pababa (Additional parental or legal guardian permission is required for those aged 17 and under),” Guevara said.

The second reason, Guevara explained, is that experts deem that it would be better to have “acceptable efficacy and safety data” available for adults before expanding the vaccine trials to minors.

“May mga ethical requirements at safety and efficacy data na dapat ma-isumite ng vaccine developers para sa pagsusuri ng vaccine experts at regulatory authorities (There are ethical requirements and safety and efficacy data that vaccine developers must submit for review by vaccine experts and regulatory authorities),” Guevara explained.

Currently, Guevara noted that only countries such as China, the United Kingdom, the United States, India, and other countries are already conducting vaccine trials on children 17 years of age and under.

“Mas maigi kung makakakuha muna ng paunang datos ang ating bansa sa mga pag-aaral na ito para sa kaligtasan at kaayusan ng ating programa sa pagbabakuna (It would be better if our country could first get preliminary data on these studies for the safety and orderliness of our immunization program),” Guevara added.

On June 8, the Department of Health (DOH) confirmed that the Food and Drug Administration (FDA) has approved the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 12 to 15.

 
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