Question

B) Answer to the following questions by writing few appropriate words
1. When did the first deadly epidemic for flu happen and which flu virus (name of the strain virus) was
responsible for such deadly epidemic?

2. In vaccine development at what point a company needs to file for IND with FDA to move forward?

3. Phase 1 and phase 2 clinical trials are performed to assess specific tests if a vaccine or a new drug
can move forward or not. Each phase 1 and 2 has its specific test and the number of individuals
involved. What it is measured in phase 1 and 2 respectively and the number of individuals involved
in each phase?

4. What is the cold chain and why it is important?

5. What are some of the Do and the Don't important facts for vaccine storage?

Answer 1

1.The 1918 influenza pandemic was the most severe deadly epidemic.which is caused by H1N1 Virus with genes of avian origin. 2.Before a clinical trial can be started ,the research must be approved.when researchers want to study a drug in humans the company needs to file for IND with FDA. 3.In phase 1 clinical trial ,investigators spend several months looking at the effects of the medication on about "20-80 people"who have no underlying health conditions.Investigators monitor participants very closely for the reaction of medication,also evaluating the ideal dosage,best way to administer the drug,such as orally ,intravenously,or topically.In phase 2 there are" several hundred participants".Investigators monitor the effectiveness of medication and gather more information regarding side effects.   4.A coldchain is a system in which the products are stored at a required temperatures so as to maintain the effectiveness of vaccine for transportation from the manufacturing site to the point of use.The cold chain maintains quality and levels of the air such as carbondioxide ,oxygen,and humidity. 5.DO'S for vaccine storage:Monitor with a data logger(a digital device that takes temperature readings).Use atemperature probe buffer.Make sure refrigerators and freezers can't be unplugged.DON'T:Use a dorm style fridge,don't use non-calibrated data loggers.