BPOM Approves Emergency Authorization for Five COVID-19 Vaccines for Boosters

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BPOM chief Penny K Lukito conveyed the BPOM decision at a press conference in Jakarta on Monday (10/1).

“So far, there are five COVID-19 vaccines that have received EUA, have gone through the evaluation process with the national committee’s expert team for drug or vaccine evaluation, and received recommendations to meet current requirements for the EUA to be implemented. It has continued with the management process of the EUA,” he said.

five vaccines amplifier These are Coronavax PT Bio Farma, Pfizer, AstraZeneca, Moderna and Zifivax.

“First, Bio Farma’s Coronavax COVID-19 vaccine, amplifier For those aged 18 and over, primary vaccination or homologous (single type vaccine) to be given as a single dose six months after the full vaccine,” he explained.

BPOM RI President Penny K Lukito said at a press conference in Jakarta on Monday (10/1) that his party has given EUA to five COVID-19 vaccines to be used as boosters (INVALIDs).

Coronavax vaccine is reported to have a localized Post Immunization Adverse Event (AEFI) and can increase antibody titers 21-35 times 28 days after administration to adults.

To be used as Pfizer and AstraZeneca vaccines amplifier homologous with a 3.3-3.5 fold increase in the mean antibody value after one month of administration.

“Fourth, the Moderna vaccine, this amplifier homologous and heterologous with half the dose. As a homologous and heterologous enhancer for individuals whose primary vaccines are AstraZeneca, Pfizer, and Johnson and Johnson]. Shows 13 times neutralizing antibody immune response after administration amplifier,” he explained.

The fifth is the Zifivax vaccine. Made in China, this vaccine is a heterologous vaccine that can be given six months later to people who have previously received a full dose of Sinovac or Sinopharm. Data show that the increase in neutralizing antibody titers will increase more than 30-fold in subjects with Sinovac or Sinopharm primary vaccine.

Decrease in Antibody Levels

Also, Penny explained amplifier This is really necessary during the COVID-19 pandemic, but with priority on achieving the target of first and second dose vaccination to the public first.

Based on the observations made by the BPOM, the immune response produced by the COVID-19 vaccine will be significantly reduced with varying intervals of decline and also depending on the type.

“Immunogenicity data from clinical observations of all COVID-19 vaccines showed a significant reduction in antibody levels below 30 percent that occurred after six months of full primary vaccine administration. Vaccination is therefore required. amplifier or a follow-up dose to restore reduced immunogenicity,” said Penny.

In line with Penny, Chairman of the Indonesian Immunization Technical Advisory Group (ITAGI), Prof. Dr. Sri Rezeki Hadinegoro also agrees on the importance of booster vaccines or vaccines. amplifier It is not yet known when it will end during the COVID-19 pandemic.

ITAGI President Prof Sri Rezeki Hadinegoro reminded that the Corona booster vaccine should prioritize the vulnerable.  (INVALID)

ITAGI President Prof Sri Rezeki Hadinegoro reminded that the Corona booster vaccine should prioritize the vulnerable. (INVALID)

“Why should we give? amplifierOf course, there’s good reason. Within six months the antibodies have drastically decreased and it is our concern, are we still strong enough to contain this transmission of SARS-CoV-2? There is also a mutation. So we have to stop the transmission first,” Sri said.

However, he reminded once again that the government should continue to give priority to high-risk groups such as the elderly, healthcare workers and those with congenital or comorbid diseases.

Independent Domestic COVID-19 Vaccine Production

On the same occasion, Penny reported that Indonesia will one day have three domestic COVID-19 vaccine production facilities.

First, he said, PT Jakarta Biopharmaceutical (JBIO) will collaborate with PT Biotis Pharmaceutical Indonesia to produce the Zifivax COVID-19 vaccine from China. Penny announces steps are being taken to speed up production amplifier in Indonesia this year.

On August 4, 2020, several staff members seem busy at the COVID-19 vaccine production facility at the Bio Farma office in Bandung, West Java.

On August 4, 2020, several staff members seem busy at the COVID-19 vaccine production facility at the Bio Farma office in Bandung, West Java.

“While we wait for JBIO to prepare the facilities, JBIO will cooperate manufacturing tools Running the process with PT Biotis Pharmaceutical to fillnd come to an end “There’s a Zifivax vaccine, so there’s a manufacturing contract,” Penny said.

He added that the construction of the JBIO factory is aimed to be completed by the middle of this year. Also, Penny explained that certification to JBIO for good drug manufacturing method, or CPOP, will likely be awarded in August.

“So there will be three vaccine production facilities in Indonesia. Apart from PT Bio Farma, which was the first vaccine pharmaceutical industry in Indonesia, followed by PT Biotis and the third, PT JBIO. I think this is a positive thing that has evolved from the emergency period of the COVID-19 pandemic.” [gi/ab]

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