The Corona Disease Emergency Use Listing (EUL) is a procedure for assessing unlicensed vaccines, therapeutics and in vitro diagnostics during public health emergencies with the ultimate goal of expediting the availability of these products to people who need them. The EUL is using during public health emergencies.
When products are not licensed yet (still in development), WHO will assess the quality, safety and efficacy (or performance) data generated during development and conduct a risk-benefit assessment to decide if they can be used outside clinical trials.
EUL Provide Public Health Emergency:
The procedure foresees a situation in which the vaccine can evaluate after a health emergency of international concern or a pandemic declare. In this particular case, WHO may select a group of experts from the pre-established list to speed up the assessment and issue a recommendation in a short time.
EUL provides an evaluation route for research products. The development of vaccines against Covid-19 began only after the outbreak. As a result, the disease caused by a new virus. An unprecedented global effort has turned several graduate vaccines into clinical trials (human studies). Early discussions between vaccine developers and the WHO PQ strongly encourage. In order for a study vaccine to consider suitable for use in a public health emergency, the data must show that there is an advantage in the target population that outweighs the risk of its use.
The Procedure Of EUL Corona Disease Use:
Yes. The fact that vaccines receive a recommendation for use in a public health emergency they are still in development is only a temporary measure to ensure the availability of preventive tools that constitute a favourable benefit-risk ratio in the context of the emergency of public health (PHE).
However, the manufacturers commit to continue development and, if complete successfully, will submit the product for registration and apply for prequalification. The manufacturer expects to provide detailed guidance and a risk management plan.
Vaccines are very safe. As with all medicines, side effects can occur after getting a vaccine. However, these are usually very minor and of short duration, such as a sore arm or a mild fever. More serious side effects are possible, but extremely rare.
Side Effects From Vaccines:
A person is far more likely to serious harm by disease than by a vaccine. Vaccine-preventable diseases like measles, meningitis or polio can be deadly or cause severe illness and disability. Possible complications of these diseases can include:
- Brain damage
- Birth defects
Coronavirus Disease Vaccines Tested:
Once a promising vaccine is identifying, it will first undergo scrupulous laboratory testing. This includes careful examination and testing of the corona disease vaccine and its ingredients. These tests evaluate the safety of the vaccine, and how well it prevents disease.
- During Phase I, small groups (for instance, approximately 20-50 people) receive the vaccine. This phase will assess the safety, side effects, appropriate dosage, method of administration and composition of the vaccine.
- If it is successful, it will proceed to Phase II. At this stage, the vaccine is usually given to several hundred people. This group will have the same characteristics (e.g. age, sex) as the people for whom the vaccine is intended to be given.
- In Phase III, the vaccine is usually given to thousands of people to help ensure it is safe and effective for broader use.
The results of all these studies will assess when regulators decide whether to approve a vaccine.
As with any medicine, the safety of a vaccine should monitor on an ongoing basis, even after the trial and introduction of the vaccine. To clarify this follow-up deals with reports from various sources. At the national level, these include people receiving vaccines, parents or caregivers, and healthcare professionals. These reports are then sent to the national health authorities. At the regional and global level, WHO and UNICEF help countries collect and monitor this information and ensure that countries have the most up-to-date evidence on available vaccines.