Cjepivo protiv COVID-19: razlika između inačica
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Update 4. sijecnja 2021. |
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{{Aktualno-koronavirus}}
[[File:COVID Vaccine (50745583447).jpg|thumb|300 px|Cijepljenje američkog zrakoplovca Ramón Colón-López u prosincu 2020.]]
'''Cjepivo protiv COVID-19''' je hipotetsko [[Cjepivo|cjepivo]] protiv [[COVID-19|koronavirusne bolesti (COVID-19)]]. Državne zdravstvene agencije odobrile su osam kandidata za javnu uporabu. Mnoge su zemlje provodile fazne planove raspodjele koji daju prioritet onima s najvećim rizikom od komplikacija poput starijih i onima s visokim rizikom od izloženosti i prijenosa, poput zdravstvenih radnika. Od [[3. siječnja]] 2021. godine diljem svijeta primijenjeno je 12,3 milijuna doza cjepiva COVID-19 na temelju službenih izvješća nacionalnih zdravstvenih agencija.
== Razvoj ==
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=== Gam-COVID-Vac ===
[[File:Вакцина Спутник V.jpg|thumb|500 px|Gam-COVID-Vac cjepivo]]
Dana 11. kolovoza 2020. godine, ruski predsjednik [[Vladimir Putin]] je objavio, da je Ministarstvo zdravlja [[Rusija|Ruske Federacije]] odobrilo prvo cjepivo protiv [[COVID-19]] bolesti,<ref>[https://www.rt.com/russia/497671-putin-covid-19-vaccine-first/ Putin says Russia’s Health Ministry has approved world’s FIRST Covid-19 vaccine, his own daughter has been vaccinated], RT, pristupljeno 12. kolovoza 2020.</ref> unatoč tome što je testirano samo na malom broju ljudi u ranim fazama kliničkih ispitivanja koja su trajala dva mjeseca, što je obično postupak koji zahtijeva godinu ili više kliničkih procjena za dokaz sigurnosti cjepiva i učinkovitosti protiv virusnih bolesti.<ref name=nature/><ref name="mahase">{{cite journal | vauthors = Mahase E | title = Covid-19: Russia approves vaccine without large scale testing or published results | journal = BMJ | volume = 370 | pages = m3205 | date = August 2020 | pmid = 32816758 | doi = 10.1136/bmj.m3205 | doi-access = free }}</ref><ref name="bar">{{cite journal | vauthors = Bar-Zeev N, Inglesby T | title = COVID-19 vaccines: early success and remaining challenges | language = en | journal = Lancet | volume = 396 | issue = 10255 | pages = 868–869 | date = September 2020 | pmid = 32896290 | pmc = 7471800 | doi = 10.1016/S0140-6736(20)31867-5 | doi-access = free }}</ref>
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=== Tozinameran ===
[[File:Covid19 vaccine biontech pfizer 3 (cropped).jpg|thumb|300 px|[[Pfizer–BioNTech cjepivo|Tozinameran]] cjepivo]]
Pod kodnim nazivom ''BNT162b2'',<ref name="INN">{{cite journal|author=World Health Organization|title=International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 124 – COVID-19 (special edition)|url=https://www.who.int/medicines/publications/druginformation/issues/WHO_DI_34-3_PL124-SpecialEdition.pdf|date=2020|journal=WHO Drug Information|volume=34|issue=3|access-date=23 November 2020|page=666|archive-date=27 November 2020|archive-url=https://web.archive.org/web/20201127075410/https://www.who.int/medicines/publications/druginformation/issues/WHO_DI_34-3_PL124-SpecialEdition.pdf|url-status=live}}</ref> poznato kao cjepivo ''Pfizer – BioNTech COVID-19'', a prodaje se pod robnom markom Comirnaty, to je cjepivo protiv COVID-19, koje je [[BioNTech SE|BioNTech]] razvilo u suradnji s [[Pfizer|Pfizerom]]. To je i prvo cjepivo protiv COVID-19 koje je odobrilo strogo regulatorno tijelo za hitnu uporabu i prvo odobrenje za redovnu uporabu.<ref name="ukgov12-2">{{cite press release|title=UK medicines regulator gives approval for first UK COVID-19 vaccine|url=https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine|publisher=[[Medicines and Healthcare products Regulatory Agency]] (MHRA)|access-date=2 December 2020|date=2 December 2020}}</ref><ref name="boseley">{{cite news|first1=Sarah|last1=Boseley|first2=Josh|last2=Halliday|title=UK approves Pfizer/BioNTech Covid vaccine for rollout next week|url=https://www.theguardian.com/society/2020/dec/02/pfizer-biontech-covid-vaccine-wins-licence-for-use-in-the-uk|access-date=14 December 2020|work=The Guardian|date=2 December 2020|name-list-style=vanc}}</ref><ref name="let19">{{Cite news|date=19 December 2020|title=Swissmedic autorise un premier vaccin contre le coronavirus|url=https://www.letemps.ch/suisse/swissmedic-autorise-un-premier-vaccin-contre-coronavirus|access-date=19 December 2020|publisher=[[Le Temps]]|language=fr}}</ref>
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Pfizer je u studenom 2020. naznačio da bi 50 milijuna doza moglo biti dostupno globalno do kraja 2020., s oko 1,3 milijarde doza 2021. godine.
Pfizer je unaprijed zaključio kupoprodajne ugovore od oko 3 milijarde američkih dolara za osiguravanje licenciranog cjepiva u [[Sjedinjene Američke Države|Sjedinjenim Državama]], [[Europska unija|Europskoj uniji]], [[Ujedinjeno Kraljevstvo|Ujedinjenom Kraljevstvu]], [[Japan|Japanu]], [[Kanada|Kanadi]], [[Peru|Peruu]] i [[Meksiko|Meksiku]].<ref name="bloom11-10">{{cite news|title=Deep-freeze hurdle makes Pfizer's vaccine one for the rich|url=https://www.bloomberg.com/news/articles/2020-11-10/deep-freeze-challenge-makes-pfizer-s-shot-a-vaccine-for-the-rich|access-date=12 November 2020|work=Bloomberg|date=10 November 2020|quote=Vaccine goes bad five days after thawing, requires two shots; Many nations face costly ramp up of cold-chain infrastructure|archive-date=22 November 2020|archive-url=https://web.archive.org/web/20201122105948/https://www.bloomberg.com/news/articles/2020-11-10/deep-freeze-challenge-makes-pfizer-s-shot-a-vaccine-for-the-rich|url-status=live}}</ref> Distribucija i skladištenje cjepiva logistički je izazov jer ga treba čuvati na temperaturama između -80 i -60 ° C,<ref name="Vaccination Storage">{{cite web|url=https://www.cvdvaccine-us.com/product-storage-and-dry-ice|title=Pfizer-BioNTech COVID-19 Vaccine Vaccination Storage & Dry Ice Safety Handling|publisher=Pfizer|access-date=17 December 2020}}</ref> do pet dana prije cijepljenja.<ref name="bloom11-10" />
=== BBIBP-CorV ===
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=== CoronaVac ===
[[File:SINOVAC COVID-19 vaccine.jpg|thumb|200 px|CoronaVac]]
CoronaVac je kandidat za cjepivo COVID-19 koji je razvila kineska biofarmaceutska tvrtka Sinovac.<ref name="jakartaglobe">{{cite web|url=https://jakartaglobe.id/news/indonesia-starts-coronavac-phase-3-clinical-trials|title=Indonesia Starts CoronaVac Phase 3 Clinical Trials|archive-url=https://web.archive.org/web/20201013211900/https://jakartaglobe.id/news/indonesia-starts-coronavac-phase-3-clinical-trials|archive-date=13 October 2020|date=11 August 2020|website=Jakarta Globe|access-date=2020-08-26|vauthors=Beritasatu, Shofa JN|url-status=live}}</ref> Cjepivo sadrži kemijski inaktivirani virus [[SARS-CoV-2]]. Počevši od sredine 2020. godine, kandidat za cjepivo prolazio je kliničko istraživanje faze III.<ref name="NCname= nct04456595=">{{ClinicalTrialsGov|NCT04456595|Clinical Trial of Efficacy and Safety of Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine in Healthcare Professionals (PROFISCOV)}}</ref><ref>{{cite web|url=https://www.ina-registry.org/index.php?act=registry_trial_detail&code_trial=16202009080721WXFM0YX|title=A Phase III, observer-blind, randomized, placebo-controlled study of the efficacy, safety, and immunogenicity of SARS-COV-2 inactivated vaccine in healthy adults aged 18-59 years in Indonesia|archive-url=https://web.archive.org/web/20201011084814/https://www.ina-registry.org/index.php?act=registry_trial_detail&code_trial=16202009080721WXFM0YX%2F|archive-date=11 October 2020|date=10 August 2020|work=PT Bio Farma|publisher=Registri Penyakit Indonesia|accessdate=15 August 2020|url-status=live}}</ref> Trenutno prolazi kroz faze III ispitivanja u [[Brazil|Brazilu]], [[Čile|Čileu]], [[Indonezija|Indoneziji]] i [[Turska|Turskoj]].
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=== mRNA-1273 ===
[[File:Moderna COVID-19 vaccine (2020).jpg|thumb|200 px|mRNA-1273]]
mRNA-1273, poznatija kao Moderna COVID-19 cjepivo, COVID-19 je cjepivo koje su razvili Nacionalni institut za alergiju i zarazne bolesti (NIAID), Uprava za napredna biomedicinska istraživanja i razvoj (BARDA) i Moderna. Primjenjuje se intramuskularnom injekcijom. Dana [[18. prosinca]] 2020., mRNA-1273 izdala je odobrenje za hitnu uporabu od strane Agencije za hranu i lijekove [[Sjedinjene Američke Države|Sjedinjenih Država]] (FDA).<ref name="nih-eua">{{cite news|title=Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine|url=https://www.nih.gov/news-events/news-releases/statement-nih-barda-fda-emergency-use-authorization-moderna-covid-19-vaccine|access-date=19 December 2020|agency=US National Institutes of Health|date=18 December 2020}}</ref><ref name="CDC ACIP Moderna COVID-19 Vaccine">{{cite journal|last=Oliver|first=Sara E.|title=The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020|url=https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm695152e1-H.pdf|date=December 2020|journal=MMWR. Morbidity and Mortality Weekly Report|volume=69|issue=5152|last14=Bell|last12=Talbot|first12=H. Keipp|last13=Lee|first13=Grace M.|display-authors=6|first14=Beth P.|last15=Dooling|first15=Kathleen|doi=10.15585/mmwr.mm695152e1|page=|first11=José R.|last11=Romero|first10=Sarah|first5=Kathryn G.|last2=Gargano|first2=Julia W.|last3=Marin|first3=Mona|last4=Wallace|first4=Megan|last5=Curran|last6=Chamberland|last10=Mbaeyi|first6=Mary|last7=McClung|first7=Nancy|last8=Campos-Outcalt|first8=Doug|last9=Morgan|first9=Rebecca L.|name-list-style=vanc}}</ref><ref name="lovelace2">{{cite news|first=Berkeley|last=Lovelace Jr|name-list-style=vanc|date=2020-12-19|title=FDA approves second Covid vaccine for emergency use as it clears Moderna's for U.S. distribution|url=https://www.cnbc.com/2020/12/18/moderna-covid-vaccine-approved-fda-for-emergency-use.html|access-date=2020-12-19|work=CNBC}}</ref> Odobren je za uporabu u [[Kanada|Kanadi]] 23. prosinca 2020.
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Convidicea je virusno vektorsko cjepivo slično AstraZenecinoj AZD1222 i Gamaleyinoj Gam-COVID-Vac koja su također u fazi III kliničkih ispitivanja protiv COVID-19.<ref>{{cite news|vauthors=Zimmer C, Corum J, Wee SL|date=2020-06-10|title=Coronavirus Vaccine Tracker|language=en-US|work=The New York Times|url=https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html|access-date=2020-12-12|issn=0362-4331}}</ref> U studenom je CanSino rekao da će započeti s privremenom analizom rezultata faze III kada se pronađe 50 slučajeva zaraze.
=== AZD1222 ===
AZD1222, također poznato kao ''Covishield'' ili ''ChAdOx1 nCoV-19'', [[cjepivo]] je protiv [[COVID-19]], razvijeno od [[Sveučilište u Oxfordu|Sveučilišta Oxford]] i [[AstraZeneca]], koje se daje intramuskularnom injekcijom, koristeći kao vektor modificirani [[adenovirus]] [[čimpanze]] ChAdOx1.<ref>{{cite news|last1=Walsh|title=The world's hopes for a coronavirus vaccine may run in these health care workers' veins|archive-url=https://web.archive.org/web/20200803211040/https://edition.cnn.com/2020/07/27/americas/brazil-covid-19-sinovac-vaccine-intl/index.html|archive-date=3 August 2020|access-date=3 August 2020|location=[[São Paulo]]|work=[[CNN]]|url=https://edition.cnn.com/2020/07/27/americas/brazil-covid-19-sinovac-vaccine-intl/index.html|date=27 July 2020|first1=Nick|name-list-style=vanc|first4=William|last4=Bonnett|first3=Eduardo|last3=Duwe|first2=Jo|last2=Shelley|url-status=live}}</ref><ref name="NCT04400838">{{cite web|url=https://clinicaltrials.gov/ct2/show/NCT04400838|title=Investigating a Vaccine Against COVID-19|archive-url=https://web.archive.org/web/20201011084750/https://clinicaltrials.gov/ct2/show/NCT04400838/|archive-date=11 October 2020|date=26 May 2020|website=[[ClinicalTrials.gov]]|publisher=[[United States National Library of Medicine]]|access-date=14 July 2020|type=Registry|id=NCT04400838|url-status=live}}</ref><ref name="EudraCT-2020-001228-32">{{cite web|url=https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001228-32/GB|title=A Phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19|archive-url=https://web.archive.org/web/20201005201654/https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001228-32/GB|archive-date=5 October 2020|date=21 April 2020|website=EU Clinical Trials Register|publisher=European Union|access-date=3 August 2020|type=Registry|id=[[EudraCT]] 2020-001228-32|url-status=live}}</ref><ref name="ISRCTN89951424">{{cite journal|title=A Phase III study to investigate a vaccine against COVID-19|date=26 May 2020|id=ISRCTN89951424|website=ISRCTN|type=Registry|doi=10.1186/ISRCTN89951424|vauthors=O'Reilly P|doi-access=free}}</ref>
Istraživanje rade Sveučilište Oxford Jenner Institute i Oxford Vaccine Group. Tim vode Sarah Gilbert, Adrian Hill, Andrew Pollard, Teresa Lambe, Sandy Douglas i Catherine Green.<ref>{{Cite web|url=https://covid19vaccinetrial.co.uk/|title=COVID-19 Vaccine Trials {{!}} COVID-19|website=covid19vaccinetrial.co.uk|access-date=2020-04-11}}</ref><ref>{{Cite web|url=https://www.ox.ac.uk/news/2020-02-07-oxford-team-begin-novel-coronavirus-vaccine-research|title=Oxford team to begin novel coronavirus vaccine research|archive-url=|archive-date=|last=|first=|date=2020-02-07|website=University of Oxford|language=en|access-date=2020-11-28|url-status=live}}</ref>
Od prosinca 2020. kandidat za cjepivo prolazi kroz fazu III kliničkog istraživanja.
[[30. prosinca]] 2020. cjepivo je odobreno za uporabu u programu cijepljenja u [[Ujedinjeno Kraljevstvo|Velikoj Britaniji]].<ref>{{cite web|url=https://www.bbc.co.uk/news/health-55280671|title=Covid-19: Oxford-AstraZeneca coronavirus vaccine approved for use in UK|date=30 December 2020|website=BBC News|publisher=BBC|access-date=30 December 2020}}</ref>
=== BBV152 ===
BBV152 (također poznat i kao Covaxin) inaktivirano je cjepivo protiv virusa COVID-19 koje razvija Bharat Biotech u suradnji s Indijskim vijećem za medicinska istraživanja.
U svibnju 2020., [[Indija|Indijsko]] vijeće za medicinska istraživanja (ICMR) Nacionalni institut za [[Virologija|virologiju]] odobrio je i osigurao sojeve virusa za razvoj potpuno autohtonog cjepiva COVID-19.<ref>{{cite news|title=ICMR teams up with Bharat Biotech to develop Covid-19 vaccine|url=https://www.livemint.com/news/india/icmr-teams-up-with-bharat-biotech-to-develop-covid-19-vaccine-11589038719666.html|work=Livemint|date=9 May 2020|language=en}}</ref><ref>{{cite news|vauthors=Chakrabarti A|title=India to develop 'fully indigenous' Covid vaccine as ICMR partners with Bharat Biotech|url=https://theprint.in/health/india-to-develop-fully-indigenous-covid-vaccine-as-icmr-partners-with-bharat-biotech/418180/|work=ThePrint|date=10 May 2020}}</ref> U lipnju 2020. godine tvrtka je dobila dozvolu za provođenje ispitivanja na ljudskoj fazi razvojnog cjepiva COVID-19 pod nazivom Covaxin u fazi 1 i fazi 2 od indijskog vlade za zaštitu lijekova (DCGI).<ref>{{cite news|title=India's First COVID-19 Vaccine Candidate Approved for Human Trials|url=https://www.nytimes.com/reuters/2020/06/29/world/asia/29reuters-health-coronavirus-india-vaccine.html|work=The New York Times|date=29 June 2020}}</ref> Indijsko vijeće za medicinska istraživanja odabralo je ukupno 12 mjesta za randomizirana, dvostruko slijepa i s placebom kontrolirana klinička ispitivanja kandidata za cjepivo faze I i II.<ref>{{cite news|title=Human clinical trials of potential Covid-19 vaccine ‘COVAXIN’ started at AIIMS|url=http://ddnews.gov.in/health/human-clinical-trials-potential-covid-19-vaccine-%E2%80%98covaxin%E2%80%99-started-aiims|work=DD News|publisher=Prasar Bharati, Ministry of I & B, Government of India|date=25 July 2020}}</ref><ref>{{cite news|last1=Press|first1=Associated|title=Asia Today: Amid new surge, India tests potential vaccine|url=https://www.washingtonpost.com/business/asia-today-skorea-records-113-new-cases-most-from-overseas/2020/07/24/21f23ad0-ce17-11ea-99b0-8426e26d203b_story.html|access-date=17 December 2020|work=Washington Post|date=25 July 2020}}</ref><ref>{{cite news|title=Delhi: 30-year-old is first to get dose of trial drug Covaxin|url=https://indianexpress.com/article/india/aiims-administers-first-dose-of-bharat-biotechs-potential-covid-vaccine-to-30-yr-old-man-6521778/|work=The Indian Express|date=25 July 2020|language=en}}</ref>
U prosincu 2020. tvrtka je objavila izvješće za ispitivanja faze I i rezultate predstavila putem medRxiv pretiska.<ref>{{cite journal|title=Safety and immunogenicity trial of an inactivated SARS-CoV-2 vaccine-BBV152: a phase 1, double-blind, randomised control trial|url=https://www.medrxiv.org/content/10.1101/2020.12.11.20210419v1|date=15 December 2020|journal=[[medRxiv]]|language=en|first19=Venkat|first15=Chandramani|last16=Redkar|first16=Sagar|last17=Gillurkar|first17=Chandra Sekhar|last18=Kushwaha|first18=Jitendra Singh|last19=Rao|last21=Guleria|last20=Mohapatra|first20=Satyajit|first14=Sanjay|first21=Randeep|last22=Ella|first22=Krishna|last23=Bhargava|first23=Balram|doi=10.1101/2020.12.11.20210419|last15=Singh|last1=Ella|first1=Raches|last7=Ganneru|last2=Mohan|first2=Krishna|last3=Jogdand|first3=Harsh|last4=Prasad|first4=Sai|last5=Reddy|first5=Siddharth|last6=Sarangi|first6=Vamshi Krishna|first7=Brunda|first13=Savita|last8=Sapkal|first8=Gajanan|last9=Yadav|first9=Pragya|last10=Panda|first10=Samiran|last11=Gupta|first11=Nivedita|last12=Reddy|first12=Prabhakar|last13=Verma|last14=Rai}}</ref> <ref>{{cite news|last1=Perappadan|first1=Bindu Shajan|title=Coronavirus {{!}} Covaxin phase-1 trial results show promising results|url=https://www.thehindu.com/sci-tech/science/coronavirus-covaxin-phase-1-trial-results-show-vaccine-is-safe/article33348040.ece|access-date=17 December 2020|work=The Hindu|date=16 December 2020|language=en-IN}}</ref><ref>{{cite news|last1=Sabarwal|first1=Harshit|title=Covaxin’s phase 1 trial result shows robust immune response, mild adverse events|url=https://www.hindustantimes.com/india-news/covaxin-s-phase-1-trial-result-shows-robust-immune-response-mild-adverse-events/story-0swYxDQsyoK5POHjjPO22M.html|access-date=17 December 2020|work=Hindustan Times|date=16 December 2020|language=en}}</ref>
U studenom 2020. Covaxin je dobio odobrenje za provođenje ispitivanja na ljudima u fazi III<ref>{{cite news|title=Coronavirus {{!}} Covaxin Phase III trial from November|url=https://www.thehindu.com/business/covaxin-phase-iii-trial-from-november/article32928549.ece|work=The Hindu|date=23 October 2020|language=en-IN}}</ref> nakon završetka faze I i II.<ref>{{cite journal|title=Evaluation of Safety and Immunogenicity of an Adjuvanted, TH-1 Skewed, Whole Virion InactivatedSARS-CoV-2 Vaccine - BBV152|date=9 September 2020|vauthors=Ganneru B, Jogdand H, Daram VK, Molugu NR, Prasad SD, Kannappa SV, Ella KM, Ravikrishnan R, Awasthi A, Jose J, Rao P|display-authors=6|doi=10.1101/2020.09.09.285445}}</ref> Pokus uključuje randomiziranu, dvostruko slijepu, placebom kontroliranu studiju među dobrovoljcima dobne skupine 18 i više i započeo je [[25. studenoga|25. studenog]].<ref>{{Cite web|url=https://clinicaltrials.gov/ct2/show/NCT04641481|title=An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers|website=clinicaltrials.gov|publisher=[[United States National Library of Medicine]]|access-date=2020-11-26|type=Registry|id=NCT04641481}}</ref> U ispitivanjima faze III sudjelovat će oko 26 000 dobrovoljaca iz cijele Indije.<ref>{{cite news|title=Bharat Biotech begins Covaxin Phase III trials|url=https://indianexpress.com/article/india/bharat-biotech-begins-covaxin-phase-iii-trials-7055237/|work=The Indian Express|date=18 November 2020|language=en}}</ref> Pokusi faze III obuhvatit će ukupno 22 mjesta koja se sastoje od nekoliko država u zemlji, uključujući Delhi, Karnataka i zapadni Bengal, a uskoro se očekuje i pridruživanje mnogih drugih država.<ref>{{cite news|vauthors=Sen M|title=List of states that have started phase 3 trials of India's first Covid vaccine|url=https://www.livemint.com/news/india/coronavirus-vaccine-in-india-these-states-have-started-phase-3-trials-of-bharat-biotech-covaxin-11606908773897.html|work=mint|date=2 December 2020|language=en}}</ref>
Bharat Biotech se prijavio generalnom kontroloru droga u Indiji (DCGI), vladi Indije, tražeći odobrenje za hitnu uporabu (EUA).<ref>{{cite news|vauthors=Ghosh N|title=Bharat Biotech seeks emergency use authorization for Covid-19 vaccine|url=https://www.hindustantimes.com/india-news/bharat-biotech-seeks-emergency-use-authorization-for-covid-19-vaccine-govt-source/story-HmmD0JnniJeigdF6xmjxBO.html|work=Hindustan Times|date=7 December 2020|language=en}}</ref> To je treća tvrtka nakon Instituta za serum iz Indije i tvrtke Pfizer koja se prijavila za odobrenje za hitne slučajeve.<ref>{{cite news|title=Coronavirus {{!}} After SII, Bharat Biotech seeks DCGI approval for Covaxin|url=https://www.thehindu.com/sci-tech/health/coronavirus-serum-institute-seeks-emergency-use-approval-for-covishield-in-india/article33265921.ece|work=The Hindu|date=7 December 2020|language=en-IN}}</ref>
Dana [[2. siječnja]] [[2021.]] godine, Centralna organizacija za kontrolu droga (CDSCO) preporučila je dopuštenje za hitnu uporabu,<ref name="rec">{{cite news|title=Expert panel recommends granting approval for restricted emergency use of Bharat Biotech’s Covaxin|url=https://indianexpress.com/article/india/bharat-biotechs-covaxin-covid-vaccine-approval-cdsco-7130213/|work=The Indian Express|date=2 January 2021|language=en}}</ref> koje je dodijeljeno [[3. siječnja]].<ref>{{Cite news|date=2021-01-03|title=Coronavirus: India approves vaccines from Bharat Biotech and Oxford/AstraZeneca|language=en-GB|work=BBC News|url=https://www.bbc.com/news/world-asia-india-55520658|access-date=2021-01-03}}</ref>
== Nezgodne situacije pri ispitivanjima ==
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