Spokesperson for the COVID-19 Task Force (Satgas) Prof Wiku Adisasmito said, until now the government has not planned to give COVID-19 vaccinations to children under 12 years old. The statement was made in response to the results of phase II and III clinical trials by Pfizer-BioNTech which showed that the Pfizer vaccine is safe for children aged 5-11 years.
He said the policy refers to the emergency use authorization (EUA) issued by the Food and Drug Supervisory Agency (BPOM).
“So far the Indonesian government is still referring to the EUA Pfizer vaccine issued by the POM since July 15. The Pfizer vaccine is appropriate for children aged 12-15 years and people over the age of 16,” said Wiku in a press conference some time ago.
Furthermore, he explained that the government would definitely announce to the public if there were any recent developments from the results of the clinical trials of the vaccine.
“If there is a change in the criteria for vaccination recipients, the government will immediately provide actual information to the public,” he said.
Head of the POM Agency, Penny K Lukito, explained that his party was still waiting for the registration of an emergency use permit from the United States Food and Drug Administration (FDA).
“Yes, if the registration of the results of clinical trials (UK) of vaccines for children under 12 years of age has been authorized by the US FDA, then Pfizer registers the use of this group in Indonesia by submitting the data, of course the POM will provide EUA for the use of children. according to UK results,” he told Mouab via text message.
He added, the sooner the FDA grants the emergency use of the Pfizer vaccine for children under the age of 12, the faster the POM will grant EUA for children of that age. “Even with reliance on the results of the US FDA review, the process will be faster,” he said.
Meanwhile, the Chairperson of the Indonesia Technical Advisory Group on Immunization (ITAGI) Prof. Dr. Sri Rezeki Hadinegoro revealed that his party had not recommended giving COVID-19 vaccinations for children aged 5-11 years. According to him, currently the government must focus on being able to vaccinate children over the age of 12 in the country. This decision, he said, was also based on the availability of vaccine supplies which were also still limited.
“Sorry ITAGI has not made recommendations because we are still concentrating on (giving COVID-19 vaccines to children) over 12 years old, later if the big and mature ones have reached the target. Also vaccine logistics and Human Resources (HR) are not sufficient,” he told Mouab via text message.
Previously, drug manufacturers Pfizer and BioNTech announced Monday (20/9) that the low-dose, two-dose COVID-19 vaccine is safe and effective for administration to children aged 5 to 11 years.
The company from the United States (US) and its German partner, BioNTech, said that the results from trials showed the vaccine was well tolerated and strong, and was able to neutralize the immune response (antibodies) at the lower dose levels required for children. -younger children.
Pfizer said it had studied lower doses, which were one-third the adult dose in trials given to more than 2,200 kindergarten and elementary students. Two-thirds of the children were vaccinated, and the remaining third were given saltwater injections. The company says the bodies of vaccinated children build up levels of antibodies that are just as strong as those found in teens and young adults. [gi/lt]