Nakon procjene i odobrenja od strane Europske agencije za lijekove (EMA), SZO je 21. prosinca 2021. izdao popis za hitne slučajeve (EUL) za Nuvaxovid. Ranije, 17. prosinca 2021., WHO izdao popis za hitne slučajeve (EUL) za Covovax.
Covovax i Nuvaxoid tako postaju 9th i 10th Covid-19 cjepiva in WHO’s emergency use list.
Both Nuvaxovid & Covovax cjepiva are protein subunit cjepiva, and use nanoparticles. These are made using recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contain patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate the high levels of neutralizing antibodies.
Ovo dvoje cjepiva contain purified protein antigen which cannot replicate, nor can cause COVID-19 disease.
Nuvaxovid & Covovax zahtijevaju dvije doze i stabilni su na temperaturama u hladnjaku od 2 do 8 °C.
Nuvaxovid je razvila Novavax, Inc., američka biotehnološka tvrtka sa sjedištem u Marylandu. To je izvorni proizvod za Covovax.
Covovax su razvili Novavax i Coalition for Epidemic Preparedness Innovations (CEPI), a proizvodi ga Institut za serum Indije (SII) prema licenci Novavaxa. Ovo je dio portfelja postrojenja COVAX, dajući prijeko potreban poticaj stalnim naporima da se cijepi više ljudi u okruženjima s ograničenim resursima.
Covovax and Nuvaxoid are similar to Cuba’s Soberana 02 and Abdala in being protein-based vaccines against COVID-19 however Cuba’s cjepiva specifically exploit the RBD (receptor binding domain) region of the spike protein, responsible for entry of virus into human cells while Nuvaxovid & Covovax target coronavirus spike (S) protein.
Like Cuba’s cjepiva, Nuvaxovid & Covovax also have advantage of being stable at 2-8° C and could be relatively easily tailored to make new vaccines against the mutated strains.
The abovementioned protein-based COVID-19 cjepiva differ markedly from existing COVID-19 cjepiva currently in use. While mRNA vaccines (manufactured by Pfizer/BioNTech and Moderna) carry message for expression of viral protein antigen in the human cells, adenovirus vector-based cjepiva (such as Oxford/AstraZeneca’s ChAdOx1 nCoV-2019 and Janssen’s) use genetically engineered adenovirus as a vector to carry spike-protein gene of novel coronavirus which is expressed in the human cells that acts as antigen for active immunity development. Further, mRNA vaccines are costly and have cold supply chain issue while adenovirus vector-based vaccines are implicated in rare side effects of Blood clot.
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Izvori:
- SZO 2021. Vijesti – SZO navodi 10. cjepivo protiv COVID-19 za hitnu uporabu: Nuvaxovid. Objavljeno 21. prosinca 2021., dostupno online na https://www.who.int/news/item/21-12-2021-who-lists-10th-covid-19-vaccine-for-emergency-use-nuvaxovid
- EMA 2021. Vijesti – EMA preporučuje Nuvaxovid za autorizaciju u EU, objavljeno 20. Dostupno online na https://www.ema.europa.eu/en/news/ema-recommends-nuvaxovid-authorisation-eu
- WHO 2021. Vijesti – SZO navodi 9. cjepivo protiv COVID-19 za hitnu upotrebu s ciljem povećanja pristupa cijepljenju u zemljama s nižim dohotkom. Objavljeno 17. prosinca 2021. Dostupno na adresi https://www.who.int/news/item/17-12-2021-who-lists-9th-covid-19-vaccine-for-emergency-use-with-aim-to-increase-access-to-vaccination-in-lower-income-countries
- Tian, JH., Patel, N., Haupt, R. i sur. SARS-CoV-2 cjepivo sa šiljastim glikoproteinom, kandidat za imunogenost NVX-CoV2373 kod pavijana i zaštita kod miševa. Nat Commun 12, 372 (2021). https://doi.org/10.1038/s41467-020-20653-8
- Khan S. i Dhama K. 2021. Uloga Indije u diplomaciji cjepiva protiv COVID-19. Časopis za medicinu putovanja, svezak 28, broj 7, listopad 2021., taab064, objavljeno: 16. travnja 2021. DOI: https://doi.org/10.1093/jtm/taab064
- Soni R., 2021.Soberana 02 i Abdala: Prva svjetska proteinska konjugirana cjepiva protiv COVID-19. Znanstveni europski. Objavljeno 30. studenog 2021. Dostupno online na http://scientificeuropean.co.uk/covid-19/soberana-02-and-abdala-worlds-first-protein-conjugate-vaccines-against-covid-19/
- Prasad U. 2021. Vrste cjepiva protiv COVID-19 u Vogueu: Može li biti nešto pogrešno? Znanstveni europski. Objavljeno 20. siječnja 2021. Dostupno na adresi http://scientificeuropean.co.uk/covid-19/types-of-covid-19-vaccine-in-vogue-could-there-be-something-amiss/
- Soni R. 2021. Budućnost cjepiva protiv COVID-19 na temelju adenovirusa (kao što je Oxford AstraZeneca) u svjetlu nedavnog otkrića o Uzroku rijetkih nuspojava krvnog ugruška. Znanstveni europski. Objavljeno 3. prosinca 2021. Dostupno online na http://scientificeuropean.co.uk/covid-19/future-of-adenovirus-based-covid-19-vaccines-such-as-oxford-astrazeneca-in-light-of-recent-finding-about-cause-of-rare-side-effects-of-blood-clot/
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