SUKABUMIUPDATE.com – Researchers from the Indonesian Institute of Sciences’ Biotechnology Research Center (LIPI) Wien Kusharyoto revealed the reason behind the registration of Covid-19 vaccine clinical trial volunteers must be aged 18-59 years.
Reporting from tempo.co, clinical trials will be conducted in the world, including in the city of Bandung, West Java, in August.
Wien said the first phase of clinical trials from the Sinovac Biotech vaccine vaccine candidate had already been carried out in his home country, China. But, the second phase of testing was only completed to adult respondents, aged 18-59 years. Wien explained, Sinovac still had to complete tests for the age group of children and adolescents under the age of 18 years and the elderly in the age range 60 years and above.
“Now all (vaccine production) is accelerating, often overlapping phases of clinical trials phase 1, 2 and 3 due to pandemic conditions,” he said in a virtual press conference, Jakarta, Tuesday, July 28, 2020.
Therefore, the third phase of clinical trials in the world, including in Indonesia for vaccine candidates from Sinovac will only be conducted at the age range of 18-59 years. If the vaccine passes the test and gets permission for mass use, it can only be given in the same age range.
“Phase two clinical trials have not been completed because they have only done clinical trials on those aged 18-59,” he said, adding, “For the elderly and children and adolescents, vaccines will still be carried out phase 3 clinical trials to see the effectiveness and side effects for different age groups. ”
Clinical trial vaccine candidates from Sinovach are planned to be conducted in August 2020 involving 1,620 volunteers in the city of Bandung. In addition to Indonesia, a final-stage clinical trial of vaccine candidates from Sinovac will also be conducted in Brazil with 9,000 volunteers, and Bangladesh with 4,200 volunteers.
In the city of Bandung, volunteer registration has been opened since 27 July and closed 31 August. On its first day, there were up to 400 enthusiasts.
The Padjadjaran University Faculty of Medicine research team that conducted the registration and implementation of clinical trials later determined a dozen criteria for the volunteers. The first is indeed a volunteer candidate or clinical trial research subjects are adults aged 18-59 years.
source: tempo.co
