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Jared Krupnick, the Founder of the Vaccine Considerations Project, as well as Katie MacQueen, one of our interns, provided one of only two presentations at the 10/15 FDA Advisory Committee meeting.

Here is their presentation:

FDA Presentation

Slide 1

I have no financial relationships to disclose.

Hi, I’m Jared Krupnick.

I’m the President of Uniting for Action, and the founder of the Vaccine Considerations Project.

We help people make informed decisions and take effective actions by providing science-based, expert COVID-19 vaccine information.

Thank you very much for this opportunity.

Because we were unable to put our slides together before the FDA submission deadline, all the articles and other reference materials 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.

I want to begin by introducing one of our student interns doing her practicum with us this fall – Katie MacQueen – and then I will be back to wrap up our presentation.

All of the assessments and recommendations that Katie and I will be sharing are our own personal viewpoints, and may be different from the neutral stance of the Vaccine Considerations Project.

 

 

I have no financial relationships to disclose.

Hi, I’m Katie MacQueen.

I’m a Masters of Public Health candidate at the Colorado School of Public Health.

Thank you very much for this opportunity.

FDA Presentation

Slide 2

A major concern is the WHO’s moratorium and their critique that the booster doses would be better served going towards lower income countries vaccinating their populations. This is especially vital as we have seen that unvaccinated populations have the potential to develop variants. A decrease in supply also further aggravates health inequities and disparities that these communities face.

Figure: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756168/figure/fig0007/

FDA Presentation

Slide 3

We must consider not only the US responsibility to the world-wide community but also to our own communities. We continue to have significant portions of our population unvaccinated and at risk. Many experts have pointed out that the way to end the pandemic is to address hesitancy. These expert opinions support the US focusing our resources on the vaccine hesitant population. The concerns discussed in the WHO moratorium are mirrored in low income versus high income areas in the United States, with vaccinations in rural areas lagging behind their urban counterparts. A large barrier to those in rural areas is in fact vaccine hesitancy. People in rural areas who already face health disparities require assistance and resources to address the hesitancy of their community members. To quote Director-General Dr. Ghebreyesus: “Economically, epidemiologically and morally, it is in all countries’ best interest to use the latest available data to make life saving vaccines available to all.” this includes all of the US as well (https://www.who.int/news/item/22-07-2021-vaccine-inequity-undermining-global-economic-recovery).

FDA Presentation

Slide 4

 The data that the CDC has collected on vaccinations reveal that the rate of people getting booster vaccinations has already overtaken the rate of people getting their first dose or getting fully vaccinated. This information is important for us to understand since the COVID-19 death toll took over a year to surpass 2.5 million globally. While with the new variant Delta, a 2.5 million death toll was recorded in under eight months. As mentioned previously, lower income people are more susceptible to the variant.

FDA Presentation

Slide 5

Thus, the focus should be on increasing vaccinations for people all around the world to protect the young and old as well as rich and poor.
(https://www.reuters.com/world/global-covid-19-deaths-hit-5-million-delta-variant-sweeps-world-2021-10-02/)

Thank you very much.

FDA Presentation

Slide 6

I’m quoting the New York Times from two days ago – “People who received a Johnson & Johnson coronavirus vaccine may be better off with a booster shot from Moderna or Pfizer-BioNTech, according to preliminary data from a federal clinical trial published on Wednesday.

That finding, along with a mixed review by the Food and Drug Administration of the case made by Johnson & Johnson for an authorization of its booster, could lead to a heated debate about how and when to offer additional shots to the 15 million Americans who have received the single-dose vaccine.”

Is this topic is worthy of thoughtful consideration and discussion?

FDA Presentation

Slide 7

The deadline to apply to present today was a week ago.

The notice of the deadline was a day before that.

Deadline for slides and written comments – three days ago.

Public release of most of the data being considered today – two to three days ago

Are any of you troubled by the fact that thousands of your colleagues across the country have been systematically and procedurally excluded from providing their meaningful input, not just for this meeting, but for meeting after meeting, for a year now, by unnecessarily tight scheduling that consistently has feedback deadlines nearly simultaneous to, or before data is released?

Trust is not an external problem out there that needs to be overcome. It’s a problem, internally, within the FDA, and frankly within this committee, as long as you’re all willing to along for the ride without speaking out on behalf of your peers that are being excluded from this process, not because of their lack of interest, but by a process designed to provide no opportunity for meaningful public input.

Quite frankly, if each one of you had the personal and professional integrity that Dr. Gruber and Dr. Krause have demonstrated, you would all refuse to participate in a process that looks more and more like a rubber stamp than a thoughtful, scientific consideration.

I encourage each one of you to consider your own reputation amongst your colleagues before you agree to participate in one more meeting that makes a mockery of the idea of peer review.

How long do you think your colleagues’ voices can be systematically excluded before they see you as part of the problem?

Please go to VaccineConsiderations.com to dig deeper.

Thank you for the opportunity to present.

One of the Vaccine Considerations Project’s interns, James Rios, a Masters in Economics candidate from FIU, was one of only seven presenters at the 10/14 FDA Advisory Committee meeting.

Here is his presentation:

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 (e.g., https://www.jmir.org/2021/9/e21974) 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.

Thank you to the Committee, and thank you all for your time.

Our Mission

Help people make informed decisions and take effective actions by providing science-based, expert COVID-19 vaccine information.

Why the Vaccine Considerations Project?

We’re largely made up of Public Health students committing our lives to ensuring the health and well being of the public through education, sound policies, and access to health resources.

We’re working with a range of stakeholders to develop end-to-end solutions to meet people where they’re at, provide them with what they need, and support them in creating the healthiest outcomes for themselves and their families.

We’re developing an extensive database of COVID-19 vaccine information, strategies, and best practices to help guide and support our clients in creating the positive impacts they seek in the communities they serve.

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Who We Are

Our Team is made up of a network of university students from around the country.  

We are streamlining the collection, organization, analysis, and production of information.

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Our clients are organizations tasked with sharing COVID vaccine information, and implementing interventions for the public.

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