Hello, this presentation will provide an overview of
the approaches for non-clinical vaccine development.
My name is Lisa Plitnick and I work for Merck.
I've been at Merck for 19 years and I am
the Therapeutic Area Leader for Vaccines in the Department of Nonclinical Safety.
I've also included here my email address,
in case you have follow-up questions for the presentation.
I'd like to start with an overview of vaccines and vaccination,
followed by a review of the current regulatory guidelines for non-clinical evaluation of vaccines.
I'll discuss considerations in the design of non-clinical toxicity studies, and go over some routine study designs.
I'll then provide examples of the testing strategies for
a typical prophylactic vaccine, and a prophylactic vaccine with a novel adjuvant.
To put into perspective the value of vaccines and vaccination,
vaccination is on a par with clean drinking water in
terms of number of lives saved due to disease prevention.
Two to three million deaths are prevented,
750,000 children are saved from disability,
low and middle-income countries will benefit from vaccines
by a $150 billion over the next 10 years,
and the estimated return on investment into vaccines is 44 times the initial investment.
The earliest description of what would become vaccination was in China in the 1000s.
That concept of vaccination (or what was referred to
as 'variolation') continued over the course of the centuries.
Early vaccines started with crude transfer of
diseased tissue from infected persons, and evolved into serums and toxoids,
and later (given advances and purification and manufacturing processes)
into the vaccines produced today.
The development of vaccines followed some of the biggest epidemics in history,
including smallpox, yellow fever, measles, rubella, polio, Ebola, and many others.
In many cases, vaccination has led to eradication of these diseases.
Another important innovation was the first aluminum adjuvant in the 1900s,
which served to boost the immune response to certain types of vaccines.
Interestingly, although the anti-vaccine movement seems like a relatively new phenomenon,
the Anti-Vaccination League of America held its first meeting in New York in 1882.
One argument they made was that smallpox was a result of 'filth', and not an actual contagion.