Razi Cov Pars

Razi Cov Pars

Vaccine description
Target	SARS-CoV-2
Vaccine type	Protein subunit
Clinical data
Routes of administration	Intramuscular, Intranasal
Legal status
Legal status	Full list of Razi Cov Pars authorizations
Identifiers
CAS Number	2696315-86-1

Razi Cov Pars (Persian: رازی کوو پارس) is a COVID-19 vaccine developed by the Iranian Razi Vaccine and Serum Research Institute Razi Cov Pars is a covid-19 vaccine based on recombinant protein, which is being produced by Razi Vaccine and Serum Research Institute, Iran. This vaccine is the first injectable-intranasal recombinant protein corona vaccine.^[1][2][3]It's the second Iranian COVID-19 vaccine reaching human trials^[1] and is currently in phase III of clinical research during which it's compared to the Sinopharm BIBP vaccine.^[4][5]

Medical uses

It requires three doses given day 0 (intramuscular), day 21 (intramuscular) and day 51 (intranasal spray).^[3]

Pharmacology

Razi Cov Pars is a recombinant protein subunit vaccine containing the SARS-CoV-2 spike protein.^[2]

Manufacturing

It's planned to produce one million doses of the vaccine each month as of September 2021.^[4]

As of 25 November 2021, 5 millions doses have been delivered to the Iranian Ministry of Health.^[6]

History

Clinical trials

Clinical trials of Razi Cov Pars

Phase	Registration number	Start	Number of participants			Age of participants	Ref
			Total	Vaccine	Placebo
I	IRCT20201214049709N1	21 January 2021	133	30 (5 μg/200 μL) 30 (10 μg/200 μL) 30 (20 μg/200 μL)	30 (placebo) 13 (sentinel)	18-50 years	[2]
II	IRCT20201214049709N2	13 April 2021	500			18-70 years	[3]
III	IRCT20201214049709N3	29 August 2021	41,128	20,564	0 (placebo) 20,564 (Sinopharm BIBP vaccine)	18+ years	[5]

See also

• Pharmaceuticals in Iran
• COVID-19 pandemic in Iran
• COVID-19 vaccine clinical research

References

1. Banihashemi SR, Es-Haghi A, Fallah Mehrabadi MH, Nofeli M, Mokarram AR, Ranjbar A, et al. (26 May 2022). "Safety and Efficacy of Combined Intramuscular/Intranasal RAZI-COV PARS Vaccine Candidate Against SARS-CoV-2: A Preclinical Study in Several Animal Models". Frontiers in Immunology. 13: 836745. doi:10.3389/fimmu.2022.836745. PMC 9179012. PMID 35693788.
2. "Phase I, Safety and Immunogenicity of Razi SARS-CoV-2 recombinant Spike protein vaccine (Razi Cov Pars), in healthy adults aged 18-55 years; parallel 4 arms design (adjuvant only and three vaccine doses of 5, 10, and 20 μg/200 μL); a Randomised, double blind, clinical trial". irct.ir. Iranian Registry of Clinical Trials. Retrieved 21 March 2021.
3. "Phase II, Safety and Immunogenicity of RAZI SARS-CoV-2 recombinant Spike protein vaccine (RAZI Cov Pars) in adults aged 18-70 years; a Randomised, double blind, parallel 2 arms clinical trial". Iranian Registry of Clinical Trials. Retrieved 22 April 2021.
4. "COVID-19 vaccine Razi Cov Pars starts third clinical trial phase". Tehran Times. 27 August 2021. Retrieved 30 August 2021.
5. "IRCT | Comparison of the safety and efficacy of Razi SARS-CoV-2 recombinant Spike protein (Razi Cov Pars) and Sinopharm vaccines in adults aged 18 and over, a phase III randomised, double blind, non-inferiority clinical trial". en.irct.ir. Retrieved 30 August 2021.
6. "۵ میلیون دز واکسن رازی به وزارت بهداشت تحویل داده شد" [5 million doses of Razi vaccine were delivered to the Ministry of Health]. ایسنا(ISNA) (in Persian). 25 November 2021. Retrieved 27 November 2021.

Further reading

• Mohazzab A, Fallah Mehrabadi MH, Es-Haghi A, Kalantari S, Mokhberalsafa L, Setarehdan SA, et al. (December 2023). "Phase II, Safety and Immunogenicity of RAZI Cov Pars (RCP) SARS Cov-2 Vaccine in Adults Aged 18-70 Years; A Randomized, Double-Blind Clinical Trial". Journal of Pharmaceutical Sciences. 112 (12): 3012–3021. doi:10.1016/j.xphs.2023.09.027. PMID 37832918.
• Erfanpoor S, Banihashemi SR, Mokhbaeralsafa L, Kalantari S, Es-Haghi A, Nofeli M, et al. (February 2024). "Immunogenicity and safety of RAZI recombinant spike protein vaccine (RCP) as a booster dose after priming with BBIBP-CorV: a parallel two groups, randomized, double blind trial". BMC Medicine. 22 (1): 78. doi:10.1186/s12916-024-03295-1. PMC 10877779. PMID 38378570.
• Solaymani-Dodaran M, Kalantari S, Banihashemi SR, Es-Haghi A, Nofeli M, Mohazzab A, et al. (March 2024). "Safety and efficacy of RCP recombinant spike protein covid-19 vaccine compared to Sinopharm BBIBP: A phase III, non-inferiority trial". Heliyon. 10 (5): e27370. Bibcode:2024Heliy..1027370S. doi:10.1016/j.heliyon.2024.e27370. PMC 10923712. PMID 38463808.