CoChat
Sign Up
Cited by 310SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesVaccine Coverage and Hesitancy

Efficacy and safety of COVID-19 vaccines

Open access
Graña, Carolina, Ghosn, Lina, Evrenoglou, Theodoros, Jarde, Alexander, Minozzi, Silvia, Bergman, Hanna, Buckley, Brian S, Probyn, Katrin +22 more·2022·Cochrane Database of Systematic Reviews
DOI 10.1002/14651858.cd015477PMC PMC9726273
Open this paper in CoChat — free accountOpen PDF

Abstract

BACKGROUND: Different forms of vaccines have been developed to prevent the SARS-CoV-2 virus and subsequent COVID-19 disease. Several are in widespread use globally. OBJECTIVES: To assess the efficacy and safety of COVID-19 vaccines (as a full primary vaccination series or a booster dose) against SARS-CoV-2. SEARCH METHODS: We searched the Cochrane COVID-19 Study Register and the COVID-19 L·OVE platform (last search date 5 November 2021). We also searched the WHO International Clinical Trials Registry Platform, regulatory agency websites, and Retraction Watch. SELECTION CRITERIA: We included randomized controlled trials (RCTs) comparing COVID-19 vaccines to placebo, no vaccine, other active vaccines, or other vaccine schedules. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. We used GRADE to assess the certainty of evidence for all except immunogenicity outcomes. We synthesized data for each vaccine separately and presented summary effect estimates with 95% confidence intervals (CIs). MAIN RESULTS: We included and analyzed 41 RCTs assessing 12 different vaccines, including homologous and heterologous vaccine schedules and the effect of booster doses. Thirty-two RCTs were multicentre and five were multinational. The sample sizes of RCTs were 60 to 44,325 participants. Participants were aged: 18 years or older in 36 RCTs; 12 years or older in one RCT; 12 to 17 years in two RCTs; and three to 17 years in two RCTs. Twenty-nine RCTs provided results for individuals aged over 60 years, and three RCTs included immunocompromized patients. No trials included pregnant women. Sixteen RCTs had two-month follow-up or less, 20 RCTs had two to six months, and five RCTs had greater than six to 12 months or less. Eighteen reports were based on preplanned interim analyses. Overall risk of bias was low for all outcomes in eight RCTs, while 33 had concerns for at least one outcome. We identified 343 registered RCTs with results not yet available. This abstract reports results for the critical outcomes of confirmed symptomatic COVID-19, severe and critical COVID-19, and serious adverse events only for the 10 WHO-approved vaccines. For remaining outcomes and vaccines, see main text. The evidence for mortality was generally sparse and of low or very low certainty for all WHO-approved vaccines, except AD26.COV2.S (Janssen), which probably reduces the risk of all-cause mortality (risk ratio (RR) 0.25, 95% CI 0.09 to 0.67; 1 RCT, 43,783 participants; high-certainty evidence). Confirmed symptomatic COVID-19 High-certainty evidence found that BNT162b2 (BioNtech/Fosun Pharma/Pfizer), mRNA-1273 (ModernaTx), ChAdOx1 (Oxford/AstraZeneca), Ad26.COV2.S, BBIBP-CorV (Sinopharm-Beijing), and BBV152 (Bharat Biotect) reduce the incidence of symptomatic COVID-19 compared to placebo (vaccine efficacy (VE): BNT162b2: 97.84%, 95% CI 44.25% to 99.92%; 2 RCTs, 44,077 participants; mRNA-1273: 93.20%, 95% CI 91.06% to 94.83%; 2 RCTs, 31,632 participants; ChAdOx1: 70.23%, 95% CI 62.10% to 76.62%; 2 RCTs, 43,390 participants; Ad26.COV2.S: 66.90%, 95% CI 59.10% to 73.40%; 1 RCT, 39,058 participants; BBIBP-CorV: 78.10%, 95% CI 64.80% to 86.30%; 1 RCT, 25,463 participants; BBV152: 77.80%, 95% CI 65.20% to 86.40%; 1 RCT, 16,973 participants). Moderate-certainty evidence found that NVX-CoV2373 (Novavax) probably reduces the incidence of symptomatic COVID-19 compared to placebo (VE 82.91%, 95% CI 50.49% to 94.10%; 3 RCTs, 42,175 participants). There is low-certainty evidence for CoronaVac (Sinovac) for this outcome (VE 69.81%, 95% CI 12.27% to 89.61%; 2 RCTs, 19,852 participants). Severe or critical COVID-19 High-certainty evidence found that BNT162b2, mRNA-1273, Ad26.COV2.S, and BBV152 result in a large reduction in incidence of severe or critical disease due to COVID-19 compared to placebo (VE: BNT162b2: 95.70%, 95% CI 73.90% to 99.90%; 1 RCT, 46,077 participants; mRNA-1273: 98.20%, 95% CI 92.80% to 99.60%; 1 RCT, 28,451 participants; AD26.COV2.S: 76.30%, 95% CI 57.90% to 87.50%; 1 RCT, 39,058 participants; BBV152: 93.40%, 95% CI 57.10% to 99.80%; 1 RCT, 16,976 participants). Moderate-certainty evidence found that NVX-CoV2373 probably reduces the incidence of severe or critical COVID-19 (VE 100.00%, 95% CI 86.99% to 100.00%; 1 RCT, 25,452 participants). Two trials reported high efficacy of CoronaVac for severe or critical disease with wide CIs, but these results could not be pooled. Serious adverse events (SAEs) mRNA-1273, ChAdOx1 (Oxford-AstraZeneca)/SII-ChAdOx1 (Serum Institute of India), Ad26.COV2.S, and BBV152 probably result in little or no difference in SAEs compared to placebo (RR: mRNA-1273: 0.92, 95% CI 0.78 to 1.08; 2 RCTs, 34,072 participants; ChAdOx1/SII-ChAdOx1: 0.88, 95% CI 0.72 to 1.07; 7 RCTs, 58,182 participants; Ad26.COV2.S: 0.92, 95% CI 0.69 to 1.22; 1 RCT, 43,783 participants); BBV152: 0.65, 95% CI 0.43 to 0.97; 1 RCT, 25,928 participants). In each of these, the likely absolute difference in effects was fewer than 5/1000 pa

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1002/14651858.cd015477

Cites

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • In 2021 there was clear evidence of the efficacy of COVID-19 vaccines in reducing mortality from SARS-CoV-2 infection.

    “In 2021 there was clear evidence of the efficacy of COVID-19 vaccines in reducing mortality from SARS-CoV-2 infection”

    From Ethical Principles in Legal Context: Vaccine Mandates During the COVID-19 Pandemic in Australia (2026) · cites this paper as Graña, et al. 2022

    The Discussion (Summary of main results) says mortality evidence was uncertain or very uncertain for most vaccines because deaths were few, though it reports reduced all-cause mortality for two vaccines. The paper therefore does not support a general claim of clear evidence in 2021 that COVID-19 vaccines reduced deaths from SARS-CoV-2 infection. (LLM, conf=0.87)

    Checked by a reasoning model — may be wrong.

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

The citation lists haven’t been fetched yet

References 150 · Cited by 310

Research works printed but not linked: 153

  1. Al Kaabi N, Zhang Y, Xia S, Yang Y, Al Qahtani MM, Abdulrazzaq N, et al. Effect of 2 inactivated SARS-CoV-2 vaccines on symptomatic COVID-19 infection in adults: a randomized clinical trial. JAMA 2021; 326(1): 35- 45. PMC8156175 34037666
  2. Asano M, Okada H, Itoh Y, Hirata H, Ishikawa K, Yoshida E, et al. Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial. International Journal of Infectious Diseases 2022; 114: 165- 74. PMC8531242 34688944
  3. Bonelli M, Mrak D, Tobudic S, Sieghart D, Koblischke M, Mandl P, et al. Additional heterologous versus homologous booster vaccination in immunosuppressed patients without SARS-CoV-2 antibody seroconversion after primary mRNA vaccination: a randomized controlled trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.05.21263125] 35027397 · DOI
  4. Bueno SM, Abarca K, González PA, Gálvez NM, Soto JA, Duarte LF, et al. Interim report: safety and immunogenicity of an inactivated vaccine against SARS-CoV-2 in healthy Chilean adults in a phase 3 clinical trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.03.31.21254494] · DOI
  5. Bueno SM, Abarca K, González PA, Gálvez NM, Soto JA, Duarte LF, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in a subgroup of healthy adults in Chile. Clinical Infectious Diseases 2021 Sep 19 [Epub ahead of print]. [DOI: 10.1093/cid/ciab823] PMC9402626 34537835 · DOI
  6. Clemens SA, Folegatti PM, Emary KR, Weckx LY, Ratcliff J, Bibi S, et al. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 lineages circulating in Brazil. Nature Communications 2021; 12(1): 5861. PMC8494913 34615860
  7. Dunkle LM, Kotloff KL, Gay CL, Áñez G, Adelglass JM, Barrat Hernández AQ, et al. Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.10.05.21264567] PMC8693692 34910859 · DOI
  8. Ella R, Vadrevu KM, Jogdand H, Prasad S, Reddy S, Sarangi V, et al. A Phase 1: safety and immunogenicity trial of an inactivated SARS-CoV-2 vaccine-BBV152. medRxiv 2020 [Preprint]. [DOI: 10.1101/2020.12.11.20210419] PMC7825810 33485468 · DOI
  9. Ella R, Vadrevu KM, Jogdand H, Prasad S, Reddy S, Sarangi V, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomized, phase 1 trial. Lancet Infectious Diseases 2021; 21(5): 637- 46. PMC7825810 33485468
  10. Ella R, Reddy S, Blackwelder W, Potdar V, Yadav P, Sarangi V, et al. Efficacy, safety, and lot to lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): a double-blind, randomized, controlled phase 3 trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.06.30.21259439] PMC8584828 34774196 · DOI
  11. El Sahly HM, Baden LR, Essink B, Doblecki-Lewis S, Martin JM, Anderson EJ, et al. Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase. New England Journal of Medicine 2021; 385(19): 1774- 85. PMC8482810 34551225
  12. Fadlyana E, Rusmil K, Tarigan R, Rahmadi AR, Prodjosoewojo S, Sofiatin Y, et al. A phase III, observer-blind, randomized, placebo-controlled study of the efficacy, safety, and immunogenicity of SARS-CoV-2 inactivated vaccine in healthy adults aged 18–59 years: an interim analysis in Indonesia. Vaccine 2021; 39(44): 6520- 8. PMC8461222 34620531
  13. Formica N, Mallory R, Albert G, Robinson M, Plested JS, Cho I, et al. Different dose regimens of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373) in younger and older adults: a phase 2 randomized placebo-controlled trial. PLOS Medicine 2021; 18(10): e1003769. PMC8486115 34597298
  14. Formica N, Mallory R, Albert G, Robinson M, Plested JS, Cho I, et al. Evaluation of a SARS-CoV-2 vaccine NVX-CoV2373 in younger and older adults. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.02.26.21252482] PMC8486115 34597298 · DOI · Paper page
  15. Frenck RW Jr, Klein NP, Kitchin N, Gurtman A, Absalon J, Lockhart S, et al. Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. New England Journal of Medicine 2021; 385(3): 239- 50. PMC8174030 34043894
  16. Guo W, Duan K, Zhang Y, Yuan Z, Zhang YB, Wang Z, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18 years or older: a randomized, double-blind, placebo-controlled, phase 1/2 trial. eClinicalMedicine 2021; 38: 101010. PMC8260504 34250456
  17. Hall VG, Ferreira VH, Ku T, Ierullo M, Majchrzak-Kita B, Chaparro C, et al. Randomized trial of a third dose of mRNA-1273 vaccine in transplant recipients. New England Journal of Medicine 2021; 385(13): 1244- 6. PMC8385563 34379917
  18. Han B, Song Y, Li C, Yang W, Ma Q, Jiang Z, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomized, controlled, phase 1/2 clinical trial. Lancet Infectious Diseases 2021; 21(12): 1645- 53. PMC8238449 34197764
  19. Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, et al. Safety and efficacy of NVX-CoV2373 Covid-19 vaccine. New England Journal of Medicine 2021; 385(13): 1172- 83. PMC8262625 34192426
  20. Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, et al. Efficacy of the NVX-CoV2373 Covid-19 vaccine against the B. 1.1.7 variant. medRxiv 2021 [Preprint].
  21. Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, et al. Phase 1-2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine. New England Journal of Medicine 2020; 383: 2320- 32. PMC7494251 32877576
  22. Kulkarni PS, Padmapriyadarsini C, Vekemans J, Bavdekar A, Gupta M, Kulkarni P, et al. A phase 2/3, observer-blind, randomized, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCOV-19 (COVID-19 vaccine) in adults in India. eClinicalMedicine 2021; 42: 101218. PMC8629682 34870133
  23. Li J, Hou L, Guo X, Jin P, Wu S, Zhu J, et al. Heterologous prime-boost immunization with CoronaVac and Convidecia. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.03.21263062] · DOI
  24. Liu X, Shaw RH, Stuart AS, Greenland M, Aley PK, Andrews NJ, et al. Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomized, non-inferiority trial. Lancet 2021; 398(10303): 856- 69. PMC8346248 34370971
  25. Liu X, Shaw RH, Stuart AS, Greenland M, Aley PK, Andrews NJ, et al. Safety and immunogenicity report from the Com-COV Study – a single-blind randomized non-inferiority trial comparing heterologous and homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine. SSRN 2021 [Preprint]. [DOI: 10.2139/ssrn.3874014] PMC8346248 34370971 · DOI
  26. Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomized controlled phase 3 trial in Russia. Lancet 2021; 397(10275): 671- 81. PMC7852454 33545094
  27. Madhi SA, Koen AL, Izu A, Fairlie L, Cutland CL, Baillie V, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomized, double-blind, placebo-controlled, phase 1B/2A trial. Lancet HIV 2021; 8(9): e568- 80. PMC8372504 34416193
  28. Mok C, Cheng S, Chen C, Yiu K, Chan TO, Lai KC, et al. A RCT of a third dose CoronaVac or BNT162b2 vaccine in adults with two doses of CoronaVac. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.11.02.21265843] · DOI
  29. Palacios R, Patiño EG, Oliveira Piorelli R de, Conde MT, Batista AP, Zeng G, et al. Double-blind, randomized, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of treating healthcare professionals with the adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac – PROFISCOV: a structured summary of a study protocol for a randomized controlled trial. Trials 2020; 21(1): 853. PMC7558252 33059771
  30. Sablerolles RS, Rietdijk WJ, Goorhuis A, Postma DF, Visser LG, Geers D, et al. Immunogenicity and reactogenicity of booster vaccinations after Ad26.COV2.S priming. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.10.18.21264979] · DOI
  31. Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, Groot AM de, et al. Interim results of a Phase 1-2a trial of Ad26.COV2.S Covid-19 vaccine. New England Journal of Medicine 2021; 384(19): 1824- 35. PMC7821985 33440088
  32. Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, Groot AM de, et al. Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial. medRxiv 2020 [Preprint]. [DOI: 10.1101/2020.09.23.20199604] · DOI
  33. Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, et al. Safety and efficacy of single-dose Ad26.COV2.S vaccine against Covid-19. New England Journal of Medicine 2021; 384(23): 2187- 201. PMC8220996 33882225
  34. Thomas SJ, Moreira ED Jr, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months. New England Journal of Medicine 2021; 385(19): 1761- 773. PMC8461570 34525277
  35. Thomas SJ, Moreira ED Jr, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Six month safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.07.28.21261159] PMC8461570 34525277 · DOI · Paper page
  36. Toledo-Romani ME, Garcia-Carmenate M, Silva-Valenzuela C, Baldoquin-Rodriguez W, Martínez-Pérez M, Rodríguez-González M, et al. Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-PLUS: double-blind, randomized, placebo-controlled phase 3 clinical trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.10.31.21265703] PMC9803910 36618081 · DOI
  37. Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomized controlled trial. Lancet 2020; 396(10249): 467- 78. [PMID: 32702298] 32702298 PMC7445431
  38. Voysey M, Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomized controlled trials in Brazil, South Africa, and the UK. Lancet 2021; 397(10269): 99- 111. [PMID: 33306989] 33306989 PMC7723445
  39. Walsh EE, Frenck R, Falsey AR, Kitchin N, Absalon J, Gurtman A, et al. RNA-based COVID-19 vaccine BNT162b2 selected for a pivotal efficacy study. medRxiv 2020 [Preprint]. [DOI: 10.1101/2020.08.17.20176651] · DOI · Paper page
  40. Walsh EE, Frenck RW Jr, Falsey AR, Kitchin N, Absalon J, Gurtman A, et al. Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates. New England Journal of Medicine 2020; 383(25): 2439- 50. PMC7583697 33053279
  41. Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomized, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infectious Diseases 2021; 21(6): 803- 12. PMC7906628 33548194
  42. Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, et al. Effect of an inactivated vaccine against SARS-CoV-2 on safety and immunogenicity outcomes: interim analysis of 2 randomized clinical trials. JAMA 2020; 324(10): 951- 60. PMC7426884 32789505
  43. Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomized, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infectious Diseases 2020; 21(1): 39- 51. PMC7561304 33069281
  44. Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, et al. Safety and immunogenicity of an inactivated COVID-19 vaccine, BBIBP-CorV, in people younger than 18 years: a randomized, double-blind, controlled, phase 1/2 trial. Lancet Infectious Diseases 2021; 22(2): 196- 208. PMC8443232 34536349
  45. Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomized, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infectious Diseases 2021; 21(2): 181- 92. PMC7832443 33217362
  46. Baden LR, El Sahly HM, Essink B, Follmann D, Neuzil KM, August A, et al. Covid-19 in the phase 3 trial of mRNA-1273 during the Delta-variant surge. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.17.21263624] PMC8609569 34731553 · DOI
  47. Barrett JR, Belij-Rammerstorfer S, Dold C, Ewer KJ, Folegatti PM, Gilbride C, et al. Phase 1/2 trial of SARS-CoV-2 vaccine ChAdOx1 nCoV-19 with a booster dose induces multifunctional antibody responses. Nature Medicine 2021; 27(2): 279- 88. 33335322
  48. Ewer KJ, Barrett JR, Belij-Rammerstorfer S, Sharpe H, Makinson R, Morter R, et al. T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial. Nature Medicine 2021; 27(2): 270- 8. 33335323
  49. Flaxman A, Marchevsky NG, Jenkin D, Aboagye J, Aley PK, Angus B, et al. Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomized controlled trials (COV001 and COV002). Lancet 2021; 398(10304): 981- 90. PMC8409975 34480858
  50. Hsieh SM, Liu WD, Huang YS, Lin YJ, Hsieh EF, Lian WC, et al. Safety and immunogenicity of a recombinant stabilized prefusion SARS-CoV-2 spike protein vaccine (MVC-COV1901) adjuvanted with CpG 1018 and aluminum hydroxide in healthy adults: a phase 1, dose-escalation study. eClinicalMedicine 2021; 38: 100989. PMC8233066 34222848
  51. Irfan N, Chagla Z. In South Africa, a 2-dose Oxford/AZ vaccine did not prevent mild to moderate COVID-19 (cases mainly B.1.351 variant). Annals of Internal Medicine 2021; 174(5): JC50. 33939483
  52. Lazarus R, Baos S, Cappel-Porter H, Carson-Stevens A, Clout M, Culliford L, et al. The safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults: a phase IV, multicentre randomized controlled trial with blinding (ComFluCOV). SSRN 2021 [Preprint]. [DOI: 10.2139/ssrn.3931758] PMC8585490 34774197 · DOI
  53. Patamatamkul S, Thammawat S, Buranrat B. Induction of robust neutralizing antibodies against the COVID-19 Delta variant with ChAdOx1 nCoV-19 or BNT162b2 as a booster following a primary vaccination series with CoronaVac. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.25.21264099] · DOI
  54. Ward BJ, Séguin A, Couillard J, Trépanier S, Landry N. Phase III: randomized observer-blind trial to evaluate lot-to-lot consistency of a new plant-derived quadrivalent virus like particle influenza vaccine in adults 18-49 years of age. Vaccine 2021; 39(10): 1528- 33. 33581920
  55. Wu K, Choi A, Koch M, Ma LZ, Hill A, Nunna N, et al. Preliminary analysis of safety and immunogenicity of a SARS-CoV-2 variant vaccine booster. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.05.05.21256716] PMC8604720 34526698 · DOI · Paper page
  56. Zdanowski W, Waśniewski T. Evaluation of SARS-CoV-2 spike protein antibody titers in cord blood after COVID-19 vaccination during pregnancy in Polish healthcare workers: preliminary results. Vaccines 2021; 9(6): 675. PMC8234119 34205434
  57. Abbasi J. COVID-19 and mRNA vaccines – first large test for a new approach. JAMA 2020; 324(12): 1125- 7. 32880613
  58. Angkasekwinai N, Sewatanon J, Niyomnaitham S, Phumiamorn S, Sukapirom K, Sapsutthipas S, et al. Comparison of safety and immunogenicity of CoronaVac and ChAdOx1 against the SARS-CoV-2 circulating variants of concern (Alpha, Delta, Beta) in Thai healthcare workers. Vaccine X 2022; 10: 100153. PMC8896862 35282410
  59. Attaway AH, Scheraga RG, Bhimraj A, Biehl M, Hatipoğlu U. Severe Covid-19 pneumonia: pathogenesis and clinical management. BMJ 2021; 372: n436. 33692022
  60. Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. New England Journal of Medicine 2021; 384(5): 403- 16. PMC7787219 33378609
  61. Borobia AM, Carcas AJ, Pérez-Olmeda M, Castaño L, Bertran MJ, García-Pérez J, et al. Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet 2021; 398(10295): 121- 30. PMC8233007 34181880
  62. Boutron I, Chaimani A, Meerpohl JJ, Hróbjartsson A, Devane D, Rada G, et al. The COVID-NMA Project: building an evidence ecosystem for the COVID-19 pandemic. Annals of Internal Medicine 2020; 173(12): 1015- 7. PMC7518109 32931326
  63. Boutron I, Chaimani A, Meerpohl JJ, Hróbjartsson A, Devane D, Rada G, et al. Interventions for preventing and treating COVID-19: protocol for a living mapping of research and a living systematic review. Cochrane Database of Systematic Reviews 2020, Issue 11. Art. No: CD013769. [DOI: 10.1002/14651858.CD013769] · DOI · Paper page
  64. Bucci EM, Berkhof J, Gillibert A, Gopalakrishna G, Calogero RA, Bouter LM, et al. Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial. Lancet 2021; 397(10288): 1881- 3. PMC9751705 33991475
  65. Bueno SM, Abarca K, González PA, Gálvez NM, Soto JA, Duarte LF, et al. Interim report: safety and immunogenicity of an inactivated vaccine against SARS-CoV-2 in healthy Chilean adults in a phase 3 clinical trial. medRxiv 2021 [Preprint].
  66. Cabanac G, Oikonomidi T, Boutron I. Day-to-day discovery of preprint-publication links. Scientometrics 2021; 126(6): 5285- 304. PMC8053368 33897069
  67. Castagneto Gissey L, Panunzi S, Maltese S, Russo MF, Angelini G, De Gaetano A, et al. Living systematic meta-analysis of COVID-19 vaccines and dose allocation strategies. SSRN 2021 [Preprint]. [DOI: 10.2139/ssrn.3827806] · DOI
  68. Chaimani A, Salanti G. Visualizing assumptions and results in network meta-analysis: the Network Graphs Package. Stata Journal 2015; 15(4): 905- 50.
  69. Chaimani A, Caldwell DM, Li T, Higgins JP, Salanti G. Chapter 11: Undertaking network meta-analyses. In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.3 (updated February 2022). Cochrane, 2022. Available from training.cochrane.org/handbook.
  70. Chappell KJ, Mordant FL, Li Z, Wijesundara DK, Ellenberg P, Lackenby JA, et al. Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Infectious Diseases 2021; 21(10): 1383- 94. PMC8055208 33887208
  71. Che Y, Liu X, Pu Y, Zhou M, Zhao Z, Jiang R, et al. Randomized, double-blinded, placebo-controlled Phase 2 trial of an inactivated severe acute respiratory syndrome coronavirus 2 vaccine in healthy adults. Clinical Infectious Diseases 2021; 73(11): e3949- 55. PMC7717222 33165503
  72. Chu L, McPhee R, Huang W, Bennett H, Pajon R, Nestorova B, et al. A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine 2021; 39(20): 2791- 9. PMC7871769 33707061
  73. Dal-Ré R, Bekker LG, Gluud C, Holm S, Jha V, Poland GA, et al. Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities. Lancet Infectious Diseases 2021; 21(11): e342- 7. PMC8131060 34019801
  74. Dal-Ré R, Orenstein W, Caplan AL. Being fair to participants in placebo-controlled COVID-19 vaccine trials. Nature Medicine 2021; 27(6): 938. 33903751
  75. DeZure AD, Berkowitz NM, Graham BS, Ledgerwood JE. Whole-inactivated and virus-like particle vaccine strategies for chikungunya virus. Journal of Infectious Diseases 2016; 214(Suppl 5): S497- 9. PMC5137244 27920180
  76. Dong Y, Dai T, Wei Y, Zhang L, Zheng M, Zhou F. A systematic review of SARS-CoV-2 vaccine candidates. Signal Transduction and Targeted Therapy 2020; 5(1): 237. PMC7551521 33051445
  77. Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997; 315: 629- 34. PMC2127453 9310563
  78. Ella R, Reddy S, Jogdand H, Sarangi V, Ganneru B, Prasad S, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomized, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomized phase 1 trial. Lancet Infectious Diseases 2021; 21(7): 950- 61. PMC8221739 33705727
  79. Enjuanes L, Zuñiga S, Castaño-Rodriguez C, Gutierrez-Alvarez J, Canton J, Sola I. Molecular basis of coronavirus virulence and vaccine development. Advances in Virus Research 2016; 96: 245- 86. PMC7112271 27712626
  80. Feikin DR, Higdon MM, Abu-Raddad LJ, Andrews N, Araos R, Goldberg Y, et al. Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression. Lancet 2022; 399(10328): 924- 44. PMC8863502 35202601
  81. Feng Y, Chen J, Yao T, Chang Y, Li X, Xing R, et al. Safety and Immunogenicity of Inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.08.06.21261696] PMC8692079 34933684 · DOI
  82. Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet 2020; 396: 467- 78. PMC7445431 32702298
  83. Formica N, Mallory R, Albert G, Robinson M, Plested JS, Cho I, et al, the 2019nCoV-101 Study Group. Evaluation of a SARS-CoV-2 vaccine NVX-CoV2373 in younger and older adults. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.02.26.21252482] PMC8486115 34597298 · DOI · Paper page
  84. Fuenmayor J, Gòdia F, Cervera L. Production of virus-like particles for vaccines. New Biotechnology 2017; 39(Pt B): 174- 80. PMC7102714 28778817
  85. Gobeil P, Pillet S, Séguin A, Boulay I, Mahmood A, Vinh DC, et al. Interim report of a Phase 2 randomized trial of a plant-produced virus-like particle vaccine for Covid-19 in healthy adults aged 18-64 and older adults aged 65 and older. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.05.14.21257248] · DOI
  86. Goepfert PA, Fu B, Chabanon AL, Bonaparte MI, Davis MG, Essink BJ, et al. Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 1-2, dose-ranging study. Lancet Infectious Diseases 2021; 21(9): 1257- 70. PMC8055206 33887209
  87. Harder T, Koch J, Vygen-Bonnet S, Kulper-Schiek W, Pilic A, Reda S, et al. Efficacy and effectiveness of COVID-19 vaccines against SARS-CoV-2 infection: interim results of a living systematic review, 1 January to 14 May 2021. Eurosurveillance 2021; 26(28): 2100563. PMC8284046 34269175
  88. Hayawi K, Shahriar S, Serhani MA, Alashwal H, Masud MM. Vaccine versus variants (3Vs): are the COVID-19 vaccines effective against the variants? A systematic review. Vaccines 2021; 9(11): 1305. PMC8622454 34835238
  89. Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, et al. Efficacy of the NVX-CoV2373 Covid-19 vaccine against the B.1.1.7 variant. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.05.13.21256639] · DOI
  90. Higdon MM, Wahl B, Jones CB, Rosen JG, Truelove SA, Baidya A, et al. A systematic review of COVID-19 vaccine efficacy and effectiveness against SARS-CoV-2 infection and disease. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.17.21263549] · DOI
  91. Hobernik D, Bros M. DNA vaccines – how far from clinical use? International Journal of Molecular Sciences 2018; 19(11): 3605. PMC6274812 30445702
  92. Korang SK, Rohden E von, Veroniki AA, Ong G, Ngalamika O, Siddiqui F, 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. PMC8782520 35061702
  93. Kow CS, Ramachandram DS, Hasan SS. The effectiveness of mRNA-1273 vaccine against COVID-19 caused by Delta variant: a systematic review and meta-analysis. Journal of Medical Virology 2022; 94(5): 2269- 74. PMC9015635 34978339
  94. Lazarus R, Taucher C, Brown C, Čorbic I, Danon L, Dubischar K, et al. Immunogenicity and safety of inactivated whole virion Coronavirus vaccine with CpG (VLA2001) in healthy adults aged 18 to 55: a randomised phase 1 /2 clinical trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.08.13.21262021] · DOI
  95. Li M, Yang J, Wang L, Wu Q, Wu Z, Zheng W, et al. A booster dose is immunogenic and will be needed for older adults who have completed two doses vaccination with CoronaVac: a randomized, double-blind, placebo-controlled, phase 1/2 clinical trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.08.03.21261544] · DOI
  96. Liu X, Shaw RH, Stuart AS, Greenland M, Dinesh T, Provstgaard-Morys S, et al. Safety and immunogenicity report from the com-COV study – a single-blind randomised non-inferiority trial comparing heterologous and homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine. SSRN 2021 [Preprint]. PMC8346248 34370971
  97. Low JG, Alwis R de, Chen S, Kalimuddin S, Leong YA, Mah TK, et al. A phase 1/2 randomized, double-blinded, placebo controlled ascending dose trial to assess the safety, tolerability and immunogenicity of ARCT-021 in healthy adults. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.07.01.21259831] · DOI · Paper page
  98. Lv M, Luo X, Shen Q, Lei R, Liu X, Liu E, et al. Safety, immunogenicity, and efficacy of COVID-19 vaccines in children and adolescents: a systematic review. Vaccines 2021; 9(10): 1102. PMC8539812 34696210
  99. Madhi SA, Koen AL, Fairlie L, Cutland CL, Baillie V, Padayachee SD, et al. ChAdOx1 nCoV-19 (AZD1222) vaccine in people living with and without HIV. Research Square 2021 [Preprint]. [DOI: 10.21203/rs.3.rs-322470/v1] PMC8372504 34416193 · DOI
  100. Makris M, Pavord S, Lester W, Scully M, Hunt B. Vaccine-induced immune thrombocytopenia and thrombosis (VITT). Research and Practice in Thrombosis and Haemostasis 2021; 5(5): e12529. PMC8178610 34136745
  101. Mammen MP Jr, Tebas P, Agnes J, Giffear M, Kraynyak KA, Blackwood E, et al. Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: a preliminary report of a randomized, blinded, placebo-controlled, Phase 2 clinical trial in adults at high risk of viral exposure. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.05.07.21256652] · DOI
  102. Marshall JC, Murthy S, Diaz J, Adhikari NK, Angus DC, Arabi YM, et al. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infectious Diseases 2020; 20(8): e192- 7. PMC7292605 32539990
  103. Mavridis D, Welton NJ, Sutton A, Salanti G. A selection model for accounting for publication bias in a full network meta-analysis. Statistics in Medicine 2014; 33(30): 5399- 412. 25316006
  104. Meng FY, Gao F, Jia SY, Wu XH, Li JX, Guo XL, et al. Safety and immunogenicity of a recombinant COVID-19 vaccine (Sf9 cells) in healthy population aged 18 years or older: two single-center, randomised, double-blind, placebo-controlled, phase 1 and phase 2 trials. Signal Transduction and Targeted Therapy 2021; 6(1): 271. PMC8281021 34267185
  105. Mortola E, Roy P. Efficient assembly and release of SARS coronavirus-like particles by a heterologous expression system. FEBS Letters 2004; 576(1-2): 174- 8. PMC7126153 15474033
  106. Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature 2020; 586(7830): 589- 93. 32785213
  107. Nguyen TP, Do Q, Phan LT, Dinh DV, Khong H, Hoang LV, et al. Safety and immunogenicity of Nanocovax, a SARS-CoV-2 recombinant spike protein vaccine. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.07.22.21260942] PMC9108376 35602004 · DOI
  108. Oikonomidi T, Boutron I, Pierre O, Cabanac G, Ravaud P, COVID-19 NMA Consortium. Changes in evidence for studies assessing interventions for COVID-19 reported in preprints: meta-research study. BMC Medicine 2020; 18(1): 402. PMC7745199 33334338
  109. Ostrowski SR, Søgaard OS, Tolstrup M, Stærke NB, Lundgren J, Østergaard L, et al. Inflammation and platelet activation after COVID-19 vaccines – possible mechanisms behind vaccine-induced immune thrombocytopenia and thrombosis. Frontiers in Immunology 2021; 12: 779453. PMC8649717 34887867
  110. Oxford Vaccine Group. Vaccine Knowledge Project: independent information about vaccines and infectious diseases. vk.ovg.ox.ac.uk/vk (accessed prior to 1 November 2022).
  111. Pajon R, Paila YD, Girard B, Dixon G, Kacena K, Baden LR, et al. Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.28.21264252] PMC9018421 35145311 · DOI
  112. Pan HX, Liu JK, Huang BY, Li GF, Chang XY, Liu YF, et al. Immunogenicity and safety of a SARS-CoV-2 inactivated vaccine (KCONVAC) in healthy adults: two randomized, double-blind, and placebo-controlled Phase 1/2 clinical trials. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.04.07.21253850] · DOI
  113. Pan HX, Wu QH, Zeng G, Yang J, Jiang DY, Deng XW, et al. Immunogenicity and safety of a third dose, and immune persistence of CoronaVac vaccine in healthy adults aged 18–59 years: interim results from a double-blind, randomized, placebo-controlled phase 2 clinical trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.07.23.21261026] · DOI
  114. Pérez-Rodríguez S, la Caridad Rodríguez-González M de, Ochoa-Azze R, Climent-Ruiz Y, Alberto González-Delgado C, Paredes-Moreno B, et al. A randomized, double-blind phase I clinical trial of two recombinant dimeric RBD COVID-19 vaccine candidates: safety, reactogenicity and immunogenicity. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.10.04.21264522] PMC8823954 35164986 · DOI
  115. Pitisuttithum P, Luvira V, Lawpoolsri S, Muangnoicharoen S, Kamolratanakul S, Sivakorn C, et al. Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: interim results of a randomised, placebo-controlled, Phase 1/2 trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.17.21263758] PMC8903824 35284808 · DOI
  116. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. New England Journal of Medicine 2020; 383(27): 2603- 15. PMC7745181 33301246
  117. Pollard AJ, Bijker EM. A guide to vaccinology: from basic principles to new developments. Nature Reviews Immunology 2021; 21(2): 83- 100. PMC7754704 33353987
  118. Pu J, Yu Q, Yin Z, Zhang Y, Li X, Yin Q, et al. The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18–59 years: a phase I randomized, double-blinded, controlled trial. Vaccine 2021; 39(20): 2746- 54. PMC8040531 33875266
  119. Qiao J. What are the risks of COVID-19 infection in pregnant women? Lancet 2020; 395(10226): 760- 2. PMC7158939 32151334
  120. Ramasamy MN, Minassian AM, Ewer KJ, Flaxman AL, Folegatti PM, Owens DR, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomized, controlled, phase 2/3 trial. Lancet 2020; 396(10267): 1979- 93. PMC7674972 33220855
  121. Richmond P, Hatchuel L, Dong M, Ma B, Hu B, Smolenov I, et al. Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomized, double-blind, placebo-controlled trial. Lancet 2021; 397(10275): 682- 94. PMC7906655 33524311
  122. Rizk JG, Gupta A, Sardar P, Henry BM, Lewin JC, Lippi G, et al. Clinical characteristics and pharmacological management of COVID-19 vaccine-induced immune thrombotic thrombocytopenia with cerebral venous sinus thrombosis: a review. JAMA Cardiology 2021; 6(12): 1451- 60. 34374713
  123. Roozen GV, Prins ML, Binnendijk R van, den Hartog G, Kuiper VP, Prins C, et al. Tolerability, safety and immunogenicity of intradermal delivery of a fractional dose mRNA-1273 SARS-CoV-2 vaccine in healthy adults as a dose sparing strategy. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.07.27.21261116] · DOI
  124. Roper RL, Rehm KE. SARS vaccines: where are we? Expert Review of Vaccines 2009; 8(7): 887- 98. PMC7105754 19538115
  125. Rotshild V, Hirsh-Raccah B, Miskin I, Muszkat M, Matok I. Comparing the clinical efficacy of COVID-19 vaccines: a systematic review and network meta-analysis. Scientific Reports 2021; 11(1): 22777. PMC8611039 34815503
  126. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromized host. Clinical Infectious Diseases 2013; 58(3): e44- e100. 24311479
  127. Ryzhikov AB, Ryzhikov ЕА, Bogryantseva MP, Usova SV, Danilenko ED, Nechaeva EA, et al. A single blind, placebo-controlled randomized study of the safety, reactogenicity and immunogenicity of the "EpiVacCorona" vaccine for the prevention of COVID-19. Russian Journal of Infection and Immunity 2021; 11(2): 283- 96.
  128. Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, Groot AM de, et al. Safety and immunogenicity of the Ad26. COV2. S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial. MedRxiv 2020 [Preprint].
  129. Salanti G, Ades AE, Ioannidis JP. Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. Journal of Clinical Epidemiology 2011; 64(2): 163- 7. 20688472
  130. Schünemann HJ, Higgins JP, Vist GE, Glasziou P, Akl EA, Skoetz N, et al. Chapter 14: Completing 'Summary of findings' tables and grading the certainty of the evidence. In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.2 (updated February 2021). Cochrane, 2021. Available from training.cochrane.org/handbook/archive/v6.2.
  131. Sharifian-Dorche M, Bahmanyar M, Sharifian-Dorche A, Mohammadi P, Nomovi M, Mowla A. Vaccine-induced immune thrombotic thrombocytopenia and cerebral venous sinus thrombosis post COVID-19 vaccination; a systematic review. Journal of the Neurological Sciences 2021; 428: 117607. PMC8330139 34365148
  132. Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, et al, for the 2019nCoV-501 Study Group. Preliminary efficacy of the NVX-CoV2373 Covid-19 vaccine against the B.1.351 variant. medRxiv 2021 [Preprint]. PMC8091623 33951374
  133. Shu YJ, He JF, Pei RJ, He P, Huang ZH, Chen SM, et al. Immunogenicity and safety of a recombinant fusion protein vaccine (V-01) against coronavirus disease 2019 in healthy adults: a randomized, double-blind, placebo-controlled, phase II trial. Chinese Medical Journal 2021; 134(16): 1967- 76. PMC8382383 34310400
  134. Sridhar S, Joaquin A, Bonaparte MI, Bueso A, Chabanon AL, Chen A, et al. Safety and immunogenicity of a SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in healthy adults: interim findings from a phase 2, randomised, dose-finding, multi-centre study. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.10.08.21264302] PMC8789245 35090638 · DOI
  135. Stephenson KE, Le Gars M, Sadoff J, Groot AM de, Heerwegh D, Truyers C, et al. Immunogenicity of the Ad26.COV2.S vaccine for COVID-19. JAMA 2021; 325(15): 1535- 44. PMC7953339 33704352
  136. Thomas SJ, Moreira ED, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Six month safety and efficacy of the BNT162b2 Mrna Covid-19 vaccine. medRxiv 2021 [Preprint]. PMC8461570 34525277
  137. Riel D van, Wit E de. Next-generation vaccine platforms for COVID-19. Nature Materials 2020; 19(8): 810- 2. 32704139
  138. Viechtbauer W. Conducting meta-analyses in R with the metafor package. Journal of Statistical Software 2010; 36(3): 1- 48.
  139. Voysey M, Costa Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomized trials. Lancet 2021; 397(10277): 881- 91. PMC7894131 33617777
  140. Walsh EE, Frenck R, Falsey AR, Kitchin N, Absalon J, Gurtman A, et al. RNA-based COVID-19 vaccine BNT162b2 selected for a pivotal efficacy study. medRxiv 2021 [Preprint].
  141. Ward BJ, Gobeil P, Séguin A, Atkins J, Boulay I, Charbonneau PY, et al. Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19. Nature Medicine 2021; 27(6): 1071- 8. PMC8205852 34007070
  142. White IR, Higgins JP, Wood AM. Allowing for uncertainty due to missing data in meta-analysis – part 1: two-stage methods. Statistics in Medicine 2008; 27(5): 711- 27. 17703496
  143. WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation. Placebo-controlled trials of covid-19 vaccines – why we still need them. New England Journal of Medicine 2021; 384: e2. [DOI: 10.1056/NEJMp2033538] 33264543 · DOI · Paper page
  144. Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, et al. Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial. Lancet Infectious Diseases 2021; 21(12): 1654- 64. PMC8313090 34324836
  145. Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, et al. Effect of an inactivated vaccine against SARS-CoV-2 on safety and immunogenicity outcomes: interim analysis of 2 randomized clinical trials. JAMA 2020; 324(10): 951- 60. PMC7426884 32789505
  146. Yang S, Li Y, Dai L, Wang J, He P, Li C, et al. Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomized, double-blind, placebo-controlled, phase 1 and 2 trials. Lancet Infectious Diseases 2021; 21(8): 1107- 19. PMC7990482 33773111
  147. Zakarya K, Kutumbetov L, Orynbayev M, Abduraimov Y, Sultankulova K, Kassenov M, et al. A single-centre, randomized, single-blind, placebo-controlled phase 1 and an open-label phase 2 clinical trials with a 6 months follow-up in Kazakhstan. EClinicalMedicine 2021; 39: 101078. PMC8363482 34414368
  148. Zeng L, Brignardello-Petersen R, Hultcrantz M, Siemieniuk RA, Santesso N, Traversy G, et al. GRADE guidelines 32: GRADE offers guidance on choosing targets of GRADE certainty of evidence ratings. Journal of Clinical Epidemiology 2021; 137: 163- 75. 33857619
  149. Zeng B, Gao L, Zhou Q, Yu K, Sun F. Effectiveness of COVID-19 vaccines against SARS-CoV-2 variants of concern: a systematic review and meta-analysis. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.23.21264048] PMC9126103 35606843 · DOI
  150. Zhang J, Hu Z, He J, Liao Y, Li Y, Pei R, et al. Safety and immunogenicity of a recombinant interferon-armed RBD dimer vaccine (V-01) for COVID-19 in healthy adults: a randomized, double-blind, placebo-controlled, Phase I trial. Emerging Microbes & Infections 2021; 10(1): 1589- 97. PMC8366678 34197281
  151. Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomized, double-blind, placebo-controlled, phase 2 trial. Lancet 2020; 396(10249): 479- 88. PMC7836858 32702299
  152. Zhu F, Jin P, Zhu T, Wang W, Ye H, Pan H, et al. Safety and immunogenicity of a recombinant adenovirus type-5-vectored COVID-19 vaccine with a homologous prime-boost regimen in healthy participants aged 6 years and above: a randomized, double-blind, placebo-controlled, phase 2b trial. Clinical Infectious Diseases 2022; 75(1): e783- 91. [DOI: 10.1093/cid/ciab845] PMC8522421 34551104 · DOI
  153. Zhu F, Jin P, Zhu T, Wang W, Ye H, Pan H, et al. Safety and immunogenicity of a recombinant adenovirus type-5-vectored COVID-19 vaccine with a homologous prime-boost regimen in healthy participants aged 6 years and above: a randomized, double-blind, placebo-controlled, phase 2b trial. Clinical Infectious Diseases 2022; 75(1): e783- 91. PMC8522421 34551104

Authors
Graña, C., Ghosn, L., Evrenoglou, T., Jarde, A., Minozzi, S., Bergman, H., Buckley, B. S., Probyn, K., Villanueva, G., Henschke, N., Bonnet, H., Assi, R., Menon, S., Marti, M., Devane, D., Mallon, P., Lelievre, J.-D., Askie, L. M., Kredo, T., Ferrand, G., Davidson, M., Riveros, C., Tovey, D., Meerpohl, J. J., Grasselli, G., Rada, G., Hróbjartsson, A., Ravaud, P., Chaimani, A., & Boutron, I.
Affiliations
  • Inserm (FR)
  • Cochrane Review Group on Drugs and Alcohol; Rome Italy
  • Cochrane (GB)
  • World Health Organization (CH)
  • Ollscoil na Gaillimhe – University of Galway (IE)
  • University College Dublin (IE)
  • Department of Clinical Immunology and Infectious Diseases, Henri Mondor Hospital; Vaccine Research Institute, Université Paris Est Créteil; Paris France
  • South African Medical Research Council (ZA)
  • University of Freiburg (DE)
  • University of Milan (IT)
  • Epistemonikos Foundation; Santiago Chile
  • University of Southern Denmark (DK)
Corresponding author
Boutron, Isabelle
ORCID
Venue
Cochrane Database of Systematic Reviews
Publisher
Wiley
Published
2022-12-07
Volume
2023
Issue
3
Pages
CD015477-CD015477
ISSN
  • 1361-6137 (ISSN-L)
  • 1465-1858
DOI
10.1002/14651858.cd015477
PMC
PMC9726273
OpenAlex
W4311703170
Cited by
310
References
150
Citations by year
2026: 14 · 2025: 65 · 2024: 107 · 2023: 114 · 2022: 7 · 2021: 2
FWCI
11.27
Type
journal article
Language
en
Open access
Locations
  • Cochrane Database of Systematic Reviews (publishedVersion)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • HAL (submittedVersion, cc-by-nc-nd)
  • University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, cc-by-nc-nd)
  • FreiDok plus (Universitätsbibliothek Freiburg) (submittedVersion)
Funders
  • World Health Organization
  • Health Research Board (ESI-2021-001)
Topics
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
  • Social Sciences › Health › Vaccine Coverage and Hesitancy
Keywords
COVID-19 vaccines, SARS-CoV-2, vaccine efficacy, vaccine safety, booster vaccination, severe COVID-19, critical COVID-19, serious adverse events, immunogenicity, immunocompromised patients, children and adolescents, pregnant women, mortality, vaccine hesitancy
MeSH terms
COVID-19, SARS-CoV-2, COVID-19 Vaccines, 2019-nCoV Vaccine mRNA-1273, Adolescent, Aged, Humans, Middle Aged, Vaccines, Inactivated

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review