Does a lack of vaccine side effects correlate with reduced BNT162b2 mRNA vaccine response among healthcare workers and nursing home residents?

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Abstract

Background

The BNT162b2 SARS-CoV-2 mRNA vaccination has mitigated the burden of COVID-19 among residents of long-term care facilities considerably, despite being excluded from the vaccine trials. Data on reactogenicity (vaccine side effects) in this population are limited.

Aims

To assess reactogenicity among nursing home (NH) residents. To provide a plausible proxy for predicting vaccine response among this population.

Methods

We enrolled and sampled NH residents and community-dwelling healthcare workers who received the BNT162b2 mRNA vaccine, to assess local or systemic reactogenicity and antibody levels (immunogenicity).

Results

NH residents reported reactions at a much lower frequency and lesser severity than the community-dwelling healthcare workers. These reactions were mild and transient with all subjects experiencing more local than systemic reactions. Based on our reactogenicity and immunogenicity data, we developed a linear regression model predicting log-transformed anti-spike, anti-receptor-binding domain (RBD), and neutralizing titers, with a dichotomous variable indicating the presence or absence of reported reactions which revealed a statistically significant effect, with estimated shifts in log-transformed titers ranging from 0.32 to 0.37 (all p < 0.01) indicating greater immunogenicity in subjects with one or more reported reactions of varying severity.

Discussion

With a significantly lower incidence of post-vaccination reactions among NH residents as reported in this study, the BNT162b2 mRNA vaccine appears to be well-tolerated among this vulnerable population. If validated in larger populations, absence of reactogenicity could help guide clinicians in prioritizing vaccine boosters.

Conclusions

Reactogenicity is significantly mild among nursing home residents and overall, subjects who reported post-vaccination reactions developed higher antibody titers.

Supplementary Information

The online version contains supplementary material available at 10.1007/s40520-021-01987-9.

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Most cited references 32

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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 Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates

Edward E Walsh, Robert W Frenck, Ann Falsey … (2021)

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (Covid-19), have spread to millions of persons worldwide. Multiple vaccine candidates are under development, but no vaccine is currently available. Interim safety and immunogenicity data about the vaccine candidate BNT162b1 in younger adults have been reported previously from trials in Germany and the United States. Methods In an ongoing, placebo-controlled, observer-blinded, dose-escalation, phase 1 trial conducted in the United States, we randomly assigned healthy adults 18 to 55 years of age and those 65 to 85 years of age to receive either placebo or one of two lipid nanoparticle–formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor–binding domain; or BNT162b2, which encodes a membrane-anchored SARS-CoV-2 full-length spike, stabilized in the prefusion conformation. The primary outcome was safety (e.g., local and systemic reactions and adverse events); immunogenicity was a secondary outcome. Trial groups were defined according to vaccine candidate, age of the participants, and vaccine dose level (10 μg, 20 μg, 30 μg, and 100 μg). In all groups but one, participants received two doses, with a 21-day interval between doses; in one group (100 μg of BNT162b1), participants received one dose. Results A total of 195 participants underwent randomization. In each of 13 groups of 15 participants, 12 participants received vaccine and 3 received placebo. BNT162b2 was associated with a lower incidence and severity of systemic reactions than BNT162b1, particularly in older adults. In both younger and older adults, the two vaccine candidates elicited similar dose-dependent SARS-CoV-2–neutralizing geometric mean titers, which were similar to or higher than the geometric mean titer of a panel of SARS-CoV-2 convalescent serum samples. Conclusions The safety and immunogenicity data from this U.S. phase 1 trial of two vaccine candidates in younger and older adults, added to earlier interim safety and immunogenicity data regarding BNT162b1 in younger adults from trials in Germany and the United States, support the selection of BNT162b2 for advancement to a pivotal phase 2–3 safety and efficacy evaluation. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

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Presymptomatic SARS-CoV-2 Infections and Transmission in a Skilled Nursing Facility

Melissa M. Arons, Kelly Hatfield, Sujan Reddy … (2020)

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection can spread rapidly within skilled nursing facilities. After identification of a case of Covid-19 in a skilled nursing facility, we assessed transmission and evaluated the adequacy of symptom-based screening to identify infections in residents. Methods We conducted two serial point-prevalence surveys, 1 week apart, in which assenting residents of the facility underwent nasopharyngeal and oropharyngeal testing for SARS-CoV-2, including real-time reverse-transcriptase polymerase chain reaction (rRT-PCR), viral culture, and sequencing. Symptoms that had been present during the preceding 14 days were recorded. Asymptomatic residents who tested positive were reassessed 7 days later. Residents with SARS-CoV-2 infection were categorized as symptomatic with typical symptoms (fever, cough, or shortness of breath), symptomatic with only atypical symptoms, presymptomatic, or asymptomatic. Results Twenty-three days after the first positive test result in a resident at this skilled nursing facility, 57 of 89 residents (64%) tested positive for SARS-CoV-2. Among 76 residents who participated in point-prevalence surveys, 48 (63%) tested positive. Of these 48 residents, 27 (56%) were asymptomatic at the time of testing; 24 subsequently developed symptoms (median time to onset, 4 days). Samples from these 24 presymptomatic residents had a median rRT-PCR cycle threshold value of 23.1, and viable virus was recovered from 17 residents. As of April 3, of the 57 residents with SARS-CoV-2 infection, 11 had been hospitalized (3 in the intensive care unit) and 15 had died (mortality, 26%). Of the 34 residents whose specimens were sequenced, 27 (79%) had sequences that fit into two clusters with a difference of one nucleotide. Conclusions Rapid and widespread transmission of SARS-CoV-2 was demonstrated in this skilled nursing facility. More than half of residents with positive test results were asymptomatic at the time of testing and most likely contributed to transmission. Infection-control strategies focused solely on symptomatic residents were not sufficient to prevent transmission after SARS-CoV-2 introduction into this facility.

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Author and article information

Contributors

David H. Canaday:

ORCID: http://orcid.org/0000-0001-5503-7888

David.canaday@case.edu

Stefan Gravenstein: stefan_gravenstein@brown.edu

Journal

Journal ID (nlm-ta): Aging Clin Exp Res

Journal ID (iso-abbrev): Aging Clin Exp Res

Title: Aging Clinical and Experimental Research

Publisher: Springer International Publishing (Cham )

ISSN (Print): 1594-0667

ISSN (Electronic): 1720-8319

Publication date (Electronic): 15 October 2021

Publication date PMC-release: 15 October 2021

Pages: 1-10

Affiliations

[1 ]GRID grid.67105.35, ISNI 0000 0001 2164 3847, Case Western Reserve University School of Medicine, ; Cleveland, OH USA

[2 ]GRID grid.511345.7, ISNI 0000 0004 9517 6868, Geriatric Research, Education and Clinical Center, VA Northeast Ohio Healthcare System, ; Cleveland, OH USA

[3 ]GRID grid.461656.6, ISNI 0000 0004 0489 3491, Ragon Institute of MGH, MIT and Harvard, ; Cambridge, MA USA

[4 ]GRID grid.239395.7, ISNI 0000 0000 9011 8547, Division of Infectious Diseases, , Beth Israel Deaconess Medical Center, ; Boston, MA USA

[5 ]GRID grid.497274.b, ISNI 0000 0004 0627 5136, Marcus Institute for Aging Research, Hebrew SeniorLife, ; Boston, MA USA

[6 ]GRID grid.512153.1, Geriatric Research, Education and Clinical Center, , Durham VA Health Care System and Duke University Medical Center, ; Durham, NC USA

[7 ]GRID grid.40263.33, ISNI 0000 0004 1936 9094, Division of Geriatrics and Palliative Medicine, , Alpert Medical School of Brown University, ; Providence, RI USA

[8 ]GRID grid.458540.8, Center on Innovation in Long-Term Services and Supports, Providence Veterans Administration Medical Center, ; Providence, RI USA

Author information

David H. Canaday http://orcid.org/0000-0001-5503-7888

Article

Publisher ID: 1987

DOI: 10.1007/s40520-021-01987-9

PMC ID: 8518269

PubMed ID: 34652783

SO-VID: 9f7e1386-0208-4094-ae3d-16d5d21c1c69

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 11 August 2021

Date accepted : 12 September 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100000060, National Institute of Allergy and Infectious Diseases;

Award ID: AI129709–03S1

Award Recipient : David H. Canaday

Funded by: FundRef http://dx.doi.org/10.13039/100000049, National Institute on Aging;

Award ID: 3U54AG063546-02S2

Award Recipient : Sarah D. Berry

Funded by: FundRef http://dx.doi.org/10.13039/100000054, National Cancer Institute;

Award ID: U01 CA260539–01

Award Recipient : Christopher L. King

Funded by: FundRef http://dx.doi.org/10.13039/100000738, U.S. Department of Veterans Affairs;

Does a lack of vaccine side effects correlate with reduced BNT162b2 mRNA vaccine response among healthcare workers and nursing home residents?

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Abstract

Background

Aims

Methods

Results

Discussion

Conclusions

Supplementary Information

Related collections

Novel Coronavirus Disease COVID-19

Most cited references 32

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates

Presymptomatic SARS-CoV-2 Infections and Transmission in a Skilled Nursing Facility

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