Adverse effects

Last updated: 2022 Aug 26
Total hit(s): 41
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Original Article
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20 days after the first dose, the estimated vaccination effectiveness against verified SARS-CoV-2 infection was 62% (95 percent confidence range, 59% to 65%), and 60 days after the second dose, the estimated efficiency was 93% (92% to 94%). Insensitivity analysis revealed that informed filtering had no impact on the outcomes. Teenagers who were unvaccinated had SARS-CoV-2 testing more frequently than those who had received vaccinations during follow-up (1114 v 874 tests per 1000 individuals per month).
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 		35410884
(BMJ)
PMID
35410884
Date of Publishing: 2022 Apr 11
Title Risk of adverse events after covid-19 in Danish children and adolescents and effectiveness of BNT162b2 in adolescents: cohort study
Author(s) nameKildegaard H, Lund LC et al.
Journal BMJ
Impact factor
30.22
Citation count: 1
Date of Entry 2022 Aug 26

On day 28 following the second vaccination, the neutralising antibody GMT against the SARS-CoV-2 virus ranged from 105.3 to 180.2 in the 3-5 years cohort, 84.1 to 168.6 in the 6-12 years cohort, and 88.0 to 155.7 in the 13-17 years cohort. On day 28 following the third vaccination, it ranged from 143.5 to 224.4 in the 3-5 years cohort, 127.9 to 184.8 in the 6-12 years The inactivated COVID-19 vaccine BBIBP-CorV is safe and well tolerated in participants ages 3 to 17 at all tested dose levels. Following two doses, BBIBP-CorV also induced potent humoral defences against SARS-CoV-2 infection.
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 		34536349
(Lancet Infect Dis)
PMID
34536349
Date of Publishing: 2021 Sep 15
Title Safety and immunogenicity of an inactivated COVID-19 vaccine, BBIBP-CorV, in people younger than 18 years: a randomised, double-blind, controlled, phase 1/2 trial
Author(s) nameXia S, Zhang Y et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 25
Date of Entry 2022 Aug 26

After the first vaccine, four people experienced side effects, while 16 people experienced side effects after the second. The facility received 19 patients in total. After an average of 2 days, everyone was released. Neither readmissions nor fatalities occurred. After developing myocarditis, two individuals received a second immunisation; neither had worsening of their symptoms. Thirteen individuals had their symptoms resolved and seven were making progress at the most recent follow-up following symptom onset.
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 		34347001
(JAMA)
PMID
34347001
Date of Publishing: 2021 Aug 4
Title Myocarditis and Pericarditis After Vaccination for COVID-19
Author(s) nameDiaz GA, Parsons GT et al.
Journal JAMA
Impact factor
14.78
Citation count: 88
Date of Entry 2022 Aug 26

The vaccine was found effective against B1.1.7 variant of COVID-19 and was found to prevent both symptomatic and asymptomatic infection in working-age adults. However the vaccine does not prevent all cases of infection. This cohort was vaccinated when the dominant variant in circulation was B1.1.7 and shows effectiveness against this variant.
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 		33901423
(Lancet)
PMID
33901423
Date of Publishing: 2021 May 8
Title COVID-19 vaccine coverage in healthcare workers in England and effectiveness of BNT162b2 mRNA vaccine against infection (SIREN) : a prospective, multicentre and cohort study
Author(s) nameHall VJ, Foulkes S et al.
Journal Lancet
Impact factor
43.38
Citation count: 301
Date of Entry 2022 Jun 20

In the four randomised trials, the ChAdOx1 nCoV-19 (AZD1222) vaccine was found to be safe with low incidence of adverse events. In the participants who received two standard doses, the efficacy after the second dose was higher in those who received the booster dose after 12 weeks when compared to those who received the second dose after 6 weeks.
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 		33617777
(Lancet)
PMID
33617777
Date of Publishing: 2021 Feb 19
Title Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials
Author(s) nameVoysey M, Costa Clemens SA et al.
Journal Lancet
Impact factor
43.38
Citation count: 396
Date of Entry 2022 Jun 20

In the following study, majority of the participants showed mild to moderate side affects. It was found that side effects were observed in patients that showed vaccine immune response. Older participants showed fewer or even no side effects.
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 		Pre-print ( papers.ssrn.com )
Title Declined antibody responses to COVID-19 mRNA vaccine within first three months
Impact factor
N/A
Date of Entry 2022 Jun 20

Majority of participants who received BNT162b2 had higher local and systemic adverse events than those who received placebo. The adverse events reported were mild to moderate and transient. In 5 to 11-year old children, two doses of 10 g of BNT162b2 vaccination given 21 days apart were found to be safe, immunogenic, and 90.7% effective against Covid-19. It was chosen as the dose level to be tested in phase 2-3 studies. a) It was found that slightly more BNT162b2 recipients (3.0%) than placebo recipients (2.1%) reported adverse events that were thought to be due to the vaccine or placebo.
b) In 0.1% of BNT162b2 recipients and 0.1% of placebo recipients, severe adverse events were reported.
c) The geometric mean ratio of SARS-CoV-2 neutralising titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 one month after the second injection.
d) The absence of longer-term follow-up to examine the duration of immune responses, efficacy, and safety is one of the study's limitations.
e) Concomitant administration of BNT162b2 with other vaccines was not evaluated, and cell-mediated responses to immunisation are not yet available.
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 		34752019
(N Engl J Med)
PMID
34752019
Date of Publishing: 2021 Nov 9
Title Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age
Author(s) nameWalter EB, Talaat KR et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 58
Date of Entry 2022 Apr 29

Serious adverse events reported were equally distributed between the vaccine and placebo groups. Most of the participants had fever which disappeared within 24 hrs after the 1st dose of ChAdOx1 nCoV-19 (AZD1222). There was no reactogenicity observed after the second dose. a) Two doses of ChAdOx1 nCoV-19 vaccine given 21 to 35 days apart were found to be safe and immunogenic.
b) Due to the B.1.351 strain, a two-dose strategy of the ChAdOx1 nCoV-19 vaccination did not provide protection against mild-to-moderate Covid-19.
c) In the United Kingdom, the ChAdOx1 nCoV-19 vaccine was 74.6% effective against the B.1.1.7 strain (95% CI, 41.6 to 88.9).
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 		33725432
(N Engl J Med)
PMID
33725432
Date of Publishing: 2021 Mar 16
Title Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant
Author(s) nameMadhi SA, Baillie V et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 488
Date of Entry 2022 Apr 29

The majority of the solicited adverse effects in participants vaccinated with Sputnik Light were mild (66.4% from all vaccines), with only a few being moderate (5.5%). There were no major side effects reported. A) Mild and transient changes were observed in erythrocyte sedimentation rate, alanine and aspartate aminotransferases, lactate dehydrogenase, leukocyte, lymphocyte and neutrophil counts.
B) Both seronegative and seropositive groups were immunogenic to "Sputnik Light" vaccine producing both binding and neutralising antibody responses. It also ellicited cell - mediated immunity along with IFN- secretion.
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 		34746910
(Lancet Reg Health Eur)
PMID
34746910
Date of Publishing: 2021 Dec
Title An open, non-randomised, phase 1/2 trial on the safety, tolerability, and immunogenicity of single-dose vaccine Sputnik Light for prevention of coronavirus infection in healthy adults
Author(s) nameTukhvatulin AI, Dolzhikova IV et al.
Journal Lancet Reg Health Eur
Impact factor
- n/a -
Citation count: 6
Date of Entry 2022 Jan 25

Among the adjuvanted vaccine formulations, the number and severity of local and systemic solicited reactions were higher than expected after the second dose, with the highest frequency in the high-dose plus AS03 groups.On an average, reactions were less frequent and milder in participants aged 50 years than younger adults. The unadjuvanted high-dose formulation produced reactogenicity profiles that were identical to placebo. In AS03-adjuvanted vaccine groups, a non-Th2 cell skewed cytokine response was elicited, with constant IFN- production and robust neutralising and binding antibody responses was observed.
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 		33887209
(Lancet Infect Dis)
PMID
33887209
Date of Publishing: 2021 Apr 19
Title Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 12, dose-ranging study
Author(s) nameGoepfert PA, Fu B et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 37
Date of Entry 2022 Jan 25

A higher number of participants exhibited significant reactogenicity after the second dose. The reactogenicity in the 50ug dose cohort after the booster dose was severe that booster dose for 60ug cohort group was dropped. For other doses, there were no significant adverse events or withdrawals due to linked adverse events. This clinical study has several limitations, including a limited sample size and a restriction on people under the age of 55.
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 		32998157
(Nature)
PMID
32998157
Date of Publishing: 2020 Oct
Title COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses
Author(s) nameSahin U, Muik A et al.
Journal Nature
Impact factor
24.36
Citation count: 621
Date of Entry 2022 Jan 25

In the combined phase 1 and phase 2 trial, the KCONVAC vaccine was found to be safe and did not elicit major adverse events. The 5ug dose of vaccine was selected for phase 3 trials. In the combined phase 1 and phase 2 trial, the KCONOVOC vaccine elicited a strong immune response. The vaccine induced good antibody response and a moderately good T-cell response.
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 		33928916
(Chin Med J (Engl))
PMID
33928916
Date of Publishing: 2021 Apr 28
Title Immunogenicity and safety of a severe acute respiratory syndrome coronavirus 2 inactivated vaccine in healthy adults: randomized, double-blind, and placebo-controlled phase 1 and phase 2 clinical trials
Author(s) namePan HX, Liu JK et al.
Journal Chin Med J (Engl)
Impact factor
1.053
Citation count: 22
Date of Entry 2021 Dec 15

In a phase I clinical trial, DNA vaccine ZyCoV-D was found to be safe, well-tolerated, and immunogenic in healthy individuals with no vaccine-related severe or solicited adverse events. The adverse events reported were mild to moderate in severity. 1) Interesting to note that all the study participants were males. 2)Solicited local and systemic adverse symptoms were reported for 7 days post each vaccine dose and any other unsolicited adverse events were reported within 28 days post each dose. 3)No subject was discontinued from the study due to a solicited adverse event. 4) One subject withdrew from the study because of asymptomatic positive COVID-19 test, 27 days after receiving the first dose of the vaccine. 5)ZyCoV-D when administered intradermally induced good humoral and cellular immune responses.
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 		34308319
(EClinicalMedicine)
PMID
34308319
Date of Publishing: 2021 Aug
Title Safety and Immunogenicity of a DNA SARS-CoV-2 vaccine (ZyCoV-D): Results of an open-label, non-randomized phase I part of phase I/II clinical study by intradermal route in healthy subjects in India
Author(s) nameMomin T, Kansagra K et al.
Journal EClinicalMedicine
Impact factor
6.68
Citation count: 32
Date of Entry 2021 Oct 30

In a phase 2 placebo-controlled clinical trial, the mRNA-1273 vaccine was found to be safe at 50 and 100 g doses given as a 2 dose-regimen. The mRNA-1273 vaccine was found to be safe and immunogenic at both the 50 and 100ug doses. The vaccine induced good titers of neutralsing antibodies.
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 		33707061
(Vaccine)
PMID
33707061
Date of Publishing: 2021 May 12
Title A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine
Author(s) nameChu L, McPhee R et al.
Journal Vaccine
Impact factor
3.31
Citation count: 64
Date of Entry 2021 Oct 30

In the four randomised trials, the ChAdOx1 nCoV-19 (AZD1222) vaccine was found to be safe with low incidence of adverse events. In the participants who received two standard doses, the efficacy after the second dose was higher in those who received the booster dose after 12 weeks when compared to those who received the second dose after 6 weeks.
✍
 		33617777
(Lancet)
PMID
33617777
Date of Publishing: 2021 Feb 19
Title Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials
Author(s) nameVoysey M, Costa Clemens SA et al.
Journal Lancet
Impact factor
43.38
Citation count: 396
Date of Entry 2021 Oct 30

In a placebo-controlled, phase 1/2 clinical trial, two doses of inactivated virus vaccine CoronaVac was found to be safe with lower adverse effects in healthy adults aged 1859 years. The vaccine was found to be safe and induced good humoral immune response.
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 		33217362
(Lancet Infect Dis)
PMID
33217362
Date of Publishing: 2020 Nov 17
Title Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial
Author(s) nameZhang Y, Zeng G et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 466
Date of Entry 2021 Oct 30

In a multicentre, phase 3 clinical trial, the BBV152 vaccine was found to be safe and immunogenic. The overall efficacy of the vaccine was 77.8%. The overall rate of adverse reactions was lower than that seen with other vaccinations. 15 deaths were reported, of which 6 deaths were related to COVID-19. The cause of death was not related to the vaccine, no analphylatic events were reported.
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 		Pre-print ( medRXiv )
Title Efficacy, safety, and lot to lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): a, double-blind, randomised, controlled phase 3 trial
Impact factor
N/A
Date of Entry 2021 Oct 30

In a randomized, double-blind placebo-controlled phase 3 trial, a single-dose of the Ad26.COV2.S vaccine was safe and efficacious against severe critical Covid 19 disease. The vaccine was found to be more efficacious against critical severe COVID-19 disease than moderate to severe COVID-19 disease. The vaccine showed good efficacy against different variants. The trial showed safety and efficacy of the single dose vaccine for ethinically and geographically diverse population.
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 		33882225
(N Engl J Med)
PMID
33882225
Date of Publishing: 2021 Apr 21
Title Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
Author(s) nameSadoff J, Gray G et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 636
Date of Entry 2021 Sep 27

In a phase 1 trial, the adjuvanted sclamp subunit vaccine was found to be safe and free from severe solicited adverse reactions. Similar frequency of adverse events were observed in the placebo and the vaccine group, irrespective of the vaccine dosage. The data are reported are up unitl day 57. The MF59-adjuvanted vaccine was found to be safe and elicited a good antigen-specific immune response.
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 		33887208
(Lancet Infect Dis)
PMID
33887208
Date of Publishing: 2021 Apr 19
Title Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial
Author(s) nameChappell KJ, Mordant FL et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 30
Date of Entry 2021 Sep 27

In two randomised, placebo-controlled, phase1/ 2 trials, RBD dimer-protein subunit vaccine ZF200 was found to be safe and well tolerated. 25g of the vaccine as a 3-dose regimen was selected for phase-3 trials. The two or three dose schedule of ZF2001 vaccine was well tolerated in both phase 1 and phase 2 trials. The adverse events reported were anticipated for alum adjuvanted protein subunit vaccines and were short-lived (resolved within 3 to 4 days after vaccination). The occurence of pain at injected site, fatigue, headache, nausea were lower with ZF2001 when compared with NVX-CoV2373 (where Matrix M1 was used as an adjuvant).
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 		33773111
(Lancet Infect Dis)
PMID
33773111
Date of Publishing: 2021 Mar 24
Title Safety and immunogenicity of a recombinant tandem - repeat dimeric RBD - based protein subunit vaccine (ZF2001) against COVID-19 in adults : two randomised, double - blind, placebo - controlled, phase 1 and 2 trials
Author(s) nameYang S, Li Y et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 126
Date of Entry 2021 Sep 27

In a placebo-controlled, phase 3 clinical trial, rAd26 and rAd5 vaccines were found to be safe with a 91.6 % efficacy. After the first dose and before administration of the second dose, 0.1% of the vaccine recipients and 1.3% of the placebo recipients contracted COVID-19 infection.
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 		33545094
(Lancet)
PMID
33545094
Date of Publishing: 2021 Feb 20
Title 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
Author(s) nameLogunov DY, Dolzhikova IV et al.
Journal Lancet
Impact factor
43.38
Citation count: 564
Date of Entry 2021 Sep 27

In a placebo-controlled phase1/2 trial, a whole inactivated COVID-19 vaccine was found to be safe with a low rate of adverse reactions. A phase 3 trial would be required to assess the long term safety of the vaccine.
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 		32789505
(JAMA)
PMID
32789505
Date of Publishing: 2020 Sep 8
Title Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials
Author(s) nameXia S, Duan K et al.
Journal JAMA
Impact factor
14.78
Citation count: 313
Date of Entry 2021 Sep 27

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.
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 		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: 105
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.
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 		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: 395
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.
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 		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: 1005
Date of Entry 2021 Aug 3