Public health impact of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in the first year of rollout in the United States

References

• World Health Organization. The true death toll of COVID-19: Estimating global excess mortality. 2022; [cited 2022 Feb 10]. Available from: https://www.who.int/data/stories/the-true-death-toll-of-covid-19-estimating-global-excess-mortality.
   Google Scholar
• Centers for Disease Control and Prevention (CDC): Estimated COVID-19 Burden 2021; [cited 2022 Feb 10]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burden.html.
   Google Scholar
• National Strategy for the COVID-19 Response and Pandemic Preparedness. 2021.
   Google Scholar
• Korang SK, von Rohden E, Veroniki AA, et al. Vaccines to prevent COVID-19: a living systematic review with trial sequential analysis and network Meta-analysis of randomized clinical trials. PLoS One. 2022;17(1):e0260733.
   PubMed Web of Science ®Google Scholar
• Sharif N, Alzahrani KJ, Ahmed SN, et al. Efficacy, immunogenicity and safety of COVID-19 vaccines: a systematic review and meta-analysis. Front Immunol. 2021;2021;12
   Google Scholar
• Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):605–2615.
   PubMed Web of Science ®Google Scholar
• Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403–416.
   PubMed Web of Science ®Google Scholar
• Kow CS, Hasan SS. Real-world effectiveness of BNT162b2 mRNA vaccine: a Meta-analysis of large observational studies. Inflammopharmacology. 2021;29(4):1075–1090.
   PubMed Web of Science ®Google Scholar
• Zheng C, Shao W, Chen X, et al. Real-world effectiveness of COVID-19 vaccines: a literature review and meta-analysis. Int J Infect Dis. 2022;114:252–260.
   PubMed Web of Science ®Google Scholar
• Moghadas SM, Vilches TN, Zhang K, et al. The impact of vaccination on coronavirus disease 2019 (COVID-19) outbreaks in the United States. Clin Infect Dis. 2021;73(12):2257–2264.
   PubMed Web of Science ®Google Scholar
• Chen X, Huang H, Ju J, et al. Impact of vaccination on the COVID-19 pandemic in U.S. states. Sci Rep. 2022;12(1):1554.
   PubMed Web of Science ®Google Scholar
• Samson LW, W T, EJ O, et al. Associations between county-level vaccination rates and COVID-19 outcomes among medicare beneficiaries. ASPE: Office Of The Assistant Secretary For Planning And Evaluation; 2021.
   Google Scholar
• Vilches TN, Moghadas SM, Sah P, et al. Estimating COVID-19 infections, hospitalizations, and deaths following the US vaccination campaigns during the pandemic. JAMA Netw Open. 2022;5(1):e2142725.
   PubMed Web of Science ®Google Scholar
• Gupta S, Cantor J, Simon KI, et al. Vaccinations against COVID-19 may have averted up to 140,000 deaths in the United States. Health Aff. 2021;40(9):1465–1472.
   PubMed Web of Science ®Google Scholar
• Kohli M, Maschio M, Becker D, et al. The potential public health and economic value of a hypothetical COVID-19 vaccine in the United States: use of cost-effectiveness modeling to inform vaccination prioritization. Vaccine. 2021;39(7):1157–1164.
   PubMed Web of Science ®Google Scholar
• Padula WV, Malaviya S, Reid NM, et al. Economic value of vaccines to address the COVID-19 pandemic: a U.S. cost-effectiveness and budget impact analysis. J Med Econ. 2021;24(1):1060–1069.
   PubMed Web of Science ®Google Scholar
• Li R, Liu H, Fairley CK, et al. Cost-effectiveness analysis of BNT162b2 COVID-19 booster vaccination in the United States. medRxiv. 2021. 2021.11.14.21266318.
   Google Scholar
• Bartsch SM, Wedlock PT, O'Shea KJ, et al. Lives and costs saved by expanding and expediting coronavirus disease 2019 vaccination. J Infect Dis. 2021;224(6):938–948.
   PubMed Web of Science ®Google Scholar
• Kirson N, Swallow E, Lu J, et al. The societal economic value of COVID-19 vaccines in the United States. J Med Econ. 2022;25(1):119–128.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention (CDC). COVID-19: Ending Isolation and Precautions for People with COVID-19: Interim Guidance 2021; [cited 2022 Feb 10]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html.
   Google Scholar
• US Census Bureau. Pandemic Impact on Mortality and Economy Varies Across Age Groups and Geographies 2021; [cited 2022 Feb 10]. Available from: https://www.census.gov/library/stories/2021/03/initial-impact-covid-19-on-united-states-economy-more-widespread-than-on-mortality.html#:∼:text=The%20COVID%2D19%20pandemic%20has,also%20devastated%20the%20nation's%20economy.&text=Declines%20in%20the%20employment%2Dto,country%20due%20to%20the%20pandemic.
   Google Scholar
• Kochhar R, Bennett J. U.S. labor market inches back from the COVID-19 shock, but recovery is far from complete: Pew Research Center; 2021; [cited 2022 Feb 10]. Available from: https://www.pewresearch.org/fact-tank/2021/04/14/u-s-labor-market-inches-back-from-the-covid-19-shock-but-recovery-is-far-from-complete/.
   Google Scholar
• Sanders GD, Neumann PJ, Basu A, et al. Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: Second panel on Cost-Effectiveness in health and medicine. Jama. 2016;316(10):1093–1103.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention (CDC). Guidance for Health Economics Studies Presented to the Advisory Committee on Immunization Practices (ACIP), 2019. Update 2019; [cited 2022 Feb 10]. Available from: https://www.cdc.gov/vaccines/acip/committee/downloads/Economics-Guidance-for-ACIP-2019.pdf.
   Google Scholar
• US FDA. Comirnaty and Pfizer-BioNTech COVID-19 Vaccine 2021; [cited 2022 Feb 10]. Available from: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine.
   Google Scholar
• US FDA. Spikevax and Moderna COVID-19 Vaccine. 2021; [cited 2022 Feb 10]. Available from: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/spikevax-and-moderna-covid-19-vaccine.
   Google Scholar
• US FDA. Janssen COVID-19 Vaccine 2021; [cited 2022 Feb 10]. Available from: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine.
   Google Scholar
• COVID-19 SeroHub [Internet]. 2021. Available from: https://covid19serohub.nih.gov/.
   Google Scholar
• Jones JM, Stone M, Sulaeman H, et al. Estimated US infection- and Vaccine-Induced SARS-CoV-2 seroprevalence based on blood donations, july 2020-May 2021. Jama. 2021;326(14):1400–1409.
   PubMed Web of Science ®Google Scholar
• Busch MP, Stone M. Serosurveillance for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) incidence using global blood donor populations. Clin Infect Dis. 2021;72(2):254–256.
   PubMed Web of Science ®Google Scholar
• Di Fusco M, Shea KM, Lin J, et al. Health outcomes and economic burden of hospitalized COVID-19 patients in the United States. J Med Econ. 2021;24(1):308–317.
   PubMed Web of Science ®Google Scholar
• Ohsfeldt RL, Choong CK-C, Mc Collam PL, et al. Inpatient hospital costs for COVID-19 patients in the United States. Adv Ther. 2021;38(11):5557–5595.
   PubMed Web of Science ®Google Scholar
• Scott A, Chambers R, Reimbaeva M, et al. Real-world retrospective analysis of patient characteristics, healthcare resource utilization, costs, and treatment patterns among unvaccinated adults with COVID-19 diagnosed in outpatient settings in the United States. J Med Econ. 2022;2022:1–68.
   Google Scholar
• Chen J, Vullikanti A, Santos J, et al. Epidemiological and economic impact of COVID-19 in the US. Sci Rep. 2021;11(1):20451.
   PubMedGoogle Scholar
• FDA Approves First COVID-19 Vaccine [press release]. 2021.
   Google Scholar
• Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older [press release]. 2021.
   Google Scholar
• Centers for Disease Control and Prevention (CDC) COVID Data Tracker: COVID-19 Vaccinations in the United States. 2021; [cited 2022 Feb 10]. Available from: https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total.
   Google Scholar
• Centers for Disease Control and Prevention (CDC). CDC Expands Booster Shot Eligibility and Strengthens Recommendations for 12-17 Year Olds. 2022; [cited 2022 Feb 10]. Available from: https://www.cdc.gov/media/releases/2022/s0105-Booster-Shot.html.
   Google Scholar
• Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Boosters. 2022; [cited 2022 Feb 10]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html.
   Google Scholar
• Husereau D, Drummond M, Augustovski F, et al. Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. BMJ. 2022;376:e067975.
   PubMedGoogle Scholar
• Guzmán Ruiz Y, Vecino-Ortiz AI, Guzman-Tordecilla N, et al. Cost-Effectiveness of the COVID-19 test, trace and isolate program in Colombia. Lancet Reg Health Am. 2022;6:100109.
   PubMedGoogle Scholar
• Reese H, Iuliano AD, Patel NN, et al. Estimated incidence of coronavirus disease 2019 (COVID-19) illness and Hospitalization-United States, February-September 2020. Clin Infect Dis. 2021;72(12):e1010–e7.
   PubMed Web of Science ®Google Scholar
• CoVariants Database. 2022; [cited 2022 Feb 10]. Available from: https://covariants.org/.
   Google Scholar
• Centers for Disease Control and Prevention (CDC). Science Brief: SARS-CoV-2 Infection-induced and Vaccine-induced Immunity. 2021.
   Google Scholar
• Kim P, Gordon SM, Sheehan MM, et al. Duration of SARS-CoV-2 natural immunity and protection against the Delta variant: a retrospective cohort study. Clin Infect Dis. 2021;2021:ciab999.
   Google Scholar
• CDC COVID Data Tracker. Demographic Trends of People Receiving COVID-19 Vaccinations in the United States; [cited 2002 Feb 16]. Available from: https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
   Google Scholar
• Medicare Administrative Contractor (MAC) COVID-19 Test Pricing January 25, 2021.
   Google Scholar
• Lavery AM, Preston LE, Ko JY, et al. Characteristics of hospitalized COVID-19 patients discharged and experiencing Same-Hospital Readmission - United States, March-August 2020. MMWR Morb Mortal Wkly Rep. 2020;69(45):1695–1699.
   PubMed Web of Science ®Google Scholar
• Yomogida K, Zhu S, Rubino F, et al. Post-Acute sequelae of SARS-CoV-2 infection among adults aged ≥18 Years – Long beach, California, april 1-December 10, 2020. MMWR Morb Mortal Wkly Rep. 2021;70(37):1274–1277.
   PubMed Web of Science ®Google Scholar
• Menges D, Ballouz T, Anagnostopoulos A, et al. Burden of post-COVID-19 syndrome and implications for healthcare service planning: a population-based cohort study. PLoS One. 2021;16(7):e0254523.
   PubMed Web of Science ®Google Scholar
• Asadi-Pooya AA, Nemati H, Shahisavandi M, et al. Long COVID in children and adolescents. World J Pediatr. 2021;17(5):495–499.
   PubMed Web of Science ®Google Scholar
• US Census Bureau. 2019; [cited 2002 Feb 12]. Available from: www.census.gov.
   Google Scholar
• Hobbs CV, Drobeniuc J, Kittle T, et al. Estimated SARS-CoV-2 seroprevalence among persons aged <18 years — Mississippi, may–september 2020. MMWR Morb Mortal Wkly Rep. 2021;70(9):312–315.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention (CDC) COVID Data Tracker. 2022; [cited 2022 Feb 10]. Available from: https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
   Google Scholar
• Campbell JD, Whittington MD, Rind DM, et al. Alternative Pricing Models for Remdesivir and Other Potential Treatments for COVID-19; Updated Report. Institute for Clinical and Economic Review November 10. 2020.
   Google Scholar
• Malden DE, Bruxvoort KJ, Tseng HF, et al. Distribution of SARS-CoV-2 variants in a large integrated health care System – California, March-July 2021. MMWR Morb Mortal Wkly Rep. 2021;70(40):1415–1419.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention (CDC) COVID-19 Pandemic Planning Scenarios - Scenario 5 2020; [cited 2022 Feb 16]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios.html.
   Google Scholar
• EPIC-HR CSR Section 5, Figure 4. Feb 16, 2022.
   Google Scholar
• Jayk Bernal A, Gomes da Silva MM, Musungaie DB, et al. Molnupiravir for oral treatment of covid-19 in nonhospitalized patients. N Engl J Med. 2022;386(6):509–520.
   PubMed Web of Science ®Google Scholar
• Gupta A, Gonzalez-Rojas Y, Juarez E, et al. Early treatment for Covid-19 with SARS-CoV-2 neutralizing antibody sotrovimab. N Engl J Med. 2021;385(21):1941–1950.
   PubMed Web of Science ®Google Scholar
• Rosenthal N, Cao Z, Gundrum J, et al. Risk factors associated with in-Hospital mortality in a US national sample of patients with COVID-19. JAMA Netw Open. 2020;3(12):e2029058.
   PubMed Web of Science ®Google Scholar
• Nasreen S, Chung H, He S, et al. Effectiveness of mRNA and ChAdOx1 COVID-19 vaccines against symptomatic SARS-CoV-2 infection and severe outcomes with variants of concern in Ontario. medRxiv. 2021. 2021.06.28.21259420.
   Google Scholar
• Tartof SY, Slezak JM, Fischer H, et al. Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study. Lancet. 2021;398(10309):1407–1416.
   PubMed Web of Science ®Google Scholar
• CMS. Medicare Administrative Contractor (MAC) COVID-19 Test Pricing. 2021; [cited 2022 Feb 16]. Available from: https://www.cms.gov/files/document/mac-covid-19-test-pricing.pdf.
   Google Scholar
• Medicare COVID-19 Vaccine Shot Payment; [cited 2022 Feb 16]. Available from: https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
   Google Scholar
• Biospace. UPDATED Comparing COVID-19 Vaccines: Timelines, Types and Prices 2021; [cited 2022 Feb 10]. Available from: https://www.biospace.com/article/comparing-covid-19-vaccines-pfizer-biontech-moderna-astrazeneca-oxford-j-and-j-russia-s-sputnik-v/. (accessed Apr 10, 2022)
   Google Scholar
• Advisory Committee on Immunization Practices (ACIP). COVID-19 ACIP Vaccine Recommendations; [cited 2022 Feb 10]. Available from: https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html
   Google Scholar
• Thomas SJ, Moreira ED, Jr., Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA covid-19 vaccine through 6 months. N Engl J Med. 2021;385(19):1761–1773.
   PubMed Web of Science ®Google Scholar
• Sullivan PS, Siegler AJ, Shioda K, et al. Severe acute respiratory syndrome coronavirus 2 cumulative incidence, United States, August 2020–December 2020. Clin Infect Dis. 2022;74(7):1141–1150.
   PubMed Web of Science ®Google Scholar
• Angulo FJ, Finelli L, Swerdlow DL. Estimation of US SARS-CoV-2 infections, symptomatic infections, hospitalizations, and deaths using seroprevalence surveys. JAMA Netw Open. 2021;4(1):e2033706.
   PubMed Web of Science ®Google Scholar
• Stadlbauer D, Tan J, Jiang K, et al. Repeated cross-sectional sero-monitoring of SARS-CoV-2 in New York City. Nature. 2021;590(7844):146–150.
   PubMedGoogle Scholar
• MMWR. Morbidity and mortality weekly report, Vol. 71, January 21, 2022.71(3).
   Google Scholar
• Centers for Disease Control and Prevention (CDC): Excess Deaths Associated with COVID-19. 2022; [cited 2022 Feb 16]. Available from: https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm. (accessed Feb 16, 2022)
   Google Scholar
• Wu SL, Mertens AN, Crider YS, et al. Substantial underestimation of SARS-CoV-2 infection in the United States. Nat Commun. 2020;11(1):4507.
   PubMed Web of Science ®Google Scholar
• Prunas O, Warren JL, Crawford FW, et al. Vaccination with BNT162b2 reduces transmission of SARS-CoV-2 to household contacts in Israel. medRxiv. 2021. https://doi.org/10.1101/2021.07.13.21260393
   Google Scholar
• Centers for Disease Control and Prevention (CDC). Science Brief: COVID-19 Vaccines and Vaccination 2021; [cited 2022 Feb 16]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
   Google Scholar
• Centers for Disease Control and Prevention (CDC). First Confirmed Case of Omicron Variant Detected in the United States [press release]. Dec 12021.
   Google Scholar
• Johnson AG, Amin AB, Ali AR, et al. COVID-19 incidence and death rates among unvaccinated and fully vaccinated adults with and without booster doses during periods of Delta and omicron variant emergence - 25 U.S. Jurisdictions, April 4–December 25, 2021. MMWR Morb Mortal Wkly Rep. 2022;71(4):132–138.
   PubMed Web of Science ®Google Scholar
• Statista. Statista. Omicron BA.2 Variant to Become Dominant in the U.S. 2022. [Available from: https://www.statista.com/chart/27076/coronavirus-variants-in-the-us/. (accessed Apr 12, 2022)
   Google Scholar
• US FDA. Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals [press release]. 2021.
   Google Scholar