Saudi Journal for Health Sciences

REVIEW ARTICLE
Year
: 2022  |  Volume : 11  |  Issue : 2  |  Page : 83--90

Recent update on treatment and preventive modalities for COVID-19 Omicron variant (B.1.1.529) in India: A comprehensive review


Deep Inder1, Seema Manak1, Md Faiz Akram1, Pawan Kumar2,  
1 Department of Pharmacology, FOD, Jamia Millia Islamia, Delhi, India
2 Additional Director, Directorate General of Health Services (DGHS), Delhi, India

Correspondence Address:
Md Faiz Akram
Department of Pharmacology, FOD, Jamia Millia Islamia, New Delhi - 110 025
India

Abstract

In India, Omicron (B1.1.529), a variant of concern of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has challenged the existing drug treatments options and available vaccines. Extensive search has been done to review updated information through original research articles, meta-analysis, and case reports available at EMBASE, SCOPUS, and Google Scholar, for treatment and preventive strategies against Omicron. Excessive mutations in SARS-CoV-2 (Omicron) led to immune escape witnessed for monoclonal antibodies, leaving very limited drug options to treat Omicron infected patients. Protection offered by existing vaccines appeared as a matter of concern as far as efficacy against Omicron is concerned. Although vaccination will not prevent re-infection in actively and passively immunized individual, but will prevent serious respiratory illness and death. The current review article imparts knowledge regarding pharmacotherapeutic agents, showing promise against Omicron. The present review also highlights updated data on newer vaccine candidates for their safety and efficacy for Omicron, based on postmarketing surveillance and Phase III clinical trials across the globe. There is a need to generate more data on drugs as well as vaccines specifically targeting Omicron, in order to contain SARS-CoV-2 new variant.



How to cite this article:
Inder D, Manak S, Akram MF, Kumar P. Recent update on treatment and preventive modalities for COVID-19 Omicron variant (B.1.1.529) in India: A comprehensive review.Saudi J Health Sci 2022;11:83-90


How to cite this URL:
Inder D, Manak S, Akram MF, Kumar P. Recent update on treatment and preventive modalities for COVID-19 Omicron variant (B.1.1.529) in India: A comprehensive review. Saudi J Health Sci [serial online] 2022 [cited 2022 Oct 3 ];11:83-90
Available from: https://www.saudijhealthsci.org/text.asp?2022/11/2/83/354163


Full Text



 INTRODUCTION



The COVID-19 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) originated in Wuhan, China, was reported in 2019. Alterations in the genetic makeup of a virus through mutations render it to change its pathogenic potential. Such viral genomic mutations are able to escape immune system, which challenge the development and success of vaccine. During its journey toward continuous evolution, SARS-CoV-2 has mutated several times in host resulted in emergence of new COVID-19 variants. Genomic sequencing helps in detection and identification of different variants evolving across the globe. Emerging new variants have challenged the role of existing treatment options including vaccine efficacy.[1],[2]

The present comprehensive review has been done to have insight into variants of concern, advances in pharmacotherapy of Omicron variant, and effectiveness of available and newly approved vaccines against emerging variants of COVID-19 in India. Comprehensive literature search from original research articles, review articles, meta-analyses, and case reports has been done to retrieve updated information using EMBASE, SCOPUS, and Google Scholar database.

Since the beginning of pandemic, major 5 variants of concerns have been identified by the WHO [Table 1] in epidemiological an update till December 2021.[3]{Table 1}

 IMPACT OF OMICRON AND LESSONS LEARNED



The first case of Omicron was detected from South Africa on November 24, 2021. Within 1 month, 108 nations across the world reported Omicron cases. The first case of Omicron variant in India was reported from Nagpur in mid-December 2021.[4] At present, India is recovering from Omicron-specific third wave. More than 43 genomic mutations have been discovered in Omicron, which has made it highly contagious, but relatively less virulent than earlier variants seen in India. The possibility of fourth COVID-19 wave due to emerging Omicron subvariants cannot be ruled out in near future in India.[3],[5] Learning lessons from past variants, the Indian Council of Medical Research, and medical experts in India have warned against the use of drugs already practiced for past variants. This may prevent emergence of drug resistance, immune escape, and secondary fungal infections such as invasive mucormycosis and aspergillosis witnessed during Delta wave in India.[6]

Therapies such as hydroxychloroquine, azithromycin, favipiravir, doxycycline, ivermectin, and convalescent plasma have no proven role in treatment of SARS-CoV-2 virus. Indiscriminate and over the counter use of these therapies may lead to disastrous consequences as discussed above.[2],[6]

Impact of Omicron variant seen in India has been very less and patients recovered within 3–6 days of contracting infection with only very mild symptoms. More than 70% of Indian population was asymptomatic for Omicron.[7] Most of the mild cases got treated in home isolation only. Therefore, treatment has been kept as simple as possible as recommended by the Ministry of Health and Family Welfare, India. This could be the result of hybrid immunity seen in Indian population. Hybrid immunity is achieved when a person already infected with virus gets vaccinated.[6],[8]

Pharmacotherapy in India has been recommended for serious, comorbid, and hospitalized patients only [Table 2]. There is a need to emphasize that recommended and approved treatments are not a substitute for vaccination for population which is still unvaccinated.[3],[6]{Table 2}

 VACCINATION STATUS OF INDIA



India is known for the world's largest COVID-19 vaccination drive, which started on January 16, 2021. Till March 2022, 1.8 billion vaccine doses have been administered. It covers 80% of total Indian population as fully vaccinated and 97% Indian population vaccinated with at least single dose. Many COVID-19 vaccines have been approved in India by regulatory authorities, Drug controller general of India (DCGI), India[24] [Table 3]. Despite vaccination coverage, world is facing challenge of immune escape from existing vaccines, with the emerging new COVID-19 variants. Vaccine developed against one variant may not be fully protective against new variant, but will be able to prevent severity of infection in vaccinated individuals.[3],[25]{Table 3}

 DISCUSSION



There are chances of immune evasion from antibody-mediated protection, especially protection directed at the spike protein in case of Omicron. Immune escape from cell-mediated immunity is further difficult to assess in Omicron-related SARS-CoV-2.[48] Research involving individual drugs affecting antigen binding/virus neutralization using monoclonal antibodies need to be prioritized by giving fast track approval to get leads which can boost T-cell response, found to be important for providing long-term immunity against Omicron and its emerging sublineage variants (B.1, B1.1, B. 2).[49],[50]

As per the WHO, the drug classes targeting host immune response such as corticosteroids and interleukin-6 receptor blockers will still continue to be efficacious against Omicron or its subvariant especially in severe or critical COVID-19 patients. Data from few studies indicate lower efficacy of few monoclonal antibodies against Omicron.[48],[51]

Recently, vaccine developers have started working on updating COVID-19 vaccines by developing Omicron-specific vaccines on fast track mode.[8],[49],[51] India's code name of vaccine (HGCO19) indigenous mRNA vaccine developed by Gennova Biopharmaceuticals, Pune, has submitted phase III clinical trial data to DCGI for final approval.[44] Vaccine developers Pfizer and Moderna have initiated clinical trials by inoculating their people with booster shots using Omicron-specific vaccine.[52] Noninvasive intranasal vaccines are being investigated in under clinical trials for easy administration. It is matter of debate at the WHO, whether Omicron-specific booster shots will work against emerging variants of SARS-CoV-2 and need to update COVID-19 vaccine composition. Requirement of fourth dose will be based on duration and efficacy of third precautionary dose. There are populations across world, which are still waiting to have access of first or second dose vaccine against SARS-CoV-2. Recommending vaccines against latest Omicron-specific variant may disseminate false message of nonefficacy and uselessness of already existing vaccines against new variants. Such perception in public may increase the gap among under vaccinated and over vaccinated populations across globe.[46],[48],[52],[53]

Despite many uncertainties of reinfection with emerging variants, we affirm that currently existing vaccines offer definite protection all SARS-CoV-2 variants including Omicron and its subvariant, against serious disease and death.[53],[54]

 CONCLUSIONS AND RECOMMENDATIONS



Nations across the world need to assess and revise their national guidelines and advisories based on their existing pandemic situation and as per their national capacities.

Special groups such as pregnant, lactating females, and children need to be enrolled in drug safety clinical trials to generate special group-related data. Coordination is expected among researchers, ethical committees, regulatory agencies, and policymakers for collaborative efforts to generate meaningful and quality data on safety of Omicron-specific drugs and vaccines. Indiscriminate use of corticosteroids or interleukin-6 receptor blockers need to be controlled by strictly adhering to national treatment guidelines revised from time to time, which will help curtailing drug resistance and secondary opportunistic infections. Despite uncertainties about vaccine efficacy in Omicron, the eligible unvaccinated population should get vaccinated. Vaccination is likely to offer protection against severe respiratory disease and death. Equitable vaccine distribution is the need of the hour to eliminate COVID-19, which can be possible by facilitating access to vaccines to poor countries. Further research is needed to better understand the mechanism of immune escape associated with Omicron and its sub-variants for vaccines. Data suggestive of duration of natural immunity following Omicron needs to be analyzed to give a thought for forth booster shot, if required.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

References

1Starr TN, Greaney AJ, Addetia A, Hannon WW, Choudhary MC, Dingens AS, et al. Prospective mapping of viral mutations that escape antibodies used to treat COVID-19. Science 2021;371:850-4.
2Aleem A, Akbar Samad AB, Slenker AK. Emerging variants of SARS-CoV-2 and novel therapeutics against coronavirus (COVID-19). In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2022.
3World Health Organization. Available from: https://www.who.int/news/item/26-11-2021-classification-of-omicron-(b.1.1.529)-sars-cov-2- variant-of-concern. [Last accessed on 2021 Nov 26].
4Available from: https://economictimes.indiatimes.com. [Last accessed on 2021 Dec 13].
5Saxena SK, Kumar S, Ansari S, Paweska JT, Maurya VK, Tripathi AK, et al. Characterization of the novel SARS-CoV-2 Omicron (B.1.1.529) variant of concern and its global perspective. J Med Virol 2022;94:1738-44.
6The Indian Council of Medical Research. Available from: https://www.icmr.gov.in/pdf/covid/strategy/Advisory_COVID_Testing_10012022.pdf. [Last accessed on 2022 Jan 10].
7Available from: https://www.hindustantimes.com. [Last accessed on 2022 May 15].
8Wratil PR, Stern M, Priller A, Willmann A, Almanzar G, Vogel E, et al. Three exposures to the spike protein of SARS-CoV-2 by either infection or vaccination elicit superior neutralizing immunity to all variants of concern. Nat Med 2022;28:496-503.
9Malin JJ, Suárez I, Priesner V, Fätkenheuer G, Rybniker J. Remdesivir against COVID-19 and other viral diseases. Clin Microbiol Rev 2020;34:e00162-20.
10What's New COVID-19 Treatment Guidelines? Available from: https://www.covid19treatmentguidelines.nih.gov. [Last updated on 2022 Ma 02].
11Gottlieb RL, Vaca CE, Paredes R, Mera J, Webb BJ, Perez G, et al. Early remdesivir to prevent progression to severe COVID-19 in outpatients. N Engl J Med 2022;386:305-15.
12The United States Food and Drug Administration. Available from: https://www.fda.gov/. [Last accessed on 2022 Jan 07].
13Bernal AJ, Gomes da Silva MM, Musungaie DB, Kovalchuk E, Gonzalez A, Delos Reyes V, et al. Molnupiravir for oral treatment of COVID-19 in nonhospitalized patients. N Engl J Med 2022;386:509-20.
14Rosas IO, Bräu N, Waters M, Go RC, Hunter BD, Bhagani S, et al. Tocilizumab in hospitalized patients with severe COVID-19 pneumonia. N Engl J Med 2021;384:1503-16.
15RECOVERY Collaborative Group. Toclizumab in patients admitted to hospital with covid-19 (Recovery): A randomized, controlled, open-label, platform trial. Lancet 2021;397:1637-45.
16Paxlovid TM Fact Sheet. Available from: https://www.pfizer.com. [Last accessed on 2022 Jun 14].
17COVID-19 Treatment Guidelines. Available from: https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/ritonavir-boosted-nirmatrelvir--paxlovid-/. [Last accessed on 2022 May 31].
18Fact Sheet for Healthcare Providers Emergency Use Authorization (EUA) of Sotrovimab. Available from: https://www.fda.gov. [Last accessed on 2022 May 26].
19Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Falci DR, et al. Early Treatment for COVID-19 with SARS-CoV-2 neutralizing antibody sotrovimab. N Engl J Med 2021;385:1941-50.
20Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19. Available from: https://www.fda. gov /news-events /press-announcements/coronavirus-covid -19-update-fda-authorizes-monoclonal-antibodies-treatment- covid-19-0. [Last accessed on 2022 Feb 11].
21Dougan M, Nirula A, Azizad M, Mocherla B, Gottlieb RL, Chen P, et al. Bamlanivimab plus etesevimab in mild or moderate COVID-19. N Engl J Med 2021;385:1382-92.
22Razonable RR, Pawlowski C, O'Horo JC, Arndt LL, Arndt R, Bierle DM, et al. Casirivimab-Imdevimab treatment is associated with reduced rates of hospitalization among high-risk patients with mild to moderate coronavirus disease-19. EClinicalMedicine 2021;40:101102.
23Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant (Press release). Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron. [Last accessed on 2022 Jan 24].
24The Ministry of Health and Family Welfare. Available from: https://mohfw.gov.in/. [Last accessed on 2022 Mar 21].
25Sah R, Shrestha S, Mehta R, Sah SK, Rabaan AA, Dhama K, et al. AZD1222 (Covishield) vaccination for COVID-19: Experiences, challenges, and solutions in Nepal. Travel Med Infect Dis 2021;40:101989.
26Voysey M, Costa Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. 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. Lancet 2021;397:881-91.
27Bharat Biotech Announces Phase 3 Results of COVAXIN: India's First COVID-19 Vaccine Demonstrates Interim Clinical Efficacy of 81%. 2021. Bharat Biotech. Available from: https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf. [Last accessed on 2021 Mar 03].
28Ella R, Reddy S, Blackwelder W, Potdar V, Yadav P, Sarangi V, et al. Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): Interim results of a randomised, double-blind, controlled, phase 3 trial. Lancet 2021;398:2173-84.
29CORBEVAXTM. The Biological E. Available from: https://www.biologicale.com. [Last accessed on 2022 Jun 06].
30Kuehn BM. New COVID-19 vaccine aims to increase global vaccine access. JAMA 2022;327:614.
31Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, et al. Safety and efficacy of NVX-CoV2373 COVID-19 vaccine. N Engl J Med 2021;385:1172-83.
32Fact Sheet Covovax, SII. Available from: https://www.seruminstitute.com. [Last accessed on 2022 May 03].
33Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, et al. Efficacy of NVX-CoV2373 COVID-19 vaccine against the B.1.351 variant. N Engl J Med 2021;384:1899-909.
34Momin T, Kansagra K, Patel H, Sharma S, Sharma B, Patel J, et al. 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. EClinicalMedicine 2021;38:101020.
35Dey A, Chozhavel Rajanathan TM, Chandra H, Pericherla HP, Kumar S, Choonia HS, et al. Immunogenic potential of DNA vaccine candidate, ZyCoV-D against SARS-CoV-2 in animal models. Vaccine 2021;39:4108-16.
36Rossi AH, Ojeda DS, Varese A, Sanchez L, Gonzalez Lopez Ledesma MM, Mazzitelli I, et al. Sputnik V vaccine elicits seroconversion and neutralizing capacity to SARS-CoV-2 after a single dose. Cell Rep Med 2021;2:100359.
37Montalti M, Soldà G, Di Valerio Z, Salussolia A, Lenzi J, Forcellini M, et al. ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance. EClinicalMedicine 2021;38:101027.
38Bruxvoort KJ, Sy LS, Qian L, Ackerson BK, Luo Y, Lee GS, et al. Effectiveness of mRNA-1273 against delta, mu, and other emerging variants of SARS-CoV-2: Test negative case-control study. BMJ 2021;375:e068848.
39Spikevax (COVID-19 Vaccine, mRNA) Suspension for Injection, for Intramuscular Use” (PDF). U.S. Food and Drug Administration (FDA). Available from: https://www.fda.gov/media/155675/download. [Last accessed on 2022 Jan 31].
40Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, et al. Safety and efficacy of single-dose Ad26.COV2.S vaccine against COVID-19. N Engl J Med 2021;384:2187-201.
41Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, et al. Final analysis of efficacy and safety of single-dose Ad26.COV2.S. N Engl J Med 2022;386:847-60.
42Williams SV, Vusirikala A, Ladhani SN, De Olano EF, Iyanger N, Aiano F, et al. An outbreak caused by the SARS-CoV-2 Delta (B. 1.617. 2) variant in a care home after partial vaccination with a single dose of the COVID-19 vaccine Vaxzevria, London, England, April 2021. Eurosurveillance 2021;26:2100626.
43Tran Kiem C, Andronico A, Bosetti P, Paireau J, Alter L, Boëlle PY, et al. Benefits and risks associated with different uses of the COVID-19 vaccine Vaxzevria: A modelling study, France, May to September 2021. Euro Surveill 2021;26:2100533.
44Safety and Immunogenicity Study of mRNA Based Vaccine (HGCO19) against COVID-19 in Healthy Adult Participants. Clinical Trials Registry India. Available from: https://ctri.nic.in. [Last accessed on 2022 Feb 04].
45Ali K, Berman G, Zhou H, Deng W, Faughnan V, Coronado-Voges M, et al. Evaluation of mRNA-1273 SARS-CoV-2 vaccine in adolescents. N Engl J Med 2021;385:2241-51.
46Shah SS, Patel CM, Patel DH, Vadgama PH, Patel M, Trivedi R. A review on modern use of intranasal vaccination in the treatment of SARS-COV-2. J Drug Deliv Therap 2021;11:263-70.
47Hindustan Times. Available from: https://www.hindustantimes.com/india-news/dcgi-approves-trials-for-internasal-booster-dose -101643393945683.html. [Last accessed on 2022 jan 28].
48Callaway E. Omicron likely to weaken COVID vaccine protection. Nature 2021;600:367-8.
49Hu J, Peng P, Cao X, Wu K, Chen J, Wang K, et al. Increased immune escape of the new SARS-CoV-2 variant of concern Omicron. Cell Mol Immunol 2022;19:293-5.
50Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, et al. Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection. Nat Med 2021;27:1205-11.
51WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group; Shankar-Hari M, Vale CL, Godolphin PJ, Fisher D, Higgins JP, et al. Association between administration of IL-6 antagonists and mortality among patients hospitalized for COVID-19: A meta-analysis. JAMA 2021;326:499-518.
52Chauhan N, Manjunath BC, Yadav V, Kumar A, Sabbarwal B, Kumar JS, et al. COVID-19 vaccine development in India during Janaury 2021-December 2021: A narrative review. Saudi J Med 2022;7:118-26.
53World Health Organization. Weekly Epidemiological Update on COVID-19; February 01, 2022. Available from: https://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19---1-february-2022. [Last accessed on 2022 Jun 01].
54Mohiuddin M, Kasahara K. Investigating the aggressiveness of the COVID-19 Omicron variant and suggestions for possible treatment options. Respir Med 2022;191:106716.