KOMPAS.com- One vaccine-developing company, Johnson & Johnson, is halting final-stage trials of candidates corona vaccine, after a participant reported experiencing an adverse event.
Not long ago, the same thing was done by Eli Lilly, a pharmaceutical company that is currently developing a monoclonal antibody treatment for a disease caused by the corona virus, SARS-CoV-2.
Quoting CNBC, Friday (16/10/2020), trials on the treatment of monoclonal antibodies were temporarily suspended by United States health regulators, due to potential safety concerns.
However, according to medical experts, pauses with clinical trials are common, and these delays should convince the public that the system is in place to protect volunteers.
Pause trial for participant safety
A group of independent experts on the monitoring board that oversees clinical trials in the United States recommends pausing for clinical trials whenever there is an ‘adverse event’.
This was conveyed by Isaac Bogoch, infectious disease specialist and professor at the University of Toronto.
Bogoch said the lull would take as long as it took to gather all the information and did not mean there were problems with the vaccine or treatment.
“The board will say let’s push to stop this. They will say, we need more data and let’s see if this person is in the vaccine arm or in the placebo group,” said Bogoch who is also a member of the board overseeing clinical trials of the drug. .
The council will also say to use all the data to determine if this is a side effect of the vaccine and if this is so then it will need to decide whether it is safe to continue this research or not.
According to Dr. Paul Offit, director of the Center for Vaccine Education at Children’s Hospital of Philadelphia, says clinical trial breaks occur all the time, especially in large-scale clinical trials in older adults.
The former member of the CDC’s Advisory Committee on the practice of immunization said adults who are sick will sometimes get sick for the same period of time after getting the vaccine or treatment.
“The Johnson & Johnson (J&J) vaccine is designed to prevent Covid-19. It is not designed to prevent everything that happens in life,” said Offit.
Bogoch added that no one before Covid-19 cared when there was a break in clinical trials for antibiotics or heart medications.
“Never before have we been in a scenario where you literally have 7 billion people watching closely and following every progress under the microscope,” says Bogoch.
With a pause the corona vaccine clinical trial and treatment to overcome the Covid-19 pandemic, according to Bogoch, indirectly has created a more health-literate community.
Bogoch further said that pauses in clinical trials are not the same as regulatory freezes, which are sometimes referred to as clinical holds imposed by health authorities such as the Food and Drug Administration (FDA).
The clinical suspension is when the FDA steps in and says it will stop certain trials because they think it is unsafe to continue based on the data they have.
The FDA still has the final stage of clinical trials of the vaccine developed by AstraZeneca, the Covid-19 vaccine developer that is superior among other vaccine candidates.
The vaccine trial is still being held in the United States, meaning the company cannot deliver a second dose of its two-dose vaccine regimen to volunteers in the US.
The delay was a result of an illness in a UK participant who was believed to have developed inflammation of the spinal cord, known as myelitis transversal.
Although trials have resumed in the UK and other countries, in the United States the test for the corona virus vaccine is still pending.
The head of global research and development at Johnson & Johnson (J&J) Janssen, Dr Mathai Mammen said the company still had very little information on the reasons for the delay, including if a patient received a vaccine or placebo.
“It will take at least a few days for the correct information to be gathered,” said Dr Mammen.
Eli Lilly and the National Institutes of Health also did not disclose what the safety concerns were, but the company said they supported the decision of the DSMB (Data and Safety Monitoring Board), the board that oversees clinical trials of the coronavirus vaccine and treatment for Covid-19.
“Security is of utmost importance to Lilly. We recognize that because of a lot of caution, ACTIV-3’s independent data security monitoring board (DSMB) has recommended a break in registrations,” said spokeswoman Molly McCully.