Breakthrough SARS-CoV-2 infections after vaccination: a critical review

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ABSTRACT

At the beginning of the current pandemic, it was believed that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection would induce lifelong immunity and that reinfections would be unlikely. However, after several cases of reinfection were documented in previously infected patients, this was understood to be a false assumption, and this waning humoral immunity has raised significant concerns. Accordingly, long-term and durable vaccine-induced antibody protection against infection have also become a challenge, as several breakthroughs of COVID-19 infection have been identified in individuals who were fully vaccinated. This review discusses the current evidence on breakthrough COVID-19 infections occurring after vaccination.

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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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Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection

David Khoury, Deborah Cromer, Arnold Reynaldi … (2021)

Predictive models of immune protection from COVID-19 are urgently needed to identify correlates of protection to assist in the future deployment of vaccines. To address this, we analyzed the relationship between in vitro neutralization levels and the observed protection from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection using data from seven current vaccines and from convalescent cohorts. We estimated the neutralization level for 50% protection against detectable SARS-CoV-2 infection to be 20.2% of the mean convalescent level (95% confidence interval (CI) = 14.4-28.4%). The estimated neutralization level required for 50% protection from severe infection was significantly lower (3% of the mean convalescent level; 95% CI = 0.7-13%, P = 0.0004). Modeling of the decay of the neutralization titer over the first 250 d after immunization predicts that a significant loss in protection from SARS-CoV-2 infection will occur, although protection from severe disease should be largely retained. Neutralization titers against some SARS-CoV-2 variants of concern are reduced compared with the vaccine strain, and our model predicts the relationship between neutralization and efficacy against viral variants. Here, we show that neutralization level is highly predictive of immune protection, and provide an evidence-based model of SARS-CoV-2 immune protection that will assist in developing vaccine strategies to control the future trajectory of the pandemic.

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Author and article information

Journal

Journal ID (nlm-ta): Hum Vaccin Immunother

Journal ID (iso-abbrev): Hum Vaccin Immunother

Title: Human Vaccines & Immunotherapeutics

Publisher: Taylor & Francis

ISSN (Print): 2164-5515

ISSN (Electronic): 2164-554X

Publication date (Electronic, pub): 18 March 2022

Publication date (Electronic, collection): 2022

Publication date PMC-release: 18 March 2022

Pages: 1-5

Affiliations

[a ]Clinical Research Development Center, Imam Reza Hospital, Kermanshah University of Medical Sciences; , Kermanshah, Iran

[b ]Student Research Committee, Virtual School of Medical Education and Management, Shahid Beheshti University of Medical Sciences; , Tehran, Iran

[c ]Students’ Scientific Research Center (SSRC), Tehran University of Medical Sciences; , Tehran, Iran

[d ]Student Research Committee, Babol University of Medical Sciences; , Babol, Iran

[e ]Faculty of Medicine, Semmelweis University; , Budapest, Hungary

[f ]O. O. Bogomolets National Medical University; , Kyiv, Ukraine

[g ]Infectious Diseases and Tropical Medicine Research Center, Health Research Institute, Babol University of Medical Sciences; , Babol, Iran

[h ]Department of Radiation Oncology, Mayo Clinic; , Phoenix, Arizona, USA

[i ]Department of Social Sciences, University of Nicosia; , Nicosia, Cyprus

[j ]Department of Life and Health Sciences, University of Nicosia; , Nicosia, Cyprus

[k ]Australian Centre for Precision Health, University of South Australia; , Adelaide, Australia

Author notes

CONTACT Arefeh Babazadeh drbabazadeh.a@ 123456yahoo.com Infectious Diseases and Tropical Medicine Research Center, Health Research Institute, Babol University of Medical Sciences; , Ganjafrooz Blvd., Babol, 4717647745, Mazandaran, Iran

Author information

Zeinab Mohseni Afshar https://orcid.org/0000-0002-1085-374X

Mohammad Barary https://orcid.org/0000-0001-8733-9370

Rezvan Hosseinzadeh https://orcid.org/0000-0001-9399-3854

Amirmasoud Alijanpour https://orcid.org/0000-0002-0734-1356

Dariush Hosseinzadeh https://orcid.org/0000-0002-3479-2515

Soheil Ebrahimpour https://orcid.org/0000-0003-3204-0448

Terence T. Sio https://orcid.org/0000-0003-4210-5479

Mark J. M. Sullman https://orcid.org/0000-0001-7920-6818

Kristin Carson-Chahhoud https://orcid.org/0000-0001-9966-9289

Arefeh Babazadeh https://orcid.org/0000-0002-1362-7203

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Publisher ID: 2051412

DOI: 10.1080/21645515.2022.2051412

PMC ID: 9115792

PubMed ID: 35302905

SO-VID: 8612412e-ce11-4f2a-870d-7deebbaf33fa

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This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.

Breakthrough SARS-CoV-2 infections after vaccination: a critical review

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Novel Coronavirus Disease COVID-19

Most cited references 49

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection

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