IATF okays PH participation in Covid-19 vaccine clinical trials

Under Resolution 39, a sub-technical working group chaired by DOST is formed and tasked to coordinate with the Department of Health (DOH), the Food and Drug Administration (FDA), Research Institute of Tropical Medicine, and the World Health Organization for matters related to the participation in clinical trials. (Pexels photo)

MANILA – The Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-EID) has given its nod to the Philippines’ planned participation in the clinical trials for a vaccine against coronavirus disease 2019 (Covid-19), Malacañang said on Saturday.

The IATF-EID’s approval was contained in its Resolution signed on May 22, Presidential Spokesperson Harry Roque said in a press statement.

“IATF Resolution No. 39 mentions the approval of the recommendations of the Department of Science and Technology (DOST) on the participation of the Philippines in the clinical trials for Covid-19 vaccines,” said Roque, also acting as IATF-EID spokesperson.

Under Resolution 39, a sub-technical working group chaired by DOST is formed and tasked to coordinate with the Department of Health (DOH), the Food and Drug Administration (FDA), Research Institute of Tropical Medicine, and the World Health Organization for matters related to the participation in clinical trials.

The IATF-EID approves the Philippines’ collaboration with organizations Adimmune Corporation, Academia Sinica, Chinese Academy of Science-Guangzhou Institute of Biomedicine and Health, and Sinopharma-Wuhan Institute of Biological Products and Beijing Institute.

The resolution states that the collaborating organizations will be provided with the WHO’s requirements for Covid-19 vaccine target product profiles; pre-qualification process for WHO approvals; and the FDA’s updated guidelines on clinical trials.

“Pursuant to the foregoing, the FDA is directed to advise on the process to facilitate the issuance of a permit for the conduct of the clinical trial in the Philippines,” the IATF-EID’s latest resolution, which was released by the Palace on Saturday, said.

The DOST has been in talks with Chinese and Taiwanese Organizations and research groups for possible clinical trials of a Covid-19 vaccine, based on President Rodrigo Duterte’s eight weekly report to Congress on his administration’s efforts to arrest the spread of the novel coronavirus.

The IATF-EID requires the identification of study sites by researches who will be involved in the clinical trials.

The clinical trials, once finished, will also be one of the requirements for the vaccine registration process by the FDA for issuance of the Certificate of Product Registration for market release in the Philippines, according to Resolution 39.

The IATF-EID, in its new resolution, also supports the DOST’s proposed creation of research centers that can initiate and strengthen local vaccine development toward the country’s vaccine self-reliance and self-sufficiency.

The DOST has recommended the establishment of the Virology S&T Institute in New Clark City and the reactivation of the Pharmaceutical Development Unit at DOST’s Industrial Technology Development Institute as a Tuklas Lunas Center for Pharmaceuticals Development.

WHO has noted that there are only six candidate vaccines for Covid-19. It has also expressed optimism that a Covid-19 vaccine will become available to the public in the next 18 months.

Duterte, in his public address delivered on May 19, sought the immediate purchase of a vaccine for the treatment of Covid-19, once it is available.

A “Solidarity Trial,” an international clinical trial, was earlier launched by WHO and its partners to test the safety and effectiveness of possible vaccines in treating Covid-19.

The Philippines’ participation in the WHO Solidarity Trial has been approved by the Single Joint Research Ethics Board on April 17 in support of the Covid-19 global response.