The need and importance of Emergency Use Authorization (EUA) by FDA (Food and Drug Administration)

Of all industries, the pharmaceutical and healthcare industry has got a major boost from this pandemic. All the efforts are going out to the development of the COVID19 vaccines. This COVID19 pandemic will leave a mark across the globe of recording the largest number of deaths in many countries.

With the continued efforts of research and clinical trials, finally, we are out with vaccines for COVID. Let’s not forget the “second wave of COVID19” where there are increasing numbers of COVID cases in the world causing a great upsurge in the spread of the coronavirus infection. The first half of 2021 has been difficult as well right from administering the vaccine to the new variants which are increasing in the air due to the COVID spread. There have been many deaths due to the spread of the coronavirus that has resulted in the loss of lives.

Are we ready for “The second wave of COVID?

With rolling out and administration of vaccines, it is important to take preventative measures such as wearing a mask, disinfection, and sanitization of hands, and maintaining physical and social distancing should be given prime importance in the current COVID scenario. 

This COVID19 pandemic will leave a mark across the globe of recording the largest number of deaths in many countries. 

Rolling out of vaccines is still not a sign of relief 

Rolling out of COVID vaccines has faced significant obstacles. Recent COVID vaccination administration and distribution problems have been highlighted across the globe. In December 2020, millions of COVID vaccines were ready to be administered to the general public with the emergence of the new year 2021. Many clinical trials were done in 2020 to get the vaccine for COVID with a good efficacy rate. The pandemic again eventually began to fade. It was quite tough to deal with during the difficult times of pandemic which required the need of essential services. 

All efforts are going towards the development of new vaccines

Besides the COVID-19 realm, the government continues to play a key role in maintaining health and care across the nation. In recent years, the department of human and health services has come to the forefront to provide help to people by taking the country and state-based initiatives. The government of all the nations worldwide is involved in COVID 19 drug and vaccine development. It has also been instrumental in the establishment of various drugs and vaccines that have been approved by the Food and Drug Administration (FDA) targeting COVID19. Perhaps the most prominent positive development to emerge from the COVID 19 pandemic is the healthcare sector which has worked unitedly for the betterment of all individuals. The ability of the government and pharmaceutical industry to collaborate successfully on vaccine development in a short span of time is completely incredible in other areas of vaccine and drug development. 

Of all industries, the pharmaceutical and healthcare industry has got a major boost from this pandemic. All the efforts are going out to development of the COVID19 vaccines. 

FDA needs to act during the emergency situations 

In this hustle and bustle during the lockdowns, the FDA has recently approved the first treatment of the COVID19, the antiviral drug redeliver. Some other investigational drugs are also coming into existence which is already there in the clinical trial. Scientists and researchers are testing drugs that are already approved for different diseases which can be safe and effective against COVID19. With this, there is a lot of confusion about medical products like drugs and vaccines which can work effectively to prevent and control the spread of coronavirus disease. Scientists are working hard to develop potential drugs for the prevention and treatment of coronavirus. 

The importance of  Emergency Use Authorization (EUA)

An Emergency Use Authorization (EUA) is one of the tools used by the Food and Drug Administration (FDA) is used to make available certain medicines and vaccines quickly to spread and control the coronavirus. In certain emergencies, the FDA can issue EUA to access medicines and vaccines that may be used potentially when there are no options available. Under EUA policy, the medical product or the medicine is made available for the betterment of the public in case of emergency with the best possible evidence without waiting for FDA approval or clearance. When evaluating the EUA, they clearly look into the potential benefits and risks of the products based on the data available. EAUs are effectively emergency declarations made by FDA during the crisis like the COVID19 pandemic which has hit the world causing many deaths. EAUs can be revoked or revised based on the data and evidence available by the patient during the healthcare emergency use.

Tags : #myhealth #medicircle #FDA #EUA #Covid19vaccine

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