Solidarity Trial for vaccines in PH starting late October, to last 18 months

Kristine Sabillo, ABS-CBN News

Posted at Sep 16 2020 05:01 PM

In this file photo Dr. Nita Patel, Director of Antibody discovery and Vaccine development, lifts a vial with a potential coronavirus, COVID-19, vaccine at Novavax labs in Gaithersburg, Maryland on March 20, 2020, one of the labs developing a vaccine for the coronavirus, COVID-19. Andrew Caballero-Reynolds, AFP

MANILA — The World Health Organization’s clinical trials for possible COVID-19 vaccines is set to start in the Philippines in October and will last for 18 months, according to the Department of Health.

“The duration of this Solidarity trial for vaccines would be 18 months. The total approved budget, which is funded by the Department of Science is P89.1 million,” Health Undersecretary Maria Rosario Vergeire said during a virtual briefing on Wednesday.

“The expected start — though we say that this is tentative because things might change — would be the 3rd week of October,” she added.

Vergeire said the allotted budget is only for operational expenses since the WHO and vaccine manufacturers will be providing the vaccines.

“Our implementing agency for this is the Philippine General Hospital,” the health official added. 

Vergeire said they already have the list of the 34 vaccines being evaluated by the WHO. The DOH earlier said that only 8 will be initially included in the trial. Of the 34, the first 9 are considered frontrunners or are in advance stages of their respective clinical trials. Vergeire said they are in separate negotiations with the Philippines.

She also said that they have an initial list of areas for the clinical trial.

“These are initial ones that signified their intent to join. But we will finalize the areas first before we share it,” she said.

The DOH also released the list of the 34 vaccines being evaluated by the WHO. The first 9 in the list, all under Phase 3 or large-scale clinical trials are the (1) University of Oxford and AstraZeneca; (2) CanSino Biological Inc.; (3) Gamaleya Research Institute of Russia; (4) Janssen Pharmaceutical Companies; (5) Sinovac; (6) Sinopharm (Wuhan); (7) Sinopharm (Beijing); (8) Pfizer, BioNTech and Fosun Pharma; and (9) Moderna.

Except for Cansino Biological and Janssen, all are already in separate talks with the Philippines. The DOST and the Food and Drug Administration told ABS-CBN News earlier that Janssen already applied for clinical trials in the Philippines but their documents are still being studied by the vaccine expert panel. 

Vergeire said the negotiations take time since it involves the exchange of documents and comments.

She said they are still waiting for the response of Sinovac to their signed Confidential Disclosure Agreement (CDA).

As to Pfizer tapos na ang DOH at DOST na makapagbigay ng mga komento (the DOH and DOST already sent comments). We are just waiting for the comments coming form the Executive Secretary’s office and then we can already transmit to Pfizer this CDA confidentiality disclosure agreement,” she added.

Vergeire said they are also waiting for Moderna’s response while they are drafting the CDA for other manufacturers such as Sinopharm, the Chinese Academy of Sciences, and the University of Queensland.