Regulatory bodies

Question 1

There are several key regulatory boards:

Answer 1

1. The Committee for Medicinal Products for Human Use (CHMP) is responsible for vaccines in Europe, defining what vaccines/
   vaccine components are.
2. The EMEA is responsible for guidelines on Biologicals. Any changes of biologic manufacturing must be clarified
3. The Paediatric Committee (PDCO)
4. The Committee for Advanced Therapies (CAT)

Question 2

Vaccines must be

Answer 2

safe, with low toxicity

Question 3

They must offer

Answer 3

effective protection against infective agents to rapidly generate herd immunity and ideally, produce long-lived immunity to reduce the amount of booster doses required; this reduces the cost involved and complexity of vaccine regimens.

Question 4

They should be cheap

Answer 4

or cost-effective, as they will be administered widely. They should contain only purified components (i.e. the key antigens only): for intracellular organisms, CTL and Abs are needed, for extracellular organisms, only Abs are needed.

Question 5

They should also be stable

Answer 5

and be correctly formulated (uniformity of dose, adjuvant, preservative & moisture content).

Question 6

Future vaccine development

Answer 6

Mycobacterium tuberculosis (TB), HIV and plasmodium falciparum (malaria) are the three biggest killers, with vaccines in development. New vaccine strategies are needed to deal with complex, intractable pathogens such as HIV, TB and malaria. These involve determining correlates of protective immunity, optimising immunogens and developing a vaccination strategy.

Question 7

Attenuated vaccine is not viable for HIV

Answer 7

as it destroys CD4+ cells, dampens the immune response and relentlessly mutates, meaning that finding a target is very difficult. However, the RV-144 trial involved showed 30% efficacy, with highest degree of protection between 6-12 months.