Philippines seen to join clinical trials for COVID-19 vaccine within the year
In this picture taken on April 29, 2020, an engineer looks at monkey kidney cells as he make a test on an experimental vaccine for the COVID-19 coronavirus inside the Cells Culture Room laboratory at the Sinovac Biotech facilities in Beijing. Sinovac Biotech, which is conducting one of the four clinical trials that have been authorised in China, has claimed great progress in its research and promising results among monkeys.
AFP/Nicolas Asfouri
Philippines seen to join clinical trials for COVID-19 vaccine within the year
Alexis Romero (Philstar.com) - May 24, 2020 - 5:47pm

MANILA, Philippines — The Philippines is expected to join clinical trials for the development of vaccines for the coronavirus within the year, Malacañang said Sunday.

The Inter-Agency Task Force on the Management of Emerging Infectious Diseases has issued Resolution No. 39 adopting the recommendation of the science department on the country's participation in clinical trials for coronavirus vaccines.

The collaborating organizations include the Adimmune Corporation, the Academia Sinica, the Chinese Academy of Science - Guangzhou Institute of Biomedicine and Health, and SinoPharma - Wuhan Institute of Biological Products and Beijing Institute.

"President Rodrigo Roa Duterte has expressed optimism over news that clinical trials for the development of COVID-19 vaccines. We expect involvement in the vaccine clinical trials by the last quarter of 2020 with the Department of Science and Technology (DOST) taking a lead role," presidential spokesman Harry Roque said in a statement.

"The president wants to save the life of each and every Filipino, and, thus, places great interest to these clinical trials," he added.

Roque said DOST has been directed to provide collaborating organizations Philippine guidelines on vaccine clinical trials. The guidelines will cover the identification of sites, the local institutions and Filipino researchers who will be involved in the collaborative trials; and tasks like assisting local participating institutions in their proposals and budgets, obtaining ethics board approvals, and formalizing agreements.  

Under Resolution No. 39, collaborating organizations will be provided with the World Health Organization (WHO) requirements for coronavirus vaccine target product profiles, pre-qualification process for WHO approvals and Food and Drug Administration (FDA) updated guidelines on clinical trials.

Once the trials are completed, they will form part of the requirements for the vaccine registration process by the FDA for the issuance of certificate of product registration for market release in the Philippines.

Roque said Duterte would also review the recommendations of the DOST to establish the Pharmaceutical Development Unit and the Virology Science and Technology Institute of the Philippines. The recommendations were approved by the IATF last May 22.

"If and once approved by (President Duterte) both can start in 2020, with the Pharmaceutical Group and the Virology Research Group evolving out of DOST’s Industrial Technology Development Institute," the Palace spokesman said.

Roque said DOST has included the establishment of the research centers in its 2021 budget proposal.

DOST has recommended the establishment of the Virology Science and Technology Institute in New Clark City and the reactivation of the Pharmaceutical Development Unit as a hub of natural products research for drug development. 

In 2017, a government anti-dengue immunization program using Dengvaxia was suspended and eventually discontinued after a disclosure by pharmaceutical firm Sanofi that "for those not previously infected by dengue virus...more cases of severe disease could occur following vaccination upon a subsequent dengue infection."

Children's deaths have since been blamed on the vaccine despite experts from the Philippine General Hospital and the Department of Health saying there was no evidence that Dengvaxia caused them.

In justifying the government's decision to launch the immunization program, former president Benigno Aquino III told a Senate panel: "I did not think of denying vaccine protection to those who most need it." 

CLINICAL TRIALS NOVEL CORONAVIRUS
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