New Delhi | Jagran News Desk: The promising results observed in early trials by UK's Oxford have come out as encouraging news but experts warn over some of the key challenges ahead in the process.

Positive signs from the data developed from early-stage human trials of a Covid-19 vaccine by Oxford University has triggered hope for a vaccine. The data shows that the vaccine is safe and induces an immune reaction but the upcoming stage of the trial will be critical to determine if the potential vaccine can protect against infections.

"The phase 1/2 Oxford COVID-19 vaccine trial is now published. The vaccine is safe, well-tolerated, and immunogenic. Congratulations to Pedro Folegatti and colleagues. These results are extremely encouraging," said Richard Horton, Editor in Chief of UK based medical Journal 'The Lancet' that published the results.

Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine in Atlanta in a statement said, "If we're making a plane, right now we're at the production level."

"We can say it looks like this can at least get off the ground and do so safely. But can it get me from here to Paris? That's the question now," The Dean was quoted as saying to the NBC News.

The vaccine named ChAdOx1 nCoV-19 was tested on 1077 people in phase I and II of the human trials. As a result, none of the volunteers faced any serious adverse effects due to the vaccine, and antibodies were generated to fight the coronavirus.

However, The Dean at the University School of Medicine in Atlanta informed that while it's not common for vaccine candidates that have delivered good results in early stages to fail in subsequent phases, it can happen.

Have a look at some of key ethical considerations published by the WHO in its journal of Human Challenge Trials for Vaccine Development and the regulatory considerations:

  • According to the WHO, clinical trials should be designed and conducted in a manner that minimizes risks to human subjects while maximizing the potential for benefit.
  • WHO says that consideration must be given to both potential individual risks and benefits, as well as to potential societal benefits and risks, such as release into the environment of a pathogen that might not otherwise be present at the time of the human trial of the vaccine.
  • Also, the provisions in clinical trial ethics are made for situations in which there may be a greater-than-minimal risk but no (or little) potential for individual benefit, when knowledge may be gained to the benefit of the larger societal population with whom the potential trial participant shares significant characteristics.
  • Another different ethical challenge at this stage erupts from the acknowledgment of the study the reality that some persons are greater risk-takers than others, while some persons are quite risk-averse and would not accept the risk of receiving a challenge. The key to asking individuals to accept the risk from a challenge study, in which they have little potential to receive individual benefit, is the element of informed consent.

However, it also states that there could be some potential for a direct benefit if the trial participant becomes immune to the disease. Keeping the laid out considerations for the human trial of the vaccine by the WHO which says that there is a need for truly informed consent of the individual prior to the trial, it is concluded that consideration of conducting human challenge studies in children, or in any other vulnerable population which would have diminished capacity to give informed consent, would not be deemed acceptable at this time.

Posted By: Simran Babbar