Reactogenicity within the first week after Sinopharm, Sputnik V, AZD1222, and COVIran Barekat vaccines: findings from the Iranian active vaccine surveillance system

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Abstract

Background

This study aimed to evaluate the reactogenicity effects of COVID-19 vaccines, used in Iran.

Methods

At least 1000 people were followed up with phone calls or self-report in a mobile application within 7 days after vaccination. Local and systemic reactogenicities were reported overall and by subgroups.

Results

The presence of one or more local and systemic adverse effects after the first dose of vaccines was 58.9% [(95% Confidence Intervals): 57.5–60.3)] and 60.5% (59.1–61.9), respectively. These rates were reduced to 53.8% (51.2–55.0) and 50.8% (48.8–52.7) for the second dose. The most common local adverse effect reported for all vaccines was pain in the injection site. During the first week after the first dose of vaccines, the frequency of the pain for Sinopharm, AZD1222, Sputnik V, and Barekat was 35.5%, 86.0%, 77.6%, and 30.9%, respectively. The same rates after the second dose were 27.3%, 66.5%, 63.9%, and 49.0%. The most common systemic adverse effect was fatigue. In the first dose, it was 30.3% for Sinopharm, 67.4% for AZD1222, 47.6% for Sputnik V, and 17.1% for Barekat. These rates were reduced to 24.6%, 37.1%, 36.5%, and 19.5%, in the second dose of vaccines. AZD1222 had the highest local and systemic adverse effects rates. The odds ratio of local adverse effects of the AZD1222 vaccine compared to the Sinopharm vaccine were 8.73 (95% CI 6.93–10.99) in the first dose and 4.14 (95% CI 3.32–5.17) in the second dose. Barekat and Sinopharm had the lowest frequency of local and systemic adverse effects. Compared to Sinopharm, systemic adverse effects were lower after the first dose of Barekat (OR = 0.56; 95% CI 0.46–0.67). Reactogenicity events were higher in women and younger people. Prior COVID-19 infection increased the odds of adverse effects only after the first dose of vaccines.

Conclusions

Pain and fatigue were the most common reactogenicities of COVID-19 vaccination. Reactogenicities were less common after the second dose of the vaccines. The adverse effects of AZD1222 were greater than those of other vaccines.

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Most cited references 48

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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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Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia

Denis Logunov, Inna Dolzhikova, Dmitry Shcheblyakov … (2021)

Background A heterologous recombinant adenovirus (rAd)-based vaccine, Gam-COVID-Vac (Sputnik V), showed a good safety profile and induced strong humoral and cellular immune responses in participants in phase 1/2 clinical trials. Here, we report preliminary results on the efficacy and safety of Gam-COVID-Vac from the interim analysis of this phase 3 trial. Methods We did a randomised, double-blind, placebo-controlled, phase 3 trial at 25 hospitals and polyclinics in Moscow, Russia. We included participants aged at least 18 years, with negative SARS-CoV-2 PCR and IgG and IgM tests, no infectious diseases in the 14 days before enrolment, and no other vaccinations in the 30 days before enrolment. Participants were randomly assigned (3:1) to receive vaccine or placebo, with stratification by age group. Investigators, participants, and all study staff were masked to group assignment. The vaccine was administered (0·5 mL/dose) intramuscularly in a prime-boost regimen: a 21-day interval between the first dose (rAd26) and the second dose (rAd5), both vectors carrying the gene for the full-length SARS-CoV-2 glycoprotein S. The primary outcome was the proportion of participants with PCR-confirmed COVID-19 from day 21 after receiving the first dose. All analyses excluded participants with protocol violations: the primary outcome was assessed in participants who had received two doses of vaccine or placebo, serious adverse events were assessed in all participants who had received at least one dose at the time of database lock, and rare adverse events were assessed in all participants who had received two doses and for whom all available data were verified in the case report form at the time of database lock. The trial is registered at ClinicalTrials.gov (NCT04530396). Findings Between Sept 7 and Nov 24, 2020, 21 977 adults were randomly assigned to the vaccine group (n=16 501) or the placebo group (n=5476). 19 866 received two doses of vaccine or placebo and were included in the primary outcome analysis. From 21 days after the first dose of vaccine (the day of dose 2), 16 (0·1%) of 14 964 participants in the vaccine group and 62 (1·3%) of 4902 in the placebo group were confirmed to have COVID-19; vaccine efficacy was 91·6% (95% CI 85·6–95·2). Most reported adverse events were grade 1 (7485 [94·0%] of 7966 total events). 45 (0·3%) of 16 427 participants in the vaccine group and 23 (0·4%) of 5435 participants in the placebo group had serious adverse events; none were considered associated with vaccination, with confirmation from the independent data monitoring committee. Four deaths were reported during the study (three [<0·1%] of 16 427 participants in the vaccine group and one [<0·1%] of 5435 participants in the placebo group), none of which were considered related to the vaccine. Interpretation This interim analysis of the phase 3 trial of Gam-COVID-Vac showed 91·6% efficacy against COVID-19 and was well tolerated in a large cohort. Funding Moscow City Health Department, Russian Direct Investment Fund, Sberbank, and RUSAL.

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Author and article information

Contributors

Mostafa Enayatrad: mostafaenayatrad@gmail.com

Mohammad Hassan Emamian:

ORCID: http://orcid.org/0000-0002-1994-1105

emamian@shmu.ac.ir

Journal

Journal ID (nlm-ta): BMC Infect Dis

Journal ID (iso-abbrev): BMC Infect Dis

Title: BMC Infectious Diseases

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2334

Publication date (Electronic): 10 March 2023

Publication date PMC-release: 10 March 2023

Publication date Collection: 2023

Volume: 23

Electronic Location Identifier: 150

Affiliations

[1 ]GRID grid.444858.1, ISNI 0000 0004 0384 8816, Clinical Research Development Unit, Bahar Hospital, , Shahroud University of Medical Science, ; Shahroud, Iran

[2 ]GRID grid.444858.1, ISNI 0000 0004 0384 8816, Department of Epidemiology, School of Public Health, , Shahroud University of Medical Sciences, ; Shahroud, Iran

[3 ]GRID grid.411583.a, ISNI 0000 0001 2198 6209, Neuroscience Research Center, , Mashhad University of Medical Sciences, ; Mashhad, Iran

[4 ]GRID grid.484406.a, ISNI 0000 0004 0417 6812, Department of Public Health, Faculty of Health, , Kurdistan University of Medical Sciences, ; Sanandaj, Iran

[5 ]GRID grid.411701.2, ISNI 0000 0004 0417 4622, Cellular and Molecular Research Center, , Birjand University of Medical Sciences, ; Birjand, Iran

[6 ]GRID grid.412105.3, ISNI 0000 0001 2092 9755, Department of Critical Care, Razi Faculty of Nursing and Midwifery, Nursing Research Center, , Kerman University of Medical Sciences, ; Kerman, Iran

[7 ]GRID grid.488433.0, ISNI 0000 0004 0612 8339, Health Promotion Research Center, , Zahedan University of Medical Sciences, ; Zahedan, Iran

[8 ]GRID grid.411874.f, ISNI 0000 0004 0571 1549, School of Medicine, , Guilan University of Medical Sciences, ; Rasht, Iran

[9 ]GRID grid.488433.0, ISNI 0000 0004 0612 8339, Infectious Diseases and Tropical Medicine Research Center, , Zahedan University of Medical Sciences, ; Zahedan, Iran

[10 ]GRID grid.444858.1, ISNI 0000 0004 0384 8816, Center for Health Related Social and Behavioral Sciences Research, , Shahroud University of Medical Sciences, ; Shahroud, Iran

[11 ]GRID grid.444858.1, ISNI 0000 0004 0384 8816, Ophthalmic Epidemiology Research Center, , Shahroud University of Medical Sciences, ; Shahroud, Iran

[12 ]GRID grid.444858.1, ISNI 0000 0004 0384 8816, Health Technology Incubator Center, , Shahroud University of Medical Sciences, ; Shahroud, Iran

[13 ]GRID grid.444858.1, ISNI 0000 0004 0384 8816, Clinical Research Development Unit, Imam Hossein Hospital, , Shahroud University of Medical Science, ; Shahroud, Iran

[14 ]GRID grid.444858.1, ISNI 0000 0004 0384 8816, School of Allied Medical Sciences, , Shahroud University of Medical Sciences, ; Shahroud, Iran

[15 ]GRID grid.412105.3, ISNI 0000 0001 2092 9755, HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, , Kerman University of Medical Sciences, ; Kerman, Iran

Author information

Mohammad Hassan Emamian http://orcid.org/0000-0002-1994-1105

Article

Publisher ID: 8103

DOI: 10.1186/s12879-023-08103-4

PMC ID: 10000357

PubMed ID: 36899326

SO-VID: 5954679f-3115-4fc5-9835-71e2e3862684

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/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 25 August 2022

Date accepted : 19 February 2023

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100004305, Shahroud University of Medical Sciences;

Award ID: 99135

Award Recipient : Mohammad Hassan Emamian

Funded by: Vice-chancellery for research and technology at Iranian Ministry of Health and Medical Education

Award ID: 2302

Award Recipient : Mohammad Hassan Emamian

Funded by: FundRef http://dx.doi.org/10.13039/100004423, World Health Organization;

Award ID: 2021/1169483-0

Award ID: 2022/1217943-1

Award Recipient : Mohammad Hassan Emamian

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ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: vaccine reactogenicity,sinopharm,sputnik v,azd1222,coviran barekat

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ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: vaccine reactogenicity, sinopharm, sputnik v, azd1222, coviran barekat

Reactogenicity within the first week after Sinopharm, Sputnik V, AZD1222, and COVIran Barekat vaccines: findings from the Iranian active vaccine surveillance system

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Novel Coronavirus Disease COVID-19

Most cited references 48

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

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

Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia

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