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ISSN (Online) : 2250-1460 Asian Journal of Pharmaceutical Research and Health Care, Vol 13(1), 1-3, 2021 DOI: 10.18311/ajprhc/2021/27078 Journey from to

Nagendra Kumar Rai1*, Anushruti Ashok1 and Butchi Raju Akondi2 1Cleveland Clinic, Cleveland, Ohio, USA; [email protected], [email protected] 2Ibn Sina National College for Medical Studies, Jeddah, ; [email protected]

Nearly one year ago the world health organization Boston-based company Moderna also received approval (WHO) identified an outbreak of pneumonia cases by FDA for emergency use. Like and BioNTech, the in , . Later, the cause of this disease was Moderna is mRNA based as well (efficacy: 94%)2. identified to be a mysterious SARS-CoV-2 coronavirus On 30th December, AZD1222 (also known as Covishield and in a matter of time, the coronavirus disease 2019 in ), manufactured by the University of Oxford and (COVID-19) spread as a pandemic across the globe. the British-Swedish company AstraZeneca, produced Currently, the total confirmed cases of COVID-19 have locally by Serum Institute of India, received approval reached over 106,301,950, with more than 2,318,094 from the Medicines and Healthcare products Regulatory deaths and 77,894,859 recoveries. The hard-hit Agency (MHRA), UK (efficacy: 62% to 90%, depending countries include the united states of America (USA) on dosage)3. Covishield is based on a weakened version with 26.7 million reported cases, followed by India (10.8 of a chimpanzee common cold virus. Johnson & Johnson million), (9.2 million), (3.9 million), and the is also developing a coronavirus vaccine known as JNJ- United Kingdom (UK) (3.8 million). Practically all these 78436735 or Ad26.COV2.S at Beth Israel Deaconess countries also rank in the top 5 on the number of deaths. Medical Center in Boston, which showed 66% efficacy Vaccines remain the most efficient tool to prevent to moderate to severe COVID-19 in phase III infectious diseases and improving global health. In trial4. Ad26.COV2.S vaccine is based on a replication- this pandemic, scientists around the world are racing incompetent adenovirus serotype 26 (Ad26) vector to develop vaccines to avert the spread of COVID-19. which encodes a full-length SARS-CoV-2 spike protein At present, more than 170 candidate vaccines are in (approval pending for emergency use). Recent evidence pre-clinical trials, and around 60 are in various phases suggests that Phase III trials of vaccines based on nucleic of clinical trials (WHO). The rapid development of acid coding for spike protein, delivered via adenoviruses numerous vaccine candidates in such a short term is or liposome exhibited effective immune responses3,5-7. remarkable, considering that the usual process takes 8-15 China has several vaccines in phase III , which years. There are four classes of vaccines in clinical trials: includes CoronaVac developed by Sinovac, BBIBP-CorV Whole virus (15), protein subunit (13), nucleic acid (20), by CNBG units/Sinopharm, (Ad5-nCoV) and (15). In few vaccines, antigen (whole by CanSino Biologicals, and ZF2001 by the Chinese virus and protein subunit) is injected into the body, while Academy of Science8. Sinopharm and Sinovac vaccines in other vaccines, viral nucleic acid and protein subunit are made from the inactivated virus while the CanSino is injected to stimulate the immune response in order vaccine is based on a replication-incompetent adenovirus to produce the antigen. Among vaccine candidates that vector. However, China has not released late-stage phase are undergoing Phase III clinical trials, few have already III data on its vaccines. In Russia, the Gamaleya Research been approved for emergency use in countries, including Institute has created a vaccine with 91.6% efficacy, which China, India, Russia, UK, and the USA (Table 1). is the mixture of two adenoviruses, i.e. Ad5 and Ad26, and In November 2020, Comirnaty, COVID-19 mRNA named it sputnik V9. India has approved two vaccines for vaccine manufactured by New York-based Pfizer and the emergency use that are Oxford-Astrazeneca’s Covishield German company BioNTech became the first fully tested and Covaxin10 manufactured by the joint collaboration of (efficacy: 95%) approved by the US Food Bharat Biotech and National Institute of virology based and Drug Administration (FDA) for emergency use1. In on their results from phase I and II clinical trials11. December 2020, another vaccine (mRNA-1273) made by

*Author for correspondence Journey from Coronavirus Pandemic to Vaccines India. U.A.E. Jordan. Status Approved in Approved , others Bahrain, Saudi Bahrain, Saudi other countries. other U.A.E., Bahrain. U.A.E., Egypt, , Egypt, Hungary, Russia, , Pakistan, Russia, UK, E.U., others. UK, E.U., others. indonesia Emergency use in Emergency use in Emergency use in Emergency use in Emergency Approval pending Approval pending Approval , , Argentina, Mexico, Early use in Russia. use in Russia. Early use in Russia. Early Approved in China, Approved Arabia, Switzerland. Switzerland. Arabia, E.U., other countries. other E.U., countries. other E.U., China, Brazil, , Turkey, China, Brazil, Limited use in China, Limited use in China, Limited Emergency use in US, Emergency use in US, Emergency Emergency use in UK, Emergency 95% 94% 92% 66% 79% 100% 89.3% 50.38% unknown unknown unknown Efficacy 62% to 90% 62% to Ad5 Ad26 mRNA mRNA Protein Protein ChAdOx1 Ad26, Ad5 Ad26, inactivated inactivated inactivated inactivated Mode of action of Mode USA USA India China China China China Russia Russia Country U.K and Sweden and U.K Belgium and USA Belgium and USA and Germany USA and Sinovac CanSino Moderna Gamaleya Sinopharm Developer Bharat BiotechBharat Vector InstituteVector Pfizer-BioNTech Sinopharm-Wuhan Johnson & Johnson Johnson Oxford-AstraZeneca COV2.S Comparison of the approved and under Phase III clinical trial Phase under and vaccines the approved of Comparison Vaccine AZD1222 Sputnik V Sputnik BNT162b2 CoronaVac Comirnaty/ mRNA-1273 BBIBP-CorV Tozinameran/ EpiVacCorona NVX-CoV2373 Sinopharm vaccine Sinopharm JNJ-78436735/ Ad26. Convidecia/ Ad5-nCoV Convidecia/ Table 1. Table websites firms/companies manufacturing Vaccine WHO, Source:

2 Vol 13 (1) | 2021 | www.informaticsjournals.org/index.php/ajprhc Asian Journal of Pharmaceutical Research and Health Care Nagendra Kumar Rai, Anushruti Ashok and Butchi Raju Akondi

Altogether, remarkable progress has been made with Kimmel, M., Van Damme, P., de Hoon, J., Smith, the effective production of several vaccines in all these W., Stephenson, K., De Rosa, S., Cohen, K., McElrath, countries. Despite this success, there are various challenges M., Cormier, E., Scheper, G., Barouch, D., Hendriks, in front of researchers, clinicians, and policy makers to J., Struyf, F., Douoguih, M., Van Hoof, J. and ensure the accessibility of vaccines to the general public Schuitemaker, H., 2021. Interim Results of a Phase and strengthening confidence towards existing vaccines 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine. N by providing their accountability, transparency, and Engl J Med. efficacy. Furthermore, the race in vaccine development 5. Pfizer.com. 2021. Pfizer and BioNTech Conclude has created a disparity in allocation and access to vaccines Phase 3 Study of COVID-19 Vaccine Candidate, between economically rich and poor countries. India is Meeting All Primary Efficacy Endpoints | Pfizer. one of the first countries, who has started shipping the [online] Available at: https://www.pfizer.com/news/ first doses of Covishield vaccines to its neighboring mid- press-release/press-release-detail/pfizer-and- and lower-income countries like , , -conclude-phase-3-study-covid-19-vaccine , , and Afghanistan as a gift, which is [Accessed 31 January 2021]. being widely appreciated as a part of "vaccine ." To ensure the procurement and equitable distribution 6. Moderna, Inc. 2021. Moderna’s COVID-19 Vaccine of COVID-19 vaccines worldwide, COVID-19 Vaccines Candidate Meets its Primary Efficacy Endpoint in Global Access (COVAX) facility has been established by the First Interim Analysis of the Phase 3 COVE WHO in collaboration with the Coalition for Study | Moderna, Inc.. [online] Available at: https://in Preparedness Innovations (CEPI) and Gavi, the Vaccine vestors.modernatx.com/news-releases/news-release Alliance. Although, the cascade of health-related and -details/modernas-covid-19-vaccine-candidate- economic damages caused by the coronavirus pandemic meets-its-primary-efficacy/ [Accessed 1 February 2021]. will probably remain for years, but we hope with great 7. En.wikipedia.org. 2021. Sputnik V COVID-19 confidence that global initiatives of vaccine development vaccine. [online] Available at: https://en.wikipedia. and procurement between nations will provide the fastest org/wiki/Sputnik_V_COVID-19_vaccine [Accessed recovery and will eradicate this pandemic from the world. 11 February 2021]. 1. References 8. Mallapaty, S., 2021. China COVID vaccine reports mixed results — what does that mean for the 1. Callaway E, Ledford H, Viglione G, Watson T, Witze pandemic?. [online] https://www.nature.com. Avail A. COVID and 2020: An extraordinary year for able at: https://www.nature.com/articles/d41586-021- science. Nature. 2020; 588: 550-552. 00094-z [Accessed 2 February 2021]. 2. Baden LR, El Sahly HM, Essink B, et al. Efficacy and 9. Voysey M, Clemens SAC, Madhi SA, et al. Safety and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N efficacy of the ChAdOx1 nCoV-19 vaccine Engl J Med. 2020; 384:403-416. (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South 3. Selectscience.net. 2021. AZD1222 vaccine met Africa, and the UK. Lancet. 2021; 397: 99-111. efficacy endpoint in preventing COVID-19. [online] Available at: https://www.selectscience.net/industry- 10. Ella R, Vadrevu KM, Jogdand H, et al. Safety and news/-covid-19-vaccine-azd1222-met- immunogenicity of an inactivated SARS-CoV-2 primary-efficacy-endpoint/?artID=53242 [Accessed vaccine, BBV152: a double-blind, randomised, phase 24 January 2021]. 1 trial. Lancet Infect Dis 2021 pp. 1-10. 4. Sadoff, J., Le Gars, M., Shukarev, G., Heerwegh, D., 11. Poland GA, Ovsyannikova IG, Kennedy RB. SARS- Truyers, C., de Groot, A., Stoop, J., Tete, S., Van CoV-2 immunity: review and applications to phase 3 Damme, W., Leroux-Roels, I., Berghmans, P., vaccine candidates. Lancet. 2020; 396: 1595-1606.

Vol 13 (1) | 2021 | www.informaticsjournals.org/index.php/ajprhc Asian Journal of Pharmaceutical Research and Health Care 3