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      Effectiveness of COVID-19 vaccines in older adults in Colombia: a retrospective, population-based study of the ESPERANZA cohort

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          Abstract

          Background

          Although clinical trials showed that vaccines have high efficacy and safety, differences in study designs and populations do not allow for comparison between vaccines and age groups. The objective of this study was to evaluate the effectiveness of vaccines against COVID-19 in real-world conditions in adults aged 60 years and older in Colombia.

          Methods

          In this retrospective, population-based, matched cohort study, we evaluated the effectiveness of vaccines against COVID-19-related hospitalisation and death in people aged 60 years and older. The full cohort consisted of every person who was eligible to receive a COVID-19 vaccine in Colombia (the ESPERANZA cohort). The exposed cohort consisted of older adults who were fully vaccinated with Ad26.COV2-S, BNT162b2, ChAdOx1 nCoV-19, or CoronaVac, and who did not have a history of confirmed SARS-CoV-2 infection. The unexposed cohort were people aged 60 years and older who had not received any dose of a COVID-19 vaccine during the study period. Participant follow-up was done between March 11, 2021, and Oct 26, 2021. Vaccine effectiveness was estimated as 1– hazard ratio from cause-specific proportional hazards models in the presence of competing risks. We estimated the overall effectiveness of being fully vaccinated, as well as effectiveness for each vaccine, adjusting by main potential confounders. The effectiveness of each vaccine was also assessed by age groups (ages 60–69 years, 70–79 years, and ≥80 years).

          Findings

          2 828 294 participants were assessed between March 11 and Oct 26, 2021. For all ages, the overall effectiveness across all assessed COVID-19 vaccines at preventing hospitalisation without subsequent death was 61·6% (95% CI 58·0–65·0, p<0·0001), 79·8% (78·5–81·1, p<0·0001) for preventing death after hospitalisation with COVID-19, and 72·8% (70·1–75·3, p<0·0001) for preventing death without previous COVID-19 hospitalisation. The effectiveness of all vaccines analysed at preventing death after hospitalisation for COVID-19 was 22·6% lower in adults who were aged 80 and older (68·4% [65·7–70·9], p<0·0001) compared with adults aged between 60 and 69 years (91·0% [89·0–92·6], p<0·0001).

          Interpretation

          All vaccines analysed in this study were effective at preventing hospitalisation and death from COVID-19 in fully vaccinated older adults, which is a promising result for the national vaccination programme against COVID-19 in Colombia and in countries where these biologics have been applied. Efforts should be improved to increase coverage among older adults. In addition, given that we observed that the effectiveness of vaccines declined with increasing age, a booster dose is also justified, which should be prioritised for older adults.

          Funding

          Colombian Ministry of Health and Social Protection.

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          Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

          Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)
          Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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            Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

            Lindsey Baden, Hana El Sahly, Brandon Essink … (2020)
            Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)
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              Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19

              Jerald Sadoff, Glenda Gray, An Vandebosch … (2021)
              Background The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation. Methods In an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants in a 1:1 ratio to receive a single dose of Ad26.COV2.S (5×10 10 viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe–critical coronavirus disease 2019 (Covid-19) with an onset at least 14 days and at least 28 days after administration among participants in the per-protocol population who had tested negative for SARS-CoV-2. Safety was also assessed. Results The per-protocol population included 19,630 SARS-CoV-2–negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe–critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4) and at least 28 days after administration (66 vs. 193 cases; efficacy, 66.1%; adjusted 95% CI, 55.0 to 74.8). Vaccine efficacy was higher against severe–critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1] for onset at ≥14 days and 85.4% [adjusted 95% CI, 54.2 to 96.9] for onset at ≥28 days). Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe–critical Covid-19 with onset at least 14 days and at least 28 days after administration, respectively, and efficacy against severe–critical Covid-19 was 73.1% and 81.7%, respectively. Reactogenicity was higher with Ad26.COV2.S than with placebo but was generally mild to moderate and transient. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19–related), and 16 in the placebo group (5 were Covid-19–related). Conclusions A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe–critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722 .)
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                Author and article information

                Journal
                Journal ID (nlm-ta): Lancet Healthy Longev
                Journal ID (iso-abbrev): Lancet Healthy Longev
                Title: The Lancet. Healthy Longevity
                Publisher: The Author(s). Published by Elsevier Ltd.
                ISSN (Electronic): 2666-7568
                Publication date PMC-release: 21 March 2022
                Publication date (Electronic): 21 March 2022
                Affiliations
                [a ]Ministerio de Salud y Protección Social, Bogotá, Colombia
                [b ]Departamento de Salud Pública, Universidad del Norte, Barranquilla, Colombia
                [c ]Facultad de Salud Pública, Universidad de Antioquia, Medellín, Colombia
                [d ]Centro de Investigación en Nutrición y Salud, Instituto Nacional de Salud Pública de México, Cuernavaca, México
                Author notes
                [* ]Correspondence to: Dr Leonardo Arregocés-Castillo, Ministerio de Salud y Protección Social, Bogotá 110311, Colombia
                Article
                Publisher Item ID: S2666-7568(22)00035-6
                DOI: 10.1016/S2666-7568(22)00035-6
                PMC ID: 8937302
                PubMed ID: 35340743
                SO-VID: 01f24c18-ebc7-46e8-8719-cc66c1cc6984
                Copyright © © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license
                License:

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

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