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Frequently Asked Questions on COVID-19 Vaccines and Immunity

Sharon R. Lewin, AO, FRACP, PhD, FAHMS
Jens D. Lundgren, MD, DMSc
Vikramjit Mukherjee, MD
Roger Paredes, MD, PhD
Released: December 29, 2020
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Aran D. Estimating real-world COVID-19 vaccine effectiveness in Israel. Preprint available at: https://www.medrxiv.org/content/10.1101/2021.02.05.21251139v1. Accessed April 5, 2021. Note: This study has not been peer reviewed.

Arvin AM, Fink K, Schmid MA, et al. A perspective on potential antibody-dependent enhancement of SARS-CoV-2. Nature. 2020;584:353-363.

Byambasuren O, Cardona M, Bell K, et al. Estimating the extent of asymptomatic COVID-19 and its potential for community transmission: systematic review and meta-analysis. Preprint available at: https://www.medrxiv.org/content/10.1101/2020.05.10.20097543v3. Accessed April 5, 2021. Note: This study has not been peer reviewed.

Centers for Disease Control and Prevention. New COVID-19 Variants. January 15, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant.html. Accessed April 5, 2021.

Centers for Disease Control and Prevention. Moderna COVID-19 vaccine. December 22, 2020. Available at: https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html. Accessed April 5, 2021.

Centers for Disease Control and Prevention. Pfizer-BioNTech COVID-19 vaccine. February 16, 2021. Available at: https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html. Accessed April 5, 2021.

Center for Disease Control and Prevention. Interim public health recommendations for fully vaccinated people. March 8, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html. Accessed April 5, 2021.

Centers for Disease Control and Prevention. Vaccination considerations for people who are pregnant or breastfeeding. February 12, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html. Accessed April 5, 2021.

Centers for Disease Control and Prevention. Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine — United States, December 14-23, 2020. January 15, 2021. Available at: https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm. Accessed April 5, 2021.

Centers for Disease Control and Prevention. Allergic reactions including anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine — United States, December 21, 2020-January 10, 2021. January 22, 2021. Available at: https://www.cdc.gov/mmwr/volumes/70/wr/mm7004e1.htm?s_cid=mm7004e1_w. Accessed April 5, 2021.

Centers for Disease Control and Prevention. Interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. Available at: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finfo-by-product%2Fpfizer%2Fclinical-considerations.html. Accessed April 5, 2021.

Centers for Disease Control and Prevention. COVID-19 vaccines and severe allergic reactions. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html. Accessed April 5, 2021.

ClinicalTrials.gov. Study to describe the safety, tolerability, immunogenicity, and efficacy of RNA vaccine candidates against COVID-19 in healthy individuals. Available at: https://clinicaltrials.gov/ct2/show/NCT04368728. Accessed April 5, 2021.

Dagan M, Barda, M, Kepten E, et al. BNT162b2 mRNA COVID-19 vaccine in a nationwide mass vaccination setting. N Engl J Med. 2021;[Epub ahead of print].

Edridge AWD, Kaczorowska J, Hoste ACR, et al. Seasonal coronavirus protective immunity is short-lasting. Nat Med. 2020;26:1691-1693.

Esteve C, Catherine FX, Chavanet P, et al. How should a positive PCR test result for COVID-19 in an asymptomatic individual be interpreted and managed? Med Mal Infect. 2020;50:633.

Goldman JD, Wang K, Roltgen K, et al. Reinfection with SARS-CoV-2 and failure of humoral immunity: a case report. Preprint available at: https://www.medrxiv.org/content/10.1101/2020.09.22.20192443v1. Accessed April 5, 2021. Note: This study has not been peer reviewed.

Hobbs CV, Khaitan A, Kirmse BM, et al. COVID-19 in children: A review and parallels to other hyperinflammatory syndromes. Front Pediatr. 2020;8:593455.

Ibarrondo FJ, Fulcher JA, Goodman-Meza D, et al. Rapid decay of anti-SARS-CoV-2 antibodies in persons with mild COVID-19. N Engl J Med. 2020;383:1085-1087.

Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA vaccine against SARS-CoV-2—preliminary report. N Engl J Med. 2020;383:1920-1931.

Johnson & Johnson, Inc. Johnson and Johnson COVID-19 vaccine authorized by US FDA for emergency use- first single-shot vaccine in fight against global pandemic. Press release. February 27, 2021. Available at: https://www.jnj.com/johnson-johnson-covid-19-vaccine-authorized-by-u-s-fda-for-emergency-usefirst-single-shot-vaccine-in-fight-against-global-pandemic. Accessed April 5, 2021.

Lee WS, Wheatley AK, Kent SJ, et al. Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies. Nat Microbiol. 2020;5:1185-1191.

Moderna, Inc. Moderna announces it has shipped variant-specific vaccine candidate, mRNA-1273.351, to NIH for clinical study. Press release. February 24, 2021. Available at: https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-it-has-shipped-variant-specific-vaccine. Accessed April 5, 2021.

Moderna, Inc. Moderna COVID-19 vaccine retains neutralizing activity against emerging variants first identified in the U.K. and the Republic of South Africa. Press release. January 25, 2021. Available at: https://investors.modernatx.com/news-releases/news-release-details/moderna-covid-19-vaccine-retains-neutralizing-activity-against. Accessed April 5, 2021

Moderna, Inc. Moderna announces primary efficacy analysis in phase 3 COVE study for its COVID-19 vaccine candidate and filing today with US FDA for emergency use authorization. Press release. November 30, 2020. Available at: https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-primary-efficacy-analysis-phase-3-cove-study. Accessed April 5, 2021.

Mulligan MJ, Lyke KE, Kitchin N, et al. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. 2020;586:589-593.

Pfizer Inc. Pfizer and BioNtech publish results of study showing COVID-19 vaccine elicits antibodies that neutralize pseudovirus bearing the SARS-CoV-2 U.K. strain spike protein in cell culture. Press release. January 20, 2021. Available at: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-puresults-study-showing-covid-19. Accessed April 5, 2021.

Pfizer Inc. Pfizer and BioNTech conclude phase 3 study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints. Press release. November 18, 2020. Available at: https://www.businesswire.com/news/home/20201118005595/en/. Accessed April 5, 2021.

Pollack FC, Thomas SJ, Kitchin, N, et al. Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. N Engl J Med. 2020;383:2603-2615.

Sadoff J, Le Gars M, Shukarev G, et al. Interim results of a phase 1-2a trial of Ad26.COV2.S Covid-19 vaccine. N Engl J Med. 2021;[Epub ahead of print].

Sariol A, Perlman S. Lessons for COVID-19 immunity from other coronavirus infections. Immunity. 2020;53:248-263.

Shukla R, Ramasamy V, Shanmugam RK, et al. Antibody-dependent enhancement: A challenge for developing a safe dengue vaccine. Front Cell Infect Microbiol. 2020;10:572681.

Tang MW, Shafer RW. HIV-1 antiretroviral resistance: scientific principles and clinical applications. Drugs. 2012;72:e1-25.

Tillett RL, Sevinsky JR, Hartley PD, et al. Genomic evidence for reinfection with SARS-CoV-2: a case study. Lancet Infect Dis. 2020;21:52-58.

To KK, Hung IF, Ip JD, et al. COVID-19 re-infection by a phylogenetically distinct SARS-coronavirus-2 strain confirmed by whole genome sequencing. Clin Infect Dis. 2020;[Epub ahead of print].

US Food and Drug Administration. FDA statement on following the authorized dosing schedules for COVID-19 vaccines. January 4, 2021. Available at: https://www.fda.gov/news-events/press-announcements/fda-statement-following-authorized-dosing-schedules-covid-19-vaccines. Accessed April 5, 2021.

US Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes first test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection. November 6, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-detects-neutralizing-antibodies-recent-or#:~:text=Binding%20antibodies%20bind%20to%20a,it%20is%20still%20being%20researched. Accessed April 5, 2021.

US Food and Drug Administration Briefing Document: Moderna COVID-19 vaccine. Available at: https://www.fda.gov/media/144434/download. Accessed April 5, 2021.

Wadhwa A, Aljabbari A, Lokras A, et al. Opportunities and challenges in the delivery of mRNA-based vaccines. Pharmaceutics. 2020;12:102.

Wang Y, Li J, Li H, Lei P, Shen G, Yang C. Persistence of SARS-CoV-2-specific antibodies in COVID-19 patients. Int Immunopharmacol. 2020;2;90:107271. 

Widge AT, Rouphael NG, Jackson LA, et al. Durability of responses after SARS-CoV-2 mRNA-1273 vaccination. N Engl J Med. 2021;384:80-82.

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