With input from Dr Monica Vasudev

Three COVID-19 Trials Have Been Paused for Safety

1. Two late-stage clinical trials - Johnson & Johnson’s vaccine and Eli Lilly’s monoclonal antibodies study - were halted owing to possible safety concerns. Just a month earlier, AstraZeneca’s vaccine trial was put on hold after two volunteers became seriously ill.
2. Eli Lilly’s antibody drug pause is rarer, and worrisome. The trial was testing the treatment on hospitalized sick patients, a group in which deterioration in health would not be surprising. So, if a trial like that one is paused, the safety concerns must have been significant.
3. Johnson & Johnson halted its trial due to an unexplained illness. Eli Lilly’s trial was halted because of a health difference between the group that received the drug and the group that was given a placebo, which has not yet been disclosed.
4. Phase 3 trial is random. People in a vaccine trial may get a checkup every month and record any symptoms they experience. People who get a drug while they’re hospitalized may be receive blood tests and medical exams.
5. Mild symptoms aren’t enough to halt a trial. But an adverse event needs to be reported.
6. If the board or the company judges the adverse event to be particularly concerning, they may pause the trial, even without yet knowing if the event happened to someone who got the treatment or the placebo.  Once a trial is paused, a safety board may ask for the participant who experienced an adverse event to be “unblinded”. If the volunteer was given a placebo, the trial can continue.
7. If it is discovered that the volunteer got the treatment, further investigations are carried out. The members may order new tests, not only for the people who experienced adverse events, but for everyone in the trial.
8. Some vaccines can cause Guillain-Barré syndrome. But it takes weeks for the condition to develop. If a volunteer shows signs of Guillain-Barré syndrome on the day of a vaccine injection, it can’t be the cause.
9. After AstraZeneca paused its global trials on Sept. 6 for a review, regulators in Brazil, India, Japan, South Africa and the United Kingdom all gave the approval for the trial to resume. However, the U.S. trial is still on pause as the regulators continue to look over the evidence.
10. When the evidence isn’t very clear, the board may let the trial resume with extra tests or exams. A second case of the same event might be more common than what is expected from chance, causing the trial to end.
11. Vaccines are designed to be given to billions of healthy people. So they require extreme safety. If even one person in a vaccine trial gets sick, a closer investigation is required.
12. A large number of vaccine candidates, about 43 till today, are undergoing clinical trials. Several of them are based on cutting-edge designs that have not been licensed earlier.
13. Pauses of treatment trials are not as common. The people getting drugs have a disease, sometimes a serious one.
14. One patient was enough to cause Johnson & Johnson to pause the trial.
15. Both Eli Lilly and Regeneron have already given monoclonal antibodies to thousands of people with COVID-19 without any previous reports of problems (although some of the trials were on people with relatively mild cases).

[Source: https://thebusinessnews.in/]

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA