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Sinovac vaccine compatible with certain comorbidities: PAPDI

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Jakarta Post - December 27, 2020

Jakarta – As the country gears up to roll out a national COVID-19 vaccination program, the Indonesian Society of Internal Medicine (PAPDI) has said that a candidate vaccine produced by China's Sinovac Biotech is suitable to be given to recipients with certain underlying health conditions.

PAPDI sent a recommendation letter dated Dec. 18 to the Indonesian Medical Association (IDI) on the list of comorbidities with which the Sinovac vaccine is compatible. The association drew up the list based on publicly released data of reports from phases one and two of clinical trials of the vaccine, as well as its last stage of the trials that took place in Bandung, West Java.

The data were gathered from research proposals, field officers' reports and completed inactivated vaccine trial reports on viruses such as influenza, as the inactivated vaccine trial for COVID-19 is yet to be completed.

"This recommendation is specifically created for the COVID-19 Sinovac vaccine, and is subject to change as the clinical trials progress," said the association in the letter, a copy of which was obtained by The Jakarta Post on Saturday.

President Joko "Jokowi" had previously expressed his hope for the national COVID-19 vaccination program to commence in January next year.

"Insya Allah [God willing], we will start the shots in January. In our prediction, we may return to normal next year. Let us all pray together so that we will return to normal quickly," said Jokowi on Dec. 18.

He reminded the public that the vaccination program would take some time due to Indonesia's large population. Jokowi also stated that the program would be carried out in stages, beginning with health workers, members of the Indonesian Military (TNI) and the National Police before reaching the general public.

The IDI, PAPDI, as well as several other associations, had previously warned the government not to rush into rolling out the COVID-19 vaccination program as the government pushed for emergency use authorization (EUA) for several COVID-19 candidate vaccines still under development.

Earlier this month, the Food and Drug Monitoring Agency (BPOM) announced that it would extend the monitoring stage of the phase three clinical trial of the Sinovac candidate vaccine for another three months to determine its efficacy and side effects.

West Java Governor Ridwan Kamil, who is participating in the clinical trial, said initially the 1,620 volunteers were scheduled to undergo their last blood tests in December.

"However, we have to take another blood test in March," Ridwan said after having his blood sample taken at the Garuda community health center (Puskesmas) in Bandung, West Java, on Dec. 14.

Ridwan explained that BPOM had ordered researchers to take further blood samples from the volunteers six months after the first injections of the Sinovac vaccine to ensure that they still had antibodies against the coronavirus in the long run.

"This means the result of the clinical trials will also be postponed to March," he said.

The late-stage clinical trial of the Sinovac candidate vaccine in Indonesia started in August in cooperation with state-owned pharmaceutical company PT Bio Farma and Padjadjaran University (Unpad).

The clinical trial is part of global multicenter clinical trials conducted by four nations, namely Brazil, Chile, Indonesia and Turkey, and involving over 20,000 volunteers.

The Indonesian government has ordered around 143 million doses of the vaccine from Sinovac in various forms, from the ready-to-administer doses to the vaccine bulk, with a total of 1.2 million doses of the vaccine arriving in the country in early December. (dpk)

Source: https://www.thejakartapost.com/news/2020/12/27/sinovac-vaccine-compatible-with-certain-comorbidities-papdi.htm

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