diff --git "a/test/parse_examples/36473651.xml" "b/test/parse_examples/36473651.xml" new file mode 100644--- /dev/null +++ "b/test/parse_examples/36473651.xml" @@ -0,0 +1,2984 @@ + + + + + + 36473651 + + 2022 + 12 + 15 + + + 2024 + 06 + 05 + +
+ + 1469-493X + + 12 + 12 + + 2022 + Dec + 07 + + + The Cochrane database of systematic reviews + Cochrane Database Syst Rev + + Efficacy and safety of COVID-19 vaccines. + + CD015477 + CD015477 + + CD015477 + 10.1002/14651858.CD015477 + + 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. + 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. + We included randomized controlled + trials (RCTs) comparing COVID-19 vaccines to placebo, no vaccine, other + active vaccines, or other vaccine schedules. + 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 participants. Evidence for SAEs is uncertain for + BNT162b2, CoronaVac, BBIBP-CorV, and NVX-CoV2373 compared to placebo (RR: + BNT162b2: 1.30, 95% CI 0.55 to 3.07; 2 RCTs, 46,107 participants; CoronaVac: + 0.97, 95% CI 0.62 to 1.51; 4 RCTs, 23,139 participants; BBIBP-CorV: 0.76, + 95% CI 0.54 to 1.06; 1 RCT, 26,924 participants; NVX-CoV2373: 0.92, 95% CI + 0.74 to 1.14; 4 RCTs, 38,802 participants). For the evaluation of + heterologous schedules, booster doses, and efficacy against variants of + concern, see main text of review. + Compared to placebo, most vaccines + reduce, or likely reduce, the proportion of participants with confirmed + symptomatic COVID-19, and for some, there is high-certainty evidence that + they reduce severe or critical disease. There is probably little or no + difference between most vaccines and placebo for serious adverse events. + Over 300 registered RCTs are evaluating the efficacy of COVID-19 vaccines, + and this review is updated regularly on the COVID-NMA platform + (covid-nma.com). Implications for practice Due to the trial exclusions, + these results cannot be generalized to pregnant women, individuals with a + history of SARS-CoV-2 infection, or immunocompromized people. Most trials + had a short follow-up and were conducted before the emergence of variants of + concern. Implications for research Future research should evaluate the + long-term effect of vaccines, compare different vaccines and vaccine + schedules, assess vaccine efficacy and safety in specific populations, and + include outcomes such as preventing long COVID-19. Ongoing evaluation of + vaccine efficacy and effectiveness against emerging variants of concern is + also vital. + Copyright © 2022 The Authors. Cochrane Database of + Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The + Cochrane Collaboration. + + + + Graña + Carolina + C + + Cochrane France, Paris, France. + + + Centre of Research in Epidemiology and Statistics (CRESS), + INSERM, INRAE, Université de Paris, Paris, France. + + + + Ghosn + Lina + L + + Cochrane France, Paris, France. + + + Centre of Research in Epidemiology and Statistics (CRESS), + INSERM, INRAE, Université de Paris, Paris, France. + + + + Evrenoglou + Theodoros + T + + Centre of Research in Epidemiology and Statistics (CRESS), + INSERM, INRAE, Université de Paris, Paris, France. + + + + Jarde + Alexander + A + + Cochrane France, Paris, France. + + + Centre of Research in Epidemiology and Statistics (CRESS), + INSERM, INRAE, Université de Paris, Paris, France. + + + + Minozzi + Silvia + S + + Cochrane Review Group on Drugs and Alcohol, Rome, Italy. + + + + Bergman + Hanna + H + + Cochrane Response, Cochrane, London, UK. + + + + Buckley + Brian S + BS + + Cochrane Response, Cochrane, London, UK. + + + + Probyn + Katrin + K + + Cochrane Response, Cochrane, London, UK. + + + + Villanueva + Gemma + G + + Cochrane Response, Cochrane, London, UK. + + + + Henschke + Nicholas + N + + Cochrane Response, Cochrane, London, UK. + + + + Bonnet + Hillary + H + + Cochrane France, Paris, France. + + + Centre of Research in Epidemiology and Statistics (CRESS), + INSERM, INRAE, Université de Paris, Paris, France. + + + + Assi + Rouba + R + + Cochrane France, Paris, France. + + + Centre of Research in Epidemiology and Statistics (CRESS), + INSERM, INRAE, Université de Paris, Paris, France. + + + + Menon + Sonia + S + + Cochrane France, Paris, France. + + + + Marti + Melanie + M + + Department of Immunization, Vaccines and Biologicals, World + Health Organization, Geneva, Switzerland. + + + + Devane + Declan + D + + Evidence Synthesis Ireland, Cochrane Ireland and HRB-Trials + Methodology Research Network, National University of Ireland, + Galway, Ireland. + + + + Mallon + Patrick + P + + UCD Centre for Experimental Pathogen Host Research and UCD + School of Medicine, University College Dublin, Dublin, Ireland. + + + + Lelievre + Jean-Daniel + JD + + Department of Clinical Immunology and Infectious Diseases, + Henri Mondor Hospital, Vaccine Research Institute, Université + Paris Est Créteil, Paris, France. + + + + Askie + Lisa M + LM + + Quality Assurance Norms and Standards Department, World + Health Organization, Geneva, Switzerland. + + + + Kredo + Tamara + T + + Cochrane South Africa, South African Medical Research + Council, Cape Town, South Africa. + + + + Ferrand + Gabriel + G + + Cochrane France, Paris, France. + + + + Davidson + Mauricia + M + + Cochrane France, Paris, France. + + + Centre of Research in Epidemiology and Statistics (CRESS), + INSERM, INRAE, Université de Paris, Paris, France. + + + + Riveros + Carolina + C + + Cochrane France, Paris, France. + + + Centre of Research in Epidemiology and Statistics (CRESS), + INSERM, INRAE, Université de Paris, Paris, France. + + + + Tovey + David + D + + Cochrane France, Paris, France. + + + + Meerpohl + Joerg J + JJ + + Institute for Evidence in Medicine, Medical Center & + Faculty of Medicine, University of Freiburg, Freiburg, Germany. + + + Cochrane Germany, Cochrane Germany Foundation, Freiburg, + Germany. + + + + Grasselli + Giacomo + G + + Department of Anesthesia, Intensive Care and Emergency, + Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, + Department of Pathophysiology and Transplantation, University of + Milan, Milan, Italy. + + + + Rada + Gabriel + G + + Epistemonikos Foundation, Santiago, Chile. + + + UC Evidence Center, Cochrane Chile Associated Center, + Pontificia Universidad Católica de Chile, Santiago, Chile. + + + + Hróbjartsson + Asbjørn + A + + Centre for Evidence Based Medicine Odense (CEBMO) and + Cochrane Denmark, University of Southern Denmark, Odense, Denmark. + + + Open Patient data Explorative Network (OPEN), Odense + University Hospital, Odense, Denmark. + + + + Ravaud + Philippe + P + + Cochrane France, Paris, France. + + + Centre of Research in Epidemiology and Statistics (CRESS), + INSERM, INRAE, Université de Paris, Paris, France. + + + + Chaimani + Anna + A + + Cochrane France, Paris, France. + + + Centre of Research in Epidemiology and Statistics (CRESS), + INSERM, INRAE, Université de Paris, Paris, France. + + + + Boutron + Isabelle + I + + Cochrane France, Paris, France. + + + Centre of Research in Epidemiology and Statistics (CRESS), + INSERM, INRAE, Université de Paris, Paris, France. + + + + eng + + + 001 + WHO_ + World Health Organization + International + + + + Journal Article + Review + Systematic Review + + + 2022 + 12 + 07 + +
+ + England + Cochrane Database Syst Rev + 100909747 + 1361-6137 + + + + 0 + sinovac COVID-19 vaccine + + + 0 + BIBP COVID-19 vaccine + + + 76JZE5DSN6 + BBV152 COVID-19 vaccine + + + EPK39PL4R4 + 2019-nCoV Vaccine mRNA-1273 + + + IM + + + Humans + + + Middle Aged + + + Aged + + + Adolescent + + + 2019-nCoV Vaccine mRNA-1273 + + + COVID-19 + prevention & control + + + SARS-CoV-2 + + + Carolina Graña: none known. Lina Ghosn: none known. Theodoros + Evrenoglou: none known. Alexander Jarde: none known. Silvia Minozzi: no relevant + interests; Joint Co‐ordinating Editor and Method editor of the Drugs and + Alcohol Group. Hanna Bergman: Cochrane Response – consultant; WHO – + grant/contract (Cochrane Response was commissioned by the WHO to perform review + tasks that contribute to this publication). . Brian Buckley: none known. . + Katrin Probyn: Cochrane Response – consultant; WHO – consultant + (Cochrane Response was commissioned to perform review tasks that contribute to this + publication). . Gemma Villanueva: Cochrane Response – employment + (Cochrane Response has been commissioned by WHO to perform parts of this systematic + review). . Nicholas Henschke: Cochrane Response – consultant; WHO + – consultant (Cochrane Response was commissioned by the WHO to perform review + tasks that contributed to this publication). . Hillary Bonnet: none known. + Rouba Assi: none known. Sonia Menon: P95 – consultant. Melanie Marti: no + relevant interests; Medical Officer at WHO. Declan Devane: Health Research Board + (HRB) – grant/contract; registered nurse and registered midwife but no longer + in clinical practice; Editor, Cochrane Pregnancy and Childbirth Group. Patrick + Mallon: AstraZeneca – Advisory Board; spoken of vaccine effectiveness to + media (print, online, and live); works as a consultant in a hospital that provides + vaccinations; employed by St Vincent's University Hospital. Jean‐Daniel + Lelievre: no relevant interests; published numerous interviews in the national press + on the subject of COVID vaccination; Head of the Department of Infectious Diseases + and Clinical Immunology CHU Henri Mondor APHP, Créteil; WHO (IVRI‐AC): + expert Vaccelarate (European project on COVID19 Vaccine): head of WP; involved with + COVICOMPARE P et M Studies (APHP, INSERM) (public fundings). . Lisa Askie: no + relevant interests; Co‐convenor, Cochrane Prospective Meta‐analysis + Methods Group. Tamara Kredo: no relevant interests; Medical Officer in an Infectious + Diseases Clinic at Tygerberg Hospital, Stellenbosch University. Gabriel Ferrand: + none known. Mauricia Davidson: none known. Carolina Riveros: no relevant interests; + works as an epidemiologist. David Tovey: no relevant interests; Emeritus Editor in + Chief, Feedback Editors for 2 Cochrane review groups. Joerg J Meerpohl: no relevant + interests; member of the German Standing Vaccination Committee (STIKO). Giacomo + Grasselli: Pfizer – speaking engagement. Gabriel Rada: none known. + Asbjørn Hróbjartsson: no relevant interests; Cochrane Methodology Review + Group Editor. Philippe Ravaud: no relevant interests; involved with Mariette + CORIMUNO‐19 Collaborative 2021, the Ministry of Health, Programme Hospitalier + de Recherche Clinique, Foundation for Medical Research, and AP‐HP Foundation. + Anna Chaimani: none known. Isabelle Boutron: no relevant interests; member of + Cochrane Editorial Board. + + + + + 2022 + 12 + 6 + 19 + 26 + + + 2022 + 12 + 7 + 6 + 0 + + + 2022 + 12 + 15 + 6 + 0 + + + 2022 + 12 + 7 + + + epublish + + 36473651 + PMC9726273 + 10.1002/14651858.CD015477 + + + References to studies included in this review + + Ali 2021 {published data only} + + Ali K, Berman G, Zhou H, Deng W, Faughnan V, Coronado-Voges M, et + al. Evaluation of mRNA-1273 SARS-CoV-2 vaccine in adolescents. New + England Journal of Medicine 2021;385(24):2241-51. + + PMC8385554 + 34379915 + + + + + Al Kaabi 2021 {published data only} + + 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 + + + + + Asano 2022 {published data only} + + 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 + + + + + Bonelli 2021 {published data only} + + 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] + + 10.1101/2021.09.05.21263125 + 35027397 + + + + + Bueno 2021 {published data only} + + 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] + + 10.1101/2021.03.31.21254494 + + + + 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] + + 10.1093/cid/ciab823 + PMC9402626 + 34537835 + + + + + Clemens 2021 {published data only} + + 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 + + + + + Dunkle 2021 {published data only} + + 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] + + 10.1101/2021.10.05.21264567 + PMC8693692 + 34910859 + + + + + Ella 2021a {published data only} + + 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] + + 10.1101/2020.12.11.20210419 + PMC7825810 + 33485468 + + + + 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 + + + + + Ella 2021b {published data only} + + 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] + + 10.1101/2021.06.30.21259439 + PMC8584828 + 34774196 + + + + + El Sahly 2021 {published data only} + + 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 + + + + 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 + + + + Food and Drug Administration. Vaccines and Related Biological + Products Advisory Committee Meeting; December 17, 2020; FDA Briefing + Document: Moderna COVID-19 vaccine. www.fda.gov/media/144434/download + (accessed prior to 1 November 2022). + + + + Emary 2021 {published data only} + + Emary KR, Golubchik T, Aley PK, Ariani CV, Angus B, Bibi S, et al. + Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant + of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomized + controlled trial. Lancet 2021;397(10282):1351-62. + + PMC8009612 + 33798499 + + + + + Fadlyana 2021 {published data only} + + 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. 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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 + + + + + Li 2021a {published data only} + + 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] + + 10.1101/2021.09.03.21263062 + + + + + Liu 2021 {published data only} + + 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 + + + + 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] + + 10.2139/ssrn.3874014 + PMC8346248 + 34370971 + + + + + Logunov 2021 {published data only} + + 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. 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Vaccines and related biological + products Advisory Committee Meeting; February 26, 2021; FDA briefing + document: Janssen Ad26.COV2.S vaccine for the prevention of COVID-19. + www.fda.gov/media/146217/download (accessed prior to 1 November 2022). + + + Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, Groot AM, + 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 + + + + Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, Groot AM, + 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] + + 10.1101/2020.09.23.20199604 + + + + + Sadoff 2021b {published data only} + + 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 + + + + + Shinde 2021 {published data only} + + Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, et + al. Efficacy of NVX-CoV2373 Covid-19 vaccine against the B.1.351 + variant. New England Journal of Medicine 2021;384(20):1899-909. + + PMC8091623 + 33951374 + + + + Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, et + al. Preliminary efficacy of the NVX-CoV2373 Covid-19 vaccine against the + B.1.351 variant. medRxiv 2021 [Preprint]. [DOI: + 10.1101/2021.02.25.21252477] + + 10.1101/2021.02.25.21252477 + PMC8091623 + 33951374 + + + + + Tanriover 2021 {published data only} + + Tanriover MD, Doğanay HL, Akova M, Güner HR, Azap A, + Akhan S, et al. Efficacy and safety of an inactivated whole-virion + SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, + randomized, placebo-controlled, phase 3 trial in Turkey. Lancet + 2021;398(10296):213-22. + + PMC8266301 + 34246358 + + + + + Thomas 2021 {published data only} + + Food and Drug Administration. Vaccines and related biological + products Advisory Committee Meeting; December 10, 2020; FDA briefing + document: Pfizer-BioNTech COVID-19 vaccine. + www.fda.gov/media/144245/download (accessed prior to 1 November 2022). + + + 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 + + + + 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. 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RNA-based COVID-19 vaccine BNT162b2 selected for a pivotal efficacy + study. medRxiv 2020 [Preprint]. [DOI: 10.1101/2020.08.17.20176651] + + 10.1101/2020.08.17.20176651 + + + + 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 + + + + + Wu 2021a {published data only} + + 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 + + + + + Xia 2020 {published data only} + + 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 + + + + 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 + + + + + Xia 2021 {published data only} + + 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 + + + + + Zhang 2021 {published data only} + + 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 + + + + + + References to studies excluded from this review + + Baden 2021 {published data only} + + 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] + + 10.1101/2021.09.17.21263624 + PMC8609569 + 34731553 + + + + + Barrett 2021 {published data only} + + 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. 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PROSPERO 2021 + CRD42021271897. + www.crd.york.ac.uk/prospero/display_record.php?RecordID=271897 (accessed + prior to 1 November 2022). + + + + + + \ No newline at end of file