Noora (vaccine)

From Wikipedia, the free encyclopedia

TargetSARS-CoV-2
Vaccine typeProtein subunit
Routes of
administrationIntramuscular
CAS Number
Noora (vaccine)
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Routes of
administration		Intramuscular
Identifiers
CAS Number

Noora (Persian: نورا) is a COVID-19 vaccine candidate developed by Baqiyatallah University of Medical Sciences in collaboration with Plasma Darman Sarv Sepid Co. (lit. White Cypress Plasma Treatment) in Iran.[1][2] Introduced in June 2021,[3] it was announced as having "successfully passed the first phase of its clinical trial" two months later.[4]

The clinical trial reported in the Journal of Medical Virology met a critical scrutiny in May 2023, after which the journal declared it as an invalid study and retracted it in March 2024.[5][6][7] Independent research in 2024 indicated that the vaccine is very weak (poor immunogenicity and neutralization efficacy) unlikely useful for the later variants of SARS-CoV-2.[8][9]

Noora vaccine was developed by an Iranian team led by Jafar Salimian and Jafar Amani at the Baqiyatallah University of Medical Sciences in Tehran,[10] which is supported by the Islamic Revolutionary Guard Corps.[11] Its design and preparation started in the early 2020 and completed in June 2021. The vaccine with its Phase I clinical trial was officially launched on 27 June 2021.[12] IRGC Commander-in-Chief Major General Hossein Salami and Health Minister Saeed Namaki officiated the unveiling, and Hossein Samadinia, head of the Baqiyatallah Hospital, received the first dose at the inaugural.[1][13] Phase I clinical trial involved 70 volunteers and was completed in August 2021.[4][12]

In March 2022, Hassan Abolqasemi, chancellor of Baqiyatallah University of Medical Sciences, announced that the Phase III clinical trial was completed that involved 10,000 participants.[14] Soon after which the Iranian Ministry of Health gave it a permit for emergency use, and became the sixth COVID-19 vaccine (after COVIran Barekat, Pasto Covac, Razi Cov Pars, SpikoGen, and FAKHRAVAC) produced in Iran.[14] The vaccine preparation and preclinical tests in mice, rabbits, and monkeys were reported in the journal Molecular Immunology in September 2022.[15]

The first clinical trial led by Salimian and Amani,[10] and supervised by Hassan Abolghasemi and Gholamhossein Alishiri, was published in the Journal of Medical Virology 27 August 2022.[16] The report claims that the vaccine is effective, safe and capable of providing immunity.[10] The report concludes:

The results of this Phase 1 trial showed acceptable safety without serious adverse events and significant seroconversions in the humoral and cellular immunity panel. The dose of 80 μg is an appropriate dose for injection in the next phases of the trial.[16]

Medical uses

Noora vaccine requires three doses given by intramuscular injection on days 0, 21 and 35.[17] Phase I clinical trial was claimed to indicate successful immunity against SARS-CoV-2 Omicron variant.[10]

Pharmacology

Noora is a recombinant RBD protein subunit vaccine.[17] It contains three truncated parts of SARS-CoV-2: spike protein, receptor-binding protein and nucleoprotein. The immune response is enhanced by the addition of alum as an adjuvant.[15][18]

Manufacturing

By early 2022, 3 million doses were produced monthly.[11] As of March 2022, 5 millions doses were produced.[14]

Clinical trials

Clinical trials of Noora
Phase Registration number Start Number of participants Age of participants Ref
Total Vaccine Placebo
I IRCT20210620051639N1 Archived 9 July 2021 at the Wayback Machine 25 June 2021 70 30 (80 μg)

30 (120 μg)

 10 (placebo) 18–50 years [17]
II IRCT20210620051639N2 10 October 2021 300 240 60 18–40 years [19]
III IRCT20210620051639N3 23 December 2021 10000 >18 years [20]

Controversy

See also

References

Related Articles

Wikiwand AI