Johnson & Johnson stopped testing the nCoV vaccine
Johnson & Johnson is the second pharmaceutical company after AstraZeneca to stop clinical trials because of volunteers suddenly infected.
"Vaccine trial participants' disease symptoms are being reviewed and evaluated by the Independent Data Safety Surveillance Board Ensemble (DSMB), together with the Johnson & Johnson internal safety and clinicians. Adverse factors such as illness, accident or side effects, even severe cases, are part of any clinical study, especially large studies, "said Johnson & Johnson. (J&J) shared on October 12.
The J&J side did not indicate the symptoms of unexplained disease among the volunteers. In the clinical trials of new drugs or vaccines, it's important to find out if they cause dangerous side effects to the recipient. Trials will have to be stopped when any adverse symptoms appear during post-injection health monitoring, whether the reason for infection is actually vaccine-related or simply by coincidence.
"Based on our strong commitment to safety, all clinical studies conducted by Johnson & Johnson's Janssen pharmaceutical company contain specific instructions. These guidelines guarantee studies. Our study may be halted if an undesirable serious adverse event (SAE) occurs, whether or not a vaccine-related study or study drug has been reported. medical information before deciding whether to restart the study, "the company said.
The J&J representative also emphasized that the company must respect the privacy of volunteers. The testing unit is also in the process of learning more about the person's symptoms. It is important to have all the facts before sharing any additional information.
Vaccine Covid-19 Ad26.COV2.S. by Johnson & Johnson in a company laboratory. Photo: Johnson & Johnson.
Serious unwanted side effects are not uncommon in clinical trials. On the other hand, the Johnson & Johnson side also reported that because of many placebo-controlled trials, it is not always easy to determine whether the volunteer was in the receiving group or was given only a placebo.
Dr. Ashish Jha, head of the Department of Public Health at Brown University agrees that the suspension of J&J's trials should not be of concern at the moment. "Johnson & Johnson's last-stage nCoV vaccine clinical trial, which ran on 60,000 volunteers, is the biggest one I know of. During the vaccine trial period, maybe the trial will be halted a few times because of that." is unavoidable ", said the Doctor.
In addition, the Johnson & Johnson side also reassured residents that there was a "significant difference" between study suspension and regulatory suspension for a clinical trial. Suspension of research means that sponsors must suspend the volunteer recruitment or use of that drug or vaccine as a standard component of the clinical trial protocol. Organized clinical trials by regulations are required by medical regulators, such as the US Food and Drug Administration (FDA).
In this case, the "candidate" of J&J is only being suspended according to regulations. The pharmaceutical company also said that as stated in the previous transparency commitment, they will proactively disclose all the important clinical trial regulations.
This is the second phase III nCoV vaccine trial to be halted in the US. AstraZeneca's trial was halted last month because of neurological complications in a volunteer in the UK. Although testing continued in the UK and a few other countries, it was suspended in the US during the FDA investigation of where the infection originated.
"We want the new vaccine to be truly safe for users. It will take a while to do that. I believe that the pharmaceutical companies are still acting responsibly and ready to suspend testing when they are. I have to, "said Dr. Jha.
The phase III clinical trial of the vaccine "candidate" developed by Johnson & Johnson started in September. It is one of six potential "candidates" currently being tested in the US, and one of four coming. tested on a large scale. J&J's nCoV vaccine requires a single injection instead of two injections like the others. Thus, federal officials say they expect testing to be a little faster than the remaining "candidates", requiring two doses, such as the vaccine developed by Moderna and Pfizer.
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