mRNA-based COVID-19 Vaccines Booster Dose: Benefits, Risks and Coverage COVID-19 Vaccines Booster Dose
Main Article Content
BNT162b2; mRNA Vaccines; mRNA-1273; COVID-19; SSARS-CoV-2; Booster Dose
The number of COVID-19 vaccine-rich countries that have started COVID-19 third-dose booster programs is growing dramatically despite the lack of robust evidence on the effectiveness, safety, and frequency of the required booster doses that makes the individuals/populations immune to COVID -19 infection. Beyond the ethical dilemma, the scarcity of studies on the optimal timing for offering booster doses, eligibility criteria, and if there is any association between premature or delayed administration and the degree of protection against infection. The aim of this mini- review was to collect and analyze published data on this topic in a trial to answer some questions related to the benefits versus the risks of offering frequent boosters of mRNA vaccines for increasing the population immunity against COVID-19 infection considering the current policy of providing SARS-CoV-2 vaccine booster doses in rich countries versus those in relatively poor countries with limited access to vaccination. (www.actabiomedica.it)
2. Park JW, Lagniton PNP, Liu Y, Xu RH. mRNA vaccines for COVID-19: what, why and how. Int J Biol Sci 2021;17:1446-60.
3. Jackson NA, Kester KE, Casimiro D, Gurunathan S, DeRosa F. The promise of mRNA vaccines: a biotech and industrial perspective. NPJ Vaccines 2020;5:1-6.
4. Krammer F. SARS-CoV-2 vaccines in development. Nature 2020;586:516-27.
5. Thomas SJ, Moreira Jr ED, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months. N Engl J Med 2021;385:1761-73.
6. Organization WH. Background document on the mRNA-1273 vaccine ( Moderna) against COVID-19: background document to the WHO Interim recommendations for use of the mRNA-1273 vaccine (Moderna), 3 February 2021. WHO; 2021.
7. Cavaleri M, Enzmann H, Straus S, Cooke E. The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines. Lancet. 2021;397:355-7.
8. Khoury DS, Cromer D, Reynaldi A, et al. Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection. Nat Med. 202127:1205-11.
9. 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; 398:1407-16.
10. Chemaitelly H, Tang P, Hasan MR, et al. Waning of BNT162b2 vaccine protection against SARS-CoV-2 infection in Qatar. N Engl J Med 2021;385:e83.
11. Rosenberg ES, Holtgrave DR, Dorabawila V, et al. New COVID-19 cases and hospitalizations among adults, by vaccination status—New York, May 3–July 25, 2021. MMWR Morb Mortal Wkly Rep2021; 70:1306-11.
12. Nanduri S, Pilishvili T, Derado G, et al. Effectiveness of Pfizer-BioNTech and Moderna vaccines in preventing SARS-CoV-2 infection among nursing home residents before and during widespread circulation of the SARS-CoV-2 B. 1.617. 2 (Delta) variant—National Healthcare Safety Network, March 1–August 1, 2021. MMWR Morb Mortal Wkly Rep 2021;70:1163-6.
13. Bar-On YM, Goldberg Y, Mandel M, et al. Protection of BNT162b2 vaccine booster against covid-19 in Israel. N Engl J Med 2021;385:1393-1400.
14. Newsroom C. Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots. www.hhs.gov August 18, 2021.
15. Coronavirus F. Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals. FDA; 2021. www.fda.gov.12 august 2021.
16. FDA strongly considers authorizing vaccine boosters for people as young as 40: WSJ; 2021. Available from: https://www.washingtonpost.com
17. Furlow B. Immunocompromised patients in the USA and UK should receive third dose of COVID-19 vaccine.. Lancet Rheumatol 202;3(11):e756.
18. Wise J. Covid-19: Booster doses to be offered to 30 million people in UK. BMJ 2021;374:n2261.
19. Mahase E. Covid-19 booster vaccines: What we know and who’s doing what. BMJ 2021;374:n2082.
20. Wong S-C, Au AK-W, Chen H, et al. Transmission of Omicron (B. 1.1. 529)-SARS-CoV-2 Variant of Concern in a designated quarantine hotel for travelers: a challenge of elimination strategy of COVID-19. Lancet Reg Health West Pac 2022;18:100360.
21. Khan NA, Al-Thani H, El-Menyar A. The emergence of new SARS-CoV-2 variant (Omicron) and increasing calls for COVID-19 vaccine boosters-The debate continues. Travel Med Infect Dis 2022; 45:102246.
22. Dolgin E. Omicron is supercharging the COVID vaccine booster debate. Nature 2021. Dec 2.
23. Iacobucci G. Covid-19: Fourth vaccine doses—who needs them and why? BMJ 2022;376:o30.
24. Israel TTo. Israeli trial, world’s first, finds 4th dose ‘not good enough’ against Omicron 2022 [updated 18 January 2022. Available from: https://www.timesofisrael.com/israeli-trial-worlds-first-finds-4th-dose-not-good-enough-against-omicron/.
25. Reuters. Pfizer and BioNTech launch trial of Omicron-targeted COVID vaccine 2022 [Available from: https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-biontech-launch-trial-omicron-targeted-covid-vaccine-2022-01-25/.
26. Reuters. Moderna starts trial for Omicron-specific booster shot 2022 [Available from: https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-starts-trial-testing-omicron-specific-booster-shot-2022-01-26/.
27. Andrews N, Stowe J, Kirsebom F, Gower C, Ramsay M, Bernal JL. Effectiveness of BNT162b2 (Comirnaty, Pfizer-BioNTech) COVID-19 booster vaccine against covid-19 related symptoms in England: test negative case-control study. medRxiv 2021.11.15.21266341.
28. Zhao X, Li D, Ruan W, et al. Effects of a Prolonged Booster Interval on Neutralization of Omicron Variant. N Engl J Med 2022;386 :894-96. .
29. Kanokudom S, Assawakosri S, Suntronwong N, et al. Safety and immunogenicity of the third booster dose with inactivated, viral vector, and mRNA COVID-19 vaccines in fully immunized healthy adults with inactivated vaccine. Vaccines 2022;10(1):86.
30. Shiri T, Evans M, Talarico CA, et al. The Population-Wide Risk-Benefit Profile of Extending the Primary COVID-19 Vaccine Course Compared with an mRNA Booster Dose Program. Vaccines. 2022; 10(2):140.
31. Zhang W, Huang L, Ye G, et al. Vaccine booster efficiently inhibits entry of SARS-CoV-2 omicron variant. Cell Mol Immunol 2022;19:445-6.
32. Kuhlmann C, Mayer CK, Claassen M, et al. Breakthrough infections with SARS-CoV-2 omicron despite mRNA vaccine booster dose. Lancet 2022;399:625-6.
33. Garcia-Beltran WF, Denis KJS, Hoelzemer A, et al. mRNA-based COVID-19 vaccine boosters induce neutralizing immunity against SARS-CoV-2 Omicron variant. Cell. 2022;185:457-66.
34. Kim JH, Marks F, Clemens JD. Looking beyond COVID-19 vaccine phase 3 trials. Nat Med 2021;27: 205-11.
35. Ritchie H, Mathieu E, Rodés-Guirao L, et al. Coronavirus pandemic (COVID-19). Our World In Data.org. https:ourworldindata.org/coronavirus.
36. The WHO is right to call a temporary halt to COVID vaccine boosters. Nature 2021;596:317.
37. Rubin R. COVID-19 Vaccines vs Variants—Determining How Much Immunity Is Enough. JAMA 2021;325:1241-3.
38. Rzymski P, Camargo CA, Fal A, et al. COVID-19 Vaccine Boosters: The good, the bad, and the ugly. Vaccines (Basel) 2021;9:1299.
39. Lu L, Mok BW, Chen LL, et al. Neutralization of SARS-CoV-2 Omicron variant by sera from BNT162b2 or Coronavac vaccine recipients. Clin Infect Dis 2021:ciab1041.
40. Dimeglio C, Migueres M, Mansuy J-M, et al. Antibody titers and breakthrough infections with Omicron SARS-CoV-2. J Infect 2022:S0163-4453(22)00060-3.
41. Peacocke EF, Heupink LF, Frønsdal K, Dahl EH, Chola L. Global access to COVID-19 vaccines: a scoping review of factors that may influence equitable access for low and middle-income countries. BMJ open. 2021;1:e049505.
42. Harman S, Erfani P, Goronga T, Hickel J, Morse M, Richardson ET. Global vaccine equity demands reparative justice—not charity. BMJ Glob Health 2021;6(6):e006504.
43. Katz IT, Weintraub R, Bekker L-G, Brandt AM. From vaccine nationalism to vaccine equity—finding a path forward. N Engl J Med 2021;384:1281-3.
44. Chen J, Liu X, Zhang X, et al. Decline in neutralising antibody responses, but sustained T‐cell immunity, in COVID‐19 patients at 7 months post‐infection. Clinical & Translational Immunology. 2021;10(7):e1319. Clin Transl Immunology 2021;10(7):e1319.
45. Dispinseri S, Secchi M, Pirillo MF, et al. Neutralizing antibody responses to SARS-CoV-2 in symptomatic COVID-19 is persistent and critical for survival. Nat Commun 2021;12:1-12.
46. Walsh EE, Frenck Jr RW, Falsey AR, et al. Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates. N Engl J Med 2020;383:2439-50.
47. Montoya JG, Adams AE, Bonetti V, et al. Differences in IgG Antibody Responses following BNT162b2 and mRNA-1273 SARS-CoV-2 Vaccines. Microbiol Spectr 2021;9:e01162-21.
48. Ebinger JE, Fert-Bober J, Printsev I, Wu M, Sun N, Prostko JC, et al. Antibody responses to the BNT162b2 mRNA vaccine in individuals previously infected with SARS-CoV-2. Nat Med 2021;27:981-4.
49. Levin EG, Lustig Y, Cohen C, et al. Waning immune humoral response to BNT162b2 Covid-19 vaccine over 6 months. N Engl J Med 2021;385(24):e84.
50. Yue L, Xie T, Yang T, et al. A third booster dose may be necessary to mitigate neutralizing antibody fading after inoculation with two doses of an inactivated SARS‐CoV‐2 vaccine. J Med Virol 2022;94:35-8.
51. Weinreich DM, Sivapalasingam S, Norton T, et al. REGN-COV2, a neutralizing antibody cocktail, in outpatients with Covid-19. N Engl J Med 2021;384:238-51.
52. Chen P, Nirula A, Heller B, et al. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19. N Engl J Med 2021;384:229-37.
53. Garcia-Beltran WF, Lam EC, Denis KS, et al. Multiple SARS-CoV-2 variants escape neutralization by vaccine-induced humoral immunity. Cell 2021;184:2372-83.
54. Chen J, Cai Y, Chen Y, et al. Nervous and muscular adverse events after COVID-19 vaccination: a systematic review and meta-analysis of clinical trials. Vaccines 2021;9:939
55. Lopez Bernal J, Andrews N, Gower C, et al. Effectiveness of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines on covid-19 related symptoms, hospital admissions, and mortality in older adults in England: test negative case-control study. BMJ 2021;373:n1088.
56. Iheanacho CO, Eze UIH, Adida EA. A systematic review of effectiveness of BNT162b2 mRNA and ChAdOx1 adenoviral vector COVID-19 vaccines in the general population. Bull Natl Res Cent 2021; 45:150.
57. WHO; Global manual on surveillance of adverse events following immunization. Available from: https://www.who.int/vaccine_safety/publications/Global Manual on Surveillance of AEFI.pdf. Accessed 28 October 2020.
58. van de Munckhof A, Krzywicka K, Aguiar de Sousa D, et al. Declining mortality of cerebral venous sinus thrombosis with thrombocytopenia after SARS-CoV-2 vaccination. Eur J Neurol 2022;29:339-44.
59. Ostovan VR, Foroughi R, Rostami M, et al. Cerebral venous sinus thrombosis associated with COVID-19: a case series and literature review. J Neurol 2021;268:3549-60.
60. See I, Su JR, Lale A, et a. US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021. JAMA 2021;325:2448-56.
61.. Krzywicka K, Heldner MR, Sanchez van Kammen M, et al. Post-SARS- CoV- 2- vaccination cerebral venous sinus thrombosis: an analysis of cases notified to the European Medicines Agency. Eur J Neurol 2021;28:3656-62.
62. Cines DB, Bussel JB. SARS-CoV-2 vaccine-induced immune thrombotic thrombocytopenia. N Engl J Med 2021;384: 2254–6.
63.Kim HW, Jenista ER, Wendell DC, et al. Patients with acute myocarditis following mRNA COVID-19 vaccination. JAMA Cardiol 2021;6:1196-1201.
64. Witberg G, Barda N, Hoss S, et al. Myocarditis after Covid-19 vaccination in a large health care organization. N Engl J Med 2021;385:2132- 9.
65. Patel YR, Louis DW, Atalay M, Agarwal S, Shah NR. Cardiovascular magnetic resonance findings in young adult patients with acute myocarditis following mRNA COVID-19 vaccination: a case series. J Cardiovasc Magn Reson 2021;23(1):101.
66. Salah HM, Mehta JL. COVID-19 Vaccine and Myocarditis. Am J Cardiol 2021;157:146-8.
67. Boehmer TK, Kompaniyets L, Lavery AM, et al. Association between COVID-19 and myocarditis using hospital-based administrative data—United States, March 2020–January 2021. MMWR Morb Mortal Wkly Rep 2021;70:1228-32.
68. Lane S, Shakir S. Reports of myocarditis and pericarditis following mRNA COVID-19 vaccines: A review of spontaneously reported data from the UK, Europe, and the US. medRxiv 2021.09.09.21263342.
69. Lane S, Yeomans A, Shakir S. Systematic review of spontaneous reports of myocarditis and pericarditis in transplant recipients and immunocompromised patients following COVID-19 mRNA vaccination. medRxiv 2021.12.20.21268102.
70. Hajra A, Gupta M, Ghosh B, et al. Proposed pathogenesis, characteristics, and management of COVID-19 mRNA vaccine-related myopericarditis. Am J Cardiovasc Drugs 2022;22:9-26.
71. Patone M, Mei XW, Handunnetthi L, et al. Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nat Med 2022;28:410-22.
72. Kornowski R, Witberg G. Acute myocarditis caused by COVID-19 disease and following
COVID-19 vaccination. Open Heart 2022;9:e001957.
73. Tsilingiris D, Vallianou NG, Karampela I, Liu J, Dalamaga M. Potential implications of lipid nanoparticles in the pathogenesis of myocarditis associated with the use of mRNA vaccines against SARS-CoV-2. Metabol Open 2022;13:100159.
74. Hajjo R, Sabbah DA, Bardaweel SK, Tropsha A. Shedding the Light on Post-Vaccine Myocarditis and Pericarditis in COVID-19 and Non-COVID-19 Vaccine Recipients. Vaccines (Basel). 2021;9 (10) :1186.
75. Puntmann VO, Carerj ML, Wieters I, et al. Outcomes of cardiovascular magnetic resonance imaging in patients recently recovered from coronavirus disease 2019 (COVID-19). JAMA Cardiol 2020;5:1265–73.
76. Garg RK, Paliwal VK. Spectrum of neurological complications following COVID-19 vaccination. Neurol Sci 2022;43:3-40.
77. Dutta S, Kaur R, Charan J, Bhardwaj P, Ambwani SR, Babu S, Goyal JP, Haque M. Analysis of Neurological Adverse Events Reported in VigiBase From COVID-19 Vaccines. Cureus. 2022 Jan 18;14(1):e21376.
78. Matsuzaki S, Kamiya H, Inoshima I, Hirasawa Y, Tago O, Arai M. COVID-19 mRNA Vaccine-induced Pneumonitis. Intern Med2022;61:81-6.
79. Hughes NM, Hammer MM, Awad MM, Jacene HA. Radiation recall pneumonitis on FDG PET/CT triggered by COVID-19 vaccination. Clin Nucl Med 2022;47:e281-e3.
80. Park JY, Kim J-H, Lee IJ, Kim HI, Park S, Hwang YI, et al. COVID-19 vaccine-related interstitial lung disease: a case study. Thorax 2022;77:102-4.
81. Khan Z, Khattak AA, Rafiq N, Amin A, Abdullah M. Interstitial Lung Disease and Transverse Myelitis: A Possible Complication of COVID-19 Vaccine. Cureus. 2022;14(2):e21875.
82. Krajewski P, Matusiak J. Psoriasis flare‐up associated with second dose of Pfizer‐BioNTech BNT16B2b2 COVID‐19 mRNA vaccine. J Eur Acad Dermatol Venereol 2021;35:e632-e 4.
83. Bellinato F, Maurelli M, Gisondi P, Girolomoni G. Cutaneous adverse reactions associated with SARS-CoV-2 vaccines. J Clin Med 2021;10(22):5344.
84. Kroumpouzos G, Paroikaki ME, Yumeen S, Bhargava S, Mylonakis E. Cutaneous Complications of mRNA and AZD1222 COVID-19 Vaccines: A Worldwide Review. Microorganisms. 2022;10(3):624.
85. Greinacher A, Thiele T, Warkentin TE, Weisser K, Kyrle PA, Eichinger S. Thrombotic thrombocytopenia after ChAdOx1 nCov-19 vaccination. N Engl J Med 2021;384:2092-101.
86. Rashedi R, Samieefar N, Masoumi N, Mohseni S, Rezaei N. COVID‐19 vaccines mix‐and‐match: The concept, the efficacy and the doubts. J Med Virol 2022;94:1294-99.
87. Deming ME, Lyke KE. A ‘mix and match’approach to SARS-CoV-2 vaccination. Nature Med 2021;27:1510-1.
88. Chiu N-C, Chi H, Tu Y-K, et al. To mix or not to mix? A rapid systematic review of heterologous prime–boost covid-19 vaccination. Expert Rev Vaccines 2021:20:1211-20.
89. Ledford H. Could mixing COVID vaccines boost immune response? Nature 2021;590:375-6.
80. Atmar RL, Lyke KE, Deming ME, et al. Heterologous SARS-CoV-2 Booster Vaccinations: Preliminary Report. medRxiv [Preprint] 2021:2021.10.10.21264827.
91. Palanica A, Jeon J. Initial Mix-and-Match COVID-19 Vaccination Perceptions, Concerns, and Side Effects across Canadians. Vaccines (Basel) 2022;10(1):93