Cavite COVID-19 vaccine trials comply with requirements, anticipate government approval

The planned participation of 10,000 Cavite residents in the Phase III clinical trials of two new potential COVID-19 vaccines is currently awaiting approval of the government as the pharmaceutical manufacturers of the vaccine candidates recently complied with the necessary regulatory processes.

A small vial is inserted with a medical syringe in front of displayed “COVID19” words in this illustration taken March 13, 2020. Source: cottonbro/Pexels

According to the Department of Health (DOH), the international companies from United States of America (USA) and United Kingdom (UK) have just completed the submission of requirements needed to execute the independent clinical trials in the province of Cavite, which are subject to evaluation by the ethics review board and the Food and Drug Administration (FDA).

Eduardo Janairo, DOH Director for Region IV-A Calabarzon, noted that the approval of the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-EID) will also be sought in addition to the regular process for testing vaccines in the country.

Cavite Governor Juan Victor “Jonvic” Remulla earlier announced in August that the province of Cavite will be participating in clinical trials of COVID-19 vaccines developed abroad, which will be spearheaded by a local research team from the De La Salle Medical and Health Sciences Institute (DLSMHSI) based in Dasmariñas City, Cavite.

“We estimated maybe up to 10,000 people will be involved in the trial… Well, in the protocol situation, we have identified the high-risk (population groups): the PNP (Philippine National Police), drivers of PUJs and PUVs (public utility jeeps and vehicles), factory workers and senior citizens who will participate in the trials,” said Remulla .

The governor further explained that the participants shall be gathered through a purely voluntary basis and will not receive cash incentives. Despite this, he assured that the vaccines from the American and British pharmaceutical companies are clinically safe.

“(The vaccines) look very promising. At best, they showed a 50 percent reduction in the transmission rate (of the virus) but that’s only for the first 1,000 (participants) so they have to go on the large-scale 100,000 (sample size) to see the efficacy (of the vaccine),” he said.

Soon after the announcement of the Cavite governor’s plans, DOH immediately alerted the proponent team from DLSMHSI and the local government of Cavite about the importance of a regulatory process before undertaking clinical trials for vaccines and allowing its entry to the Philippines.

“I read the article [and someone gave us the report], so we immediately contacted the proponent — [the researcher who will lead the Cavite trial] — and we have discussed with him [the necessary processes] and they should notify DOH,” said DOH Undersecretary Maria Rosario Vergeire in an online media forum.

The health official further remarked that no clinical trial should start without the approval of FDA and an ethics review board; otherwise, specific laws will be violated, citizens could be put to harm, and the team may be asked to stop and will be sanctioned.

“We have to remember [these] clinical trials [we are conducting]... This involves individuals so [it needs to be regulated by the government to ensure that it will be safe for our fellow citizens],” she added.

To date, no vaccines around the world have been approved yet to combat COVID-19. Other vaccine frontrunners are still also undergoing large-scale testing under Phase III clinical trials.