Health Official Says Astrazeneca Vaccine Has Gone Through Layers Of Approval

The Ministry of Health and Wellness says the AstraZeneca COVID-19 vaccine would have gone through a very stringent process, with layers of approval prior to being made available to the public.

In an interview with JIS News, Director of the Family Health Unit at the Ministry, Dr. Melody Ennis, said that persons have expressed concern about the speed with which the COVID-19 vaccine was developed. “The process is long for routine vaccines; however, it’s a different platform that’s being used now and, therefore, that has shortened the process significantly. Although the process has been shortened, the steps have not been skipped,” Dr. Ennis explained.

The Family Health Director pointed out that the process involves at least four trial phases. “You have your Phase One trials, which are the safety trials; Phase Two trials that also look at safety as well as dosing, and you have your Phase Three trials that look at the possibility of having any adverse reactions,” she added. Dr. Ennis pointed out that in order to get to Phase Three, all the other phases must be passed for safety and that in the Phase Three trials, and thousands of persons must be involved.

The Ministry of Health official added that Phase Four trials are the long-term look at the possible adverse events that may happen if millions of persons are on the medication.

The Family Health Director noted that prior to the pandemic “it would have been very difficult to find thousands of persons across the world that would be affected to see how your vaccine or your medication can react positively or negatively on them”, adding that it would normally take up to five years to find enough persons.

She argued, however, that with the pandemic, based on the number of persons that had the illness, it was easy in a short time to get thousands of persons to participate in the trials. “If we look at the AstraZeneca vaccine, for example, their clinical trial Phase Three had over 40,000 persons involved; Pfizer had an equal number and Moderna had 30,000,” Dr. Ennis noted. This, she explained, would assist the developers in identifying the adverse events that can occur.

The Family Health Director said that for the history of vaccines, the standard time is about 60 days, pointing out that beyond that, over the centuries of using vaccines side effects have not been found to project longer than 60 days.