Vaccines In Circulation Have Underwent Clinical Trials, Ensuring They Are Safe and Effective

AYOBANDUNG, COM – President Joko Widodo has continually emphasized that in the provision of the COVID-19 vaccine, safety and effectiveness factors must be paramount.

The existence of a safe and effective vaccine is very important and is expected by Latief Siregar, a COVID-19 survivor who is terrified when he is tested positive and has to undergo intensive care. According to him, the presence of vaccines is vital because there is no cure for COVID-19.

Regarding the effectiveness of vaccines, Prof. Dr. dr. Cissy Rachiana Sudjana, Professor of the Faculty of Medicine, Padjadjaran University. According to him, vaccines are the most effective way to reduce morbidity, mortality and disability. Although the level of effectiveness of vaccines differs from one another, one thing that is certain is, vaccines that have been circulating must have received permission from the competent authority and meet the safety and effectiveness requirements.

The same thing was also expressed by a vaccinologist and specialist in internal medicine, doctor Dirga Sakti Rambe. “Each vaccine has a different effectiveness. However, vaccines will not receive permission for use or distribution if their effectiveness does not meet WHO requirements and standards, “he said. “For the COVID-19 vaccine, WHO has set a minimum effectiveness of 50%. The hope is that the effectiveness of vaccines will be higher than the figures set by WHO. “

The manufacturing process for each vaccine must go through a lengthy research process to clinical trials. However, due to advances in science and technology, the process can be much faster.

Even if it is faster, there is no compromise with security. Prof. I Gusti Ngurah Mahardika, Virologist and Molecular Biology Expert at Udayana University, as well as a member of the Red and White vaccine development team, emphasized that even though the vaccine discovery process must be done quickly and immediately, vaccine safety is an important thing that must be the concern of all parties. “Besides also guaranteeing access to vaccines that are cheap, and equitable for the whole community. The regulatory process must be fast and the question of vaccine safety is absolutely no compromise. Vaccines really have to be safe before use, “he said.

To emphasize security, the manufacturing process is also supervised by various competent institutions. For example, clinical trials for the COVID-19 vaccine in Bandung with the same standards as in other countries are also supervised by supervisory bodies, namely the POM, the Data Safety Monitor Board (DSMB), and the FK Unpad Ethics Committee. Really layered.

“This supervision is important and needs to be done to ensure the safety and effectiveness of the COVID-19 vaccine which is currently being developed by Bio Farma,” explained Prof. Dr. dr. Soedjatmiko, Sp.A (K), Member of the National Immunization Expert Advisory Committee from ITAGI. The POM also does not play games and has strict standards in granting licenses to use vaccines.

The quality of vaccines is guaranteed through the evaluation of quality requirements and ensuring that the vaccine is made in accordance with the Good Manufacturing Practices (CPOB). After the evaluation process has been passed and the vaccine is considered to meet the requirements from the aspect of safety and effectiveness, then the POM can grant a license for use.

Furthermore, Dr Dirga also emphasized that the news that the vaccine is not effective contains poison is wrong information. “Any vaccine, including the COVID-19 vaccine, when it is widely used by the community, it must have received approval from the POM. If there is a vaccine that has obtained permission to be used, it is certain that it is safe and effective, “he concluded.

– .