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By EDD K. USMAN and DOST-STII
HEALTH and safety first!
The Department of Science and Technology (DOST) assured this, emphasizing there will be no compromises in speeding up the World Health Organization (WHO) Solidarity Trials for a Covid-19 vaccine.
Under the leadership of Science Secretary Fortunato T. de la Peña, the DOST is in the midst of putting in place all the needed preparations and safeguard for the trials.
The department has gladly embraced its participation in the effort to find a cure for the SARS-CoV-2 pandemic that first struck in December 2019 in Wuhan City in China’s Hubei Province.
Urgent race to develop, find coronavirus vaccine
“Masaya naming tinatanggap ang hamon na pabilisin ang paglabas ng vaccine laban sa Covid-19,” ani dela Peña. “Ngunit hindi namin ikokompromiso ang bilis para sa kaligtasan ng ating mga mamamayan. Upang mapangalagaan ng husto ang kalusugan at kapakanan ng mga sasali sa vaccine trials ay masusing nakikipag-ugnayan and DOST sa ibat-ibang ahensya ng pamahalaan kagaya ng DOH, DILG at FDA.”
Translation: “We are happy to accept the challenge to speed up the release of a vaccine for Covid-19. But we will not compromise the safety of 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.”
(DOH is Department of Health; DILG means Department of Interior and Local Government; FDA stands for Food and Drug Administration.)
The race to develop and find a vaccine or cure against the coronavirus disease (Covid-19) is made more urgent as global confirmed infections rose to over 36.87 million with fatalities reaching more than 1.068 million according to the American Johns Hopkins University (JHU) in Baltimore, Maryland, as of October 9, 2020. More than
In the Philippines, the tally of confirmed cases per the DOH have climbed to 334,770 while 6,152 have succumbed to the disease. Recovered totalled 275,307.
De la Peña said the DOST prioritizes participants’ health and safety in the forthcoming trials.
DOST chairs the Sub-Technical Working Group (Sub-TWG) on Covid-19 Vaccine Development created under the Inter-Agency Task Force (IATF) Resolution No. 39 issued on May 22, 2020. The DOST heads the Sub-TWG together with the DOH, 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 process or 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, it 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 FDA, the authorized agency that will make the final decision who will be allowed to conduct the clinical trial. Individually, these agencies are tasked with the following:
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 acts as vice-chair of the Sub-TWG for Vaccine Development. The department is co-member of the DOST with regard to health research in line with the Philippine National Health Research System (PNHRS) established through Republic Act 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 connection to operational and logistics management of clinical trials.
FDA, which is under the DOH, 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 to be led by Dr. Jodor Lim of the Philippine General Hospital (PGH). To date, 12 hospitals have been identified in National Capital Region (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 Adimmune 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.
On the other hand, the DOST cited the need to clarify news reports circulating about the 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. “Ilalabas ito sa government website sa susunod na araw.”
Translation: “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 publiko na wala pang aprubadong bakuna laban sa Covid-19. Hinihikayat namin ang publiko, para sa kaligtasan ng lahat, na ipaalam sa kinauukulan gaya ng Philippine FDA, Philippine National Police (PNP) o National Bureau of Investigation (NBI) kung may mapag-alamang impormasyon ukol sa mga napapabalitang kontrabandong bakuna na ipinagbibili,” de la Peña warned.
Translation: “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.”
The public is advised to consult or refer to reliable and official government sources of information regarding Covid-19 Vaccine Clinical Trials and visit the websites of DOST-PCHRD, DOH and https://covid19.gov.ph/. Inquiries can also be sent through email: firstname.lastname@example.org for correct and accurate information. (✓)
Featured image of a vaccine by Martin Lopez on Pexels.
STII (Science and Technology Information Institute) is the media arm of the DOST.