Based on the evaluation, on February 5, 2021, the BPOM issued the EUA for CoronaVac for people aged 60 years old and above.Jakarta (ANTARA) - Indonesia's COVID-19 Handling Task Force confirmed that CoronaVac is safe to use for senior citizens, as the National Food and Drug Control Agency (BPOM) had issued an Emergency Use Authorization (EUA) for the vaccine.
"Based on the evaluation, on February 5, 2021, the BPOM had issued the EUA for CoronaVac for people aged 60 years and above, with two doses of vaccine injections given at an interval of 28 days," Prof. Wiku Adisasmito, a spokesman of the task force, noted in a statement here on Wednesday.
Priority has been accorded to the elderly population to receive the COVID-19 vaccine shot, as the mortality rate associated with the coronavirus disease has continued to increase, and the group is at high risk of infection.
The vaccine will first be administered to medical workers in the elderly group.
Adisasmito pointed out that the EUA was issued after conducting extensive evaluation and was based on the result of clinical trials in Brazil and China.
The approval was given through discussions conducted by the BPOM with related parties, such as the National Commission for Drug Evaluation, Indonesian Technical Advisory Group on Immunization (ITAGI), allergy and immunology specialists, and geriatric specialists on the results of the CoronaVac vaccine clinical trials in China and Brazil involving groups aged 60 years and above.
The BPOM had earlier monitored and obtained the clinical trial data for the first and second phases of the CoronaVac vaccine in China and the third phase in Brazil. The approval was given after examining the clinical trial data in both countries.
The move was aimed at collecting data on the security and efficacy of the vaccine for the elderly.
"At the end of January 2021, the second phase of the clinical trial in China and the third phase of the trial in Brazil, involving groups aged 60 years and above, had reached adequate subjects, and the details were submitted to the BPOM for evaluation," he revealed.
For the next phase of the vaccination program covering public service officers, Indonesia will produce its own COVID-19 vaccine.
The state-owned vaccine manufacturer PT Bio Farma will produce the vaccine for the program.
"Hence, Indonesia can achieve self-sufficiency in vaccine supply and be ready to run its vaccination program for public service officers after the completion of vaccination for medical workers," he affirmed.
Earlier, BPOM Head Penny K. Lukito noted that the agency had issued an approval for the emergency use of the CoronaVac vaccine produced by China’s Sinovac Biotech for the elderly aged 60 years and above.
Despite the approval for emergency use, Lukito called to exercise prudence and caution in vaccinating the elderly population since this group is at high risk and tends to have comorbidities.
"The third phase of clinical trials that took place in Brazil involved 600 elderly subjects. It shows that giving this vaccine to the age group of 60 years and above is safe, with no serious side-effects being reported," she remarked.
Lukito also pointed to mild side-effects reported during the clinical trial, such as pain, nausea, fever, swelling, redness of the skin, and headaches.
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Translator: Muhammad Zulfikar, Sri Haryati
Editor: Suharto
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