Giving priority to the health and safety of those who will participate in the World Health Organization (WHO) Solidarity Trials to find a vaccine for COVID-19, the Department of Science and Technology (DOST) is now looking into all the necessary preparations and safeguards.
“Masaya naming tinatanggap ang hamonnapabilisin ang paglabas ng vaccine labansa COVID-19,” ani Secretary dela Peña. “Ngunithindinaminikokompromiso ang bilis para sakaligtasan ng atingmgamamamayan. Upangmapangalagaan ng husto ang kalusugan at kapakanan ng mgasasalisa vaccine trials ay masusingnakikipag-ugnayan and DOST saibat-ibangahensya ng pamahalaankagaya ng DOH, DILG at FDA.”(We are happy to accept the challenge to expedite the release of a vaccine for COVID-19 but we are not compromising safety for our people over speed. To fully safeguard the health and welfare of those who will participate in the vaccine trials, we are closely coordinating with the different agencies of government like DOH, DILG and FDA.)
DOST chairs the Sub-Technical Working Group (Sub-TWG) on COVID-19 Vaccine Vaccine Development created under IATF Resolution No. 39 that was issued on 22 May 2020. The Sub-TWG on COVID-19 Vaccine Development will be spearheaded by the DOST together with the Department of Health (DOH), Food and Drug Administration (FDA), Research Institute for Tropical Medicine (RITM), Department of Foreign Affairs (DFA), Department of Trade and Industry (DTI) and the National Development Company (NDC). These agencies continue to plan the appropriate steps and measures to ensure that the processor roadmap for the vaccine trials will not adversely affect the participants.
Responsibilities of agencies involved in the vaccine trials
Despite the many multilateral and bilateral partners being considered by the DOST, the agency ensures that the COVID-19 vaccine clinical application adheres to the processes approved by the Sub-TWG for Vaccine Development. This, in turn, is endorsed to the Sub-TWG for processing of the necessary requirements and documents needed. Thereafter, it will be reviewed by the Vaccine Expert Panel (VEP) and the Ethics Review Committees. The last step involves the Food and Drug Administration (FDA), the authorized agency that will make the final decision on who will be allowed to conduct the clinical trial. Individually, these agencies are tasked with the following:
DOST - DOST sits as the Chair of the Sub-TWG for Vaccine Development. Part of the mandate of the department is to conduct research. It is taking the lead to promote bilateral partnerships, together with the DFA, in relation to clinical trials. It is also working with DTI and NDC in encouraging local pharmaceuticals to consider local manufacturing of Covid-19 vaccines in partnership with foreign vaccine developers.
DOH - DOH acts as vice-chair of the Sub-TWG for Vaccine Development. The department is a co-member of the DOST with regard to health research in line with the Philippine National Health Research System established through RA 10532. With this, the DOH and the DOST are partners with reference to clinical trials. The DOH is also tasked to oversee the hospitals that will join the clinical trials and other entities with a connection to operational and logistics management of clinical trials.
FDA - The Philippine FDA is the lead agency that evaluates and approves applications for the conduct of the clinical trials in the Philippines. As a regulatory agency, the FDA will monitor the entities approved to conduct the clinical trials. With or without the vaccine trials, the FDA is the agency authorized to approve any vaccine that will be released and sold to the public.
Roadmap of COVID-19 Vaccine Trials
The first step to find a vaccine is the country’s participation in the WHO Solidarity Vaccine Trials that will be led by Dr. Jodor Lim of the Philippine General Hospital. To date, there were 12 hospitals identified in NCR, Cavite, Cebu City, and Davao City as trial sites. To ensure the safety of those who will participate in the vaccine clinical trials, the DOST created the Data and Safety Monitoring Committee (DSMC).
Aside from the WHO Solidarity Vaccine Trials, the Sub-TWG is now coordinating with six pharmaceutical companies that signed the Confidentiality Data Agreement (CDA) allowing the VEP to study the results of their Phase I and II clinical trials. These companies are Sinovac, Sinopharm, and Anhui Zhifei from China; Gamaleya from Russia; the University of Queensland, CSL, and Seqirus from Australia; and immune Corporation from Chinese Taipei.
The Sub-TWG still requires these companies to submit complete requirements and documents so they can study them extensively to ensure the safety of the participants to the clinical trials.
“Maraming balita din na kumakalat ukol sa vaccine trials na kailangang bigyan ng linaw. Tumutulong ang aming ahensya upang makagawa ng FAQs on Vaccine Trials kasama ang DOH,”dagdag pa ni Secretary dela Peña. “Ilalabasitosa government website sa susunod na araw.” (There are some news circulating about the vaccine trials that need to be cleared. The agency is helping out to create FAQs on Vaccine trials together with the DOH and this will be released in government websites in the coming days.)
Because of the pandemic, there might be parties who will exploit the situation, so the public is advised to be extra careful since there is still no approved vaccine as the DOST continues to work closely with the Sub-TWG, DOH, and FDA for the clinical trials that will be conducted in the Philippines.
Black market vaccines, not approved
“Muli’t muli ang DOST ay nagpapaalala sa publikonawala pang aprubadong bakuna laban sa COVID-19. Hinihikayatnamin ang publiko, para sa kaligtasan ng lahat, naipaalam sa kinauukulan gaya ng Philippine FDA, Philippine National Police o National Bureau of Investigation kung may mapag-alamang impormasyon ukol sa mga napapabalitang kontrabandong bakuna naipinagbibili,” said Secretary dela Peña. (Time and again, the DOST reminds the public that there is still no approved vaccine against COVID-19. The pubic is encouraged, for the safety of all, to inform the Philippine FDA, Philippine National Police or the National Bureau of Investigation if they have any information about contraband vaccine that is being sold.)