COVI-VAC (U.S. COVID-19 vaccine) explained

Type:	vaccine
Target:	SARS-CoV-2
Vaccine Type:	attenuated
Tradename:	CDX-005^[1]
Routes Of Administration:	Intranasal
Synonyms:	Covi-Vax

COVI-VAC (codenamed CDX-005) is a COVID-19 vaccine developed by Codagenix, Inc. In December 2020, COVI-VAC started a Phase I clinical trial, involving 48 participants. The trial was scheduled to complete in June 2021, with results to be reported by May 2022.^{[2] [3]} On September 29, 2021, Codagenix presented positive phase 1 data for COVI-VAC at IDWEEK2021. Data indicates that COVI-VAC is well tolerated, with no significant adverse events reported and that administration of the intranasal vaccine was immunogenic and capable of blocking nasal replication of the virus with minimal viral shedding, recorded at levels lower than those likely to result in subsequent transmission of COVID-19. Furthermore, COVI-VAC was shown to stimulate both serum and mucosal antibody immune responses.^[4]

Medical uses

The vaccine is administered intranasally and requires a single dose.

Pharmacology

COVI-VAC is a live attenuated vaccine.^[5]

Clinical trials

Phase I

In December 2020, Codagenix started a Phase I trial in the United Kingdom.

In September 2021, Codagenix reported that the trial had shown COVI-VAC to be safe and immunogenic.^[6]

Further reading

• Web site: Codagenix, Inc. 2021-07-26. First-in-human, Randomised, Double-blind, Placebo-controlled, Dose-escalation Study in Healthy Young Adults Evaluating the Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Candidate for Prevention of COVID-19.

Notes and References

1. News: Serum Institute starts manufacturing Codagenix's nasal COVID-19 vaccine . mint . 22 September 2020 . en.
2. Web site: Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Against COVID-19 . ClinicalTrials.gov . United States National Library of Medicine . 8 June 2021.
3. Wang Y, Yang C, Song Y, Coleman JR, Stawowczyk M, Tafrova J, Tasker S, Boltz D, Baker R, Garcia L, Seale O, Kushnir A, Wimmer E, Mueller S . 6 . Scalable live-attenuated SARS-CoV-2 vaccine candidate demonstrates preclinical safety and efficacy . Proceedings of the National Academy of Sciences of the United States of America . 118 . 29 . e2102775118. July 2021 . 34193524 . 10.1073/pnas.2102775118 . 8307828 . 2021PNAS..11802775W . free .
4. Codagenix Presents Positive Phase 1 Data for COVI-VAC Intranasal COVID-19 Vaccine at IDWeek 2021.
5. Web site: COVI-VAC for SARS-CoV-2 (COVID-19) . Codagenix, Inc. . 8 June 2021.
6. Codagenix Announces Safety and Immunogenicity Data from Phase 1 COVID-19 Intranasal Vaccine Trial and stated the intention to progress to the Phase 2/3 trials. 2021-09-23. www.prnewswire.com. en.