Covid-19 vaccination permit has yet to be issued, but has been distributed, BPOM says

KOMPAS.com – The Covid-19 vaccine from the Sinovac company has started to be distributed in various regions of Indonesia.

The vaccine is scheduled to be administered to the main priority group of medical personnel.

Although it has been distributed, the Food and Drug Administration (BPOM) has so far not issued an Emergency Use Authorization (EUA) related to the vaccine.

BPOM Director Penny K Lukito said the vaccines received a special distribution permit because it took time to leave the region.

“The USA is still in process, but the vaccine has received special permission for distribution because it takes time to reach all the target areas in Indonesia,” Penny said. Antaranews, Monday (1/4/2021).

Also read: Sinovac vaccine distribution begins, when will Covid-19 vaccination start in Indonesia?

The vaccination process awaits permission

Meanwhile, for the injection process, Penny emphasized that this was done waiting after the vaccine received approval from the EUA.

Penny also said that BPOM is still evaluating clinical trials of the Sinovac vaccine in Bandung, West Java.

The BPOM will also continue to carefully study various issues related to the Covid-19 vaccine, including data from several countries on clinical trials of the vaccine.

Meanwhile, BPOM spokesperson Rizka Andalucía said that BPOM was conducting tests to obtain data that would be used to obtain USA.

License parameters

As for the EUA process, explains Penny, it requires parameters such as efficacy and immunogenicity.

Also read: As of soon, these are 4 stages and priority groups for Covid-19 vaccination in Indonesia

Efficacy parameters are clinical parameters that are measured by the percentage reduction in disease rates in subjects or groups who received the vaccine compared to people who received placebo in phase three clinical trials.

Meanwhile, immunogenicity parameters were obtained based on the results of measurement of the levels of antibodies formed after injection.

Antibody neutralization measures were also carried out to neutralize the virus.

“The measurements were taken after the last two weeks of the dose. Then, it is measured again three to six months after the vaccine is injected throughout the body. After the data is collected, approval can be given to its use or USA, “Rizka was quoted as saying by Antaranews (1/4/2020).

Meanwhile, in relation to the effectiveness of the vaccine, Rizka said, it will be measured later after the vaccination has been widely carried out in the community under real conditions in the field.

“For the effectiveness of vaccines, we will continue to monitor the ability of vaccines to reduce the incidence of disease in the community for a long time. So, the effectiveness of vaccines is measured after the vaccine is widely used in the community, in real conditions in the field or in the real world of health services, ”said Rizka.

Also read: Vaccinations to 181.5 million people will be carried out in 15 months, what is the process?

Vaccine distribution

So far, the Sinovac coronavirus vaccine has been distributed to various regions of Indonesia.

Quoting from Kompas.com (1/4/2021) vaccines have been distributed since Sunday (1/3/2021) and around 700,000 doses have been distributed.

“On January 3, 2021, it was sent to 14 provinces with a total of 401,240 vials, and on January 4, 2021 to 18 provinces, a total of 313,000 vials,” said Bio Farma’s Head of Corporate Communication, Iwan Setiawan .

KOMPAS.com/Akbar Bhayu Tamtomo
Infographic: Covid-19 2021 Vaccination Rules