how do we develop a new vaccine after lots of laboratory work how do we know it is ready to get tested in humans and then how do we know whether or not it works we test new vaccines in clinical trials to determine that they are both safe and effective before they get licensed in the US stick with us this is going to be interesting
Develop a New Vaccine:-
this applies to all kinds of drugs and vaccines, we’re going to focus here on vaccines used for the prevention of a specific type of infection the first thing to know is that a lot of testing is done before
vaccine ever gets tested in humans there is a long process of development in the laboratory and testing both for safety and for protection in animal studies after we have a vaccine that looks both safe and promising and prevents infection in a laboratory we begin testing in humans because we don’t know whether or not the vaccine will work we begin a very structured set of studies called clinical trials these studies involve healthy volunteers who are told in detail about how and why this vaccine is being tested and about any potential harm this educational process is a
process called informed consent and goes on before and during the trial, there’s a continual discussion that happens between the researchers and the study volunteers describing the study and informing the volunteers about any new information that happens at any time
during the study and answering all questions that the volunteers have the study staff also determine whether the volunteer meets all the eligibility criteria to participate which involves physical exams and blood tests next we start what is called a randomized double-blinded clinical trial what that
means is that after volunteers enroll in a study a computer randomly decides whether they will get the vaccine or whether they will get the placebo which is usually just saltwater we do this to be able to separate outside effects that are due to the vaccine from those that are just happening to people in the community at the same time like the rate of cold symptoms or headaches and we double-blind meaning neither the participant nor the study staff knows who is getting
type of injection that prevents both volunteers and the staff from over or under-reporting symptoms we advise participants to tell us about everything that is happening to them before a
the vaccine is licensed by the US Food and Drug Administration it usually goes through
Three phases of clinical trials:-
Phase One trial:-
specific purpose phase one trials which can last up to two years it compares the safety does the vaccine cause any side effects and tolerability does the injection hurt and for how long in this phase of studies scientists are also gathering information about the body’s immune.
response to the vaccine to see whether it is a promising approach to preventing the specific infection if is one trial do not determine whether.
Phase two trials
which can last longer than two years will confirm the safety in a larger group of volunteers and focus on the best dose and the best timing of vaccinations to produce the strongest immune response promising vaccines that are safe and generate a strong immune response move into…..
Phase three trials:-
these are the largest trials and compare the rate of infection in the vaccine and placebo groups this will tell us whether the vaccine is able to prevent infection and if so if it is effective in all of the volunteers or only a subgroup like younger volunteers or women along with the safety data that is collected in all phases of vaccine studies this efficacy data is used by the FDA to decide if the vaccine should be licensed and if so for whom it is recommended in the best case scenario it could take six to ten years for a promising vaccine to move from
Phase 1 testing:-
to real-world distribution often it takes longer the clinical trials are absolutely necessary to determine that a vaccine is safe and effective in preventing new infection
Comment And download:-
vaccine development pdf
how to implement vaccines
|how are new vaccines developed