Proponents of COVID-19 vaccine trials in Cavite told to undergo regulatory process

Gaea Katreena Cabico - Philstar.com
Proponents of COVID-19 vaccine trials in Cavite told to undergo regulatory process
This file handout picture taken on August 6, 2020 and provided by the Russian Direct Investment Fund shows the vaccine against COVID-19, developed by the Gamaleya Research Institute of Epidemiology and Microbiology.
AFP / Russian Direct Investment Fund, Handout

MANILA, Philippines — Proponents of any clinical trials for coronavirus vaccines or treatments in the country must secure regulatory approval first before their study could begin, the Department of Health said Wednesday.

Health Undersecretary Maria Rosario Vergeire issued the statement following the announcement of Cavite Gov. Jonvic Remulla that the province, through the De La Salle Medical and Health Sciences Institute, would participate in large-scale clinical trials for two coronavirus vaccines—one developed in the United States and the other in the United Kingdom.

Remulla said the vaccines would be tested on 10,000 people from Cavite. He said the trials would begin in the next two weeks.

Vergeire said the department had reached out to the proponent of the clinical evaluations to inform them that they have to secure the approval of the country’s Food and Drug Administration and an ethics board before starting Phase 3 of the clinical research.

She said the proponent of the study agreed and promised to update the DOH regularly.

“For now, they are still trying to negotiate and they’re finalizing their protocol,” Vergeire said.

“No one can start any clinical trials if they do not have approval from the FDA and ethics review. If you do that, you will be violating specific laws so you will be sanctioned and you will be asked to stop,” she added.

The health official stressed that going through proper regulatory process ensures the safety of the participants.

“Remember the clinical trials we are doing for vaccines and new medicines involves individuals so the government needs to regulate these to ensure that our citizens will be safe,” she said.

The government has been engaging with vaccine manufacturers from Russia and China for the conduct of clinical trials but not have been finalized yet. Officials are expecting that a vaccine against COVID-19 may be available in the country by the second quarter of 2021.

The country’s confirmed coronavirus cases reached over 226,440.

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