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Tags Posts tagged with "COVID-19 Vaccine"

COVID-19 Vaccine

Photo by Daniel Schludi on Unsplash

The Pennsylvania Department of Health (DOH) has a website that is dedicated strictly to the COVID-19 vaccine. Members are encouraged to save this page due to the valuable and important information regarding the vaccine that is posted there on a regular basis. This information includes a number of frequently asked questions (FAQ’s), a link to the COVID-19 vaccine provider locations, and much more.

This morning, Barbara Merrill, Chief Executive Officer for the American Network of Community Options and Resources (ANCOR), issued the following statement regarding the prioritization of people with intellectual and developmental disabilities (IDD) in the distribution of forthcoming COVID-19 vaccines. Merrill’s statement comes just hours after a promising announcement from Moderna about its plans to seek approval from the US Food and Drug Administration (FDA) for its vaccine and one day before the anticipated publication of vaccine allocation recommendations from ACIP, the Advisory Committee on Immunization Practices of the US Centers for Disease Control and Prevention (CDC).

“Having spent much of 2020 waiting for good news about a COVID-19 vaccine, ANCOR is incredibly optimistic about several recent positive developments from vaccine developers such as Pfizer, Moderna, and others. These developments suggest that we could be within 10 days of the FDA approving at least one highly effective COVID-19 vaccine.

“With FDA approval on the horizon, states will soon begin implementing the vaccine distribution frameworks that they have spent the past several months developing. We believe that across the board, these frameworks rightly identify several high-priority groups who ought to be vaccinated as soon as possible given the risks that they face if they contract COVID-19. These groups include frontline health care workers, people living in long-term care facilities, and people over the age of 65. Missing from most states’ lists of priority groups, however, are people with IDD.

“For months, ANCOR has advocated that people with IDD be explicitly included in the top priority tier to receive the vaccine because mounting research shows particularly significant risks facing this group. Data recently collected from eight states in partnership with ANCOR’s state association members found that people with IDD were twice as likely as members of the general population to die from COVID-19 despite being no likelier to contract the virus. Meanwhile, an analysis of insurance claims data conducted by Fair Health found that people with ‘developmental disorders’ were among the likeliest to die from COVID-19 while another study in the United Kingdom found that people with Down syndrome were 10 times likelier to die from COVID-19 compared to members of the general population.

“Furthermore, ANCOR firmly believes that direct support professionals (DSPs)—those on the frontlines who are keeping people with IDD safe during the pandemic—must be prioritized in states’ vaccine distribution plans. DSPs are critical to supporting people with IDD in doing everything from activities of daily living to taking precautions to avoid exposure to the coronavirus. Because they often work in people’s homes and in situations where social distancing is not possible, prioritizing DSPs to receive the vaccine will be a critical step in keeping the people they support safe and healthy.

“Given the expedited timeline on which forthcoming COVID-19 vaccines will be approved by the FDA and allocated according to states’ distribution frameworks, it is absolutely imperative for states that have yet to identify people with IDD as a top-tier priority to do so prior to December 10—the date on which the FDA is expected to approve the first COVID-19 vaccine for distribution. It is also crucial that ACIP, through its formal vaccine allocation recommendations, clearly signals to states the need to prioritize people with IDD in the allocation of any FDA-approved COVID-19 vaccine.

“Federal and state governments should be applauded for the important work they’ve done in response to the record speed at which vaccine developers have created a highly effective antidote to this deadly virus. However, the reality is that the work is far from over. ANCOR stands as a ready and eager partner to these lawmakers as we all work to ensure the fastest possible recovery from a global pandemic that has wreaked havoc on the lives of far too many Americans.”

On September 30, the Oversight and Investigations Subcommittee (of the Energy & Commerce (E&C) Committee) held a virtual hearing (Pathway to a Vaccine: Ensuring a Safe and Effective Vaccine People Will Trust) with public health experts on the continued oversight of the development and safety of potential COVID-19 vaccines. Key witnesses from the hearing included:

  • Helene Gayle, M.D., M.P.H., Co-Chair, Committee on Equitable Allocation of Vaccine for the Novel Coronavirus, National Academies of Sciences, Engineering, and Medicine
  • Ashish K. Jha, Dean, M.D., M.P.H., Dean, School of Public Health, Brown University
  • Ali S. Kahn, M.D., M.P.H., M.B.A., Dean, College of Public Health, University of Nebraska Medical Center
  • Mark McClellan, M.D., Ph.D., Founding Director, Duke-Margolis Center for Health Policy, Duke University
  • Paul A. Offit, M.D., Director, Vaccine Education Center, Children’s Hospital of Philadelphia

 

The E&C website contains the videos from the hearing. The key takeaways from the hearing include:

  • There are many safeguards in place for a COVID-19 vaccine approval process;
  • All the guardrails in place should make it difficult to politicize the COVID-19 vaccine approval process;
  • The emergency use authorization process is similar to full approval;
  • Unlike Russia and China, the United States is only going to approve or authorize COVID-19 vaccines with large phase 3 clinical trials that meet high safety and efficacy standards;
  • No corners are being cut; and
  • States are not able to replicate FDA’s gold standard of vaccine review.