DoST looking into vax’s side effects
The Department of Science and Technology (DoST) on Saturday assured that experts will look into reported side effects of the Janssen Covid vaccine as its Phase 3 clinical trials formally started in the Philippines.
“There are side effects reported in other countries and based on our procedure, we will conduct our own investigation to determine if the reported side effects were really caused by the vaccine or if there are other causes,” DoST Undersecretary Rowena Guevarra said during the Laging Handa briefing.
Guevarra added that at present, the DoST has yet to report adverse events brought by the clinical trial of Janssen after the clinical trial took place last week.
She said aside from Janssen, two other independent clinical trials are being done by Sinovac and Clover Covid-19 vaccines.
“The clinical trials of Janssen are being done in the National Capital Region (NCR), in Region IV-A and Region VI,” she added.
Guevarra added that Janssen Pharmaceuticals is still screening participants for the clinical trials.
“The process include recruitment and after that those who signified for the trials will be screen and there will be inclusion and exclusion. Those who can participate will be part of the inclusion and those who will fail will be part of the exclusion. Covered by the exclusion are those pregnant women,” she explained.
She added that those who will pass the screening will be covered by the trials.
“Those who will be vaccinated will report for follow up visits to determine who among those received the anti-bodies for Covid-19,” according to Guevarra.
She said that the results of the clinical trials will be reported to the Food and Drug Administration (FDA).
“If there are adverse events, the hospitalization of the individuals who volunteered for the trials will be shouldered by the pharmaceutical company which is conducting the clinical trial,” Guevarra added.
She said the health workers will not be covered by clinical trial since they are in the priority list in the government’s inoculation program.
Guevarra said that those being included in the clinical trials are areas with high Covid-19 cases.
“We are choosing barangay with high cases of Covid-19. The clinical trials can also be done simultaneously with the vaccine rollout once the government starts with the vaccination program,” he said.
Guevarra refused to disclose the number of participants in the clinical trials for Janssen, saying it is part of the confidentiality data agreement.
“That information will need to come from Janssen as part of the confidentiality data agreement. The spokesperson of the pharmaceutical company will provide that information.