The chairman of BPOM, Penny K Lukito, conveyed the BPOM decision in a press teleconference in Jakarta, Monday (10/1).
“Until now, there are five COVID-19 vaccines that have received EUA which have gone through an evaluation process with the expert team of the national committee for drug or vaccine evaluation and have received recommendations to meet the existing requirements so that the EUA can be continued with the process of administering the EUA,” he said.
Five vaccines booster These are Coronavax PT Bio Farma, Pfizer, AstraZeneca, Moderna and Zifivax.
“First, Bio Farma’s Coronavax COVID-19 vaccine, is for booster homolog (one type of vaccine) which will be given as much as one dose after six months from primary vaccination or complete vaccine for ages 18 years and over,” he explained.
The Coronavax vaccine is reported to have a localized Post-Immunization Adverse Event (AEFI), and can increase antibody titers by 21-35 times after 28 days of being administered to adults.
Pfizer and AstraZeneca vaccines will be used as booster homologous with an increase in the mean antibody value of 3.3-3.5 times after one month of administration.
“Fourth is the Moderna vaccine, this is booster homologous and heterologous, with half the dose. As a homologous and heterologous booster]for people whose primary vaccines are AstraZeneca, Pfizer and Johnson and Johnson. Shows neutralizing antibody immune response 13 times after administration booster,” he explained.
Fifth is the Zifivax vaccine. This vaccine made in China is a heterologous vaccine that can be given to people who have previously vaccinated a complete dose with Sinovac or Sinopharm, after six months. The data show that the increase in neutralizing antibody titers will increase more than 30 times in subjects who have received the Sinovac or Sinopharm primary vaccine.
Decreased Antibody Levels
Furthermore, Penny explained that booster This is indeed needed during the COVID-19 pandemic, but by prioritizing the achievement of the target for the first and second doses of vaccination to the public first.
Based on observations made by BPOM, the immune response produced by the COVID-19 vaccine will decrease significantly, with varying intervals of decline and also depending on the type.
“Immunogenicity data from clinical observations of all COVID-19 vaccines showed a significant decrease in antibody levels to below 30 percent which occurred after six months of complete primary vaccine administration. Therefore, it is necessary to give vaccines booster or a follow-up dose to re-increase immunogenicity that has decreased,” said Penny.
In line with Penny, the Chair of the Indonesian Technical Advisory Group on Immunization (ITAGI) Prof. Dr. Sri Rezeki Hadinegoro also agrees with the importance of booster vaccines or booster During the COVID-19 pandemic, it is not yet known when it will end.
“Why should we give booster, of course there is a good reason. In six months the antibodies have decreased greatly and this is our concern, are we still strong enough to contain the transmission of this SARS-CoV-2? Moreover, there has been a mutation. So we have to stop the transmission first,” said Sri.
However, he again reminded that the government must continue to prioritize groups of people who have a high risk, such as the elderly, health workers and those who have congenital or comorbid diseases.
Independent Domestic COVID-19 Vaccine Production
On the same occasion, Penny reported that Indonesia would one day have three domestic COVID-19 vaccine production facilities.
First, he said, PT Jakarta Biopharmaceutical (JBIO) will cooperate with PT Biotis Pharmaceutical Indonesia to produce Zifivax COVID-19 vaccine from China. Penny explained the step was taken to speed up production booster in Indonesia this year.
“While waiting for JBIO to prepare the facilities, JBIO will cooperate tool manufacturing with PT Biotis Pharmaceutical to carry out the process fill and finish Zifivax vaccine, so there is a production contract,” said Penny.
He added that the construction of the JBIO factory is targeted to be completed by the middle of this year. Furthermore, Penny explained that the certificate of good medicine production method or CPOP to JBIO is likely to be given in August.
“So there will be three vaccine production facilities in Indonesia. Apart from PT Bio Farma, which has been the first vaccine pharmaceutical industry in Indonesia, and then PT Biotis, and the third will be PT JBIO. I think this is a positive thing, developing from the emergency period of the COVID-19 pandemic,” he concluded. [gi/ab]