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CoviVac Chronicle

An In-Depth Analysis of Russia's Inactivated Viral Vaccine Against COVID-19.

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Vaccine Overview

Vaccine Type

CoviVac is classified as an inactivated virus-based vaccine designed to elicit an immune response against SARS-CoV-2, the virus responsible for COVID-19. This traditional vaccine technology involves using a deactivated form of the virus.

Developer and Origin

The vaccine was developed by the Chumakov Centre, a prominent research institute affiliated with the Russian Academy of Sciences. It represents one of Russia's contributions to the global effort against the pandemic.

National Approval

CoviVac received official authorization for use in the Russian Federation on February 20, 2021. It was the third COVID-19 vaccine to achieve regulatory approval within Russia, signifying a key milestone in the nation's vaccination program.

Vaccine Composition

Active Component

The primary active component is the SARS-CoV-2 strain AYDAR-1 antigen. This antigen is rendered non-infectious through inactivation via beta-propiolactone. Each standard dose contains a minimum quantity of 3 micrograms (ยตg) of this inactivated antigen.

Excipients and Adjuvants

In addition to the antigen, CoviVac includes an adjuvant, specifically 0.3โ€“0.5 mg of aluminum hydroxide, to enhance the immune response. The vaccine is formulated in a phosphate buffer solution (0.5 mL or less), containing disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, and sterile water for injection.

Manufacturing Process

Traditional Methodology

CoviVac's production adheres to established methodologies for inactivated vaccines, drawing parallels with the manufacturing process of the polio vaccine. This approach involves cultivating the virus and then rendering it inactive.

Key Steps

The process commences with the isolation of the specific SARS-CoV-2 strain AYDAR-1 by the Chumakov Centre. This strain is then propagated in substantial quantities using Vero cells. Following viral growth, the viruses undergo inactivation using beta-propiolactone, a chemical agent that binds to viral genetic material, thereby preventing replication while preserving the structural integrity of the viral particles. The inactivated viral material is subsequently combined with an aluminum-based adjuvant.

Clinical Data & Administration

Administration Protocol

CoviVac is administered via intramuscular injection. The standard regimen consists of two doses, administered with a 14-day interval between the first and second dose to optimize immune system priming.

Storage Requirements

Maintaining the vaccine's stability and efficacy necessitates specific storage conditions. CoviVac must be transported and stored at standard refrigerated temperatures, ranging from 2 to 8 degrees Celsius (35.6 to 46.4 Fahrenheit).

Efficacy Status

It is important to note that the definitive efficacy of CoviVac has not yet been conclusively established through comprehensive Phase III clinical trials. Further data is required for a complete assessment of its effectiveness.

Developmental Timeline

Clinical Trial Phases

The initial stages of clinical evaluation, encompassing Phase I/II trials, commenced on September 21, 2020, and were projected to conclude by October 15, 2020. Subsequently, Phase III clinical trials were initiated in early 2021, with an anticipated completion date of December 30, 2022.

Regulatory Authorization

The vaccine achieved regulatory approval in Russia on February 20, 2021. This authorization permitted its broader use within the country as part of the national COVID-19 response strategy.

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References

References

A full list of references for this article are available at the CoviVac (Russia COVID-19 vaccine) Wikipedia page

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Academic Disclaimer

Important Considerations

This document has been generated by an artificial intelligence system for educational and informational purposes. The content is derived from publicly available data, primarily Wikipedia, and has been refined to meet academic standards for clarity and depth.

This content does not constitute medical advice. The information presented herein is not a substitute for professional medical consultation, diagnosis, or treatment. Readers are strongly advised to consult with qualified healthcare professionals for any health-related concerns or decisions. Reliance on any information provided in this document is solely at the user's own risk.

The creators of this content are not liable for any errors, omissions, or consequences arising from the use of the information provided.