Polio

IPOL by Sanofi Pasteur (Polio)

Captured 2022-11-17
Document Highlights

IPOL vaccine is a highly purified, inactivated poliovirus vaccine with enhanced potency. Each of the three strains of poliovirus is individually grown in vero cells, a continuous line of monkey kidney cells

The cells are… supplemented with newborn calf bovine serum

Approximately 90% to 95% of poliovirus infections are asymptomatic. Nonspecific illness with low-grade fever and sore throat (minor illness) occurs in 4% to 8% of infections. Aseptic meningitis occurs in 1% to 5% of patients a few days after the minor illness has resolved. Rapid onset of asymmetric acute flaccid paralysis occurs in 0.1% to 2% of infections, and residual paralytic disease involving motor neurons (paralytic poliomyelitis) occurs in approximately 1 per 1,000 infections.

As with any vaccine, vaccination with IPOL vaccine may not protect 100% of individuals.

IPOL vaccine is contraindicated in persons with a history of hypersensitivity to any component of the vaccine, including 2-phenoxyethanol, formaldehyde, neomycin, streptomycin, and polymyxin B.

Vaccination of persons with an acute, febrile illness should be deferred…

GBS has been temporally related to administration of another inactivated poliovirus vaccine. Deaths have been reported in temporal association with the administration of IPV

Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient’s history with respect to possible sensitivity to the vaccine or similar vaccines.

Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.

Post-marketing Experience
– lymphadenopathy
– agitation, injection site reaction
including injection site rash and mass
– type I hypersensitivity including allergic reaction, anaphylactic
reaction, and anaphylactic shock
– arthralgia, myalgia
– convulsion, febrile convulsion, headache, paresthesia,
somnolence, syncope
– rash, urticaria

Comments

IPOL was not tested for safety in a placebo-controlled clinical trial.

Why this is important.