The White House recently discussed President Joe Biden’s COVID-19 strategy, including what they refer to as “a historic vaccination program” that has led to 220 million vaccinated Americans with another 100 million booster shots administered. With the vaccines widely distributed and available—and free—the White House has declared that consequently, COVID-19 deaths are down 90% since he took office. But is this a true statement? TrialSite probes into that matter plus reviews POTUS' operational plan to ensure high ongoing vaccination rates targeting COVID-19. The key to this approach is the vaccination of young children aged 5 and under. Next week, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) consider this vulnerable cohort for mass vaccination—calling for a greenlight for this “historic milestone in the nation’s fight against the virus.” What is this operational plan? What are the underlying assumptions? Does the President of the United States (POTUS) and his administration consider risk at all? Have they already made up their minds that mass COVID-19 vaccination must occur even though the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) haven’t even made formal decisions yet?
What follows is a TrialSite breakdown of the POTUS approach.
What is the core underlying assumption of the POTUS’ plan?
The core underlying assumption of the plan is that vaccination with the current batch of vaccine products is the most effective and safe way to ensure the entire American population is adequately protected against SARS-CoV-2.
What’s the underlying theme in terms of delivery and administration?
The White House acknowledges both the localized, state-wide, and national nature of this pandemic response declaring, “State and local governments, healthcare providers, federal pharmacy partners, national and community-based organizations, and other entities will be critical to the success of this historic, nationwide effort.”
The Biden administration brings very much a top-down approach packed with local buy-in, declaring that local resources such as physicians or community groups are “trusted messengers” that work with the administration in a “concerted effort to ensure that all families have answers to their questions and know about the importance of getting their children vaccinated.”
Is the Biden Administration eager to vaccinate young children?
Absolutely. The White House declared in this statement that even though the FDA and CDC haven’t completed their independent review processes—and that POTUS plans for “all scenarios,” the first such scenario will be that they can commence “first vaccinations…as early as the week of June 20th” with a scale of thereafter.
POTUS has been working hard in anticipation of this milestone, even though the safety hasn’t been verified for this vulnerable cohort. For example, the President’s team communicated that they have been working across states, regions, and communities including healthcare providers to offer 10 million ready-to-administer doses. They have ensured that 85% of children in the US reside within five miles of a potential vaccination site.
What are the elements of Biden’s plan?
First and foremost, POTUS wants a secure supply of vaccine products starting with 10 million available doses by late June. Biden’s administration is concerned about diverse access—e.g., across a broad range of pediatric providers, for example, in both urban and rural settings. Consequently, they have ordered package sizes of 100 doses bundled with appropriate supplies to serve younger kids, even including smaller needles.
Additionally, this means convenience, bringing the vaccine to healthcare clinics and centers situated in the most vulnerable of populations, from inner-city lower-income African American and Latino neighborhoods to Native American tribal lands to rural areas where other socioeconomically vulnerable populations reside.
How does POTUS reach into these disparate and diverse communities for mass vaccination?
Key to this top-down approach is collaborative stakeholder buy-in. For example, the Administration seeks buy-in and participation from healthcare organizations to community-based groups across states, localities, tribes, and territories.
Does the local pediatrician factor into this plan?
Absolutely. Pediatricians and primary care providers are key to the President’s scheme to make vaccinations available at thousands of pediatric and primary care sites across the country.”
Why such a focus on pediatricians?
For the obvious reason that they are the most trusted by families for important healthcare decisions. The administration reminds all that “three in four children under the age of five receive their flu vaccine in a doctor’s office.” Moreover, additional healthcare “screening” and “counseling” can be offered locally. But in poor areas, health centers are also a vital part of the POTUS’ strategy.
Why are children’s health systems important?
Many of America’s most vulnerable children are seen at Children’s Health Systems and hospitals. These institutions “play an essential role in our efforts to ensure access for our nation’s highest-risk kids, including those with obesity, diabetes, asthma, or immunosuppression.”
What about the poorest families?
For the poorest of American families and their children, POTUS depends on the participation of state and local public health clinics and sites. With “longstanding” ties to these centers, the POTUS admin is concerned about the nation’s most vulnerable children in very low-income households—they may not have regular access to a family doctor or pediatrician. The administration will work to ensure vaccination via local public health clinics, for example.
What about pharmacies?
The POTUS admin will also collaborate with local pharmacies, enabling them to offer the vaccine for young children at as many local pharmacies as possible.
Messaging as to the importance of mass vaccination against COVID-19?
The current White House administration believes strongly in getting the message out, shaping the narrative, and influencing the influencers in local communities. They do so via the “leveraging” of federal programs “to reach parents and families with information and advance equity.” The Administration will repurpose strategies that leverage existing programs including:
Women, Infants, and Children (WIC) program (over 6 million families served)
Head Start Program (1 million families served)
Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program (over 140,000 parents and young children across the country at risk for poor maternal and child health outcomes)
Department of Housing and Urban Development (HUD) programs (over 800,000 children aged 5 and under supported by these programs)
Medicaid and the Children’s Health Insurance Program (CHIP)—a massive federal program, which emphasizes state-by-state governance.
However, the administration notes:
“This effort builds on the work that CMS has already done to require state Medicaid programs to pay healthcare providers for providing counseling visits to parents and guardians about the importance of kids’ vaccination—giving families the support they need to engage with trusted community providers.”
What other societal channels are being called out?
A range of other avenues to educate and influence are called out by Biden’s administration, from tapping into the educational system to medical societies to various associations and ethnic and racial demographic-focused organizations for ongoing vaccine advocacy.
What other unique social networking and influencing does POTUS have planned?
Noteworthy, the administration will use a “What to Expect” platform with over 20 million moms to author a blog series that showcases doctors and various “trusted experts” to answer questions about pediatric COVID-19 vaccines, for example. They also will use this and other social media to “dispel myths about the COVID-19 vaccine and children.”
Has the POTUS administration already deemed the vaccine safe for young children even though the regulatory agencies charged with doing so have yet to determine a decision?
Yes. This certainly seems to be the case. Too much planning has gone into the mass vaccination of children to consider the alternative. Already, the administration is planning to dispel what it deems misinformation about vaccine safety.
Does POTUS mention that the decision by parents should be based on a risk-benefit analysis?
No. POTUS and his administration assume the vaccine is safe and that a massive unleashed federal apparatus must now execute a wide array of actions to disseminate information, win mindshare, and execute the vaccination campaign.
The FDA recently acknowledged there are safety issues with the mRNA-based vaccines, especially for younger people aged 12 to 29 who are the most vulnerable.
Are any safety issues mentioned in the recent White House administration strategy?
No.
Is this the typical way that a government should go about educating the population about drugs and vaccines?
Well, it depends on one’s point of view. From one vantage, this approach seems to represent an overreach of the federal government into individual Americans’ lives, but from the POTUS point of view, this is a dire emergency that needs immediate action and vaccination is the best way to reduce collective healthcare risks.
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