[Co-author: Camryn Towle]
- Recent advances in the race for a COVID-19 vaccine, as well as the transition from the Trump Administration to a Biden Administration, have generated new questions about how a vaccine would be authorized, approved, and equitably and safely delivered to hundreds of millions of Americans.
- This Holland & Knight alert provides an overview of various activities within and outside of the federal government to address these issues, as well as who will or may be in charge of these efforts in the near-term.
Since March 2020, and in some cases before, the U.S. government, Congress and external entities have worked to design plans to reduce the impact of COVID-19 and ultimately prepare for the development and distribution of a vaccine to the American public. Recently, new advances in the vaccine development race, as well as the transition from the Trump Administration to a Biden Administration, have generated new questions about how a vaccine would be authorized, approved, and equitably and safely delivered to hundreds of millions of Americans. This Holland & Knight alert provides an overview of various activities within and outside of the federal government to address these issues, as well as who will or may be in charge of these efforts in the near-term.
At the beginning of the COVID-19 pandemic, more than 50 companies rushed to position themselves as potential candidates for the development of a safe and effective COVID-19 vaccine. The federal process to work with these companies became what is known as Operation Warp Speed (OWS), which is a partnership among federal agencies, including the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), and the U.S. Department of Defense (DoD). The White House tapped General Gustave Perna, a four-star general and former commanding general of U.S. Army Materiel Command, to serve as OWS Chief Operating Officer on July 2, 2020, and Moncef Slaoui, Ph.D., formerly of GlaxoSmithKline, as Chief Adviser.
Although many vaccine candidates have been considered, there are a handful of companies in various late stages of development that were monetarily and publicly supported by OWS. Many observers anticipate that at least two vaccine candidates will be authorized under the U.S. Food and Drug Administration's (FDA) Emergency Use Authorization (EUA) process, and that it may happen shortly. For more information, refer to this updated vaccine tracker or similar public information sources that are providing daily updates on the status of the vaccine candidates as they approach some form of FDA approval.
Biden Administration COVID-19 Advisory Board
In anticipation of its extensive and focused work to combat COVID-19, the transition team for President-Elect Joe Biden has assembled a COVID-19 Advisory Board, which includes scientific experts, former government officials and others who will help guide the nascent Administration in its efforts to combat the virus. Members of the COVID-19 Advisory Board include:
- Vivek Murthy, M.D., Co-Chair, 19th U.S. Surgeon General, Obama Administration
- David Kessler, M.D., Co-Chair, 17th Commissioner of Food and Drugs, FDA
- Marcella Nunez-Smith, M.D., Co-Chair, Associate Dean for Health Equity Research, Yale University
- Luciana Borio, M.D., Vice President, In-Q-Tel, former Director for Medical and Biodefense Preparedness, National Security Council
- Rick Bright, Ph.D., former Director, Biomedical Advanced Research and Development Authority (BARDA)
- Ezekiel Emanuel, M.D., Ph.D., former Chief of Bioethics Department, NIH Clinical Center; Obama Administration health adviser
- Atul Gawande, M.D., Surgeon, Brigham and Women's Hospital, and Professor of Surgery, Harvard Medical School
- Celine Gounder, M.D., Assistant Professor, NYU Grossman School of Medicine
- Julie Morita, M.D., Executive Vice President, Robert Wood Johnson Foundation
- Michael Osterholm, Ph.D., Director, Center for Infectious Disease Research and Policy, University of Minnesota
- Loyce Pace, MPH, Executive Director and President, Global Health Council
- Robert Rodriguez, M.D., Professor of Emergency Medicine, University of California San Francisco
- Eric Goosby, M.D., former U.S. Global AIDS Coordinator
The Advisory Board's expertise will be called upon to make determinations about the appropriate actions to protect the public health, including ensuring an adequate supply of personal protective equipment, distributing vaccines, securing resources for health and other facilities for hardening against COVID-19, and other related issues.
Operation Warp Speed Leadership and Relevant Federal Agencies/Contacts
As mentioned previously, several agencies have been tapped to assist with the distribution of a COVID-19 vaccine as well as developing additional materials and guidance for the benefit of the public health. Listed below are a few of the most relevant agencies and their committees involved in these efforts. In many cases, the transition to a Biden Administration will likely not affect the involvement of these groups but rather how these groups coordinate with one another in the COVID-19 response. In certain cases, politically appointed leaders may change based on recommendations of the aforementioned COVID-19 Advisory Board.
Operation Warp Speed
In addition to the aforementioned Gen. Perna and Dr. Slaoui leading operational and scientific capabilities, OWS has several tactical and scientific advisers developing strategy around the distribution of the vaccine:
- Janet Woodcock, M.D., Ph.D.; Director, FDA Center for Drug Evaluation and Research (CDER)
- Sean Biggerstaff, Ph.D.; Acting Director, Research and Development, Defense Health Agency
- Maj. Gen. Lee Payne, M.D., MBA; Assistant Director for Combat Support, Defense Health Agency
- Bruce Jason Tromberg, Ph.D.; Director, National Institute of Biomedical Imaging and Bioengineering (NIBIB), NIH
- Col. Matthew Hepburn, M.D.; Program Manager, Biological Technologies Office, Defense Advanced Research Projects Agency (DARPA)
- Stacy Cummings, OWS Production and Distribution Advisor; Principal Deputy Assistant Secretary of Defense for Acquisition Enablers, DoD
- Andrew Kilianski, Ph.D., OWS Security and Assistance Advisor; Chief Intelligence Officer, Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (CBRND), DoD
CDC Advisory Committee on Immunization Practices (ACIP)
The CDC's ACIP was chartered under Section 222 of the Public Health Service Act and includes medical and public health experts who provide recommendations on the distribution and use of vaccines within the United States. ACIP traditionally sets the immunization schedules for children and adults on a variety of vaccines, including the seasonal flu vaccine. The ACIP has established a working group on the COVID-19 issue to provide recommendations on the equitable distribution of vaccines and other relevant issues. Beth Bell, M.D., MPH, Director of the National Center for Emerging and Zoonotic Infectious Diseases, is serving in a leadership capacity for the COVID-19 ACIP working group. The next public ACIP meeting is scheduled to take place on Nov. 23, 2020, and will partially cover the COVID-19 response.
As has been utilized extensively during the COVID-19 response, the FDA's EUA process allows bringing unapproved technologies to the public in the instance of a public emergency as declared under Section 564 of the Federal Food, Drug, and Cosmetic Act. (Note that this is a separate determination from a public health emergency declaration under Section 319 of the Public Health Service Act.) In addition to diagnostics, testing and other technologies, the EUA process will be utilized by vaccine manufacturers to bridge the gap between data collection during the clinical trials phase and the approval of a vaccine for marketing under a Biologics License Application (BLA). The EUA would allow for vaccine developers to market their otherwise unapproved products if, based on the totality of scientific evidence available, the FDA finds it is reasonable to believe that the vaccines may be effective in preventing COVID-19 and the known and potential benefits of the vaccines outweigh their known and potential risks. Thus, it is not the same as a product approval. In addition to being considered under the EUA, vaccine candidates will also be considered by the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). Although the review of the vaccines by the VRBPAC is influential, their decisions and votes are not binding on the approval of a vaccine candidate. Vaccines approved under an EUA may be distributed as soon as 24 hours after approval.
Vaccine Distribution and Issues
As the U.S. approaches a functioning vaccine for COVID-19, many are increasingly concerned about the mechanism and timing of vaccine distribution as well as how the government and private entities will prioritize which groups will receive the vaccine. Certain groups, including the National Academies of Sciences, Engineering, and Medicine (NASEM), have examined how an equitable framework may be developed for this distribution that would prioritize high-risk groups while ensuring that vaccine supplies are able to keep up with demand. NASEM's early October 2020 report led to the development of a basic framework for distribution based on priority:
- Phase 1a (about 5 percent of U.S. population): High-risk health workers; first responders
- Phase 1b (about 10 percent of U.S. population): People of all ages with comorbid and underlying health conditions that put them at significantly higher risk; older adults living in congregate settings
- Phase 2 (about 30-35 percent of U.S. population): K-12 teachers, school staff, child care workers; critical workers in high-risk settings or those in critical industries with high-risk exposure; people of all ages with comorbid or underlying health conditions that put them at moderate risk; people in homeless shelters or group homes; those with disabilities and staff in such settings; people in prisons, jails and detention centers and related staff; older adults not included in phase 1
- Phase 3 (about 40-45 percent of U.S. population): Young adults; children; workers in essential industries with increased risk of exposure not included in phases 1 or 2
- Phase 4 (about 5 to 10 percent of U.S. population): Those residing in the United States who did not have access to the vaccine in prior phases
This phase-based plan would be combined with policies that include no cost-sharing for any vaccinated individual as well as the formation of aggressive vaccine risk communication and community engagement programs, and the establishment of a promotional campaign to educate the populace about the virus and the need to be vaccinated. It would also include a robust surveillance program to track vaccinations and any adverse events.
NASEM's plan is currently being utilized by the U.S. Department of Health and Human Services (HHS), CDC and DoD to inform a comprehensive centralized distribution effort for the vaccine. The current distribution plan outlined by HHS, which was developed in September 2020, envisions a centralized distribution mechanism utilizing CDC's 64 jurisdictions (50 states, six localities, and remaining territories and freely associated states) as well as tribes, industry partners and others. Each jurisdiction will operate off its own "micro-plan" developed from initial pilot demonstrations earlier in the year in California, Florida, Minnesota, North Dakota and Philadelphia. These plans will determine the amount of vaccine delivered, timing on the delivery and the method of distribution to individuals within relevant jurisdictions.
This distribution plan was also supplemented by a COVID-19 Vaccination Program Interim Playbook, updated on Oct. 29, 2020, meant to assist state, territorial and local public health programs in operationalizing a vaccination response to COVID-19 within their jurisdictions. The playbook provides additional detail on everything from targeting and phasing relevant healthcare entities for vaccine distribution to the infrastructure, care and handling needed to safely transport, store and administer a potential vaccine, including vaccines that require supercooling.
Key to this distribution plan is the use of a centralized distributor, McKesson Corporation, which distributed vaccines during the H1N1 pandemic in 2009 and obtained a contract with the federal government in 2016 through a competitive bidding process to supplement the CDC's Vaccines for Children Program (VFC). OWS opted to reaffirm the contract in mid-August 2020 given the VFC contract's option to distribute vaccines in the event of a pandemic. Another crucial factor in the vaccine delivery process requires secure health IT systems that can help scale up HHS' Vaccine Tracking System by assisting with incorporating new vaccine providers in each jurisdiction. This work is crucial, as HHS and DoD have recently issued partnerships with an extensive network of pharmacy chains that cover nearly 60 percent of pharmacies throughout the CDC's jurisdictions. This network builds off of previous, targeted agreements with large pharmacy chains for facility-targeted administration of the vaccine when available.
Important issues related to these vaccines include transportation of vaccines required to be kept at cold storage (or, in the case of the Pfizer vaccine, ultra-cold storage) as well as the availability of materials associated with the vaccine (i.e. vials, plungers, needles, etc.). HHS has already announced several contracts related to vaccine manufacturing products, such as liquid and dry powder cell culture media, mixer bags and bioreactors, as well as glass vials and glass-coated plastic containers needed to house certain vaccines. The discussion of developing a cold storage supply chain has become more active, with entities looking at options from ultra-cold thermos technology currently used for storage of Ebola vaccines to more basic coolers that require an independent supply of dry ice. In addition, analysts have expressed skepticism that the U.S. has sufficient freezers to store vaccines throughout the country. Although the McKesson contract covers cold storage and transfer requirements, it is unclear if additional vendors or entities will be required to bolster this supply chain should the relevant vaccine require such refrigeration. OWS indicated on Nov. 19 that it had determined a cold storage transport system for an initial batch of 40 million doses to be sent in mid-to-late December 2020.
Certain federal entities have already attempted to provide recommendations on which individuals would be considered as part of essential industries. Similar to its role at the beginning of the COVID-19 pandemic related to essential businesses, the Cybersecurity and Infrastructure Security Agency (CISA) issued a memorandum on Aug. 18, 2020, titled "Guidance on the Essential Critical Infrastructure Workforce: Ensuring Community and National Resilience in COVID-19 Response Version 4.0." The purpose of the memorandum is to help state, local, tribal and territorial officials in identifying essential/critical infrastructure workers and may serve as a potential guide to the Biden Administration on essential industries related to vaccine distribution.
State Distribution Plans
Given its role in providing recommendations on a jurisdictional basis, the CDC also set a deadline of Oct. 16, 2020, for states to submit their own vaccine distribution plans. These plans include recommendations from state public health agencies regarding affected industries in those states and provides vaccine prioritization phases tailored to each state. Links to state distributions plans may be found below:
Also of note, several states have announced the formation of their own review panels to determine the safety and efficacy of COVID-19 vaccines. For example, California, Oregon and Nevada have chosen a committee of experts to make this review prior to distribution in those states.
Vaccines and Liability
Given that a potential vaccine sourced from one or more entities will be potentially administered to hundreds of millions of individuals, questions of liability for vaccine-related injuries have been raised. Individuals may be covered under the Public Readiness and Emergency Preparedness(PREP) Act for vaccines approved by FDA under a BLA or authorized under an EUA. (For more details, see previous Holland & Knight alert, "COVID-19 Vaccinations Are Coming, But What Will the PREP Act Immunize?", Nov. 17, 2020.)
Should you have any questions concerning information in this Holland & Knight alert, please contact authors Ethan Jorgensen-Earp, Michael Werner or Camryn Towle.
DISCLAIMER: Please note that the situation surrounding COVID-19 is evolving and that the subject matter discussed in these publications may change on a daily basis. Please contact your responsible Holland & Knight lawyer or the author of this alert for timely advice.
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