Daily Management Review

Serious Adverse Event In Brazil Prompts Halting Of China Vaccine Trial


Serious Adverse Event In Brazil Prompts Halting Of China Vaccine Trial
A serious adverse event has resulted in the halting of the final-stage trial for a Chinese frontrunner vaccine candidate in Brazil. This is the first occasion that any of the vaccine candidates that are being rapidly developed by China has faced a serious setback.
The Brazil Health Agency has said that after an event that occurred on October 29, the authorities of the country decided to halt the trials of Sinovac Biotech Ltd.’s Covid-19 vaccine, called Coronavac. The authorities however did not provide any further details of the illness. It said that the trial was halted on the basis of the regulations and in the meantime the agency will analyse if the study should be allowed to be continued.
Death, immediate risk of death, long term or serious incapacitation, and hospitalization are the serious adverse events that occur in drug trials.
Such halting of trials is however not uncommon in the case of large scale drug trials. Two vaccine candidates being developed by the drug making companies AstraZeneca Plc and Johnson & Johnson have had to recently temporarily halt their trials because of serious adverse events after some of the volunteers administered the trial vaccine developed illnesses.  The trials have since restarted after investigation.
In the case of China however, authorities there have already started to administer its vaccines which includes Coronavac. An expansive emergency use approval was granted to the vaccines and then administered to hundreds of thousands of people. That makes the possibility of a safety issue being detected at this stage of the trials even more concerning.
Vaccines manufactured by Chinese companies have already inoculated about 60,000 volunteers in final-stage trials, China’s science ministry said last month. It said that those no reports of serious adverse events have been made in those administrations.
There were no comments on the vaccine trial halt made by Sinovac’s company representative.
In the global race for development of an effective immunization against the virus, a number of Chinese vaccine developers have been at the forefront. This race has assumed critical importance because countries all over the world are trying to move beyond the Covid-19 crisis and to open up their economies in a more definitive manner.
Global players have been forced to compress the vaccine development process which typically takes years to complete because of pressure from governments and politicians who want to have a quick fix solution to get out of the pandemic that has infected more than 50 million all over the world.
It was last week that drug makers Pfizer Inc. and BioNTech SE announced that the interim results from the final stage trials of its Covid-19 vaccine candidate exhibited more than 90 per cent efficiency in preventing symptomatic infections. The trial of the companies’ vaccine being conducted upon tens of thousands of volunteers and its announcement last week has boosted the hopes for a vaccine for the disease that has brought the world to a halt.