FDA Presentation

Hi, I’m James Rios. I have no financial relationships to disclose.

I’m pursuing my Masters in Economics at Florida International University, and am currently in the midst of an internship with the Vaccine Considerations Project.

While the Vaccine Considerations Project has encouraged and supported me in applying for, and preparing for, this presentation opportunity, all of the assessments and recommendations I’ll be sharing are my own, and may be different from the neutral stance of the Vaccine Considerations Project.

All the peer reviewed research papers and other reference materials that I used to create this presentation are available live on VaccineConsiderations.com right now. If you have the ability, I encourage you to follow along on VaccineConsiderations.com right now.

FDA Presentation

My intention is to open a discussion that will address the need to increase trust in new “vaccines”.

States across the country are encountering hesitancy and resistance to getting vaccinated among their populace. The overall success of new vaccines will rely on more than the public fully accepting these vaccines into their everyday lives. It is critical that the FDA and these new vaccine producers create communication guidelines in order to identify, clarify and explain potential risks. Here are a few of the suggestions from the 2019 CDRH communications guide 1. Further, expand the reach of communications 2. clarify the FDA’s role. 3. Constant outreach and accurate information to promote understanding, trust and adaptation. I encourage a full mechanism to be developed moving forward.

Focusing on increasing trust and credibility through mechanisms and systems that produce consistent and scientifically accurate information regarding the vaccine, will reduce uncertainty regarding the vaccine. This will hold long term implications as people learn to trust the information they consume through these systems.

FDA Presentation

Even before the pandemic, it was common for patients to seek information about health conditions and treatment options from health-related sites and sources of information on the internet.

As the pandemic began to spread, individuals once again turned to the internet for information. According to many experts, including Dr.Akpan the effect of the “Lagging responses by governments and public health agencies to prioritize the dissemination of information about the coronavirus outbreak” drove many back to the sources they were familiar with.

The vacuum in the supply of information regarding covid-19 was then filled by popular media producers on social network platforms, news platforms, websites and blogs; with unsubstantiated, incorrect data, or misinformation.

To understand consumer perspectives recent studies have employed an Infodemiology approach, or method which is designed to measure and track health information demand and supply by analyzing search queries or social network communications.

Other studies have focused directly on patient education and intervention or internet technology application.

https://infodemiology.jmir.org/2021/1/e28800

https://www.jmir.org/2021/9/e28975

https://www.jmir.org/2021/9/e30854

https://www.jmir.org/2021/9/e21974

https://publichealth.jmir.org/2021/2/e17149

https://www.jmir.org/2021/5/e22933

The overarching conclusion in these studies is the individual is becoming a savvy patient consumer. A savvy consumer is a consumer who is media literate and knowledgeable about marketing and targeting, as well as cynical about advertising, and can see through the traditional sales pitch.

FDA Presentation

In trying times, some have come to expect extreme solutions as the only methods for progress. However, I do not believe we are at such a point. This Committee, and others like it, are charged with putting the patient consumer first above all else. I implore you to continue to do so, by making it a priority to build trust and credibility parallel to addressing efficacy and safety concerns.

Increasing levels of trust and credibility should become an iterative process at every level, through business development, regulatory approval, and finally communications with the patient consumers.

This is why I encourage the Committee to continue these events and increase its focus on the mechanisms and systems most efficient at taking on the tremendous task of organizing consistent and scientifically accurate information regarding the vaccine.

Taking these steps now could prevent future hesitancy with new medical technology as patient consumers begin to trust these reputable sources.

FDA Presentation

As a reminder, all the peer reviewed research papers and other reference materials that I used to create this presentation are available live on VaccineConsiderations.com right now. I encourage you to dig deeper.

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