AIIMS vaccine trials: 80% volunteers found unfit for study
Nearly two weeks ago, AIIMS Delhi had started the Phase 1 human trial of COVAXIN — the first candidate vaccine developed indigenously in India to fight the spread of COVID-19. The study has since been progressing, but if a new report by The Indian Express is anything to go by, it is moving rather slowly than originally expected. Here's why.
Only 16 volunteers enrolled, vaccinated
Speaking to multiple sources, IE has learned that AIIMS has screened more than 80 volunteers for COVAXIN's trial but only 16 - or about 20% - have been enrolled so far. The high rejection rate comes as most of the volunteers were found to be unfit for the study which requires the participants to be completely healthy and be aged between 18 and 55.
20% of rejected ones already had antibodies
A doctor closely involved in the trial at AIIMS claimed that nearly 20% of the rejected volunteers already had COVID-19 antibodies. The presence of antibodies, as many know, indicates that a person has already contracted and recovered from the novel coronavirus infection. "So, (in that case), it is difficult to study the impact of the vaccine in them," the doctor noted.
Others had lung, liver problems
The rest of the rejected volunteers were not chosen due to other pre-existing conditions, comorbidities. "The remaining people do not have optimum liver or kidney function," the doctor said, adding that "we can only recruit healthy volunteers" with no issues of heart, lung illnesses, or uncontrolled diabetes or hypertension. The volunteers are tested for all these problems during the pre-recruitment screening for the trial.
Over 3,500 people have registered for COVAXIN's AIIMS trial
Though the high rejection rate has decreased AIIMS' pace of recruitment for COVAXIN trials, it will not affect the overall study as more than 3,500 people have registered to help with the testing of the experimental shot. Also, the first volunteer, a 30-year-old male, who was enrolled to receive the vaccine has been tolerating it well, without any side effects.
He will get the next dose after August 7
"He has completed the first week and hasn't reported any discomfort so far. We will monitor him till next Friday (August 7) before administering the next dose of the vaccine," the doctor told The Indian Express.
375 participants to be enrolled for Phase-1 COVAXIN study
AIIMS Delhi is one of the 12 Indian sites chosen by ICMR for Phase 1/2 human trials of COVAXIN. In Phase 1, 375 participants have to be enrolled, of which 100 will be from AIIMS, while the second phase will have 750 volunteers. The goal of the study is to establish the safety of the vaccine, its right dose, and its effectiveness.
When will this vaccine be available?
The experimental vaccine, developed by Hyderabad-based Bharat Biotech, has to clear Phase 1, 2, and the final and the largest Phase 3 of human trials to be ready for approval and public use. ICMR had previously said it aims to make the shot available by August 15, but Bharat Biotech's founder Dr. Krishna Ella believes it is too early to announce a launch date.
