Indonesia Allows Sinovac Vaccine for Children 6-11 Years

Jakarta, MINA – Indonesian Food and Drug Supervisory Agency (BPOM) issued an emergency use authorization for the Sinovac vaccine for children aged 6-11 years on Monday. The Head of BPOM Penny K Lukito said the Sinovac vaccine was safe for children that age.

“BPOM allows the use of Sinovac from China for children aged 6-11 years and of course also for adults,” said Penny K Lukito in an online press conference on Monday as quoted from Republika.

Penny said based on the results of clinical trials of children, Sinovac is safer both in terms of safety and immunogenicity. “So, the immunogenicity shows a fairly high percentage, 96.5 percent,” she said. With this permit, the Sinovac vaccine can be used for children aged six years to adults.

Furthermore, BPOM also immediately granted emergency use permits for Pfizer and Sinopharm vaccines for the age group of children aged 6 to 11 years.

Currently, said Penny, BPOM is still waiting for details from the US drug regulator regarding the evaluation data so that the granting of the permit must be postponed for a while.

“Our Sinopharm from Kimia Farma is still waiting and I think Pfizer will hopefully be able to register with us soon so we can get the data on the evaluation results from the USFDA and in the not too distant future the permit for its use will be issued,” said Penny.

Penny explained specifically for Pfizer, the US drug regulator had actually issued a permit for emergency use of vaccines before. With this permit, through the reliance mechanism, BPOM can immediately grant immediate permission for the use of Pfizer in Indonesia.

“I think that with the reliance mechanism program that we have enforced especially during this emergency period, of course we can quickly issue a license to use it in Indonesia because Pfizer has also entered Indonesia,” said Penny.

However, Pfizer has not yet received a permit for use for the child age group. In order to be used, BPOM actively seeks to ask Pfizer to immediately fulfill the requirements needed so that the permit can be issued immediately.

“That’s what we are waiting for, we are even proactive in pursuing it because of course we want to provide several alternatives for vaccines that can be used for children,” said Penny.

Similar problems also occur with the Sinopharm vaccine. On the similarity of the problems between the two, BPOM urges related parties to immediately complete the necessary data, so that the vaccine can be immediately used for the age group of children. (T/RE1)

Mi’raj News Agency (MINA)