COVAXIN : India's First vaccine Treated For Covid-19

                             COVAXIN

      Covaxin vaccine is a vaccine that aims to protect against covid - 19.

Research name 

          BbV152 

Developer by 

     Bharat biotech collaboration with Indian council of Medical research(ICMR )-National Institute of virology (NIV).

Composition 

• Whole virion Inactivated vaccine,covaxin uses a more traditional technology that similar to inactivated polio vaccine.

•  A  sample of SARS - Co - 2 isolated by NIV and used to grow large quantities of viruses using vero cells.

• The viruses soaked in beta propiolactone, which deactivates them by binding to their gene.

• Resulting, inactivated viruses are then mixed with aluminum based adjustment. 

Posology

          Covaxin included along with immune potentials also known as vaccine adjuvant,added to    vaccine to increse and boost immunogen
          Two dose vaccination regimen given 28 days apart with sub - zero storage, no reconstitution and ready to use quid presentation in multi dose vials, stable at 2 - 8 * C. 

Method of administered 

    Intra muscular injection only, preferably in deltoid muscle. 

Clinical trials 

       Vaccine received dcgi approval for phase 1 and 2 Human clinical trial in july, 2020.

Trial 1 study

      Double blind, multi centre study of safety, reactogenicity and immunogenicity in 375 healthy volunteers.

Cohorts/vaccine : 

                BBV152A,

        BBV152B,

        BBV153C,

        Placebo. 

Age group :      

               18 years to 55 years 

Dosage (D0, D14) :

• 0.5ml of whole virion inactivated SARS - co v -2 vaccine. 

• 0.5ml of vaccine .

Enrolled person :

           Total 375 participant volunteers.

Population :

      Either gender of age between 18 years to 55 years. 

Result of 1st trial:

•  Safety (mild AEs were noted within 2 hours after dose 1st.

•  No immediate AEs were reported after dose.

• Immunogenicity. 

Duration:

• 12 month follow up study after last vaccination administration.

Trial 2 study

     Double blind, multi centre study of safety, reactogenicity, tolerability and immunogenicity im 380 healthy volunteers.

Cohorts:

        BBV152A

    BBV152B  

Age group:

          Greater than 12 to less than 65.

Dosage (D0, D28) :

           0.5ml for both cohorts and vaccine. 

Enrolled person:

              Total 380 participant volunteers.

Population :

      Either gender of age between greater than 12 to less than 65.

Result of 2nd trial:

      No immediate AEs occurred with 2 hours after vaccination there were no SAEs reported immunogenicity. 

Duration:

      6 month follow up study after last vaccine administration.

Overall 2 trial result:

• Both humoralamd cell mediated response. 
• No neutralising antibody difference were observed across age group. 

• BBV152 well tolerated in both dose group with serious adverse event. 

Trial 3 study :

• 25,800 total participant and randomized 1:1 ratio to receive vaccine and control im event -driven, 

     randomized, double blind, placebo- controlled,
     multi centre phase 3 study. 

• Evaluate the efficacy, safety and immunogenicity of covaxin in volunteers aged 

     less than 18 years. 

• 25,800,greater than 2400 volunteers above 60 years

•  25,800 ,greater than 4500 with comorbid condition

Shelf life 

       Expiry date of vaccine indicated on label and packaging. 

Precautions for storage 

•  Store in refrigerator atleast at 2 - 8*C.
• Don't freeze 
• Protect from light 

Approval 

        Granted approval for emergency restricted use, while covishield has been allowed for restricted use in emergency situation that Drug  controller general of india. 

Reference 

https://www.bharatbiotech.com/covaxin.html

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