A Comprehensive Review on Efficacy and Adverse Events Associated With Different Covid-19 Vaccines‎

Authors

  • Swathi Swaroopa Borra JSS Academy of Higher Education and Research, India
  • Narenthiran C K JSS Academy of Higher Education and Research, India
  • Dinesh Kumar JSS Academy of Higher Education and Research, India
  • Ayilya M JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, India
  • Sadagoban G. K JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, India

DOI:

https://doi.org/10.35516/jjps.v15i2.326

Keywords:

COVID-19 Vaccine, Vaccine Efficacy, Vaccine Adverse effects

Abstract

To combat COVID-19, various health agencies around the world gave emergency approval for vaccines. Therefore, the long-term protective effect and the potential adverse effects of the vaccines on immunocompromised patients, pregnant women and geriatrics might not be well-established. The aim of this review was to assess the safety and efficacy of a number of the most commonly approved vaccines all over the world. A review was made to identify clinical trials that studied the vaccines’ efficacy and case reports of potential suspected vaccine-related adverse events. The electronic databases searched to identify relevant studies were Science Direct, PubMed/Medline, Scopus and MedRxiv. Seven randomized controlled trials which assessed the efficacy of COVID-19 vaccines and case reports which reported the vaccines’ adverse events were included in the review. The efficacy of the vaccines was found to be 94.6% for Pfizer vaccine, 94.1% for Moderna vaccine, 66.1% for Johnson and Johnson’s, 76.4% for Covishield, 91.6% for Sputnik, and 77.8% for Covaxin. No severe adverse events were reported in the studies. All the reported adverse events were mild, self-sustaining and did not require any medical intervention. All the COVID-19 vaccines demonstrated promising immunogenicity profile, different degrees of protective effectiveness and a tolerable safety profile. However, further research to evaluate the efficacy and safety in vulnerable populations including immunocompromised patients, pregnant women and geriatric populations are needed. The long term post marketing surveillance becomes a very important part of identifying the efficacy and side effects among different populations.

Author Biographies

Swathi Swaroopa Borra, JSS Academy of Higher Education and Research, India

Department of Pharmacy Practice, JSS College of Pharmacy

Narenthiran C K, JSS Academy of Higher Education and Research, India

Department of Pharmacy Practice, JSS College of Pharmacy

Dinesh Kumar, JSS Academy of Higher Education and Research, India

Department of Pharmacy Practice

Ayilya M, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, India

Department of Pharmacy Practice

Sadagoban G. K, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, India

Department of Pharmacy Practice

References

WHO. Director-General’s Opening Remarks at the Media Briefing on COVID19. Available from <https://www.who.int/news/ item/27-04-2020-who-timeline---covid-19 >

WHO. COVID-19 Dashboard. Available from <https://covid19.who.int/>

Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine[J]. N Engl J Med, 2020, 383(27): 2603-2615.

Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N. Engl. J. Med. 2020, 384, 403–416.

Logunov DY, Dolzhikova I.V, Shcheblyakov DV, Tukhvatulin A, Zubkova OV, Dzharullaeva AS, et al. 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. Lancet. 2021,

Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, De Groot AM, et al. Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine. N. Engl. J. Med. 2021.

Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. 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. Lancet 2021, 397, 99–111

Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: A randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect. Dis. 2021, 21, 39–51.

Ella R, Reddy S, Jogdand H, Sarangi V, Ganneru B, Prasad S, et al. 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 trial. Lancet Infect. Dis. 2021.

Fueyo-Rodriguez O, Valente-Acosta B, Jimenez-Soto R, Neme-Yunes Y, Inclán-Alarcón SI, Trejo-Gonzalez R, et al. Secondary immune thrombocytopenia supposedly attributable to COVID-19 vaccination. BMJ case reports, 14(5), e242220. Doi:10.1136/bcr-2021-242220

Lopatynsky-Reyes EZ, Acosta-Lazo H, Ulloa-Gutierrez R, Ávila-Aguero ML, Chacon-Cruz E. BCG Scar Local Skin Inflammation as a Novel Reaction Following mRNA COVID-19 Vaccines in Two International Healthcare Workers. Cureus, 13(4), e14453. Doi:10.7759/cureus.14453

Patel SU, Khurram R, Lakhani A, Quirk B. Guillain-Barre syndrome following the first dose of the chimpanzee adenovirus-vectored COVID-19 vaccine, ChAdOx1. BMJ case reports, 14(4), e242956. Doi:10.1136/bcr-2021-242956

Finsterer J. Exacerbating Guillain-Barré Syndrome Eight Days after Vector-Based COVID-19 Vaccination. Case reports in infectious diseases, 2021, 3619131. Doi:10.1155/2021/3619131

Helms JM, Ansteatt KT, Roberts JC, Kamatam S, Foong KS, Labayog JS, et al. Severe, Refractory Immune Thrombocytopenia Occurring After SARS-CoV-2 Vaccine. Journal of blood medicine, 12, 221–224. Doi:10.2147/JBM.S307047

Lebedev L, Sapojnikov M, Wechsler A, Varadi-Levi R, Zamir D, Tobar A, et al. Minimal Change Disease Following the Pfizer-BioNTech COVID-19 Vaccine. American journal of kidney diseases: the official journal of the National Kidney Foundation, 78(1), 142–145. Advance online publication. Doi:10.1053/j.ajkd.2021.03.010

Albert E, Aurigemma G, Saucedo J, Gerson D. Myocarditis following COVID-19 vaccination. Radiology Case Reports. 2021;16 (8):2142-2145.

Reactions and Adverse Events of the Pfizer-BioNTech COVID-19 Vaccine | CDC. Cdc.gov. 2021. Available from

<https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html>

Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events: Moderna COVID-19 Vaccine | CDC. Cdc.gov. 2021. Available from <https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/ reactogenicity.html>

Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events: Janssen COVID-19 Vaccine (J&J) | CDC. Cdc.gov. 2021. Available from <https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/ reactogenicity.html>

Amit S, Regev-Yochay G, Afek A, Kreiss Y, Leshem E. Early rate reductions of SARS-CoV-2 infection and COVID-19 in BNT162b2 vaccine recipients. The Lancet. 2021;397(10277):875-877.

Thompson MG, Burgess JL, Naleway AL, Tyner HL, Yoon SK, Meece J, et al. Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers — Eight U.S. Locations, December 2020–March 2021. MMWR Morb Mortal Wkly Rep 2021;70:495–500. Doi:10.15585/mmwr.mm7013 e3external icon

Abu-Raddad L, Chemaitelly H, Butt A. Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants. New England Journal of Medicine. 2021;.

The Pharmaceutical Journal, PJ, June 2021, Vol 306, No 7950;306(7950)::DOI:10.1211/PJ.2021.1.71237

Assets.publishing.service.gov.uk. 2021. Available from <https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/989360/PHE_COVID-19_vaccine_effectiveness_report_March_2021_v2.pdf>

Moderna Announces TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint and Plans to Submit Data to Regulators in Early June | Moderna, Inc. 2021. Available from <https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-teencove-study-its-covid-19-vaccine>

Liu Y, Liu J, Xia H, Zhang X, Fontes-Garfias C, Swanson K et al. Neutralizing Activity of BNT162b2-Elicited Serum. New England Journal of Medicine. 2021;384(15):1466-1468.

Dejnirattisai W, Zhou D, Supasa P, Liu C, Mentzer A, Ginn H et al. Antibody evasion by the Brazilian P.1 strain of SARS-CoV-2. 2021;.

Corchado-Garcia J, Puyraimond-Zemmour D, Hughes T, Cristea-Platon T, Lenehan P, Pawlowski C et al. Real-world effectiveness of Ad26.COV2.S adenoviral vector vaccine for COVID-19. 2021.

Coronavirus Disease 2019. Centers for Disease Control and Prevention. 2021. Available from <https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html>

Emary K, Golubchik T, Aley P, Ariani C, Angus B, Bibi S, et al. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial. The Lancet. 2021;397(10282):1351-1362.

Wang P, Nair MS, Liu L, Iketani S, Luo Y, Guo Y, et al. Antibody Resistance of SARS-CoV-2 Variants B.1.351 and B.1.1.7. Nature Doi:10.1038/s41586-021-03398-2

Public library - PHE national - Knowledge Hub. Khub.net. 2021. Available from <https://khub.net/web/phe-national/public-library/-/document_library/v2WsRK3ZlEig/ view_file/479607329?_com_liferay_document_library_web_portlet_DLPortlet_INSTANCE_v2WsRK3ZlEig_redirect=https%3A%2F%2Fkhub.net%3A443%2Fweb%2Fphe-national%2Fpublic-library%2F-%>

Khub.net. 2021. Available from

<https://khub.net/documents/135939561/430986542/Early+effectiveness+of+COVID+vaccines.pdf/ffd7161c-b255-8e88-c2dc-88979fc2cc1b?t=1614617945615>

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021 - European Medicines Agency. European Medicines Agency. 2021. Available from

<https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-may-2021>

Pagotto V, Ferloni A, Soriano M, Díaz M, Golde M, González M et al. ACTIVE SURVEILLANCE OF THE SPUTNIK V VACCINE IN HEALTH WORKERS. 2021.

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine. U.S. Food and Drug Administration. 2021. Available from: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine in Children Ages 5 through 11 Years | Pfizer. Pfizer.com. 2021. Available from:

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-first-us-fda-emergency-use-0

Follow-Up Data from Phase 3 Trial of Pfizer-BioNTech COVID-19 Vaccine Support Safety and High Efficacy in Adolescents 12 Through 15 Years of Age | Pfizer. Pfizer.com. 2021. Available from: https://www.pfizer.com/news/press-release/press-release-detail/follow-data-phase-3-trial-pfizer-biontech-covid-19-vaccine

CDC Recommends Use of Johnson & Johnson’s Janssen COVID-19 Vaccine Resume. Centers for Disease Control and Prevention. 2021. Available from:

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html#

Sputnik V Vaccine. Precision Vaccinations. 2021. Available from:

https://www.precisionvaccinations.com/vaccines/sputnik-v-vaccine

WHO issues emergency use listing for eighth COVID-19 Vaccine. World Health Organization. 2021. Available from:

https://www.who.int/news/item/03-11-2021-who-issues-emergency-use-listing-for-eighth-covid-19-vaccine

Mahase E. Covid-19: Where are we on vaccines and variants? BMJ. 2021. Available from: https://www.bmj.com/content/372/bmj.n597/related

Sanderson K. COVID vaccines protect against Delta, but their effectiveness wanes. Nature. 2021. Available from: https://www.nature.com/articles/d41586-021-02261-8.

Rajagopal K, Byran G, Swaminathan G, Ramachandran V. Activity of Isoxazole substituted 9-aminoacridines against SARS CoV-2 main protease for COVID19: A computational approach. Jordan Journal of Pharmaceutical Sciences, 2021, 14(4), 403-416.

Raeda AQ, Musa TA, Mohammad A, Immanuel AM. Viewpoint: Jordan’s Public and Surveillance Health Policies: During and After COVID-19. Jordan Journal of Pharmaceutical Sciences, 2020; 13(3): 1-10.

Downloads

Published

2022-06-01

How to Cite

Borra, S. S. ., C K, N. ., Kumar, D. ., M, A. ., & G. K, S. (2022). A Comprehensive Review on Efficacy and Adverse Events Associated With Different Covid-19 Vaccines‎. Jordan Journal of Pharmaceutical Sciences, 15(2), 289–304. https://doi.org/10.35516/jjps.v15i2.326

Issue

Section

Articles