Jakarta, CNN Indonesia –
Griffith University epidemiologist Dicky Budiman says a lot vaccine who failed in a phase III clinical trial. So it does not rule out clinical trials corona virus SARS-CoV-2 penyebab Covid-19 also experienced the same thing.
He said the higher failure rate of the previous phase clinical trial was due to various factors.
“On average, there were more failures in stage III clinical trials, about 50 percent compared to previous stages,” said Dicky CNNIndonesia.com, Wednesday (19/8).
Dicky said the factors that most often cause a vaccine to fail in phase III clinical trials are the result of poor and weak initial research planning.
Then, the failure of clinical trials can also be caused by a number of other factors, such as misrepresenting key principles of biology and the principles of vaccine development.
Not only that, clinical trial failures can also occur because human knowledge of the new disease is still completely unknown. Another factor is that the interaction between the product under study and the human body is not fully understood.
“Even the response to placebo is one of the contributors to the failure of clinical trials, especially in phase III,” he said.
Furthermore, Dicky emphasized that vaccine clinical trials are very vital and important to ensure the effectiveness and safety aspects. Ignoring the clinical trial stage, he continued, will cause serious problems, as has happened in many vaccine research during the previous pandemic.
“For example, during the H1NI Swine Flu pandemic, the discovery of the pandemrix vaccine actually caused serious effects in the form of narcolepsy, a disruption of the central nervous system characterized by excessive daytime sleepiness (EDS) due to disruption in the brain’s ability to regulate the wake and sleep cycle,” said Dicky.
Molecular biology scientist Ahmad Rusdan Utomo says clinical trials are important to ensure vaccines are safe as well as effective. However, he said clinical trials could fail due to difficulties in finding volunteers until the pandemic was over, such as MERS and SARS.
“Or death,” Ahmad told CNNIndonesia.com.
Ahmad also said there was no guarantee that phase III clinical trials would prove successful in a vaccine’s protective effect. All researchers involved in clinical trials, he said, also no one dared to guarantee.
“My advice to public officials is not to give too high expectations, which scientists alone are very careful about,” he said.
(jps / DAL)
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