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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.

Salmonella infection (Salmonellosis) is a common bacterial disease that affects the intestinal tract and is the most frequently reported cause of food-related illness in the United States. Salmonella infection is officially called as salmonellosis.

This bacterial disease Salmonella, typically live in animal and human intestines and are shed through feces. Humans become infected  through contaminated water or food which accidentally they transfer from their hands to mouth. If people get Salmonella on their hands or clothes, they can spread the bacteria to other people, objects, and surfaces which results in spreading of the said disease from one person to another.

 Symptoms of Salmonella:
Salmonella infections can be classified as stomach flu (gastroenteritis). Symptoms in people start within 6 hours to 6 days after ingesting the bacteria. The illness usually lasts 4 to 7 days, and most people recover without treatment. Possible signs and symptoms are as under:

• Nausea
• Vomiting
• Abdominal cramps
• Diarrhea
• Fever
• Chills
• Headache
• Blood in the stool

A few varieties of salmonella bacteria result in typhoid fever and become a deadly disease, that is more common in developing countries.

Salmonella Infection Causes:

Salmonella bacteria live in the intestines of people, animals and birds. Commonly infected foods include:

• Raw meat, poultry and seafood: Feces may get onto raw meat and poultry during the butchering process. Seafood may be contaminated if harvested from contaminated water.
• Raw eggs: While an egg’s shell may seem to be a perfect barrier to contamination, some infected chickens produce eggs that contain salmonella before the shell is even formed.
• Fruits and vegetables: Some fresh produce, particularly imported varieties, may be hydrated in the field or washed during processing with water contaminated with salmonella. Contamination also can occur in the kitchen, when juices from raw meat and poultry come into contact with uncooked foods, such as salads.

The Food and Drug Administration of United State also indicates that some salmonella outbreaks have been traced to contaminants in spices. The agency is seeking ways to increase the safety of spices.

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