BPOM Issues Emergency Use Permits for 5 Booster Vaccines

JAKARTADAILY.ID – The Indonesian Food and Drug Supervisory Agency (BPOM) has issued an emergency use authorization (EUA) for five Covid-19 vaccine products that are used as a booster dose of vaccine. The five vaccines are the CoronaVac vaccine produced by PT Bio Farma, the Pfizer vaccine, the AstraZeneca vaccine, the Moderna vaccine, and the Zifivax vaccine.

"There are also several clinical trials of booster vaccines that are still ongoing and in the next few days we will also be able to decide on the emergency use authorization," said Head of BPOM Penny-K-Lukito">Penny K Lukito, in a press statement quoted in Jakarta, Tuesday.

Penny said this booster vaccine can be given to people aged 18 years and six months have passed since their initial doses, furthermore, he said that there are specific requirements for the booster shots. 

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First, CoronaVac produced by PT Biofarma is for a homologous booster with a dose of one dose. The results of the immunogenicity test showed an increase in neutralizing antibody titers up to 21-35 times after 28 days of giving this booster vaccine in adult subjects.

Second, Pfizer or Comirnaty vaccines are also for homologous boosters with a dose of one dose. The results of the immunogenicity test showed an increase in the average value of the neutralization antibody titer after 1 month (booster administration) of 3.3 times.

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Third, the AstraZeneca vaccine is also homologous with a single dose. The results of the immunogenicity test showed an increase in the average antibody titer value of about 3.5 times after giving this type of booster vaccine.

Fourth, the Moderna vaccine was used for homologous and heterologous boosters at half-dose doses. Moderna vaccine heterologous boosters are used for AstraZeneca, Pfizer, and Janssen or Johnson & Johnson vaccines. It exhibited a neutralizing antibody immune response 13 times after administration of a booster dose.

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Fifth, Zifivax vaccine was used as a heterologous booster with Sinovac and Sinopharm primary vaccines. Neutralizing antibody titers increased more than 30 times in subjects who had received primary doses of Sinovac or Sinopharm.

"Of course, before getting emergency use authorization (for the five vaccine products), BPOM has gone through an evaluation process with the expert team of the National Vaccine Assessment Committee Covid-19 and has received recommendations to meet the existing requirements," concluded Penny. (*)