Sinovac Vaccine Ready for Use

The issuance of an emergency use authorization for the Covid-19 vaccine produced by Sinovac has sparked new hope. Regardless, health protocols must still be strictly implemented.

KOMPAS/DIONISIUS REYNALDO TRIWIBOWO

Officers check the boxes for the Sinovac vaccine that just arrived at Tjilik Riwut Airport, Palangkaraya City, Central Kalimantan, Tuesday (5/1/2021).

JAKARTA, KOMPAS – The Indonesian Food and Drug Monitoring Agency (BPOM) has issued an emergency use authorization (EUA) for the CoronaVac Covid-19 vaccine produced by China’s Sinovac Biotech. The issuance of the EUA was based upon, among other things, an analysis of the vaccine’s phase three clinical trials in Bandung, which concluded that the vaccine has an efficacy rate of 65.3 percent. Taking its efficacy rate into consideration, the coverage of mass vaccination must be broadened, while the implementation of health protocols must be continued.

During a virtual press conference on Monday (11/1/2021) in Jakarta, BPOM head Penny K. Lukito said the results of the analysis on the CoronaVac vaccine’s efficacy showed that the vaccine managed to reduce the number of Covid-19 infections by 65.3 percent. Furthermore, it was also found that the vaccine could boost immunogenicity, or the ability to produce antibodies against a given antigen, to neutralize 99.23 percent of the virus within one’s body up to three months after vaccination.

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Sinovac’s Covid-19 vaccine has now been declared to meet the requirements of the World Health Organization’s (WHO) guidelines for issuing an EUA. The organization stipulates that prospective vaccines must have at least an efficacy rate of 50 percent.

Other than the phase three clinical trials in Bandung, the BPOM also referred to the results of clinical trials in Turkey and Brazil, which respectively found the efficacy rate of Sinovac’s Covid-19 vaccine at 91.25 percent and 78 percent. “On this day, Monday, January 11, 2021, the BPOM for the first time has approved the emergency use, or EUA, of the CoronaVac Covid-19 vaccine produced by Sinovac Biotech in cooperation with PT Bio Farma,” said Penny.

Five criteria

The WHO underlines five criteria to issue an EUA. The criteria include the imposition of emergency by the government, sufficient scientific evidence regarding the safety and efficacy of drugs and vaccines based on both non-clinical and clinical data as well as disease management guidelines and good standards in producing drugs and vaccines.

Also read: Transmission Control Determines Vaccination Success

Moreover, an EUA may also be issued if a prospective drug or vaccine’s benefits are greater than its risks or if there are no other treatment alternatives and adequate facilities to diagnose, prevent and treat patients from a disease.

KOMPAS/MACHRADIN WAHYUDI RITONGA

BUMN Minister Erick Thohir shows the drug manufacturing permit certification from the Food and Drug Administration (BPOM) at PT Bio Farma, Thursday (7/1/2020). Certification for 100 million vaccines will be packaged by Bio Farma with raw materials from a Chinese pharmaceutical company, Sinovac.

Penny said CoronaVac vaccine’s safety had been ensured, with possible mild to moderate side effects. The potential side effects consist of local side effects, such as pain, irritation, swelling, and systemic side effects, such as muscle pain, fatigue and fever. Meanwhile, severe side effects such as headache, skin problems and diarrhea only occur for 0.1-1 percent during the clinical trials.

The BPOM will continue carrying out an evaluation of vaccine usage, including its production and distribution process as well as post-immunization accidents (KIPI). The vaccine’s efficacy rate may also change following an evaluation.

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Head of the Indonesian Technical Advisory Group on Immunization, Sri Rezeki Hadinegoro, affirmed that all procedures conducted by the BPOM in issuing an EUA for Sinovac’s Covid-19 vaccine had met the established standard. The agency remained independent in assessing the vaccine.

“After following the phase three clinical trials in Bandung, we are sure that the CoronaVac vaccine is safe for public use and could complement the implementation of health protocols in our fight against the pandemic,” said Sri.

If [the vaccine’s efficacy rate] is above 50 percent, we can use this number as our reference.

Regarding the target of mass vaccination to obtain herd immunity, Sri said the setting of the target was unrelated to the vaccine’s efficacy rate. The target to vaccinate around 70 percent of the population, or approximately 180 million people, is deemed appropriate.

If one person infected with Covid-19 passes it onto three other people, the target of vaccination must encompass two-thirds of the population, or approximately 180 million people in Indonesia. “If [the vaccine’s efficacy rate] is above 50 percent, we can use this number as our reference. The calculation would be different, however, if the efficacy rate is less than 50 percent,” explained Sri.

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Asrorun Ni’am Sholeh

The Covid-19 vaccine produced by Sinovac and Bio Farma is halal and holy.

Head of the Indonesian Ulema Council’s (MUI) fatwa commission, Asrorun Ni’am Sholeh, said the MUI’s fatwa regarding the use of the Covid-19 vaccine produced by Sinovac and PT Bio Farma had been issued in Fatwa No. 2/2021 on the Covid-19 Vaccine Produced by Sinovac Life Sciences China and PT Bio Farma. The fatwa was issued following the issuance of an EUA by the BPOM.

“The Covid-19 vaccine produced by Sinovac and Bio Farma is halal and holy,” said Asrorun.

Health protocols

Head of the Indonesia Immunology and Allergy Association, Iris Rengganis, asserted that while mass vaccination would soon be carried out, the public must continue following the “3M” health protocols (wearing masks, washing hands and maintaining distance). Controlling the pandemic through massive tracing, testing and treatment must also be conducted.

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Meanwhile, head of the Indonesian Public Health Association, Ede Surya Darmawan, said the issuance of an EUA for Sinovac’s Covid-19 vaccine had sparked new optimism. Regardless, the public must not solely rely on vaccination in fighting the pandemic. “Mass vaccination will take some time. While the issue of vaccine safety and efficacy has been solved, how about its production and distribution?” said Ede.

Another factor that must be considered is the target of vaccination and the possibility of reinfection. Until mass vaccination can help the public to achieve herd immunity, health protocols must still be enforced. “Smoking is not an option as well,” said Ede.

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According to epidemiologist Dicky Budiman of Griffith University, with Sinovac’s vaccine having an efficacy rate of 65.5 percent, more than 80 percent of the total population must be vaccinated.

To prevent health crises caused by a spike of Covid-19 cases, President Joko Widodo held a limited meeting yesterday. After the meeting, Airlangga Hartarto, who heads the national economic recovery and Covid-19 response team, said the total number of Covid-19 cases had reached 828,026.

“Since the long holiday in late October, the number of Covid-19 cases has continued to increase until after the Christmas and New Year holidays. The daily number of new Covid-19 cases has reached more than 10,000 cases. This underlines the importance of maintaining discipline in following health protocols,” said Airlangga.

This article was translated by Astria Zahra Nabila.