DCGI nod sought for ZyCoV-D

#GS3 #VACCINE POICY #TECHNOLOGY

Context:

 Recently, Ahmedabad-based Zydus Cadila has applied to the Drug Controller General of India (DCGI) seeking Emergency Use Authorisation (EUA) for ZyCoV-D.

Key elements:

  • If approved by the regulator, ZyCov-D are going to be the world’s first plasmid DNA vaccine against infection with SARS-CoV-2.
  • This was the first time that any COVID-19 vaccine had been tested in the adolescent population within the age bracket of 12-18 years in India.
  • The primary efficacy of 66.6% for symptomatic RT-PCR positive cases was achieved in the interim analysis.  
  • No moderate case of COVID-19 disease was observed post administration of the third dose, which suggests 100% efficacy for moderate disease.
  • No severe cases or deaths had been reported after administration of the second dose of the vaccine.
  • The vaccine will associate with PharmaJet, a needle-free applicator which will ensure painless intradermal vaccine delivery. this might cost extra.

About ZyCoV-D:

  • It is a “plasmid DNA” vaccine — or a vaccine that uses a genetically engineered, non-replicating version of a kind of DNA molecule referred to as a ‘plasmid’.
  • The plasmids, in this case, are coded with the instructions to make the spike protein of SARS-CoV-2, the coronavirus that causes Covid-19.
  • Vaccination gives the code to cells within the recipient’s body, in order that they can begin making the spiky outer layer of the virus.  
  • The immune system is expected to recognize this as a threat and develop antibodies in response.
  • Administration of Vaccine:
  • Most Covid-19 vaccines currently are given in two doses, with a few of single-shot ones also available.  
  • ZyCov-D against this are going to be given in three doses, with an interval of 28 days between the first and second and second and third shots.

PharmaJet:

  • No needle is employed — instead, a spring-powered device delivers the shot as a narrow, precise stream of fluid that penetrates the skin.

Vaccine efficacy against the Delta Variant:

  • The large-scale phase 3 trial of ZyCov-D was conducted at 50 clinical test sites across the country “during the height of the second wave of Covid-19”.  
  • The company believes that this “reaffirms” the vaccine’s effectiveness against the Delta variant of the coronavirus.
  • The company can upgrade ZyCov-D if needed to focus on other variants of concern and variants of interest that become more infectious or virulent in nature.

 

SOURCE: THE HINDU 

Print Friendly and PDF
blog comments powered by Disqus