Philippines to participate in 5 clinical trials for vaccine

MANILA, Philippines — As the Philippines starts to shift to the new normal after almost two months of lockdown, the Inter-Agency Task Force (IATF) on the Management of Emerging Infectious Diseases has given the go signal for the Philippines’ participation in at least five clinical trials for vaccines against the coronavirus disease 2019 (COVID-19).

Under IATF resolution number 39, the body approved the recommendation of the Department of Science and Technology for the Philippines to collaborate with Adimmune Corp. of Chinese Taipei, Academia Sinica of the Chinese Academy of Science-Guangzhou Institute of Biomedicine and Health and SinoPharma-Wuhan Institute of Biological Products and Beijing Institute.

“The collaborating organizations will be provided with a) the World Health Organization (WHO) requirements for COVID-19 vaccine target product profiles; b) pre-qualification process for WHO approvals; and c) the Philippine Food and Drug Administration (FDA) updated guidelines on clinical trials,” the resolution read.

Health Secretary Francisco Duque III and Secretary of the Cabinet Karlo Alexei Nograles, IATF co-chairmen, signed the resolution.

The IATF also called on the FDA to map out the guidelines to facilitate the issuance of permits for the clinical trials in the Philippines.

The study sites would be identified together with the researchers in the clinical trials and once the clinical trials are finished, these would form part of the requirements for the vaccine registration process by the FDA, the IATF said.

The clinical trials would also be instrumental in the issuance of Certificate of Product Registration for market release in the Philippines.

In its May 22 resolution, the IATF also formed a sub-technical working group chaired by the DOST to coordinate with the Department of Health, FDA, Research Institute of Tropical Medicine and the WHO to have a free hand in choosing the members of the sub-group.

The IATF also expressed support to the DOST to establish research centers that can initiate and strengthen local vaccine development towards the country’s vaccine self-reliance and self-sufficiency.   

This includes the establishment of the Virology Institute in New Clark City and the reactivation of the Pharmaceutical Development Unit at DOST-Industrial Technology Development Institute as a Tuklas Lunas Center for Pharmaceuticals Development.

The IATF came out with the two-page resolution after the members held another meeting via video conference last May 22.

Last May 18, President Duterte said the Department of Health (DOH) has set aside P18 million for the clinical trials of Japanese anti-influenza drug Avigan as a potential treatment for the new coronavirus disease.

In his eighth weekly report to Congress on the government’s coronavirus response, Duterte said around 80 to 100 patients are expected to undergo the clinical research for the use of Avigan in the country.

“The DOH, through its Advancing Health through Evidence-Assisted Decisions with Health Policy and Systems Research, has allocated P18 million for Avigan trials,” Duterte said.

According to the President, at least 24 hospitals will participate in the Solidarity Trials initiated by the WHO to search for a coronavirus treatment. 

There are 12 hospitals actively recruiting participants. There are 87 participants or enrollees in the clinical trials.

The government is also exploring involvement in other clinical studies for coronavirus treatment. It was then when Duterte revealed that the DOST has also conducted exploratory talks for possible involvement in the clinical trials of several vaccine research groups and organizations abroad.

Duterte also appealed to members of the Association of Southeast Asian Nations (ASEAN) last month to enhance scientific cooperation, particularly in the area of vaccine and anti-viral treatment research and development.

The Philippines is ready to participate in clinical trials and medical studies of potential vaccines and medicines such as Avigan, he said.

Duterte also called for “fair and easy access” to vaccines and treatments for all countries once a coronavirus cure and vaccine are found.