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The Covid-19 Vaccine Used Must Be Ensured Safe and Effective for the Community

Covesia.com – The government is currently conducting a research on the Covid-19 vaccine before it is given to the wider community. In this case the government also ensures the safety and effectiveness of vaccines, the manufacturing process must go through a long research process to clinical trials. The process is also supervised by various competent world-class institutions.

The secretary of the Bukuttinggi city office, dr. Vera Mayasari, when confirmed, revealed that the vaccine research process really has to pass a clinical trial before it is given to the public. That should also be of concern to the research team, because this vaccine will be inserted into the body.

“Right now the vaccine is still in phase three, so before mass production it must be ensured that it is safe, effective, stable and cost efficient. However, its use still refers to the Covid-19 protocol,” he explained, Wednesday (11/25/2020).

He explained that this vaccine is not a drug but rather how a vaccine can maintain the immune system to form strong antibodies so that the virus can die.

The same thing was conveyed by dr, Deddy Herman, a lung specialist who treats Covid-19 patients at Bukittinggi Hospital who said that through vaccines the government has helped the health world, especially the health team who directly handles Covid-19 patients in providing immune vaccines against the virus. .

“Through the vaccine that is inserted into the body, the vaccine will weaken the virus in the body so that antibodies are formed which will weaken the viruses and bacteria in the body,” he said.

He explained that if the vaccine has been put into the body, it will cause the body’s immune system to be stronger than before the vaccine. Later, the body’s resistance will form an antibody so that a reaction will arise that will bring all the body’s defenses into action to kill the virus.

“Even if infected, the case will not be so serious and can be saved because the body’s antibodies already exist because the virus has been weakened by the vaccine,” he said.

Meanwhile, President Joko Widodo has issued a statement and continues to emphasize that in terms of providing the Covid-19 vaccine, its safety and effectiveness must be ensured. The existence of a safe and effective vaccine is very important because the presence of a vaccine is vital because there is no cure for Covid-19.

Regarding the effectiveness of vaccines, Prof. Dr. dr. Cissy Rachiana Sudjana, Professor at the Faculty of Medicine, Padjadjaran University, emphasized that 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 for sure is that 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 as well as an internal medicine specialist, doctor Dirga Sakti Rambe, who revealed that each vaccine has different effectiveness. However, vaccines will not receive permission for use or distribution if their effectiveness does not meet WHO requirements and standards.

“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, “he said.

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, the Covid-19 vaccine clinical trial in Bandung with the same standards as in other countries, is also supervised by regulatory bodies, namely the POM, the Data Safety Monitor Board (DSMB), and the Ethics Committee of FK Unpad, are completely layered.

“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.

(deb)

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