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      Effect of the third dose of BNT162b2 COVID-19 mRNA vaccine on anti-SARS-CoV-2 antibody levels in healthcare workers

      research-article
      Author(s): a , b , c , d , d , d , e , f , f , b , g , h , h , i , a , h , * , a
      Publication date (Electronic):
      Journal: Vaccine
      Publisher: Published by Elsevier Ltd.
      Keywords: BNT162b2 vaccine, SARS-CoV-2 spike protein, Booster vaccination, Healthcare workers, AEFIs, adverse events following immunization, CLEIA, chemiluminescent enzyme immunoassay, COVID-19, coronavirus disease 2019, HCWs, healthcare workers, IgG, Immunoglobulin G, IQR, interquartile range, NP, nucleocapsid protein, SARS-CoV-2, severe acute respiratory syndrome coronavirus 2, SP, spike protein

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          Abstract

          Purpose

          Administration of three doses of Pfizer-BioNTech BNT162b2 COVID-19 mRNA vaccine was completed in Japan in the spring of 2022. This study aimed to evaluate the antibody responses, and kinetics of three doses of vaccine in healthcare workers (HCWs).

          Patients and methods

          We conducted a longitudinal cohort study with HCWs, who had no history of COVID-19 or serologic evidence of SARS-CoV-2 infection, from a single hospital. Immunoglobulin G (IgG) titers of anti-SARS-CoV-2 spike protein (SP) and nucleocapsid protein (NP) titers were measured using an automated chemiluminescent enzyme immunoassay system.

          Results

          A total of 636 HCWs participated in the study. The anti-SP IgG titers decreased slowly after the second dose of the BNT162b2 vaccine in all participants, and robust antibody response was observed after the third dose of the vaccine. The peak anti-SP IgG titer after the third dose was approximately 4.1-fold higher than that after the first and second doses, and the rate of decrease in the anti-SP IgG titer after the third dose was significantly more gradual, than that after the second dose. After the second dose of vaccine, the antibody response was weaker in older participants than in younger participants, and in males than in females respectively, whereas the response to the third dose of vaccine did not differ significantly by sex or age. Adverse events following immunization were generally mild to moderate.

          Conclusion

          The third dose of the BNT162b2 vaccine induced a significant and sustained increase in anti-SP IgG titers, and was generally safe and well-tolerated.

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          Most cited references28

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          A Novel Coronavirus from Patients with Pneumonia in China, 2019

          Na Zhu, Dingyu Zhang, Wenling Wang … (2020)
          Summary In December 2019, a cluster of patients with pneumonia of unknown cause was linked to a seafood wholesale market in Wuhan, China. A previously unknown betacoronavirus was discovered through the use of unbiased sequencing in samples from patients with pneumonia. Human airway epithelial cells were used to isolate a novel coronavirus, named 2019-nCoV, which formed a clade within the subgenus sarbecovirus, Orthocoronavirinae subfamily. Different from both MERS-CoV and SARS-CoV, 2019-nCoV is the seventh member of the family of coronaviruses that infect humans. Enhanced surveillance and further investigation are ongoing. (Funded by the National Key Research and Development Program of China and the National Major Project for Control and Prevention of Infectious Disease in China.)
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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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              Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months

              Stephen J. Thomas, Edson D. Moreira, Nicholas R.E. Kitchin … (2022)
              Background BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable. Methods In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination. Results BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed. Conclusions Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728 .)
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                Author and article information

                Journal
                Journal ID (nlm-ta): Vaccine
                Journal ID (iso-abbrev): Vaccine
                Title: Vaccine
                Publisher: Published by Elsevier Ltd.
                ISSN (Print): 0264-410X
                ISSN (Electronic): 1873-2518
                Publication date PMC-release: 24 November 2022
                Publication date (Electronic): 24 November 2022
                Affiliations
                [a ]Department of Respiratory Medicine, Izumi City General Hospital, 4-5-1 Wakecho, Izumi, Osaka 594-0073, Japan
                [b ]Department of Pharmacy, Izumi City General Hospital, 4-5-1 Wakecho, Izumi, Osaka 594-0073, Japan
                [c ]General Affairs Division, Izumi City General Hospital, 4-5-1 Wakecho, Izumi, Osaka 594-0073, Japan
                [d ]Department of Clinical Laboratory, Izumi City General Hospital, 4-5-1 Wakecho, Izumi, Osaka 594-0073, Japan
                [e ]Department of Surgery, Izumi City General Hospital, 4-5-1 Wakecho, Izumi, Osaka 594-0073, Japan
                [f ]Infection Control Room, Izumi City General Hospital, 4-5-1 Wakecho, Izumi, Osaka 594-0073, Japan
                [g ]Medical Affairs Division, Izumi City General Hospital, 4-5-1 Wakecho, Izumi, Osaka 594-0073, Japan
                [h ]Clinical Research Center, Izumi City General Hospital, 4-5-1 Wakecho, Izumi, Osaka 594-0073, Japan
                [i ]Department of Nursing, Izumi City General Hospital, 4-5-1 Wakecho, Izumi, Osaka 594-0073, Japan
                Author notes
                [* ]Corresponding author at: Department of Respiratory Medicine, Izumi City General Hospital, 4-5-1 Wakecho, Izumi, Osaka 594-0073, Japan.
                Article
                Publisher Item ID: S0264-410X(22)01462-1
                DOI: 10.1016/j.vaccine.2022.11.049
                PMC ID: 9684125
                PubMed ID: 36460533
                SO-VID: e1505499-afb2-42d2-a12d-a76360b15820
                Copyright © © 2022 Published by Elsevier Ltd.
                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.

                History
                Date received : 20 September 2022
                Date revision received : 26 October 2022
                Date accepted : 20 November 2022
                Categories
                Subject: Article

                ScienceOpen disciplines: Infectious disease & Microbiology
                Keywords: bnt162b2 vaccine,sars-cov-2 spike protein,booster vaccination,healthcare workers,aefis, adverse events following immunization,cleia, chemiluminescent enzyme immunoassay,covid-19, coronavirus disease 2019,hcws, healthcare workers,igg, immunoglobulin g,iqr, interquartile range,np, nucleocapsid protein,sars-cov-2, severe acute respiratory syndrome coronavirus 2,sp, spike protein
                Data availability:
                ScienceOpen disciplines: Infectious disease & Microbiology
                Keywords: bnt162b2 vaccine, sars-cov-2 spike protein, booster vaccination, healthcare workers, aefis, adverse events following immunization, cleia, chemiluminescent enzyme immunoassay, covid-19, coronavirus disease 2019, hcws, healthcare workers, igg, immunoglobulin g, iqr, interquartile range, np, nucleocapsid protein, sars-cov-2, severe acute respiratory syndrome coronavirus 2, sp, spike protein

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