The Indonesian Food and Drug Monitoring Agency, predicts that it will authorize the emergency use of China’s Sinovac COVID-19 candidate vaccine, at the end of January 2021.
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KOMPAS TEAM
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AFP/JOEL SAGET
This illustration picture taken in a studio in Paris on November 16, 2020, shows a syringe and a vial with the logo of US biotech firm Moderna. - Moderna on November 16, 2020 announced its experimental vaccine against Covid-19 was almost 95 percent effective, marking a second major breakthrough in the quest to end the pandemic.
JAKARTA, KOMPAS – The Indonesian Food and Drug Monitoring Agency (BPOM) predicts that it will authorize the emergency use of China’s Sinovac COVID-19 candidate vaccine, which is currently undergoing clinical trials in Indonesia, at the end of January 2021. This is because data from the final stage of trials will only be submitted to the BPOM in the second week of January. The data is required to ensure the quality, safety and effectiveness of the vaccine.
BPOM chief Penny K. Lukito said on Thursday (19/11/2020) in Jakarta that the emergency use of the candidate vaccine could only be authorized once the data on its quality, safety and effectiveness was complete. Data on the Sinovac candidate vaccine and the results of its clinical trials in Indonesia, Brazil and China are not yet available.
The BPOM expects to receive the data in the second week of January 2021. It is hoped that the emergency use could then be authorized in the third or fourth week of January, after which the mass vaccination would be carried out. “Despite the fact that we are in a state of emergency, the mass vaccination must prioritize quality, safety and effectiveness,” said Penny.
Compliance
Emergency use authorization must fulfill a number of requirements: the candidate vaccine must have comprehensive data on the results of its phase one and phase two clinical trials as well as an interim analysis of its phase three clinical trials. The data will be used to determine the vaccine’s effectiveness and safety. During a pandemic, candidate vaccines must be more than 50 percent effective to be approved.
The World Health Organization (WHO), the US Food and Drug Administration and the European Medicines Agency have outlined the process for the emergency approval of candidate vaccines.
An employee works on the production line of COVID-19 coronavirus vaccines at the Bio Farma Pharmacy, in Bandung, West Java on August 12, 2020.
A cross-sectoral COVID-19 vaccine assessment team visited the Sinovac factory in China to evaluate the production of the Sinovac vaccine, particularly to ensure its halal status. A comprehensive evaluation is indeed required, including the vaccine’s raw materials and the equipment used.
PT Bio Farma director Honesti Basyir reported that phase three clinical trials of the Sinovac vaccine had started in Bandung and that 1,620 people had volunteered to receive the candidate vaccine. The trials are being carried out by a team of researchers from the Padjajaran University Medical School in collaboration with PT Bio Farma and Sinovac Biotech China.
More than 1,500 volunteers have received the second injection of the candidate vaccine. The effectiveness and safety of the vaccine is still being assessed and the process is expected to conclude within six months.
“There have yet to be any reports of volunteers experiencing serious side effects following the vaccination. We still have to wait, however, until the trials finish. We are also preparing facilities to ensure a safe and effective production process,” said Honesti.
AFP/TIMUR MATAHARI
A doctor displays a vaccine for COVID-19 coronavirus at Padjadjaran university educational hospital in Bandung, West Java on July 6, 2020, in preparation for efforts to vaccinate 1,620 volunteers in the community next week.
Sri Rezeki Syaraswati Hadinegoro, head of the Indonesia Technical Advisory Group on Immunization, said monitoring of the quality and effectiveness of vaccines did not stop at the production stage. Vaccine cold chain logistics had to be tightly controlled as well because a change of temperature could reduce a vaccine’s safety and effectiveness.
Data obtained from the WHO Landscape on the COVID-19 Vaccine shows that as of Nov. 12, 212 COVID-19 candidate vaccines existed. According to Penny, the BPOM is assessing several other candidate vaccines that the government plans to import. The imported vaccines must be authorized for use by the BPOM before being distributed.
National COVID-19 task force spokesman Wiku Adisasmita has urged people not to doubt vaccines’ effectiveness and safety as the government was continuing to make thorough preparations and would ensure that the vaccines given were safe, effective and halal.
On Thursday, 4,798 new cases were confirmed, bringing the national tally to 483,518 cases. Some 406,612 COVID-19 patients have recovered – approximately 84 percent of total cases. This tops the world’s average recovery rate, which stands at 69.58 percent.
The WHO has again reminded people not to wait for COVID-19 vaccines because of the uncertainty of when they will be available. Efforts to control the pandemic had to continue, the organization said, especially now that a number of countries were experiencing second waves of infection. The warning was issued by WHO emergencies director Michael Ryan during an online broadcast on Wednesday (18/11/2020) Geneva time. (TAN/NTA/LAS/AIK)
