POM Ensures The Safety And Effectiveness Of The COVID-19 Vaccine

Vaccine illustration (Photo by Daniel Schludi on Unsplash)

JAKARTA - The government has confirmed that the COVID-19 vaccine is free without any conditions. Currently, planning for vaccination is also being finalized. The Food and Drug Administration (BPOM) ensures that it will oversee the safety and effectiveness of the COVID-19 vaccine.

Spokesperson for COVID-19 Vaccination from the POM Dr. dra. Lucia Rizka Andalusia, M.Pharm, Apt said, according to the direction of President Joko Widodo (Jokowi) regarding the provision of the COVID-19 vaccine, all procedures must be followed properly in order to ensure public safety, as well as vaccine effectiveness.

"Including the phase III clinical trial phase, as the food and drug supervisory authority in Indonesia, the POM is obliged to closely monitor the safety of the efficacy and quality of the COVID-19 vaccine, before and during use in the later vaccination program," he said, in a written statement received by VOI, Saturday, December 19.

As is known, on Sunday, December 6, the COVID-19 vaccine, a product of Sinovac from China, arrived in Indonesia, totaling 1.2 million doses. The vaccine is transported using an aircraft belonging to the airline PT Garuda Indonesia Tbk (GIAA), an aircraft of the Boeing 777-300ER type.

This vaccine from a Chinese pharmaceutical company is the first COVID-19 vaccine to land in Indonesia. In the first phase, the government brought in 1.2 million doses. Followed by plans for the arrival of the second phase of 1.8 million doses.

Regarding the Sinovac vaccine, said Lucia Rizka, the POM is conducting an evaluation of the efficacy and quality of the vaccine by referring to international standards such as WHO, the American Food and Drug Administration (FDA), the European Drug Administration (EMA) in evaluating the provision of EUA.

Vaccine evaluation is carried out by the POM and the National Committee for Drug Assessment and experts in the field of vaccines including the Indonesian Technical Advisory Group on Immunization (ITAGI), and experts in the field of vaccines. Making decisions based on scientific grounds that can be justified and are independent.

"For EUA, WHO's recommendation states that interim observation data 3 months after injection can be used as a basis for granting emergency use permits," he said.

In addition, Lucia Rizka said that the phase III clinical trial in Bandung was running according to the planned timeline, all subjects (volunteers) had received two injections followed by monitoring with a period of 1 month, 3 months, and 6 months, to ensure the safety and efficacy of the vaccine. the.

As is well known, the vaccine that Sinovac produces is also being tested in clinics in other countries including Brazil, Turkey and Chile.

"Researchers will collect these data and carry out analysis to be reported to the POM, which will then be evaluated before vaccines are used for the vaccination program," he said.

Lucia Rizka also emphasized that even though using the EUA scheme, safety and quality aspects must be fulfilled based on adequate supporting data. "Apart from Sinovac, we will carry out the same evaluation steps for the other five types of vaccines that are determined by the Minister of Health's Decree," he said.

For your information, in the Decree of the Minister of Health Number 9860 of 2020 it is possible to change the type of vaccine used by the government, if there are vaccine candidates that meet the safety and quality requirements set by the Minister of Health, the POM will carry out an evaluation process and issue an EUA.

The implementation of COVID-19 vaccination aims to accelerate efforts to reduce transmission rates, morbidity and mortality due to COVID-19, which must be carried out together with 3T strengthening or testing, investigation and follow-up by the government, and discipline of health protocols by the community.

"We urge the public to provide support for this vaccination program. Do not be lax in practicing the discipline of wearing masks, washing hands, keeping your distance, and being ready to be vaccinated when the vaccine is ready. Together we build group immunity to protect ourselves, protect the country, and end the pandemic. "he said.