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What you need to know if you’re volunteering for vaccine clinical trials in PH

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Kristine Sabillo, ABS-CBN News

<p>MANILA — While the Philippines is gearing up for the COVID-19 vaccine roll-out, the government is also preparing for separate clinical trials with the World Health Organization and pharmaceutical companies.</p><p>Clinical trials are different from the anticipated vaccine rollout since the former involves vaccines that have yet to be approved for emergency use. </p><p>During a virtual townhall with health workers on Monday, Department of Science and Technology - Philippine Council for Health Research and Development (PCHRD) Director Jaime Montoya explained that clinical trials are being done to see if a COVID-19 vaccine is safe and effective for Filipinos. </p><p>This will “ensure a shorter and easier route of registration with the Philippine Food and Drug Administration (FDA),” he explained.</p><p>So far, the FDA has approved clinical trial applications of Johnson &amp; Johnson’s Janssen, Clover Biopharmaceuticals and Sinovac from China.</p><ul class="op-related-articles">	<li><a href="https://news.abs-cbn.com/news/01/19/21/china-sinovac-may-start-covid-19-clinical-trial-in-ph-says-fda ">READ: China&#x27;s Sinovac may start COVID-19 vaccine clinical trials in PH anytime — FDA</a></li></ul><p>For WHO’s multi-country trial, which will involve the testing of several candidate vaccines, the Philippines already committed 15,000 volunteers. It is unclear how many volunteers are expected for the above mentioned independent trials. There are also no definite dates yet for the start of the various trials although the government is just awaiting the organizers’ go signal. </p><ul class="op-related-articles">	<li><a href="https://news.abs-cbn.com/news/01/08/21/wanted-anti-coronavirus-vaccine-volunteers-in-metro-manila ">READ: Wanted: Volunteers for COVID-19 vaccine trials in Metro Manila</a></li></ul><blockquote class="twitter-tweet"><p dir="ltr" lang="en">2 kinds of trials: The WHO Solidarity Trial is supported by the government. While the WHO pays for the vaccines, the PH gov&#x27;t will cover logistics within the country. There are also independent clinical trials paid for by pharma companies. <a href="https://twitter.com/ABSCBNNews?ref_src=twsrc%5Etfw">@ABSCBNNews</a> <a href="https://t.co/ZuTFCo00Cq">pic.twitter.com/ZuTFCo00Cq</a></p>— Kristine Sabillo 🇵🇭 (@kristinesabillo) <a href="https://twitter.com/kristinesabillo/status/1356212943319228416?ref_src=twsrc%5Etfw">February 1, 2021</a></blockquote><div><script async="" src="https://platform.twitter.com/widgets.js" charSet="utf-8" type="text/javascript"></script></div><p>For those who may be interested in volunteering, here’s what you need to know:</p><div><strong>SCREENING AND FOLLOW-UP</strong></div><p>Only those 18 years old and up, without any illness, can participate in a vaccine clinical trial. He or she will also be asked to sign an informed consent form before joining the trial.</p><p>The risks and benefits of the trial will be carefully explained to the participant. Among the possible risks is that the vaccine won’t work and that it might have side effects.</p><p>According to Montoya, volunteers from the pre-picked areas will be screened. </p><p>This includes a short physical exam and a review of medical history. Upon enrollment into the trial, the participant will also be given a schedule of his follow-up visits.</p><p>Montoya said the follow-up visits after the actual vaccination will involve assessment of the participant’s health and depending on the brand, a 2nd dose.</p><p>“During the conduct of the clinical trial, participants are also monitored to ensure their safety,” Montoya said.</p><p>The participant will be monitored for 6 to 18 months after vaccination.</p><div><strong>PLACEBO OR NO TREATMENT</strong></div><p>To test if a vaccine is effective, a portion of the volunteers in each trial will be given the candidate vaccine while the other group will be given a placebo or another vaccine. </p><p>Asked if it is still ethical to use a placebo, which is usually water with salt, when there are COVID-19 vaccines already approved for emergency use, Dr. Cristina Torres of the Forum for Ethical Research Committee in Asia and Western Pacific Region said the WHO might end up only assigning a fewer number of volunteers for placebo.</p><p>On the other hand, she said the vaccines are just approved for emergency use and have yet to receive a certificate for product registration. </p><p>“Lahat sila ay experimental pa lamang. Kasi nga may emergency use authorization,” she said. </p><p>Montoya also said the WHO continues to engage with their group of ethicists and they might change their protocol from using a placebo to another COVID-19 vaccine to serve as a benchmark or comparison.</p><div><strong>COMPENSATION</strong></div><p>For their time devoted to the study, volunteers may receive compensation, according to Torres.</p><p>“Hindi ko alam kung sa WHO clinical trial meron silang tatanggapin. Subalit kung ang isang sponsor ay pharmaceutical company, standard operating procedure po yan na ang kalahok ay may tatanggapin,” she explained.</p><p>(I do not know about the WHO clinical trial if volunteers will receive anything. But if the sponsor is a pharmaceutical company, it’s standard operating procedure that the volunteer should receive something.)</p><p>In the slide presented by Torres, she showed a sample computation of P500 for loss of time and P200 for transportation expenses after each visit.</p><p>Montoya previously told ABS-CBN News that the compensation is meant to cover for the volunteer’s possible loss of earnings for the day. It compensation should not be too high that it would be considered “undue inducement.”</p><p>“Undue inducement” in research is defined as an attractive offer that may lead people to do something that would normally have objections to. This raises ethical concerns. </p><p>If the volunteer will not receive anything, the research group will inform him or her that they will only give the vaccine in exchange for participation. </p><div><strong>TREATMENT AFTER VACCINATION</strong></div><p>“At kung sakaling mapinsala, even if it’s WHO, will cover treatment of all study-related injury,” Torres said.</p><p>(And if there is injury, even if it’s WHO, they will cover treatment of all study-related injury.)</p><p>But Montoya said the volunteers will be given emergency treatment even if they can’t determine yet if it’s because of the vaccine.</p><p>“Kailangan tignan kayo agad, gawin ang kailangan gawin pag kayo ay nagkaroon ng side effects,” he said.</p><p>(You should be immediately checked, treat what needs to be treated if you get side effects.)</p><p>He said it will be important to see if the vaccine caused the adverse effect in case there will be a financial claim against the manufacturer.</p><p>Torres said the study’s principal investigator and the ethics committee should be easily contacted by the volunteers for any additional question or concerns.</p><div><strong>IMMUNIZATION</strong></div><p>And what if the volunteer wants to get vaccinated against COVID-19 through the government’s immunization program?  The two doctors said the volunteers must wait until the study is over since they will have to check if the vaccine really did have an effect.</p><p>Even for those who received a placebo, it will be impossible to know that they did not get an actual vaccine.</p><p>Montoya said the details of the study, which ones received the placebo and which ones received the vaccine, won’t be known until the recruitment and the study is ongoing.</p><p>For now, there are still no details on how people can volunteer for the trials since the trial sites will need to be finalized and announced by the WHO and the other pharmaceutical companies. Montoya said they will ensure that the clinical trial sites won’t overlap with each other and withof the government’s vaccination program.</p><div><strong>RELATED VIDEO</strong></div><figure class="op-interactive"><iframe height="315" src="https://www.youtube.com/embed/mRnEXAS9hBE?enablejsapi=1" width="560"></iframe></figure><div class="iwantbar">Watch more in <a href="//www.iwantv.com.ph/">iWantv</a> or <a href="//tfc.tv/">TFC.tv</a></div>

<p>MANILA — While the Philippines is gearing up for the COVID-19 vaccine roll-out, the government is also preparing for separate clinical trials with the World Health Organization and pharmaceutical companies.<br /> </p>

MANILA — While the Philippines is gearing up for the COVID-19 vaccine roll-out, the government is also preparing for separate clinical trials with the World Health Organization and pharmaceutical companies.

What you need to know if you’re volunteering for vaccine clinical trials in PH

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What you need to know if you’re volunteering for vaccine clinical trials in PH

Kristine Sabillo,

ABS-CBN News

Published Feb 01, 2021 09:47 PM PHT

Read More:

COVID-19 vaccine

COVID-19 vaccine in the Philippines

vaccine clinical trial

World Health Organization

Sinovac

Janssen

Clover

Department of Health

Food and Drug Administration

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