Locally-made COVID-19 vaccine Inavac could likely be used as a booster for adolescents by the end of this year, President Director of PT Biotis Pharmaceutical Indonesia, F.X. Sudirman, has said.
“The Inavac heterologous booster (vaccine) can be used later this year for adolescents. The emergency-use permit (EUA) is targeted to be issued in September 2022 by the National Agency of Drug and Food Control (BPOM),” he informed during a domestic drug development workshop at Ayana MidPlaza Hotel here on Friday.
The Inavac vaccine, which is based on an inactivated virus platform, has been developed by a research team from Airlangga University (Unair) in collaboration with Biotis as the production facility provider.
The vaccine, whose development was started on May 12, 2020, has currently entered Phase 3 clinical trials, which have involved 4,005 participants receiving two primary vaccine injections.
The research on the use of the vaccine for primary doses is linked to research on the use of Inavac as a booster for children, adolescents, and adults, Sudirman said. “Now, what is being carried out is research for primary doses for adults,” he added.
He affirmed that all stages of the clinical trial implementation protocol are regularly being discussed with the BPOM.
The Inavac vaccine is planned to be used for heterologous booster vaccinations, wherein the booster vaccine is from a different brand or platform from the one used in the primary vaccination.
According to him, the production facility of PT Biotis in Gunung Sindur sub-district, Bogor district, West Java, has started preparations for production. In the initial stage, five million doses are targeted to be produced for primary doses.
“We have started to ‘exercise’ for production following the granting of a Good Manufacturing Practice (CPOB) certificate some time ago. If we can obtain EUA, we can speed up production, but if we do not obtain EUA, we will release it next year,” he informed.
Source: Antara News