Stability Study of Razi Trivalent and Monovalent Oral Poliomyelitis Vaccine
نویسنده
چکیده
Stability studies play a critical role in assuring product quality at all points in the vaccine life cycle. These studies used to determine vaccine expiry date and vaccine efficacy. Accelerated stability and long term stability study performed for three batches of trivalent oral poliomyelitis vaccine (OPV) and three batches of monovalent OPV (type1) manufactured by Razi institute. After sampling, the samples tested intervals in months for long term stability and after 48 incubation in 37 C for accelerated stability. All of quantitative and qualitative control tests including Potency, Sterility, Mycoplasma detection and Physicochemical testes performed in each period. Potency test for trivalent OPV (tOPV) in three batches of vaccines until 26 months and in two batches, until 27 months after production, met the specification. Potency test for monovalent OPV (mOPV) in all batches of vaccines until 18 month after production met the specification. Sterility, mycoplasma and physicochemical testes on these samples for mOPV and tOPV until expiry date and after that, passed. All batches of vaccines in accelerated stability met the specification after incubation and the reduction titer of vaccines was less than 0.5(-LogCCID50/dose). Results of this research indicated razi polio vaccines are stable for 24 months if the cold chain considered properly.
منابع مشابه
Stability Study of Razi Trivalent and Monovalent Oral Poliomyelitis Vaccine
Stability studies play a critical role in assuring product quality at all points in the vaccine life cycle. These studies used to determine vaccine expiry date and vaccine efficacy. Accelerated stability and long term stability study performed for three batches of trivalent oral poliomyelitis vaccine (OPV) and three batches of monovalent OPV (type1) manufactured by Razi institute. After samplin...
متن کاملMonovalent type 1 oral poliovirus vaccine in newborns.
BACKGROUND In 1988, the World Health Assembly resolved to eradicate poliomyelitis. Although substantial progress toward this goal has been made, eradication remains elusive. In 2004, the World Health Organization called for the development of a potentially more immunogenic monovalent type 1 oral poliovirus vaccine. METHODS We conducted a trial in Egypt to compare the immunogenicity of a newly...
متن کاملEffectiveness of immunization against paralytic poliomyelitis in Nigeria.
BACKGROUND The number of cases of paralytic poliomyelitis has declined in Nigeria since the introduction of newly licensed monovalent oral poliovirus vaccines and new techniques of vaccine delivery. Understanding the relative contribution of these vaccines and the improved coverage to the decline in incident cases is essential for future planning. METHODS We estimated the field efficacies of ...
متن کاملParalytic poliomyelitis associated with Sabin monovalent and bivalent oral polio vaccines in Hungary.
Historical records of patients with vaccine-associated paralytic poliomyelitis (VAPP) in Hungary during 1961-1981 were reviewed to assess the risk of VAPP after oral polio vaccine (OPV) administration. A confirmed VAPP case was defined as a diagnosis of paralytic poliomyelitis and residual paralysis at 60 days in a patient with an epidemiologic link to the vaccine. Archived poliovirus isolates ...
متن کامل