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Alpha-1 Foundation Frequently Asked Questions regarding the COVID-19 Vaccine and Distribution

December 16, 2020
I. What is the federal approval process for a COVID-19 vaccine?

The federal approval process for a COVID-19 vaccine is the same as the federal approval process for any vaccine product. The Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is responsible for approving and regulating vaccines. The FDA is a part of the U.S. Department of Health and Human Services (HHS), which is a federal agency led by Presidential appointees. All COVID-19 vaccines developed in the United States will go through the same steps of development, testing, and safety checks as any other vaccine. These steps include three phases of clinical trials of increasing size, and safety and efficacy standards. When Phase 3 of a clinical trial is complete, the vaccine developer can then apply to the FDA for approval and use. In certain types of emergencies, the FDA can issue an Emergency Use Authorization (EUA) to provide more timely access to critical medical products, such as vaccines, medications, and supplies, that may help during the emergency. The EUA was granted to Pfizer and Moderna this week.  The Centers for Disease Control and Prevention (CDC) does not have a role in developing COVID-19 vaccines but will support local and state health departments and partners in planning dissemination efforts and monitoring for vaccine safety and effectiveness.

Resources: FDA:  https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-frequently-asked-questions

FDA EAU: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

CDC: How is CDC Making COVID-19 Vaccine Recommendations: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html

II. What is Operation Warp Speed and how does it impact the federal approval process for a COVID-19 vaccine?

Operation Warp Speed (OWS) is a partnership among the Department of Health and Human Services (HHS) and the U.S. Department of Defense (DoD) to help develop, make, and distribute 300 million doses of COVID-19 vaccines in the United States by mid-2021. The role of OWS is to invest in and coordinate vaccine development between the public and private partners in order to accelerate the development and distribution of a safe and effective vaccine.

Resources:

HHS Fact Sheet: Explaining Operation Warp Speed https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html

Developing Safe and Effective COVID Vaccines – Operation Warp Speed’s Strategy and Approach https://www.nejm.org/doi/full/10.1056/NEJMp2027405

III. What current vaccine developments are under way?
Over 100 vaccine candidates are currently in development. OWS has invested in 14 of the candidates deemed most likely to succeed. Currently, four COVID-19 vaccine candidates are in Phase 3 clinical trials in the United States*:

  1. Pfizer/BioNTech: BNT162b2 (2 dose) – Pfizer/BioNTech submitted a request to the FDA for an Emergency Use Authorization which was approved.
  2. AstraZeneca/Oxford University: AZD 12222 (2 dose)
  3. Moderna/NIH: mRNA-1273 (2 dose) submitted a request to the FDA for an Emergency Use Authorization which was approved.
  4. Janssen Pharmaceutical Companies of Johnson & Johnson: AD.26.COV2.S (1 dose)

Several other companies also currently have vaccine candidates in clinical trials. The Novavax vaccine candidate (NVX-CoV2373, 2 doses) is expected to enter Phase 3 of clinical trials soon.

IV. COVID-19 vaccine has been approved for emergency use, has manufacturing started?
Yes, through OWS, the federal government has announced the start of several manufacturing partnerships. The goal is to have millions of vaccine doses available for distribution. Currently, the federal government is financially supporting the large-scale manufacturing of vaccine candidates from Pfizer/BioNTech, Novavax, Sanofi and GlaxoSmithKline, Jannsen Pharmaceutical, Moderna, and AstraZeneca. The government’s manufacturing contracts secure over 300 million doses of potential COVID-19 vaccines. It is important to note, however, that most of the vaccine candidates require two doses for effectiveness. Additionally, at least two of the vaccines must be stored at an unusually cold temperature, which will require storage and transport procedures that may delay the timeline for getting a vaccine from manufacturer to patients.
V. Has the Alpha-1 Foundation provided any guidance for COVID-19 vaccine distribution to federal and/or state governments?

Yes, Alpha-1 submitted formal comments to an advisory committee convened the National Academies of Science (NAS) recommending that the definition of Chronic Obstructive Pulmonary Disease be expanded to include Alpha-1 which is genetic COPD. The Foundation comments to the National Academies of Sciences, Engineering, and Medicine’s Committee on Equitable Allocation of Vaccine for the Novel Coronavirus. The CDC Advisory Committee on Immunization Practices (ACIP) who have the final word on distribution recommendations met and determined that it would not follow the NAS Allocation recommended.  Instead the CDC ACIP recommended that health care workers be first; and placed nursing home and long term care facility residents before those with underlying conditions. The CDC ACIP made this determination based on the number of deaths.  Ultimately the states are now going to be responsible for distribution.

Resources:

National Academies of Science Framework https://www.nationalacademies.org/our-work/a-framework-for-equitable-allocation-of-vaccine-for-the-novel-coronavirus

VI. What guidance has my state provided for COVID-19 vaccine distribution?
All states and territories had to submit draft plans to the CDC for how they would distribute the vaccine by October 16, 2020. CDC will review the plans and provide technical assistance. The CDC also published the COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations describing what the plans should cover. The key parts of the plans include: public health preparedness planning, phased approaches to vaccination, identification of critical populations, provider recruitment and enrollment, capacity to administer, program monitoring, and vaccine storage and handling.
VII. Where do I find my state’s plan?

The Council of State Governments has created a webpage with each state and territory’s current draft vaccination plan. Additionally, the CDC has the Executive Summaries of every state and territory’s plan on their website. Some large municipalities are developing their own plans. For those, you should search for the city directly. In most cases, the state Department of Health is the primary author of the plan. There may also be a special COVID Task Force that is working on the plan. Each plan says who developed and submitted it. Thus far only the first drafts of the plans have been sent to CDC. The plans are likely to continue to be developed and changed even as distribution occurs. Your COVID vaccination state plan may give you the outline of how public health is organized in your state and a place to start.

Resources:

The Council of State Governments state and territory’s current draft vaccination plan https://web.csg.org/covid19/state-vaccine-plans/

CDC Guidance for States https://www.cdc.gov/vaccines/covid-19/covid19-vaccination-guidance.html

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