UNAIR NEWS – The Food and Drug Supervisory Agency (BPOM) on Monday, January 11, 2021 issued an Emergency Use Authorization (EUA) for Sinovac vaccine. In this press release which was carried out online, it was stated that the vaccine efficacy was 65.3 percent.
UNAIR Epidemiology Expert Dr. M. Atoillah Isfandiari, dr. M.Kes, said that the announcement of the relatively high efficacy rate was quite a relief. The reason is, the standard given by WHO is 50 percent, so that at least the announced efficacy rate has exceeded.
Ato said that the announcement of the vaccine’s efficacy is a form of scientific honesty as an effort to believe that efficacy is obtained through clinical trials in accordance with the principles of good clinical practice (GCP). In addition, he continued, the announcement of vaccine efficacy is also part of upholding scientific honesty responsibly.
“If they are not honest, it may be reported to have a higher value but with such result it means that the application was obtained responsibly,”said Ato on Wednesday, January 13, 2021.
“Generally, those people for the sake of setting up their agenda will manipulate data with higher number. But by reporting the efficacy value as it is, as obtained from clinical trials, this vaccine can be accounted for, “added Ato who is also Vice Dean II Faculty of Public Health (FKM) UNAIR.
Furthermore, Ato said, although the efficacy value obtained was much lower than other vaccines, the Sinovac vaccine had several advantages, like using an old platform that is well known to vaccine manufacturers, inactivated viruses or viruses that are killed. The side effect of the vaccine was less than 1 percent. It has very high safety rate.
“It’s different from the others, although the efficacy is 90 percent, it uses a new technology, mRNA.” New technology on the other hand, in the short term, the impact might be observed during clinical trials. In the long term they don’t know because this is a new platform,” he explained.
Sinovac vaccine is also easily to store and logistics do not require sophisticated cold chain as Pfizer vaccines that require storage of minus 70 degrees. It means it is still possible to store it in the refrigerator.
Ato also said that the issuance of an emergency use authorization by the BPOM as a way out when a vaccine or drug that has just been carried out clinical trials must be used immediately, either commercially or by the government. The measure was taken as Covid-19 victims keeps rising, even through the ideal time needed was 6 months for monitoring the side effects.
“So, the phase 3 clinical trial has been completed, so that the data recorded during the clinical trials can be obtained and analyzed. The clinical trial has been completed, but the post-test monitoring version is what we are waiting for, considering the 1st to 3rd trials reports related to safety and efficacy obtained,” he said.
For Ato, vaccines are different from drugs. Drugs are used to treat sick people while vaccines are used to prevent healthy people from getting sick. “So the vaccine must be given to people who are still healthy. “If you are already sick, you are not the target of the vaccine because the person already has natural antibodies which may degrade over time,” he said.
Regarding the use of the Sinovac vaccine, Ato said that at this time it was prioritized at least for those who did not have any immunity at all. So, vaccinations are given to healthy people, not sick people.
“Who are given first are of course the ones who can help, in this case are medical personnel. Because the analogy, when medical personnel are safe from infection, then they can be more optimal in helping others, including helping to gain immunity, “he concluded. (*)
Author: Asthesia Dhea Cantika
Editor : Binti Q. Masruroh
