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KOMPAS.com – United States (US) drug company Eli Lilly and Co is temporarily suspending government-funded clinical trials for Covid-19 antibody drug for security reasons.
Launch Reuters, Wednesday (14/10/2020), temporary suspension is not uncommon in a drug trial.
The decision is said to not always indicate a serious problem.
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Because of the urgent need for drugs and related vaccines corona virus, the drug developed by Eli Lilly is also closely watched.
“Out of careful concern, the independent data security monitoring board (DSMB) ACTIV-3 recommended this break,” said Eli Lilly spokesman Molly McCully.
According to him, Lilly supports the DSMB recommendation to carefully ensure the safety of patients involved in this study.
However, Eli Lilly did not explain the implications of the so-called ACTIV-3 trial.
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Comparing patients
ACTIV-3 testing itself has been started since last August and recruited 10,000 patients, mainly in the US.
The trial compared patients who received this antibody drug plus the antiviral drug remdesivir from Gilead Science Inc and patients who were given remdesivir alone.
As is known, this antibody drug is one of the drugs used by the President of the United States (US) when he was being treated for Covid-19 infection.
Trump also praised the drug along with the antibody drug from Regeneron Pharmaceuticals Inc REGN.O, which he also took.
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Following Johnson & Johnson and AstraZeneca
The announcement of the temporary suspension of the Eli Lilly antibody drug trial came one day after Johnson & Johnson decided to do so.
Johnson & Johnson also temporarily halted the third phase of trials for a coronavirus vaccine that was being developed because a volunteer suddenly fell ill.
Launch CNN, Monday (12/10/2020), the company did not explain further about the pain experienced by the Covid-19 vaccine trial volunteers.
“We respect the privacy of volunteers. We are also studying their illness. It is important to gather all the facts before sharing any additional information,” Johnson & Johnson said.
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Volunteers are reported to be sick
The company also said it did not know whether the volunteers were included in the vaccine or placebo recipient class.
Before Johnson & Johnson, the drug company developing the corona virus vaccine AstraZeneca also temporarily suspended the trials it was carrying out.
Launch NBC News, Tuesday (10/13/2020), AstraZeneca, which started a third phase trial of the candidate for the coronavirus vaccine last month, also decided to temporarily stop testing after a volunteer was reported to be sick.
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Last month, the director of the National Institutes of Health, Dr Francis Collins said that the temporary suspension should be used to ascertain any safety issues that may arise.
“If anyone thinks that we are ignoring this kind of problem and hastily approving a vaccine, our decision should shed some light,” Collins said at the time.
Experts hailed the company’s decision as an example of the scientific rigor that needs to be maintained.
“We want a vaccine that is safe. For that, let the process run for the time it takes. For me, it is reassuring to see companies take responsibility and suspend testing when needed,” said Brown University of Public Health Dean Dr Ashish Jha.
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