Dear Sir,Based on the PATH report, we must immediately demand from DCGI office or GOI for use of IPV through Intradermal Route as well, otherwise people would be cheated as they have been with Rabies vaccine. Though I disagree with the report on one point that is a device is required for effective delivery of vaccine as this can be done with needle and syringe as well in India as we are doing with BCG/ ARV. also I disagree with the report that the needle syringe method would cost more, especially the costs calculated for disposal of waste are not appropriate. What, important is the delivery of vaccine through intradermal method. Read the report... In this report, results are presented from an economic model that calculates the costs involved in delivering IPV vaccine in Indian immunization clinics according to the first three strategies listed above. The model analyzed the costs associated with four delivery devices: disposable needle and syringe, disposable-syringe jet injectors (DSJI), an ID adapter (which controls the depth and angle of the ID injection), or a syringe-mounted hollow microneedle (MN). Clinical trials have shown that IDD of reduced doses (delivering 20% of the volume of a standard dose) can be sufficiently immunogenic. The results of the economic analysis suggest that IDD of IPV using needle and syringe, DSJI, or ID adapter could result in cost savings of up to 71%â€“73% per immunized infant compared with delivery of the standard dose via the usual intramuscular (IM) route using needle and syringe. Combining IPV with adjuvant so that only 10% of the original antigen content was needed, whilst still using the IM route, had the potential to save 82% to 83% of the immunization costs, depending upon the delivery device used. An aim of this strategy is to reduce the amount of vaccine antigen required to induce a protective immune response by intradermal (ID) delivery of fractional or reduced doses, i.e., administering a smaller volume of the existing formulation. If this could be achieved for IPV, it would have the potential to stretch the manufacturing capacity of existing IPV facilities and also to reduce the manufacturing cost per dose. Some logistics costs might also be reduced as it is possible that a lower-volume dose would require less space in the cold chain during distribution and storage.Intradermal delivery (IDD) of fractional doses has been investigated for a number of vaccines, most notably rabies, influenza, and hepatitis B.* Three studies of IDD of fractional doses of IPV have been published: * Reviewed in Intradermal Delivery of Vaccines. A review of the literature and the potential for development for use in low- and middle-income countries. PATH, August 2009. http://www.path.org/files/TS_opt_idd_review.pdf.IDD of reduced doses (20% of the standard volume and therefore 20% of the standard antigen content) induced striking antibody responses in adults and children who had previously been immunized. No IM comparator arm was included in this trial. A schedule of two ID doses (20% of the standard dose) in nonimmune subjects resulted in a seroconversion index of 82% which was described as being comparable to an index of 91% seen in a previous study following two IM doses. Nirmal et al. reported that two or three 0.1 ml doses ID were equivalent in terms of seroconversion to two 0.5 ml doses of IPV delivered IM in a previous study. The overall seroconversion rates to all three poliovirus types were 85.5% and 89.0% following two or three ID doses, respectively. Seroconversion was seen in all infants (following either two or three ID doses) who did not have maternal antibodies present in prevaccination sera. More recently, two GPEI-sponsored trials used the Biojector 2000Â® disposable syringe jet injector (DSJI) device to deliver a 20% dose ID compared with full-dose IM.5 Two different immunization schedules were tested, one in each of the two countries (Oman and Cuba) selected to run the study, and vaccines from two different suppliers were used. Thanks, Dr. Omesh Kumar BhartiM.B.B.S.,D.H.M.,M.A.E.(Epidemiology)Directorate of Health Safety and Regulation, SHIMLA, Himachal Pradesh, India.+91-9418120302[firstname.lastname@example.org]email@example.com[/email]; [email]firstname.lastname@example.org[/email]
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