Janssen’s COVID-19 vaccine phase 3 clinical trial underway — DOST

The Phase 3 clinical trial of Janssen Pharmaceuticals for its coronavirus vaccine is already underway, the Department of Science and Technology (DOST) said Friday.

“Janssen has already started with the clinical trial proper, which covers patient screening, recruitment, and vaccination,” Undersecretary Rowena Guevara said during a virtual briefing. 

Last month, the DOST said the firm was targeting San Pablo and Cabuyao in Laguna, La Paz in Iloilo, Bacolod City, and Metro Manila as its trial sites. 

In a separate statement later in the day, the DOST clarified that Janssen has already identified trial sites in the National Capital Region, Region IV-A, and Region VI.

The Phase 3 clinical trial application of Janssen, the pharmaceutical firms of Johnson & Johnson, was approved in December 2020. 

Other trials

Meanwhile, Guevara said the start of the World Health Organization (WHO)’s solidarity trial in the Philippines is being delayed by several factors, including the need for more personnel due to an increased number of trial sites and participants.

Guevara also said the standard operating procedure for the trial has not yet been released by the WHO and the changing of COVID-19 case rates in Metro Manila have caused difficulty in identifying the final trial sites.

The trial site preparations for China’s Sinovac and Clover Biopharmaceuticals are also ongoing, the DOST official added. 

Emergency use authorization

Guevara said Philippine authorities are still awaiting Bharat Biotech’s submission of its interim Phase 3 clinical trial data for evaluation by the Vaccine Expert Panel.

American firm Moderna has yet to submit its requirements for an EUA, while the Food and Drug Administration is still waiting for Russia’s Gamaleya Institute to submit regulatory requirements for final evaluation.

The Philippines has so far approved the Pfizer-BioNTech and AstraZeneca vaccines for emergency use. —With a report from Joahna Lei Casilao/RSJ/LDF, GMA News