Safety monitoring body to be formed for Covid-19 vaccine trials

Safety monitoring body to be formed for Covid-19 vaccine trials

MANILA – The Inter-Agency Task Force’s sub-technical working group (TWG) on vaccine development, headed by the Department of Science and Technology (DOST), will form a Data and Safety Monitoring Committee (DSMC) for the World Health Organization (WHO) Solidarity Trial for coronavirus disease 2019 (Covid-19) vaccine, an official said.

In an interview with the Philippine News Agency on Monday night, DOST Undersecretary Rowena Cristina Guevara explained that every clinical trial is required to have a DSMC, whose committee members should be completely independent from the sponsor.

“The DSMC will make written recommendations to continue, modify, suspend, or terminate the study. These recommendations will be received by the sponsor, and communicated to the researchers so they could forward them to the respective Research Ethics Committees,” she said, adding that the DSMC, sponsor, and clinical trial team will meet to resolve issues and recommendations.

Guevara noted that the DSMC’s role is crucial in monitoring the safety of vaccines.

“AstraZeneca’s vaccine clinical trial, for instance, was ‘voluntarily halted’ after a volunteer developed an unexplained illness considered a serious adverse reaction to the vaccine. The action will allow review of safety data by an independent like the DSMC, while maintaining the integrity of the clinical trial,” she said.

The DSMC, she said, usually consists of at least three people with one of the following qualifications:

  • Medical specialist — experienced in carrying out studies related to the object of the study
  • Epidemiologist — experienced in conducting studies, or epidemiological surveillance related to the object of the study
  • Statistician — undergraduate or graduate degree in Statistics; with experience in the health field
  • other health professionals — experienced in the design, conduct, or analysis of clinical trials

Guevara said that the DOST, through the sub-TWG on vaccine development, will appoint the DSMC.

DOST Secretary Fortunato de la Peña said for clinical trials not included in the WHO solidarity trial, the sponsor vaccine developers will designate their own DSMCs.

De la Peña said the sub-TWG on vaccine development also oversees the clinical trials outside of the WHO solidarity trial, but such role would end once the sub-TWG provides them all the necessary information and instructions to start the clinical trials.

The sub-TWG on vaccine development will continue to oversee the clinical trials under the WHO Solidarity Trial until these are finished, he added.

Meanwhile, Guevara said the hospital sites for the WHO solidarity trial are: the Philippine General Hospital, Manila Doctors Hospital, San Lazaro Hospital, Lung Center of the Philippines, St. Luke’s Medical Center – Quezon City, Research Institute for Tropical Medicine, Makati Medical Center, The Medical City, St. Luke’s Medical Center – BGC, Vicente Sotto Memorial Medical Center, De La Salle Health Sciences Institute, and Southern Philippines Medical Center.

“Vaccine recipients in the WHO Solidarity Trial will be recruited from the top five to 10 barangays reporting high Covid-19 cases based on the attack rates per 1,000 population per barangay,” Guevara said. (PNA)

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