Adverse effects


Last updated: 2021 Aug 3
Total hit(s): 19
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In a randomised, placebo-controlled phase 1 trial, protein subunit vaccine SCB-2019 formulated with either AS03 or CpG/Alum adjuvants had a good safety profile and was well-tolerated. The vaccine was considered for further clinical development. The SCB-2019 vaccine, comprising S-Trimer protein formulated with either AS03 or CpG/Alum adjuvants, elicited robust humoral and cellular immune responses against SARS-CoV-2, with high viral neutralising activity.
33524311
(Lancet)
PMID
33524311
Date of Publishing: 2021 Feb 20
Title Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial
Author(s) nameRichmond P, Hatchuel L et al.
Journal Lancet
Impact factor
43.38
Citation count: 2
Date of Entry 2021 Aug 3


In an open, non-randomised, combined phase 1/2 trial, heterologous vector-based vaccine rAd26 and rAd5 COVID vaccines, was found to be safe. The vaccine did not elicit any severe adverse reaction in the recipients. The vaccine was available in two formulations, frozen form (Gam-COVID-Vac) and lyophilised form (Gam-COVID-Vac-Lyo). The frozen form had a volume of 0.5mL and the lyophilised form was reconstituted in 1.0mL of sterile water.
32896291
(Lancet)
PMID
32896291
Date of Publishing: 2020 Sep 26
Title Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia
Author(s) nameLogunov DY, Dolzhikova IV et al.
Journal Lancet
Impact factor
43.38
Citation count: 65
Date of Entry 2021 Aug 3


In the phase 1/2 trial, the ChAdOx1 nCov-19 vaccine was found to be safe with no severe adverse reactions. The side effects resulted in mild and moderate symptoms but were reduced by taking paracetamol after taking the vaccination. 1. ChAdOx1 nCoV-19 vaccine was found to be safe. Local and sytemic side effects were very minimum after the administeration of prophylactic paracetamol. One severe adverse effect, haemolytic anaemia, was associated with the control group after nine days of administeration. 2. Reactogenicity profile appeared less severe in the participants who received the vaccine booster dose.
32702298
(Lancet)
PMID
32702298
Date of Publishing: 2020 Aug 15
Title Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial
Author(s) nameFolegatti PM, Ewer KJ et al.
Journal Lancet
Impact factor
43.38
Citation count: 162
Date of Entry 2021 Aug 3


In a placebo-controlled, randomised, double-blind phase 2 clinical trial, the safety of two dosage groups ( 5*10^10 viral particles and 1*10^11 viral particles) of Ad5 vectored vaccine was evaluated. The safety profile of the 5*10^10 dosage group was better and chosen for phase the 3 trial.
32702299
(Lancet)
PMID
32702299
Date of Publishing: 2020 Aug 15
Title Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial
Author(s) nameZhu FC, Guan XH et al.
Journal Lancet
Impact factor
43.38
Citation count: 81
Date of Entry 2021 Aug 3


In phase 2, double-blind, randomised, multicentre clinical trial, BBV152, an inactivated vaccine, elicited mild symptoms in participants and hence was considered to be safe 1. 27 unsolicited adverse events were reported and 9 of them were related to the vaccine.
33705727
(Lancet Infect Dis)
PMID
33705727
Date of Publishing: 2021 Mar 8
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 tria
Author(s) nameElla R, Reddy S et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 9
Date of Entry 2021 Jun 22


In a phase 1 trial with an inactivated viral vaccine, BBV152 elicited mild to moderate adverse effects in a few study participants and hence was declared safe. The overall incidence of solicited local and systemic adverse events in this study was 1421% in all vaccine-treated groups.
33485468
(Lancet Infect Dis)
PMID
33485468
Date of Publishing: 2021 Jan 21
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial
Author(s) nameElla R, Vadrevu KM et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 1
Date of Entry 2021 Jun 22


In phase 1, dose-escalation trial, mRNA vaccine mRNA-1273 was found to be safe with a very low occurrence of adverse side effects. Most of the adverse effects observed were mild to moderate and mostly occurs after the second dose of the vaccine. One participant did not receive second dose of vaccine after experiencing paronychia two days after receiving the first dose of the vaccine. However, the rash was considered to be unrelated to vaccination by the investigators
32991794
(N Engl J Med)
PMID
32991794
Date of Publishing: 2020 Dec 17
Title Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults
Author(s) nameAnderson EJ, Rouphael NG et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 62
Date of Entry 2021 Jun 22


In a phase 1 trial, two types of RNA based vaccines were tested: a) BNT162b2, coding for membrane-bound full-length spike protein; b) BNT162b1 coding secreted domain which is trimerized. Milder systemic events were found with BNT162b2. Hence BNT162b2 was chosen for the next phase of trials. 1. 100ug dose of vaccine was included in the clinical trial study but was discontinued after one dose because of reactogenicity in the participants ( BNT162b1 vaccine and placebo)
33053279
(N Engl J Med)
PMID
33053279
Date of Publishing: 2020 Dec 17
Title Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates
Author(s) nameWalsh EE, Frenck RW Jr et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 46
Date of Entry 2021 Jun 22


In a dose-escalating phase 1 trial, Ad5 vectored COVID-19 vaccine was found to be safe with minimal severe adverse events. Most of the symptoms observed across the three dosage group were mild or moderate in severity.
32450106
(Lancet)
PMID
32450106
Date of Publishing: 2020 Jun 13
Title Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial
Author(s) nameZhu FC, Li YH et al.
Journal Lancet
Impact factor
43.38
Citation count: 205
Date of Entry 2021 Jun 22


A phase2/3 trial of the ChAdOx1 nCoV-19 vaccine shows that it is safe and well-tolerated in older and young adults. Local reactions were more common than systemic reactions. Fewer adverse reactions were reported after the booster dose and reduced with increasing age. The ChAdOx1 nCoV-19 (AZD1222) vaccine was found to be safe and well-tolerated with better reactogenicity profile in older adults than in younger adults.
33220855
(Lancet)
PMID
33220855
Date of Publishing: 2021 Dec 19
Title Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial
Author(s) nameRamasamy MN, Minassian AM et al.
Journal Lancet
Impact factor
43.38
Citation count: 26


Among the 175 adverse events reported during the clinical trial with the Pfizer-BioNTech COVID-19 vaccine, severe allergic reactions including anaphylaxis were reviewed.
33444297
(MMWR Morb Mortal Wkly Rep)
PMID
33444297
Date of Publishing: 2021 Jan 15
Title Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine United States, December 1423, 2020
Author(s) name CDC COVID-19 Response Team; Food and Drug Administration.
Journal MMWR Morb Mortal Wkly Rep
Impact factor
14.4
Citation count: 9


In a phase1/2 clinical trial, BBIBP-CorV inactivated vaccine given in a 2 dose regimen was found to be safe and well-tolerated. The vaccine-induced a robust humoral response in 100% of the vaccine recipients. The inactivated SARS-CoV-2 vaccine BBIBP-CorV was found to be safe and well-tolerated in the age groups.
33069281
(Lancet Infect Dis)
PMID
33069281
Date of Publishing: 2021 Jan
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial
Author(s) nameXia S, Zhang Y et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 17


In a phase1/2 clinical trial, BBIBP-CorV inactivated vaccine given in a 2 dose regimen was found to be safe and well-tolerated. The inactivated SARS-CoV-2 vaccine BBIBP-CorV was found to be safe and well-tolerated in the age groups between 18-59 years and above 60 years of age.
33069281
(Lancet Infect Dis)
PMID
33069281
Date of Publishing: 2021 Jan
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial
Author(s) nameXia S, Zhang Y et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 17


In four ongoing blinded, randomized, controlled trials done across the UK, Brazil, and South Africa, the ChAdOx1 nCoV-19 vaccine was found to be safe and efficacious against COVID-19 The ChAdOx1 nCoV-19 vaccine was found to be safe and well-tolerated with good efficacy.
33306989
(Lancet)
PMID
33306989
Date of Publishing: 2020 Dec 8
Title Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
Author(s) nameVoysey M, Clemens SAC et al.
Journal Lancet
Impact factor
43.38
Citation count: 28


In a placebo-controlled, observer-blinded, pivotal efficacy trial, nucleoside-modified RNA vaccine BNT162b2 was found to be safe with very low incidences of serious adverse events. The adverse events reported were mild or moderate and reactions were more common in younger adults compared to older adults. A two-dose regimen of the BT162b2 vaccine was found to be safe. The incidence of serious adverse events were similar in the vaccine and placebo groups.
33301246
(N Engl J Med)
PMID
33301246
Date of Publishing: 2020 Dec 31
Title Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Author(s) namePolack FP, Thomas SJ et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 67


In phase 3 clinical trial study, the mRNA-1273 vaccine was found to be safe. The local reactions to the vaccine were mild to moderate and resolved within a day or two.
33378609
(N Engl J Med)
PMID
33378609
Date of Publishing: 2020 Dec 30
Title Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine
Author(s) nameBaden LR, El Sahly HM et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 16


The INO-4800 DNA vaccine was found to be safe. Out of the 11 adverse events reported, only 6 were related to the INO-4800 vaccine. The INO-4800 DNA Vaccine was found to be safe with no serious local or systemic adverese effects.
33392485
(EClinicalMedicine)
PMID
33392485
Date of Publishing: 2020 Dec 24
Title Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A preliminary report of an open-label, Phase 1 clinical trial
Author(s) nameTebas P, Yang S et al.
Journal EClinicalMedicine
Impact factor
6.68
Citation count: 2


In a phase 1/2 trial, NVX-CoV2373, a recombinant severe acute respiratory syndrome coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine was found to be safe and elicited an immune response that exceeded levels in COVID-19 convalescent serum. The adjuvanted, recombinant, full-length spike protein nanoparticle vaccine NVX-CoV2373 was found to be a safe in adult participants in the age group of 18-59 and is a promising vaccine candidate.
32877576
(N Engl J Med)
PMID
32877576
Date of Publishing: 2020 Dec 10
Title Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine
Author(s) nameKeech C, Albert G et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 72


In a phase I/II study of COVID-19 RNA vaccine BNT162b1, local and systemic events were mild to moderate and transient.
32785213
(Nature)
PMID
32785213
Date of Publishing: 2020 Oct
Title PhaseI/II study of COVID-19 RNA vaccine BNT162b1 in adults
Author(s) nameMulligan MJ, Lyke KE et al.
Journal Nature
Impact factor
24.36
Citation count: 49