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A Vaccine’s Journey

At IEM MED, our team of medical, public health, and program management experts have an in-depth understanding of the different COVID-19 vaccines becoming available and the journey a vaccine goes through from development to distribution.  IEM MED’s “COVID-19 Vaccine Working Group” started analyzing and developing solutions for the nation two months ago.

The vaccine journey from development to manufacturing and distribution is usually a prolonged process that takes years to perfect, test, and distribute. The development of a potential Coronavirus vaccine under normal circumstances would take around ten years to perform the research, undergo multiple clinical trials, and receive government approval.  However, due to the deadliness and severity of COVID-19, a vaccine for the virus required an unprecedented quickening of the process to save lives.

The federal government’s Operation Warp Speed (OWS) is responsible for the acceleration of testing, development, and distribution of diagnostics, therapeutics, and vaccines, to combat COVID-19. OWS’s mission is to ensure that a vaccine will be produced as rapidly as possible while adhering to standards of safety and efficacy. While OWS accelerates the process, it does not eliminate steps. Rather the program allows steps to occur simultaneously, such as starting mass manufacturing of a vaccine before a vaccine is finished with clinical trials, permitting the vaccine to progress faster without compromising the safety of the product. Protocols established by the federal government, rather than public-private partnerships also help ensure the vaccine is produced safely and rapidly.

Figure 1. OWS Vaccine Process

(Source: www.defense.gov/Explore/Spotlight/Coronavirus/Operation-Warp-Speed/)

The mission of OWS was to deliver over 300 million doses of a safe and effective vaccine to 150 million Americans by January 2021 as noted in Figure 1 above. Although there have been some delays and challenges, OWS has been highly successful – leading to the creation of multiple potential COVID-19 vaccines and countermeasures at record speed, some of which could be distributed to the public as early as mid-December 2020. This astonishing given the fact that no vaccine or therapeutic has been developed during an exploding pandemic.

The five leading vaccines being evaluated in the United States are produced by Pfizer/BioNTech, Moderna, AstraZeneca/Oxford, Jassen, and Novavax. The timeline for the vacancies is shown in Figure 2 below.

  • Pfizer/BioNTech: Pfizer/BioNTech’s Phase 3 clinical trial for its mRNA vaccine included over 43,000 volunteers. The trial found the coronavirus vaccine was 95% effective in preventing infections and submitted its results to the U.S. Food & Drug Administration (FDA) for emergency use on November 20, 2020. Following the confirmation of the safety and efficacy of the vaccine, the FDA advisory panel voted on December 10, 2020 to endorse the vaccine, and granted it an Emergency Use Authorization (EUA) on December 11, 2020 for people 16 years and older. With a FDA EUA granted, the first vaccinations in the U.S. were administered on December 14, 2020. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA), the equivalent of the U.S. FDA gave the green light to the vaccine on December 2, 2020 and vaccinations began on December 8, 2020. This vaccine requires two doses and must be stored at a temperature of minus 70O However, it can be stored at 2O to 8 O centigrade for up to 5 days. Pfizer expects to have 50 million doses of the vaccine ready to distribute worldwide before the end of the year and up to 1.3 billion does by the end of 2021.[1]
  • Moderna: Moderna submitted its vaccine to FDA for EUA on November 30, 2020 to review data showing the vaccine is 94.1% effective at preventing Covid-19 and 100% effective at preventing severe cases of the disease. The FDA granted the vaccine an EUA on December 18, 2020 for people 18 years and older, prompting vaccinations to begin on December 21, 2020. This vaccine also requires two doses and must be stored at a temperature of minus 20O However, it can be stored at 2O to 8O centigrade for up to 30 days. Moderna intends to distribute 20 million doses of the vaccine in the United States before the end of this year.[2]
  • AstraZeneca/Oxford: AstraZeneca’s Phase 3 of its viral vector (non-replicating) Covid-19 vaccine trial with 23,000 volunteers found that the vaccine was 70% effective in its first half of the dose and up to 90% effective after the second dose. The vaccine is proven to be less expensive and involve fewer steps in distribution and administration compared to Moderna and Pfizer’s vaccines. However, there were some errors in data reporting that might result in a few months delays for an FDA EUA submission, with their submission expected to come in early to mid-March 2021.
  • Janssen: Janssen’s (Johnson & Johnson) viral vector (non-replicating) vaccine is in Phase 3 trails and has enrolled up to 30,000 volunteers. This is a single dose vaccine and must be stored at minus 20O However, it can be safely stored at 2O to 8O centigrade for 3 months. It is expected that Phase 3 trials will be completed by the end of January 2021 and the FDA EUA will be submitted around mid-February.
  • Novavax: Novavax’s protein subunit vaccine resumed Phase 3 trials. This is a two-dose vaccine and can be stored at 2O to 8O It is expected to complete Phase 3 trials in late February/early-March 2021 and the FDA EUA application by mid-March.
Figure 2. Timeline for Leading COVID-19 Vaccines

Steps in the Vaccine Journey include…

  1. Discovery and pre-clinical – In the first stage of a trial, researchers analyze the organism and decide the optimal method for developing a vaccine. This includes understanding the structure of the organism, how it enters the body, and how the immune system responds at a molecular level. Once an initial vaccine is developed it is then tested on animals in a laboratory.
  1. Clinical Trials – If a vaccine shows favorable results in the pre-clinical stage it can then enter clinical trials and be tested on humans. The COVID-19 studies are randomized, double-blinded, placebo-controlled clinical trials, meaning some participants receive the COVID-19 vaccine while others will get a placebo. There are three phases of clinical trials a vaccine must pass:
    1. Phase 1 Trials – The vaccine is tested on a small group of healthy adults (less than 100) who are monitored carefully for any adverse symptoms or immune response. This phase also seeks to determine the most effective dosage.
    2. Phase 2 Trials – The vaccine is tested on a larger group of people (several hundred) and the immune response is observed more closely.
    3. Phase 3 Trials – Thousands of individuals receive the vaccine or a placebo and the immune response is observed to determine vaccine safety, most common side effects, and efficacy.
  1. Developer applies for an Emergency Use Authorization – The FDA convenes an advisory committee of infectious disease experts, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), to review the trial data and submits an official recommendation to the FDA. If the FDA approves the vaccine or grants an emergency use authorization, the Centers for Disease Control and Prevention (CDC) will then convene a separate committee, the Advisory Committee on Immunization Practices (ACIP), to review the data and submit recommendations on when and how the vaccine should be administered to different populations.

For the COVID 19 Vaccine (as of 12/11/20):  Following the VRBPAC’s advisory committee meeting on December 10, 2020, FDA decided to endorse the vaccine and rapidly work to finalize Pfizer and BioNTech’s request for an EUA for their mRNA COVID-19 vaccine. Current data on the vaccines efficacy and safety suggests it will be the first vaccine approved against COVID-19. The vaccine developed by Moderna also completed an EUA for its mRNA COVID-19 vaccine. Moderna’s vaccine also demonstrated high efficacy and meets the safety requirements. The United Kingdom approved the

  1. Manufacturing and procurement – Developers must decide how many vaccine doses will be needed for widespread distribution, and plan for how many doses will be necessary in each phase of distribution. Manufacturing a nation-wide vaccine involves finding a proper facility and acquiring all the necessary resources such as proper storage containers, glass vials, and safety equipment.
  1. Distribution – Operation Warp Speed developed a comprehensive plan for a centralized phased distribution of the COVID-19 vaccines that will be carried out by the federal government, all 50 states, localities, U.S. territories, tribes, industry partners, and other entities. Successful implementation of the national COVID-19 vaccination program requires precise coordination among all of these many public and private partners. Cooperation on each of these fronts has already begun, as detailed in HHS’s strategy document.

When a vaccine first becomes available only a limited number of doses will be available. In December 2020, Pfizer and Moderna (if approved) plan to distribute 40 million doses of its multi-dose vaccine, meaning 20 million people will be vaccinated in their first round of distribution. Assuming both the Pfizer and Moderna vaccines are approved for emergency use, OWS leadership anticipates a roll out of approximately 60 million doses in January 2021, vaccinating 30 million people, and 100 million doses in February/March, vaccinating another 50 million individuals. These numbers could increase if either company is able to safely increase production at their manufacturing facilities. These numbers could increase if either company is able to safely increase production at their manufacturing facilities.

Nationwide Distribution and Prioritization

The COVID-19 vaccination program will require a phased approach due to limited supply. Throughout distribution, recipients will continue to be monitored for adverse symptoms and immune response. The CDC recommended that public health officials identify the critical and at-risk populations in their communities to best determine who should receive the vaccine first.

On Tuesday, December 1, 2020, the ACIP recommended health care personnel and residents of nursing homes and similar facilities be the first to receive the vaccine in “Phase 1a” of the nationwide distribution.

Vaccine advisers to the CDC voted 13-1 on December 1, 2020, to recommend that both healthcare workers and residents of long-term care facilities be first in line for any coronavirus vaccines that get emergency authorization from the FDA. The ACIP voted to include both groups in what they’re calling Phase 1a of the CDC’s coronavirus vaccine distribution plan. The CDC is expected to decide whether to accept the groups recommendation as the Agency’s formal guidance later in the week, and the ACIP is expected to discuss recommendations on the following phases later in December.

Currently, there are approximately 21 million healthcare workers in the United States spread across hospitals, long-term care facilities, outpatient facilities, home health, pharmacies and emergency medical services. With 40 million doses available in December (20 million people to be vaccinated) only healthcare workers can be vaccinated assuming all of them are included in the first round. The final prioritization guidance from the CDC will be more detailed; however, based on preliminary planning conversations, the initial vaccine distribution plan will likely prioritize as the ACIP recommends: 

  • healthcare workers in harm’s way (working with COVID-19 patients); and
  • senior citizens with co-morbidities, particularly in nursing homes and long-term care facilities (currently the highest rate of fatality in this group – making sure that the disease is controlled in this community will decrease hospitalizations and death significantly).

As more doses become available, other groups will be prioritized according to their risk of infection. That prioritization will probably look like:

  • people 65 years and older; immunocompromised people and; who have significant co-morbidities;
  • workers in essential and critical industries (e.g., healthcare workers not in direct harm’s way, law enforcement, firefighters, mission essential workers);
  • teachers and students (K-12) provided that the vaccine is recommended by the CDC for children as very limited clinical data is available in children 12 and below; and
  • the general population.

Some states may issue their own prioritizations that will supersede ACIP’s recommendations. It is expected that the vaccine will be equitably distributed on a per capita basis to states.

As another example, the National Academy of Medicine’s[3], offers the following recommendations for vaccine allocation:

  • Phase 1– Vaccine recipients will include high-risk health workers, first responders, people of all ages with underlying health issues that put them at high-risk, and older adults living in congregate or overcrowded settings.
  • Phase 2- Recipients will include child care workers, K-12 teachers and school staff, critical workers in high-risk settings, people of all ages with underlying condition that put them at moderate risk, people living in homeless shelters or group homes for individuals with disabilities, and all older adults not included in Phase 1.
  • Phase 3- Recipients will include young adults, children and individuals working in occupations important to the functioning of society not included in Phase 1 or 2.
  • Phase 4- Everyone residing in the United States who did not receive the vaccination in previous phases.

The OWS Vaccine Distribution IT Infrastructure

Throughout vaccine development, safety and efficacy remain essential and Operation Warp Speed is prioritizing these factors in every step of vaccine development and distribution.

OWS is developing an extensive information technology (IT) infrastructure for monitoring the vaccine throughout distribution. That infrastructure will be critical to monitoring safety and tracking any adverse events, identifying when an individual needs a second dose, and tracking movement of the vaccine. This monitoring will include an IT architecture composed of existing IT capabilities and new IT solutions to ensure a comprehensive system is in place. This vaccine monitoring IT infrastructure will include:

  • Significant enhancements to existing IT supporting data exchange;
  • Immunization Information Systems used by states, territories, and other entities that deliver public vaccinations;
  • Vaccination data and records from major pharmaceutical retailers, health care systems, hospitals, and private providers; and
  • Free access and training in web-based applications to support thorough vaccine administration and tracking data at administration points with undeveloped infrastructure, such as mobile clinics.

All of the clinical trial data will be reported to a collective IT infrastructure managed by OWS to support analysis and reporting. To protect individual’s privacy all of the data will be aggregated, anonymized, and de-identified. The primary purpose of this data collection and pharmacovigilance is to study and monitor the efficacy of the vaccine and any adverse side effects. The pharmacovigilance will also provide up-to-date information to patients, healthcare professionals, and the public about the safety of each vaccine.

The information contained in IEM’s A Vaccine’s Journey is current as of 3:00 p.m. ET on December 11, 2020.

[1] Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine, November 20, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-emergency-use-authorization.

[2] Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization. November 30, 2020. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-primary-efficacy-analysis-phase-3-cove-study.

[3] National Academies of Sciences, Engineering, and Medicine. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: The National Academies Press, 2020. https://doi.org/10.17226/25917.

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