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.
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:
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 |
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:
Pfizer
Moderna
Oxford
Janssen
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
Phase 2
Phase 3
Phase 4
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.