Before recommending a vaccine for use, it should be tested in labs. This procedure can take many years. FDA uses the information from these tests to agree whether to test the vaccine with people or not.
Regulatory bodies like the FDA meticulously review data from these trials before granting authorization for public use. Monitoring continues post-approval to track any adverse effects and maintain safety standards.Efficacy measures the vaccine's ability to prevent disease under ideal conditions, while safety ensures its minimal side effects.
Throughout a clinical trial, a vaccine should be tested on people who agree to get vaccinated. The Clinical trials start with 20 - 100 volunteers, but ultimately include thousands of volunteers. These tests take so many years and answer important questions like:
Adverse effect (medicine): An adverse effect is an unwanted harmful effect resulting from an intervention or other medication, such as surgery. An adverse effect also called as a "side effect", when judged to be secondary to a main or therapeutic effect.
Adverse drug reaction: An adverse drug reaction (ADR) can be defined as an unwanted or an unappreciated harmful reaction resulting from an intervention related to the use of a medicinal product. Adverse effects usually predict dangerous from future administration and warrant prevention, or alteration of the dosage regimen, or specific treatment or withdrawal of the product.
Artificial induction of immunity: The process of artificial induction of immunity enhances people immunity to a specific disorder by means other than waiting for them to catch the disease. The aim is to decrease the risk of death and suffering. Artificially acquired active immunity can be introduced to our body by a vaccine, a drug that contains the antigen. It will encourage the response against the antigen without causing symptoms of the disease.
Title : Novel regulatory mechanisms of innate immunity and inflammation
Ping Xie, Rutgers University, United States
Title : Human challenge clinical trial of vaccines for infectious diseases – A necessary evil
Sudhakar Bangera, AILEEN Clinical Research Services, India
Title : Your vaccine attitude determines your altitude. What are the determinants of attitudes toward vaccination
Vincenzo Alfano, University of Napoli Parthenope, Italy
Title : Neutralizing antibodies response to SARS-COV-2 XBB1.5 mRNA vaccine in nephrology patients on dialysis against different viral variants
Agostino Riva, University of Milan, Italy
Title : Why Antimicrobial Resistance is a Global Threat and Its Impact On Everyone
Regina Au, BioMarketing Insight, United States
Title : The influence of physical factors on recombinant human serum albumin
Patrycja Dolibog, Medical University of Silesia in Katowice, Poland
Title : Current investments and future directions of biomedical advanced research and development authority’s CBRN vaccines portfolio
Lindsay Parish, BARDA, United States
Title : Development and characterization of a virus-like particle-based subunit vaccine candidate against Indian isolate of Porcine Circovirus 2d
Rajib Deb, ICAR-National Research Centre on Pig, India
Title : The Ethiopian vaccine supply chain and logistics system’s performance after the last mile delivery initiative: Phenomenological study
Samson Gebremedhin Gebreselassie, Project HOPE, Ethiopia
Title : Limits of vaccine quality control in India: Possible solutions
Bhoj R Singh, Indian Veterinary Research Institute, India