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SAPP: Anxiety over stalled clinical trial

Kota Kinabalu, 17 May 2022

KOTA KINABALU: The Federal Health Ministry must engage in more effective communication and teamwork with our medical team in Sabah on the vaccine clinical trial program protocol PRO-nCOV-3002, said Chin Vui Kai.

Chin, SAPP information chief, said children and adolescent participants after taking two shots, the program was then stalled for over 3 weeks without any information or communication from the health authorities of the next schedule or course of action. Under the program children and adolescent participants were supposed to receive a total four injections of trial vaccine or placebo.

“The parents of these children who participated in the vaccine study program, protocol named PRO-nCOV-3002, complained the health authorities of passing the buck left them with a cloud of uncertainty over it,” he said.

“The program was conducted at the Likas Women and Children’s Hospital. However, the medical personnel were not told or given directive by KL/Putrajaya on what should be done next. This further left the parents anxious and confused.

“We don’t want to wait until the relevant authorities start their finger-pointing for such incident. They should resolve the matter as soon as possible,” Chin opined.

According to Chin, feelings of uncertainty, anxiety, stress or even panic among the parents, are listed as follows:-

1) The registration for the National Covid-19 Immunisation Programme for Children (PICKids) is ending soon.

2) The interval between first and second vaccine dose has exceeded the recommended 2-4 weeks, if their child were given the real shot first and a placebo for the second injection.

3) The immunity level of their child against COVID-19 virus is still unclear.

PRO-nCOV-3002 is a multi-centre, randomised, double-blind, placebo-controlled, Phase III Clinical Trial to evaluate the efficacy, immunogenicity and safety of COVID-19 vaccine in children and adolescents aged 3 to 17 years.

This study has been approved by the Medical Research and Ethics Committee under the Ministry of Health Malaysia. Healthy participants took part voluntarily in this study in Malaysia.