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Unpacking the COVID-19 Vaccine

The Federal Drug Administration (FDA) has approved the Pfizer-BioNTech COVID-19 vaccine for emergency use authorization (EUA) and deployment has started. In light of this news, let’s take a look at the development of the leading vaccines that may also be approved for EUA soon.

Vaccine Types

Scientific advancement has led to the development of numerous types of vaccines that safely ignite immune responses in humans that protect against infectious diseases.

The development of the COVID-19 vaccines has focused on these methodologies:

  • Non-replicating viral vector – Provides a convenient means to deliver vaccine antigens to select target cells or tissues to induce necessary levels of protective immunity
  • RNA – Uses RNA to spike protein genetic sequence that will serve as instructions/code to cells to induce immune response

The four front-runners in COVID-19 development include Pfizer, Moderna, the University of Oxford, and Janssen. Both Pfizer and Moderna leverage RNA to drive immunity while Oxford and Janssen rely on non-replicating viral vector methodology.

The chart below summarizes some of the key differences between the four vaccines.

  Dosing Study Time-Frame for Collecting Data Safety Outcomes
Pfizer 2-IM doses (21 days apart) Day 7 - 2 years Local reactions, systemic events/lab markers, adverse drug events
Moderna 2-IM doses (29 days apart) Day 29 - day 759 Adverse drug events leading to withdrawal day 1 up to day 759; local and systemic reactions, unsolicited adverse events 28 days after each dose
Oxford 2-IM doses (4 weeks apart) Over 1 year Incidence of adverse events. Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest. Incidence of local and systemic solicited adverse events.
Janssen 1-IM dose Day 1 - 2.1 years Adverse drug events, solicited and medically attended, unsolicited

Emergency Use Authorization (EUA)

EUA by the FDA is a relatively new tool, launched in 2009. The FDA can only issue an EUA in conjunction with a declared emergency, and the FDA must acknowledge that the vaccine’s benefits outweigh the known potential risks before an EUA can be released.

In order to receive EUA, the following steps must occur:

  • EUA declaration by Health and Human Services Secretary that the virus can cause a serious life-threatening disease or condition (March 27, 2020 for SARS-CoV-2)
  • Totality of scientific evidence supports that the vaccine may be effective in preventing the serious life-threatening disease or condition
  • Known and potential benefits of the vaccine, for its proposed use under EUA, outweigh the known and potential risks
  • No adequate, approved, and available alternative vaccine for preventing the disease condition caused by the virus

Shipping and Storage Considerations

Pfizer

  • Has spent $2B building on its own global supply chain
  • US location in Kalamazoo, MI
  • Packaging into dry ice pods, loaded into boxes that can keep ultra-cold temperatures for up to 5 days
  • Once thawed is stable at refrigerated temperatures for up to 24-48 hours and 2 hours at room temperature

Moderna

  • Frozen temperature of -20OC for up to 6 months
  • Refrigerate 2-8OC up to 7 days after thawing
  • Once opened must administer within 12 hours
  • Ancillary supply kits direct to site from USG and/or McKesson

Oxford

  • Shipped to McKesson via states selected distribution sites; distribution coordination with state public health officials
  • Shipping refrigerated; no special requirements but may require ultra-cold for extended storage
  • Refrigerate 2-8OC
  • Ancillary supply kits direct to site from USG and/or McKesson

Janssen

  • Shipped to McKesson via states selected distribution sites; distribution coordination with state public health officials
  • Shipping refrigerated; no special requirements but may require ultra-cold for extended storage
  • Refrigerate 2-8OC for 3 months
  • Expected stability of 2 years frozen (-20OC)
  • Ancillary supply kits direct to site from USG and/or McKesson

Vaccine Priority Phases

Based on Advisory Committee on Immunization Practice consensus, the Centers for Disease Control recommends vaccinating healthcare personnel and long-term care facility residents to support the early Phase 1. Approximately 21 million U.S. health care personnel work in settings such as hospitals, long-term care facilities, outpatient clinics, home health care, public health clinical services, emergency medical services, and pharmacies. Health care personnel comprise clinical staff members, including nursing or medical assistants and support staff members (e.g., those who work in food, environmental, and administrative services). Approximately 3 million adults reside in long-term care facilities, which include skilled nursing facilities, nursing homes, and assisted living facilities. Depending upon the number of initial vaccine doses available, jurisdictions might consider first offering vaccination to residents and health care personnel in skilled nursing facilities because of high medical acuity and COVID-19– associated mortality among residents in these settings.[i]

The current plan for distribution and administration of the vaccine is as follows[ii]:

Phase 1

  • High-risk health workers
  • First responders
  • People of all ages with comorbid and underlying health conditions
  • Older adults living in congregate or overcrowded settings

Phase 2

  • Teachers, school staff, childcare workers
  • Critical workers in high-risk settings
  • People of all ages with comorbid and underlying conditions
  • People in homeless shelters and group homes and related staff
  • People in prisons and related staff
  • All older adults not included in Phase 1

Phase 3

  • Young adults
  • Children
  • Workers in industries and occupations important to the functioning of society and at risk for exposure not included in Phase 1 or 2

Phase 4

  • Everyone residing in the US who did not have access to the vaccine in previous phases

Conclusions

It is not possible to contract COVID-19 from m-RNA or non-replicating vector vaccine candidates. The Pfizer vaccine is approved for ages sixteen and older. Pregnant females are not prohibited from being vaccinated, but they are advised to consult with their OB/GYN. No data is available as pregnant females were excluded from studies.

The distribution and administration of the vaccine(s) will require complex coordination between vaccine manufacturers, the Centers for Disease Control, state health departments, shipping companies, distribution facilities, and administration sites that include hospitals, health systems, primary care physician offices, and retail partners like CVS and Walgreens.

For more information, contact the Clinical Team at CPS: contactus@CPSpharm.com.

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[i] https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6949e1-H.pdf
Accessed 12.16.20.
[ii] National Academy of Medicine.

Posted: Thursday, December 17, 2020

Tags: CPS Blog Posts