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In the middle of the fight against the second wave of coronavirus in India, doctors are reporting cases of a rare fungal infection called the “Black Fungus or Mucormycosis,” occurring among people recovering from the Covid-19 disease. As per the doctor’s infection of Black Fungus can be life threatening and has a mortality rate between 46–96 percent depending on severity.

What is Black Fungus: Mucormycosis?

Black Fungus or Mucormycosis is a very rare fungal infection caused by a class of molds called mucormycetes. These fungi are ubiquitous and are commonly found in soil, plants, manure, and decaying fruits and vegetables.

Humans get the infection by inhaling the fungal spores floating around in the air and in dust. It affects the sinuses, the brain and the lungs and can be life-threatening in diabetic or severely immunocompromised individuals, such as cancer patients or people with HIV/AIDS.

Cause of Black Fungus or Mucormycosis in Covid-19 Patients:

People with compromised immune systems may easily fall victim to Mucormycosis, for example, those with blood cancer undergoing chemotherapy or bone-marrow transplant patients.

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Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. It is defined as illness caused by a novel coronavirus now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It started in Wuhan, China in late 2019 and has since spread across the world. Like, SARS, the novel coronavirus is a zoonotic disease which begins in animals and then transmitted from animals to people.

What Does Covid-19 Stands for?

The coronavirus disease of 2019 was given the abbreviated name of COVID-19 by the WHO in a press release on February 11, 2020. Full form or abbreviation of Covid-19 is CO’ stands for corona, ‘VI‘ for virus, ‘D’ for disease and ‘19’ for 2019

How does coronavirus (COVID-19) spread?

The experts believe that the virus responsible for Covid-19 spread is a respiratory virus which spreads primarily through persons to persons.

Indirect Transmission: This usually happens when an infected person coughs or sneezes near other persons. The droplets generated by coughs or sneezes of the infected person may infect another person.

Direct Transmission: It may also be possible to get sick if you touch a surface that has the virus on it and then touch your mouth, nose, or eyes.

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What is emergency use authorisation (EUA)?

In the field of medical science, any vaccines, medicines, diagnostic tests, medical devices etc needs to get approval from a regulatory authority before they can be administered. In USA Food and Drug Administration (FDA) is the regulatory authority and in India Central Drugs Standard Control Organisation (CDSCO) is the regulatory authority.

In general situations, regulatory authority will grant approval for vaccines and medicines only after proper assessment of their safety and effectiveness based on data received from every stages of the trials. It is a long process, designed to ensure that a medicine or vaccine is absolutely safe and effective.

In the pandemic situations, like the current one (Covid-19), regulatory authorities may grant interim approvals if there is sufficient evidence to suggest a medical product is safe and effective. Final approval is granted only after completion of the trials and analysis of full data; until then, emergency use authorisation (EUA) allows the medicine or the vaccine to be used on the public.

When Emergency Use Authorization (EUA) Can be Granted by Regulatory Authorities?   

In emergency situation like Covid-19, Emergency Use Authorization can be granted by regulatory authorities like USA Food and Drug Administration (FDA), India Central Drugs Standard Control Organisation (CDSCO) only after sufficient efficacy data has been generated at the end of Phase III trials for Covid-19 vaccine. The Emergency Use Authorisation cannot be provided based on the data provided from Phase 1 or phase 2 trials. Ensuring patient safety is the highest priority while providing the approval.

USA FDA has released guidance explaining the conditions that need to be met before a vaccine receives an EUA for COVID-19. For effectiveness, this includes at least a 50% reduction in coronavirus infection. For safety, this means a strong track record through at least a median of two months of follow-up time.

Process of Emergency Use Authorization (EUA) in India?

Experts and activists say India’s drug regulations do not have provisions for an EUA, and the process for receiving one is not clearly defined or consistent. Despite this, CDSCO has been granting emergency or restricted emergency approvals to Covid-19 drugs during this pandemic — for remdesivir and favipiravir in June, and itolizumab in July.

Present Status Emergency Use Authorization (EUA) for Covid-19 Vaccines in India

In India,Pune-based Serum Institute of India (SII) has sought emergency approval for the vaccine Covishield developed along with AstraZeneca and Oxford University and Hyderabad-based Bharat Biotech sought emergency approval for the vaccine Covaxin developed in collaboration with the Indian Council of Medical Research.