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Saturday, 02/05/2022 11:18:44 PM

Saturday, February 05, 2022 11:18:44 PM

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1/30/22 In 2020, one of the big hurdles the frontrunner vaccines had to face was managing to have enough trial participants ready and waiting in just the places that outbreaks would roll over them – something that required both good management and luck. Setting up trials takes a lot of time, and you couldn’t predict where the lightning was going to strike. I wrote about that challenge at WIRED.

Now there’s no shortage of outbreaks, unfortunately, but there’s another issue: how do you get enough unvaccinated people to run a big phase 3 trial when pretty much everyone who is both easy enough to reach and wants to be vaccinated already is vaccinated? Here’s hoping that there have been conversations with the WHO SOLIDARITY trial for vaccines about this.

That’s a big phase 3 trial with a shared placebo group to test 4 easy-to-distribute and scale up vaccines. As of the middle of December, 5,000 people had already been recruited in the Philippines alone. There are 2 vaccines already in the trial – a protein subunit vaccine from Medigen (Taiwan) and a DNA vaccine from Inovio (USA). The next 2 candidates are the self-amplifying RNA vaccine from Arcturus (USA) and a live attenuated vaccine from Codagenix (USA – to be manufactured by the Serum Institute of India). More vaccines could be added, though.
https://absolutelymaybe.plos.org/2022/01/30/new-triumphs-struggles-for-non-profit-covid-vaxes/

“As of January 3, 2022, eight hospitals and two community-based sites have already conducted the recruitment activities with a total of 5,901 have already been vaccinated with first dose and 3,840 participants have already completed the two-dose schedule of the first study vaccine,” DOST Undersecretary for Research and Development Dr. Rowena Cristina L. Guevara told the Manila Bulletin in an interview.

The lead investigators of the trial are Dr. Jodor A. Lim and Dr. Marissa M. Alejandria of the University of the Philippines (UP) Manila-Philippine General Hospital (PGH).

Guevara explained that the WHO-coordinated global study “Solidarity Trial Vaccines” is implemented locally through the project “Solidarity Vaccine Trial in the Philippines: Randomized Trial of Candidate Vaccines for COVID-19”.

She said recruitment of participants are ongoing on the following sites:

Philippine General Hospital (PGH)
Lung Center of the Philippines (LCP)
Makati Medical Center (MMC)
Quirino Memorial Medical Center (QMMC)
St. Luke’s Medical Center (SLCM)
Medical Center Manila (MCM)
Baguio General Hospital
San Juan De Dios Hospital (SJDH)
Sampaloc, Manila (community-based)
Crame, Quezon City (community-based)

The project team is eyeing to enroll 15,000 to 20,000 Filipinos aged 16 and above [40K worldwide in Mali, Colombia] to participate in the trial.
The enrolment of participants for the WHO STV started on Sept. 30, 2021.
Guevara said the study “will continue to run until the second quarter of 2022.”
https://mb.com.ph/2022/01/07/5901-participants-of-who-solidarity-trial-already-received-first-dose-of-covid-19-vaccines-dost/
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