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Govt. gives nod for Cipla to import Moderna’s vaccine

Topics Covered:  Government policies and interventions for development in various sectors and issues arising out of their design and implementation. 

Govt. gives nod for Cipla to import Moderna’s vaccine: 


Context: 

The Drugs Controller General of India (DCGI) has granted permission to Mumbai-based pharma major Cipla to import Moderna’s COVID-19 vaccine, making it the fourth vaccine in the country to be given the emergency use authorisation (EUA). 

  • Currently, India has made available three COVID vaccines — Covaxin, Covishield and Sputnik. 

 

About the Vaccine: 

The vaccine, mRNA-1273, manufactured by Moderna TX, Inc., is a two-dose vaccine with the shots to be given 28 days apart. 

Messenger RNA vaccines, also called mRNA vaccines, are a new vaccine technology platform. 

  • The mRNA vaccines teach human cells how to make a protein, or even just a piece of a protein of the virus, triggering an immune response inside human bodies. 
  • The benefit of mRNA vaccines, like all vaccines, is that those vaccinated gain protection without ever having to risk the serious consequences of getting sick with Covid-19. 

 

Regular procedure for drug approval:

Vaccines and medicines, and even diagnostic tests and medical devices, require the approval of a regulatory authority before they can be administered. 

  • In India, the regulatory authority is the Central Drugs Standard Control Organisation (CDSCO).
  • For vaccines and medicines, approval is granted after an assessment of their safety and effectiveness, based on data from trials. 

 

When can emergency use authorisation (EUA) be granted? 

India does not have a term like the EUA as in the US or UK in its regulatory processes. But in the New Drugs and Clinical Trials Rules, 2019, there are provisions for pharmaceutical companies to get approvals for clinical trials for new drugs or vaccines in India. 

  • When there is a declared emergency, the regulator, in India’s case the DCGI, can take a call whether it is worth releasing a drug or vaccine that is not fully tested for efficacy and safety. 
  • If there is evidence to suggest it may benefit patients, then the regulator is well within its rights to issue an emergency use authorisation to a medical product to make it widely available for use. 

 

Is there a risk in using a product that has only been granted an EUA?

According to the US FDA, the public has to be informed that a product has only been granted an EUA and not full approval. 

  • In the case of a Covid-19 vaccine, for example, people have to be informed about the known and potential benefits and risks, and the “extent to which such benefits or risks are unknown”, and that they have a right to refuse the vaccine. 

 

Insta Curious: 

Do you know the different types of COVID -19 vaccines and different approaches to designing a vaccine? Read Here

 

InstaLinks: 

Prelims Link: 

  1. What is vaccine nationalism? 
  2. Which drugs are being used in the treatment of COVID 19 disease? 
  3. Various tests to detect SARS- COV 2. 
  4. What is mRNA? 

Mains Link: 

What is Vaccine Nationalism? What are the concerns associated? Discuss. 

Sources: the Hindu.