Why are clinical trials for COVID-19 vaccines important?

Published July 13, 2021, 10:24 PM

by Merlina Hernando-Malipot

The Philippines, through the Department of Health (DOH) and the World Health Organization (WHO) have formally reached an agreement for the conduct of the WHO Solidarity Vaccines Trial (SVT) in the country.

(ALI VICOY / MANILA BULLETIN)

DOST Undersecretary Rowena Guevara, during the Laging Handa public briefing on Tuesday, July 13, confirmed this after DOH Secretary Francisco Duque III, as the representative of the Philippine government, and Dr. Soumya Swaminathan, the Chief Scientist of WHO, signed a letter of agreement.

The inclusion of the Philippines in the WHO’s SVT is very crucial since it will help in finding the “most effective COVID-19 vaccines” suitable for the needs of the Filipino people.

Aside from this, Guevara explained clinical trials are conducted to assess or investigate the “safety, efficacy and immunogenicity” of the vaccines.

“Ang positibong outcome mula sa mga pag-aaral nito ay hango sa datos at ebidensiya na kakailanganin sa registration at approval ng vaccines kapag iko-commercialize na ito at gagamitin na ng publiko (The positive outcome from this is that the studies are derived from the data and evidence which will be required for the registration and approval of vaccines when they are commercialized and used by the public),” Guevara explained.

As the situation continues to change due to COVID-19, Guevara said that there will be new challenges especially in the detection of new variants.

“Kakailanganin nito ang patuloy na assessment ng efficacy of COVID-19 vaccines sa bagong variant (This will require ongoing assessment of the efficacy of COVID-19 vaccines in the new variant),” Guevara said. “At kung kinakailangan ay ia-update ang bakuna o gagawa ng panibagong bakuna – lahat ng ito ay mangangailangan ng clinical trials (And if necessary, there might be a need to update the vaccine or make another vaccine – all of these will require clinical trials,” she added.

Ongoing clinical trials in PH

Guevara explained that currently, there are four clinical trials in the Philippines that have been approved by the Food and Drug Administration (FDA).

One has ongoing recruitment while the other one has just completed the recruitment stage and is currently monitoring the vaccinated participants. “Ang ibang dalawang clinical trials ay hindi pa po nagsisimula sa kanilang pag-aaral (The other two clinical trials have not yet begun their studies),” she explained.

Meanwhile, Guevara noted that there are seven vaccine clinical trial applications that are undergoing various stages of review by the Vaccine Expert Panel (VEP), the Single Joint Research Ethics Review Board (SJREB) at FDA.

Guevara explained that the schedule of these clinical trials will depend on their submission of the requirements and the approval coming from the FDA, SJREB and VEP.

 
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