COVID-19 vaccine candidate clinical trial prioritizes efficacy, safety

COVID-19 vaccine candidate clinical trial prioritizes efficacy, safety

Screen Capture of Head of the Food and Drug Supervisory Agency (BPOM), Penny Lukito, at a press conference in Jakarta, Tuesday (19/5/2020). ANTARA/Prisca Triferna/ac.

Clinical trials are important stages in the vaccine development
Jakarta (ANTARA) - Food and Drug Supervisory Agency (BPOM) Head Penny Lukito emphasized that efficacy along with guaranteed safety and quality were the key parameters during the clinical trial process conducted by Indonesia for the COVID-19 vaccine candidate.

"Clinical trials are important stages in the vaccine development," Lukito said as quoted from the BPOM official site on Monday.

The agency’s head noted that the clinical trials underway must meet scientific aspects and uphold research ethics in accordance with the Guidelines for Good Clinical Practice (GCP). Test results are required to support the COVID-19 vaccine registration process as a form of access to the product's needs.

In addition to the clinical trials, Lukito remarked that the vaccine to be tested must also be produced in accordance with the standards for Good Manufacturing Practices (GMP). Specifically, for vaccines, the BPOM extensively conducts release certifications to maintain product safety and quality.

"Given the urgent need for the COVID-19 vaccine, the BPOM remains committed to monitoring compliance with regulations, standards, and requirements throughout the vaccine journey cycle, starting from the phase-appropriate formulation development to drug distribution, including the stage III clinical trial stage," she expounded.

On Thursday (August 6), Lukito stated that the BPOM, along with several stakeholders, had held a kick-off meeting and simulation of the COVID-19 vaccine’s clinical trials at the Faculty of Medicine Bandung's Padjadjaran University. This was aimed at commencing a clinical trial of the SARS-CoV-2 virus vaccine attenuated by Sinovac, China.

The BPOM head sought the public’s continued support to the government's efforts to expedite the handling of COVID-19, including through becoming a phase III clinical trial volunteer.

Lukito also appealed to the research team and parties involved in the vaccine’s clinical trials to comply with all applicable regulations for their smooth implementation.

"Availability of the COVID-19 vaccine offers a ray of hope to all Indonesian people. Hence, the aspect of caution and accuracy in the implementation of this clinical trial procedure must be a common concern. Thus, the vaccine produced can actually provide efficacy along with guaranteed safety and quality in addition to being available within the expected timeframe," she remarked.

Lukito believes the public can also play an active role by being prudent and wise in responding to information circulated on the development of the COVID-19 drug. Residents should not easily believe news or information from unaccounted sources.
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