Pfizer Wants Govt to Take a Shot at its Vac­cine

Co in talks with govt to in­clude its multi-dose vial pack of pneu­mo­coc­cal vac­cine Prevnar 13 in the coun­try’s im­mu­ni­sa­tion pro­gramme Pfizer Packs a Vac­cine Punch

The Economic Times - - Companies - Vikas.Dan­dekar@ times­

Mum­bai: Phar­ma­ceu­ti­cal giant Pfizer is in talks with the In­dian gov­ern­ment for in­clu­sion of its mul­ti­dose vials of pneu­mo­coc­cal vac­cine, Prevnar 13, in the coun­try’s im­mu­ni­sa­tion pro­gramme. The New York-head­quar­tered com­pany won Euro­pean ap­proval for the multi-dose vial pack of the in­fant and chil­dren’s vac­cine, which works against 13 strains of strep­to­coc­cus pneu­mo­nia bac­te­ria. The drug is Pfizer’s top-sell­ing brand lo­cally (ahead of Corex cough syrup). It raked in .₹ 251 crore in sales last year. Su­san Sil­ber­mann, pres­i­dent for Pfizer’s global vac­cines op­er­a­tions, told ET that if the new vials of Prevnar 13 are to be in­cluded in In­dia’s na­tional im­mu­ni­sa­tion pro­gramme (NIP), the com­pany will be keen to work with the gov­ern­ment to en­sure that the prod­uct is in­tro­duced by the end of the year. She said the com­pany has dis­cussed with health of­fi­cials for an ac­cel­er­ated re­view process for the vac­cine in the new pack. Prevnar 13 com­petes with GSK’s brand Syn­florix, which is also avail­able in the pri­vate mar­ket. Each multi-dose vial can be used for four doses as against the one-time use of the pre-filled sy­ringes of Prevnar 13 that are cur­rently mar­keted.

Data shows that over 100,000 child- ren be­low the age of five die of pneu­mo­coc­cal pneu­mo­nia in In­dia ev­ery year. In the new form, a box that once car­ried vac­cines for 50 in­fants and chil­dren can now po­ten­tially vac­ci­nate 200, and is ex­pected to lead to sig­nif­i­cant sav­ings in health bud­gets of scores of coun­tries that have in­cluded the prod­uct in their na­tional vac­ci­na­tion pro­grammes.

Pfizer ex­pects the multi-dose vials play an in­stru­men­tal role as the coun­try closely ex­am­ines the modal­i­ties to in­clude the vac­cine in its Univer­sal Im­mu­ni­sa­tion Pro­gramme, which of­fici- als have hinted may be an­nounced by the end of the year. The com­pany an­nounced that the vials laced with a preser­va­tive can be used for four doses and will be priced at $3.1 for each shot un­der the GAVI (Global Al­liance for Vac­cine and Im­mu­ni­sa­tion) Ad­vance Mar­ket Com­mit­ment pro­gramme. In In­dia, the vac­cine has a max­i­mum re­tail price of .₹ 3,801 per dose in the pri­vate mar­ket.

An April 6 state­ment from Pfizer said its prod­uct re­ceived an ap­proval from the Com­mit­tee for Medic­i­nal Pro- ducts for Hu­man Use (CHMP) of the Euro­pean Medicines Agency (EMA). “This new multi-dose vial pre­sen­ta­tion was de­vel­oped to help max­imise ef­fi­ciency for health­care work­ers by help­ing to sig­nif­i­cantly re­duce stor­age re­quire­ments and ship­ping costs in com­mu­ni­ties with health sys­tems that are still de­vel­op­ing,” the com­pany noted in the state­ment.

Pfizer said it plans to make new sub­mis­sion to the World Health Or­gan­i­sa­tion (WHO) for pre­qual­i­fi­ca­tion, which, if ap­proved, will al­low for the global use of the new pre­sen­ta­tion of Preve­nar 13 by United Na­tions agen­cies and coun­tries that re­quire WHO pre­qual­i­fi­ca­tion. “If and when pre­qual­i­fied, the MDV pre­sen­ta­tion is ex­pected to be in­tro­duced un­der the Ad­vance Mar­ket Com­mit­ment pro­gram in early 2017, for ship­ment to coun­tries cov­ered by GAVI,” it said.

Ear­lier this year, GAVI com­mit­ted $500 mil­lion to be spent over a five year pe­riod (2016-2021) to bol­ster In­dia’s ex­ist­ing im­mu­ni­sa­tion pro­gramme and add newer vac­cines to its list. Last month, MSF, the hu­man­i­tar­ian aid agency, filed a patent op­po­si­tion against Prevnar 13, call­ing the gov­ern­ment to block grant­ing patent for the vac­cine so as to fa­cil­i­tate wide avail­abil­ity of lower-cost ver­sions of the prod­uct. Pfizer’s Sil­ber­mann told ET that the com­pany has re­viewed the op­po­si­tion and is in the process of re­spond­ing.

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