Managing Director of Bio Farma, Honesti Basyir, said that the National Food and Drug Supervisory Agency (BPOM) has granted emergency-use authorization (EUA) for IndoVac’s use as a booster vaccine for people aged 18 and above who took the Pfizer vaccines as their primary vaccination.
"It is according to the letter issued by BPOM on April 21, 2023," he said in a press release received from Bio Farma on Tuesday.
Earlier, BPOM had also issued an EUA for IndoVac’s use as a booster for adults who were administered the Sinovac and AstraZeneca vaccines for their primary vaccination, the president director informed.
He said that the issuance of the permit showed that IndoVac has met the safety, quality, and efficacy requirements for COVID-19 vaccines, thus it is on par with global vaccine products.
According to the statement, clinical trial results have shown that the IndoVac vaccine has good immunogenicity and safety as a booster vaccination for people who received the Sinovac, AstraZeneca, and Pfizer vaccines as their primary vaccination.
The trials also showed that the use of IndoVac as a heterologous booster for Sinovac, AstraZeneca, and Pfizer primary vaccines could increase antibody titers and neutralization titers against the Omicron variant of Coronavirus.
According to the trial’s results, the most common adverse events following immunization (AEFI) were pain at the injection site and mild muscle pain.
According to Basyir, the Religious Affairs Ministry's Halal Product Assurance Agency (BPJPH) earlier issued a halal certificate for IndoVac, while the Indonesian Ulema Council (MUI) issued a fatwa regarding the halal profile of the vaccine.
"Thus, this product can be accepted by all people throughout the world. Halal certification is one of IndoVac's value added in the global market," he remarked.
The domestically produced vaccine has been developed based on a protein recombinant subunit technology.
As of May 2, the COVID-19 Task Force recorded 14,205 active cases of COVID-19 in Indonesia.
The Health Ministry reported that the coverage of the first dose, second dose, primary booster, and secondary booster vaccinations in Indonesia reached 86.86 percent, 74.52 percent, 37.87 percent, and 1.73 percent, respectively, as of May 2.
Related news: IndoVac administration started for second booster vaccinations
Related news: Bio Farma aims to make IndoVac as COVID-19 multi-strain vaccine
Translator: Ajat Sudrajat, Uyu Liman
Editor: Anton Santoso
Copyright © ANTARA 2023
