· What
are Biologicals?
Biologicals is
a term generally used to describe immunogens derived from a biological
system. Modern Vaccines, antisera and Biotechnology products are included in
this definition. Immunogens are those high molecular weight protein
molecules that are capable of triggering an immune response either in the
form of IgG or cell mediated response.
· Are
all Biologicals safe?
Generally
Biologicals are considered safe, because when a Biological is commercially
available it has a past history of development comprising of different
stages of safety testing. However, when in field some Biologicals may cause
some reaction in individuals which are recorded as Adverse Events Following
immunization or AEFI. this behavior is normal and is investigated to show
that the product causing AEFI is within the defined limits. In case the
response is severe or uncalled for the Biological in question is immediately
stopped from being used and is ultimately recalled from market.
· What
are the safety issues in the use of multiple Biologicals?
Multiple
Biologicals are used in some case of treatment, for example in case of rabid
animal bite Cell Culture Vaccine is given as well as Rabies Immune Serum is
used at the site of bite. This is necessary to neutralize free virus at the
site of bite using IgG and to trigger the immune response for longer
protection using the vaccine antigen.
· Is
there any allergic content in the Biologicals?
Sometimes the
components of vaccines, which are in very minute quantity, may trigger an
allergic reaction. Components such are antibiotics, or some antigens derived
from eggs of poultry, or hyper immune sera derived from horses may cause
allergic reactions. Generally these reaction are very rare, but for the
person allergic to constituents of vaccine it is important to have the
necessary protective measures ready before using a Biological.
· How
is Pakistan ensuring the quality of Biologicals?
Government of
Pakistan through Ministry of Health has ensured that only safe Biologicals
are registered and only safe batches of registered vaccine are imported. For
this purpose every batch or lot of biological imported in the country goes
through a procedure of lot release. Since this system was started in 2007,
no failure of quality has been reported.