Taken from ASBMB’s monthly research newsletter: The Monthly Digest (Feb. 2021, Issue 2).

Written by Priscilla Cho

On December 11^th, 2020, the U.S. Food and Drug Administration (FDA) issued the first Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. There are currently no FDA-approved vaccines for COVID-19. However, under the EUA, which is supported by a Secretary of Health and Human Services (HHS) declaration that certain situations can exist to justify the use of drugs and biological products during the COVID-19 pandemic, the Pfizer-BioNTech vaccine was permitted for emergency use [1]. The Pfizer-BioNTech vaccine had an efficacy of 95% in a late-stage clinical trial of nearly 44,000 people, age 16 or older [1,2,3]. Some general side effects of this vaccine included fatigue, headache, muscle and joint pain, chills, and fever. The Pfizer-BioNTech vaccine must be administered in two doses, three weeks apart, and must be stored at a very low temperature of -94⁰F [2]. An initial shipment of the vaccine containing around 2.9 million doses was sent around the United States the week after the vaccine was authorized for emergency use, with frontline healthcare workers and residents of long-term care facilities being prioritized [3,4]. The vaccines were packed in boxes designed to store them at -94⁰F and packed with dry ice. Due to this vaccine’s low storage temperature, only facilities with ultracold freezer capacity could receive doses [5]. 

At Emory, Nicole Baker, MSN, RN, an emergency department nurse manager and frontline emergency room nurse at Emory University Hospital, was the first to receive the Pfizer-BioNTech vaccine [6]. 

Clinical trials for another COVID-19 vaccine were conducted at Emory late last year. This vaccine is called mRNA-1273 and was co-developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID) and biotech company Moderna, Inc., of Cambridge, Mass [7]. Emory enrolled about 700 people as part of the Phase 3 trials. The Moderna vaccine was tested at Emory Hope Clinic, Emory Children’s Center – Vaccine Research Clinic, and Ponce De Leon Center/Grady Clinic, with principal investigators Nadine Rouphael, MD, a professor of medicine (infectious diseases) at Emory University School of Medicine and interim director at the Hope Clinic; Evan Anderson, MD, a professor of medicine and pediatrics at Emory University School of Medicine and physician at Children’s Healthcare of Atlanta; and Colleen Kelley, MD, MPH, an associate professor of medicine (infectious diseases) at Emory University School of Medicine [7]. This study enrolled more than 30,000 participants in the U.S., with each participant receiving two shots spaced 28 days apart. Half of the participants received a placebo, while half received the vaccine. In an analysis released by Moderna, 95 participants contracted COVID-19, but 90 of those participants were in the placebo group. Eleven of the COVID-19 cases were reported as severe, but all cases were from the placebo group. 

As a result of successful clinical trials, on December 18^th, 2020, the Moderna vaccine was the second vaccine to be authorized for emergency use by the FDA under an EUA for individuals age 18 or older [8]. In large clinical trials, the vaccine was around 94.5% effective with an administration of 2 doses spaced 4 weeks apart [2,9]. The Moderna vaccine must be stored for 30 days with refrigeration and afterwards at -4⁰F for 6 months. The possible side effects for the Moderna vaccine are similar to the Pfizer-BioNTech vaccine. However, the Moderna vaccine can be distributed more widely than the Pfizer-BioNTech vaccine because it can be stored at normal freezer temperatures [9]. The Moderna vaccine also comes in smaller batches, making it easier for hospitals in less populated areas to use quickly [9]. 

The Centers for Disease Control and Prevention (CDC) stated on Friday, January 29^th, that around 22.9 million people have received at least one dose of a COVID-19 vaccine, including about 4.8 million people who have received both doses [10]. 1.3 million doses of the vaccine are being administered every day on average. The federal government has delivered about 49.2 million doses to states, territories, and federal agencies and has recently recommended for states to permit adults of age 65 and older to be vaccinated [10]. However, states create and implement their own plans, leading to differing policies for each state. In Georgia, adults of age 65 or older are eligible to be vaccinated.

At Emory, Clinical trials for more COVID-19 vaccines are being conducted currently, including a vaccine by Novavax [11] and one by Janssen Pharmaceutical Companies of Johnson & Johnson [12]. The vaccine by Janssen Pharmaceutical Companies of Johnson & Johnson is notable because it requires only one dose.

References

[1] U.S. Food & Drug Administration. (2021, January 28). Pfizer-BioNTech COVID-19 Vaccine. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine

[2] The Health and Science Desk. (2021, January 11). What to Know About the World’s Top Covid-19 Vaccines. The New York Times. https://www.nytimes.com/interactive/2021/01/12/health/covid-vaccines-list.html?searchResultPosition=3

[3] Thomas, K., LaFraniere, S., Weiland, N., Goodnough, A., & Haberman, M. (2020, December 11). F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away. The New York Times. https://www.nytimes.com/2020/12/11/health/pfizer-vaccine-authorized.html

[4] McDermott, M. T. (2020, December 18). What It Was Like to Participate in a Covid-19 Vaccine Trial. The New York Times. https://www.nytimes.com/2020/12/18/us/covid-vaccine-trial.html?searchResultPosition=7

[5] Weise, E. (2020, December 12). First Pfizer COVID-19 vaccine shipments to be delivered to US distribution sites starting Monday. USA Today. https://www.usatoday.com/story/news/health/2020/12/12/covid-vaccine-distribution-first-pfizer-shipments-arrive-monday/6521379002/

[6] Woodruff Health Sciences Center. (2020, December 17). Emory Healthcare administers first COVID-19 vaccinations to its frontline health care workers. Emory News Center. https://news.emory.edu/stories/2020/12/ehc_first_covid_vaccination/index.html

[7] Woodruff Health Sciences Center. (2020, November 17). Vaccine tested at Emory highly effective in preventing COVID-19, study says. Emory News Center. https://news.emory.edu/stories/2020/11/coronavirus_moderna_vaccine_highly_effective/index.html

[8] U.S. Food & Drug Administration. (2021, January 28). Moderna COVID-19 Vaccine. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine

[9] Grady, D., Goodnough, A., Zimmer, C., & Wu, K. J. (2020, December 17). F.D.A Panel Endorses Moderna’s Covid-19 Vaccine. The New York Times. https://www.nytimes.com/2020/12/17/health/covid-vaccine-fda-moderna.html?searchResultPosition=16

[10] The New York Times. (2021, January 30). See How the Vaccine Rollout Is Going in Your State. The New York Times. https://www.nytimes.com/interactive/2020/us/covid-19-vaccine-doses.html?name=styln-coronavirus-vaccines&action=click&pgtype=Article&state=default&module=styln-coronavirus-vaccines&region=MAIN_CONTENT_3&context=styln-vaccines-faq&region=TOP_BANNER%E2%96%88=storyline_menu_recirc&action=click&pgtype=Interactive&impression_id=262176c0-6174-11eb-9bbe-43be4a0f7ee0&variant=1_Show

[11] Woodruff Health Sciences Center. (2020, December 29). Emory Begins Phase 3 study of Novavax COVID-19 vaccine. Emory News Center. https://news.emory.edu/stories/2020/12/coronavirus_novavax_vaccine_study/index.html#:~:text=ATLANTA%20%E2%80%93%20Emory%20University%20is%20participating,U.S.%20biotechnology%20company%20Novavax%2C%20Inc.

[12] Woodruff Health Sciences Center. (2020, October 29). Emory begins advanced stage clinical trial for another COVID-19 vaccine. Emory News Center. https://news.emory.edu/stories/2020/10/coronavirus_jj_vaccine_phase31/index.html