BPOM Issues Emergency Use Authorization for Five Booster Vaccines

By Office of Assistant to Deputy Cabinet Secretary for State Documents & Translation     Date 10 Januari 2022
Category: News
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Documentation of Public Relations of Cabinet Secretariat

The Food and Drug Monitoring Agency (BPOM) has officially issued an Emergency Use Authorization (EUA) for five types of COVID-19 vaccines to be used as booster shots.

“Today, we report there are five vaccines that obtained the EUA. Before the EUA was issued, the BPOM and a team of experts consisting of members from the National Committee on Drug Evaluation have conducted an evaluation The five vaccines have also met the existing requirements,” Head of the BPOM Penny K. Lukito said in a press statement, in Jakarta, Monday (01/10).

The five COVID-19 vaccines that have obtained the EUA from the BPOM, namely CoronaVac produced by PT Bio Farma, Pfizer, AstraZeneca, Moderna, and Zifivax.

According to Penny, a number of vaccines are still at clinical trials to obtain the EUA as additional doses of vaccines.

“Clinical trials on several booster vaccines are still on track. We will decide the issuance of the EUA in the next few days,” she said.

Head of the BPOM also explained that booster vaccines can be administered to people aged 18 and above with a minimum spacing of six months after a full dose of primary series.

First, she said, CoronaVac vaccine produced by PT Biofarma will be used for a homologous booster with a single dose.

“[The observation results] of immunogenicity shows that neutralizing antibody titers increase up to 21-35 times higher in approximately 28 days after booster shot [injected] to adult subjects,” Penny said.

Second, Pfizer or Comirnaty vaccine will also be used for homologous boosters with a single dose.

“[The observation results] of immunogenicity shows that the average value of neutralizing antibody titer increased by 3.3-fold after one month of booster shot,” she explained.

Third, AstraZeneca vaccine will also be used for a homologous booster with a single dose.

On that occasion, Penny asserted that the immunogenicity test results show that the average antibody titer value increased by 3.5-fold after the administration of AstraZeneca booster vaccine.

Fourth, Moderna vaccine will be used for homologous and heterologous boosters at half dose. Moderna vaccine as heterologous booster is used for AstraZeneca, Pfizer, and Janssen or Johnson & Johnson vaccines.

“This [the vaccine] shows a 13-fold increase in neutralizing antibody immune response after the booster shot,” Penny said.

Fifth, Zifivax vaccine will be used as a heterologous booster with Sinovac and Sinopharm as primary vaccines.

“Neutralizing antibody titers increase more than 30 folds in subjects who have received primary doses of Sinovac or Sinopharm,” she added.

Closing her press statement, Penny said that the administration of booster shots has been recommended by the World Health Organization (WHO) and is needed to increase the level of COVID-19 antibodies which have decreased significantly six months after receiving a full dose of vaccine.

“Immunogenicity data from observations of clinical trials consisting of all COVID-19 vaccines show a significant decrease in antibody levels lower than 30 percent, which occurs after six months of a complete dose of primary series. Therefore, it is necessary to give a booster vaccine or a further dose to increase the immunogenicity,” she remarked. (UN) (RIF/MMB)

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