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Moderna’s vaccine and DCGI nod for its emergency use

  • Posted By
    10Pointer
  • Categories
    Polity & Governance
  • Published
    2nd Jul, 2021

The Drugs Controller General of India (DCGI) granted permission to import Moderna’s Covid-19 vaccine for restricted emergency use in the country.

Context

The Drugs Controller General of India (DCGI) granted permission to import Moderna’s Covid-19 vaccine for restricted emergency use in the country.

  • With Moderna’s approval, India now has four vaccines that have been granted emergency use authorization, the other three being Covishield, Covaxin, and Sputnik V.

About the Moderna Vaccine

  • After being injected into the body, the Moderna vaccine particles bump into cells and fuse to them, releasing messenger RNA (mRNA), which are genetic materials that our cells read to make proteins.
  • The cell’s molecules read the sequence and build spike proteins. These spike proteins in turn build spikes that move to the surface of cells and protrude out their tips.
  • The immune system recognizes these protruding spikes and the fragments generated by vaccinated cells by breaking up proteins.
  • The mRNA, which was released by the vaccine, is eventually destroyed by the cells of the body.
  • When immune cells known as B cells collide with the spikes on the protein fragments, some of them lock onto these spike proteins.
  • After activation by helper T cells, they start generating antibodies that target the spike protein.

Effectiveness of Moderna

  • Clinical trials have shown that Moderna’s mRNA-1273 vaccine has an efficacy of approximately 94.1 percent, starting from 14 days after taking the first dose.
  • Moderna is among the four vaccines that have been included on the list approved by the European Medicines Agency for the “vaccine passport” program that will allow free movement of people in and out of Europe starting from July 1.
  • The Moderna doses can be of particular benefit to India as WHO states that countries that have a high number of Covid cases and are facing vaccine shortages can consider delaying the second dose up to 12 weeks to achieve a higher first dose coverage in high priority populations.

Drugs Controller General of India (DCGI)

  • DCGI is the head of the department of the Central Drugs Standard Control Organization.
  • It is responsible for the approval of licenses of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.
  • Drugs Controller General of India comes under the Ministry of Health & Family Welfare.
    The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics.

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