JAKARTA - The pharmaceutical company from the United States (US) Johnson & Johnson stopped further clinical trials of the COVID-19 vaccine because it found symptoms of the disease in one of its volunteers. Until now, it is not clear what disease the volunteers experienced. This proves that vaccine production cannot be rushed.
"Following our guidelines, participants' illnesses are being reviewed and evaluated by the Data Security Monitoring Board (DSMB) as well as our internal clinical and safety physicians," reads the company statement. "Adverse events - such as illness or accidents - even serious ones, are part of any clinical trial, especially large studies."
Quoted from CNN , Tuesday, October 13, the company did not say what type of disease could not be explained. Trials are stopped so doctors can check whether the disease can be linked to the vaccine or just a coincidence.
In its inquiry letter, the company explained that the company had carried out clinical trial procedures with predetermined guidelines. "This ensures our study can be suspended if an unexpected serious event that may be related to the vaccine or research drug is reported," it wrote.
Johnson & Johnson itself acknowledges that serious side effects in clinical trials are not uncommon. And it encourages more people-involved trials to be scaled up.
"Furthermore, because there are so many placebo-controlled trials. It's not always clear whether participants are receiving treatment or a placebo," said Johnson & Johnson.
It can't be instant
The temporary suspension of vaccine trials is unfortunately not an immediate concern, according to Ashish Jha, a doctor from the Brown University School of Public Health. Even though this is evidence in the progress of vaccines, it cannot be rushed because many things will happen during the experiment.
"Things like this are totally expected and a reminder of how ridiculous it is to try and meet the political vaccine timeline before November 3," said Jha.
"The Johnson & Johnson trial is the largest vaccine trial I know of, involving 60,000 people," said Jha. "In the trial you would expect some lags."
The Johnson & Johnson vaccine is the second US trial of the COVID-19 Phase 3 vaccine. The AstraZeneca vaccine trial was postponed last month due to neurological complications in a volunteer in the UK, then resumed. Meanwhile in the US, trials remain temporarily suspended in the US when the US Food and Drug Administration conducts an investigation.
"We want a vaccine that is safe and we have to let the process go and it will take a while," said Jha. "For me, it reassures that the company is acting responsibly and taking breaks when needed."
Johnson & Johnson Phase 3 Trials begin in September. The vaccine is one of six COVID-19 vaccines being tested in the US and one of four in the most advanced stage, Phase 3. Federal officials say they hope testing can be completed a little faster than other vaccines, including those made by Moderna and Pfizer. .
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