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      The SARS-CoV-2 mutation versus vaccine effectiveness: new opportunities to new challenges

      review-article
      Author(s): a , b , c , d , e , f , f , g , *
      Publication date (Electronic):
      Journal: Journal of Infection and Public Health
      Publisher: The Author(s). Published by Elsevier Ltd on behalf of King Saud Bin Abdulaziz University for Health Sciences.
      Keywords: ACE2, Angiotensin-converting enzyme receptor 2, GISAID, Global Initiative on Sharing All Influenza Data, CDC, Centre for Disease Control and Prevention, VOI, Variant of Interest, VOC, Variant of Concern, VOHC, Variant of High Consequence, CMV, Cytomegalovirus, NIAID, National Institute of Allergy and Infectious Diseases, COVE, Coronavirus Efficacy, VE, Vaccine effectiveness, PHE, Public Health Emergency, EUAL, Emergency Use Assessment and Listing, R.C.T., Randomised Clinical Trials, SAE, Serious adverse events, CNBG, China National Biotec Group, BIBP, Beijing Institute of Biological Products, WIBP, Wuhan Institute of Biological Products, ADDE, Antibody dependent disease enhancement, NERVTAG, New and Emerging Respiratory Virus Threats Advisory Group, WGS, whole-genome sequencing, SIADP, Sharing All Influenza Data platform, HPVV, human papillomavirus vaccine, RVZV, recombinant varicella-zoster vaccine, HBV, hepatitis B virus vaccine, AAs, Amino acids, NTD, N-terminal domain, RBD, receptor-binding domain, Covid-19, mutations, variant strains, vaccine efficacy, clinical trials

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          Abstract

          Background

          The SARS-CoV-2 coronavirus epidemic is hastening the discovery of the most efficient vaccines. The development of cost-effective vaccines seems to be the only solution to terminate this Pandemic. However, the vaccines’ effectiveness has been questioned due to recurrent mutations in the SARS-CoV-2 genome. Most of the mutations are associated with the spike protein, a vital target for several marketed vaccines. Many Countries were highly affected by the 2nd wave of the SARS-CoV-2, like the UK, India, Brazil, France. Experts are also alarming the further COVID-19 wave with the emergence of Omicron, which is highly affecting the South African populations. This review encompasses the detailed description of all vaccine candidates and COVID-19 mutants that will add value to design further studies to combat the COVID-19 Pandemic.

          Methods

          The information was generated using various search engines like google scholar, PubMed, clinicaltrial.gov.in, WHO database, ScienceDirect, and news portals by using keywords SARS-CoV-2 Mutants, COVID-19 Vaccines, Efficacy of SARS-CoV-2 Vaccines, COVID-19 waves.

          Results

          This review has highlighted the evolution of SARS-CoV2 variants and the vaccine efficacy. Currently, various vaccine candidates are also undergoing several phases of development. Their efficacy still needs to check for newly emerged variants. We have focused on the evolution, multiple mutants, waves of the SARS-CoV-2, and different marketed vaccines undergoing various clinical trials and the design of the trials to determine vaccine efficacy.

          Conclusion

          Various mutants of SARS-CoV-2 arrived, mainly concerned with the spike protein, a key component to design the vaccine candidates. Various vaccines are undergoing clinical trial and show impressive results, but their efficacy still needs to be checked in different SARS-CoV-2 mutants. We discussed all mutants of SARS-CoV-2 and the vaccine's efficacy against them. The safety concern of these vaccines is also discussed. It is important to understand how coronavirus gets mutated to design better new vaccines, providing long-term protection and neutralizing broad mutant variants. A proper study approach also needs to be considered while designing the vaccine efficacy trials, which further improved the study outcomes. Taking preventive measures to protect from the virus is also equally important, like vaccine development.

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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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            Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

            Lindsey Baden, Hana El Sahly, Brandon Essink … (2020)
            Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)
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              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

              Merryn Voysey, Sue Ann Costa Clemens, Shabir Madhi … (2022)
              Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; p interaction =0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. Funding UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D’Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Infect Public Health
                Journal ID (iso-abbrev): J Infect Public Health
                Title: Journal of Infection and Public Health
                Publisher: The Author(s). Published by Elsevier Ltd on behalf of King Saud Bin Abdulaziz University for Health Sciences.
                ISSN (Print): 1876-0341
                ISSN (Electronic): 1876-035X
                Publication date PMC-release: 5 January 2022
                Publication date (Electronic): 5 January 2022
                Affiliations
                [a ]Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, Guwahati, India
                [b ]Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, Mohali, India
                [c ]Department of Pharmacology, Jamia Hamdard, New Delhi, India
                [d ]Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research, Guwahati, India
                [e ]Biotechnology Institute, Ankara University, Ankara, Turkey
                [f ]Department of Pharmaceutics, College of Pharmacy, University of Hail, Hail, Saudi Arabia
                [g ]Department of Pharmacology and Toxicology, College of Pharmacy, University of Hail, Hail, Saudi Arabia
                Author notes
                [* ]Corresponding author.
                Article
                Publisher Item ID: S1876-0341(22)00002-8
                DOI: 10.1016/j.jiph.2021.12.014
                PMC ID: 8730674
                PubMed ID: 35042059
                SO-VID: 44519a28-64c6-4d93-8733-d22e6563ee74
                Copyright © © 2022 The Author(s). Published by Elsevier Ltd on behalf of King Saud Bin Abdulaziz University for Health Sciences.
                License:

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                Date received : 27 October 2021
                Date revision received : 13 December 2021
                Date accepted : 25 December 2021
                Categories
                Subject: Review

                Keywords: ace2, angiotensin-converting enzyme receptor 2,gisaid, global initiative on sharing all influenza data,cdc, centre for disease control and prevention,voi, variant of interest,voc, variant of concern,vohc, variant of high consequence,cmv, cytomegalovirus,niaid, national institute of allergy and infectious diseases,cove, coronavirus efficacy,ve, vaccine effectiveness,phe, public health emergency,eual, emergency use assessment and listing,r.c.t., randomised clinical trials,sae, serious adverse events,cnbg, china national biotec group,bibp, beijing institute of biological products,wibp, wuhan institute of biological products,adde, antibody dependent disease enhancement,nervtag, new and emerging respiratory virus threats advisory group,wgs, whole-genome sequencing,siadp, sharing all influenza data platform,hpvv, human papillomavirus vaccine,rvzv, recombinant varicella-zoster vaccine,hbv, hepatitis b virus vaccine,aas, amino acids,ntd, n-terminal domain,rbd, receptor-binding domain,covid-19,mutations,variant strains,vaccine efficacy,clinical trials
                Data availability:
                Keywords: ace2, angiotensin-converting enzyme receptor 2, gisaid, global initiative on sharing all influenza data, cdc, centre for disease control and prevention, voi, variant of interest, voc, variant of concern, vohc, variant of high consequence, cmv, cytomegalovirus, niaid, national institute of allergy and infectious diseases, cove, coronavirus efficacy, ve, vaccine effectiveness, phe, public health emergency, eual, emergency use assessment and listing, r.c.t., randomised clinical trials, sae, serious adverse events, cnbg, china national biotec group, bibp, beijing institute of biological products, wibp, wuhan institute of biological products, adde, antibody dependent disease enhancement, nervtag, new and emerging respiratory virus threats advisory group, wgs, whole-genome sequencing, siadp, sharing all influenza data platform, hpvv, human papillomavirus vaccine, rvzv, recombinant varicella-zoster vaccine, hbv, hepatitis b virus vaccine, aas, amino acids, ntd, n-terminal domain, rbd, receptor-binding domain, covid-19, mutations, variant strains, vaccine efficacy, clinical trials

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