Investigator’s brochures on 4 vaccine brands to be used in WHO Solidarity Trial under review —DOST

Published July 16, 2021, 7:24 PM

by Charissa Luci-Atienza 

The Department of Science and Technology (DOST) said Friday, July 16, that the investigator’s brochures on the four vaccine brands that will be used in the World Health Organization’s (WHO) Solidarity Vaccine Trial (SVT) have already been under review by its expert panel.

(Photo by ALI VICOY/ MANILA BULLETIN FILE PHOTO)

DOST Secretary Fortunato “Boy” T. de la Peña said the WHO has already forwarded the standard operating protocols or SOPs for the SVT on July 5 and that the study team “is awaiting two more SOPs”, citing the report provided by Philippine Council for Health Research and Development (DOST-PCHRD) Executive Director Dr. Jaime C. Montoya.

Two days after it submitted the SOPs, the WHO provided the investigator’s brochures (IBs) for four vaccines that will be tested in the SVT.

“The said investigational brochures were already submitted to the Vaccine Expert Panel for review, in addition to the initial submissions made last June 25, 2021,” de la Peña said during his weekly report on Friday.

The IB contains the non-clinical and clinical data relevant to the study.

De la Peña noted that the WHO SVT team met with the Metro Manila Development Authority (MMDA) and mayors in the National Capital Region (NCR) to apprise them of the status of the SVT and to map out strategies for the smooth implementation of the vaccine trials.

The meeting was held on July 9.

“The WHO STV team in coordination with DOST and DOH (Department of Health) held a meeting with the MMDA and the Manila mayors to reorient them about the recent developments for the study and to plan a more effective approach for the upcoming clinical trial proper on the target NCR communities and barangays,” de la Peña said.

During the Laging Handa public briefing on July 13, DOST Undersecretary for Research and Development Rowena Cristina L. Guevara announced that DOH Secretary Francisco Duque III and WHO Chief Scientist Dr. Soumya Swaminathan signed a letter of agreement for the conduct of SVT in the country.

Related story: https://mb.com.ph/2021/07/13/why-are-clinical-trials-for-covid-19-vaccines-important/

In an interview with the Manila Bulletin on July 10, Guevara, who chairs the Task Group on Vaccine Evaluation and Selection (TG-VES), disclosed that the actual rollout of the WHO SVT could be expected by the end of this month or early August.

Related story: https://mb.com.ph/2021/07/10/actual-rollout-of-whos-vaccine-trials-phs-study-on-covid-19-vaccine-mixing-matching-eyed-by-end-of-july-early-august/

 
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