The world needs an effective, rapid and reliable assessment of a wide range of new vaccine candidates for coronary pneumonia, according to a review published in the Lancet newspaper by a team of experts from the World Health Organization’s (WHO) vaccine solidarity trials. The commentary says three issues are critical in planning a new crown vaccine trial:
First, whether there is a need to prove not only the efficacy of certain vaccines, but also the value of their efficacy;
Second, whether the initial trial of a placebo-controlled vaccine should give priority not only to single vaccine trials, but also to multi-vaccine trials;
Third, there is a need to continue blind follow-up of vaccine and placebo groups to assess their safety, protective effects on severe diseases, and duration of protection, after determining the short-term effectiveness of the vaccine, but prior to local deployment of the vaccine in the general population.
Rapid use of the new crown vaccine could lead to our widely deployed vaccine actually becoming a weak vaccine (for example, reducing the incidence of new coronary pneumonia by only 10 to 20 percent), the paper said. If local governments mistake the vaccine for a significant reduction in the risk of infection, or if individuals who get the vaccine mistakenly believe they have acquired immunity, thereby reducing prevention and control, the new coronary pneumonia pandemic may continue to worsen.
The deployment of a “barely effective” vaccine may also interfere with the evaluation of other vaccines, as subsequent vaccines have to be compared. If the new vaccine is more effective than the weak vaccine, researchers will need a larger sample size and recognition of its efficacy will be delayed accordingly. More seriously, if you compare a weak vaccine to a weak vaccine, it is likely that one of the vaccines will be evaluated for its effectiveness, creating a so-called “bio-creep”, a risk that must be avoided in clinical trials.
The commentary also notes that, for this reason, in preliminary clinical trials compared to vaccinations and placebos, the criteria used to define a “successful vaccine” need to be strict enough to avoid the risk of deploying a weak vaccine, especially as many candidate vaccines for new coronary pneumonia are currently being tested and the effectiveness of the vaccine is highly likely to be overestimated. Therefore, comparing preliminary trials of new crown vaccines and placebos should seek reliable evidence not only for the efficacy of the vaccine, but also for the efficacy of a valuable vaccine.
In addition, global multi-vaccine trials with shared control groups can provide faster and more reliable results than individual trials for each of the many different vaccines. Continued use of established clinical trial infrastructure can save time and effort and accelerate the discovery of several safe and effective vaccines. Flexible trial design and hundreds of research sites in disease-risk areas have contributed to high entry rates for subjects, and short-term results for each vaccine can be obtained in just a few months after the corresponding vaccine trials are conducted.
The paper also mentions that the main outcome indicator of the study was laboratory-confirmed symptoms 14 days after vaccination. In any case, placebo-controlled follow-up should last at least 12 months, or until an effective vaccine is available locally, to assess the safety, level of protection, and duration of the vaccine.
Now that funding providers, vaccine research and development agencies, researchers and government agencies have signed a statement on international cooperation in vaccine research, all hope is unanimous in their hope of ending the massive disease, death and destruction caused by the global new coronary pneumonia pandemic as soon as possible.