BioSpectrum (India) - - BIO CONTENT - Dr Man­beena Chawla man­beena.chawla@mmac­

The In­dian vac­cine in­dus­try be­gan as a network of state-owned man­u­fac­tur­ers sup­ply­ing ba­sic pe­di­atric vac­cines to the na­tional im­mu­niza­tion pro­gramme. In re­cent times, the num­ber of pri­vate owned firms ac­tive in the sec­tor has grown rapidly. Their suc­cess in bring­ing low cost vac­cine so­lu­tions to the pub­lic vac­cine mar­ket is an im­por­tant driver be­hind the emer­gence of the sec­tor. As the in­dus­try is be­com­ing more so­phis­ti­cated, there is an in­creas­ing fo­cus on in­no­va­tion. Across the in­dus­try, a dozen or so new vac­cines are in clin­i­cal de­vel­op­ment.

The In­dian vac­cine in­dus­try be­gan as a network of state-owned man­u­fac­tur­ers sup­ply­ing ba­sic pe­di­atric vac­cines to the na­tional im­mu­niza­tion pro­gramme. In re­cent times, the num­ber of pri­vate owned firms ac­tive in the sec­tor has grown rapidly. Their suc­cess in bring­ing low cost vac­cine so­lu­tions to the pub­lic vac­cine mar­ket is an im­por­tant driver be­hind the emer­gence of the sec­tor. As the in­dus­try is be­com­ing more so­phis­ti­cated, there is an in­creas­ing fo­cus on in­no­va­tion. Across the in­dus­try, a dozen or so new vac­cines are in clin­i­cal de­vel­op­ment.

The In­dian vac­cine in­dus­try has been grad­u­ally build­ing its R&D ca­pac­ity for at least a decade. Spurred by the prospect of sales to the Global Al­liance for Vac­cines and Im­mu­niza­tions (GAVI), firms have strength­ened their ca­pa­bil­i­ties in biotech­nol­ogy, built col­lab­o­ra­tions with in­ter­na­tional part­ners, and moved from ba­sic vac­cines to more so­phis­ti­cated tech­nolo­gies.

“The trade mar­ket is cur­rently dom­i­nated by multi­na­tional com­pa­nies (GSK, Pfizer, MSD) as many of the In­dian man­u­fac­tur­ers have only con­ven­tional vac­cines in their prod­uct bas­ket at the present mo­ment. In­dian man­u­fac­tur­ers have sev­eral prod­ucts in their R&D pipe­line and as they roll out, the dom­i­nance of the multi­na­tional com­pa­nies will sub­side in the com­ing years. With the introduction of vac­cines by the In­dian man­u­fac­tur­ers, the mar­ket now will have a choice and pric­ing pres­sures will make it more af­ford­able than what is be­ing sold cur­rently. In­dian man­u­fac­tur­ers have the tech­ni­cal ex­per­tise to pro­duce sev­eral vac­cines at an af­ford­able price. In­dian man­u­fac­tur­ers have ac­counted for 60 per cent of sup­plies made to UNICEF. Hav­ing tasted suc­cess sev­eral com­pa­nies have ex­panded fa­cil­i­ties to cater to the global mar­kets to get a bet­ter price”, points out Dr K Anand Ku­mar, Managing Director, In­dian Im­muno­log­i­cals Ltd.

In­dus­try’s Role

Very re­cently, Hy­der­abad based In­dian Im­muno­log­i­cals Ltd (IIL), a sub­sidiary of the Na­tional Dairy De­vel­op­ment Board (NDDB), has launched Vax­tar 5, its pen­tava­lent vac­cine of­fer­ing pro­tec­tion against Diph­the­ria, Per­tus­sis, Tetanus, Hep­ati­tis B and Hae­mophilus in­fluen­zae type B (HiB). This de­vel­op­ment has led the com­pany to bag Rs 210-crore or­der from the gov­ern­ment to sup­ply 140 mil­lion doses of the 5-in-one pen­tava­lent vac­cine. At the same time, the com­pany is ac­tively pur­su­ing work on its hex­ava­lent vac­cine which in­cludes in­ac­ti­vated po­lio anti­gen.

An­other Hy­der­abad based key vac­cine player

Bharat Biotech was re­cently in the news with re­spect to the an­nounce­ment of the Na­tional Tech­nol­ogy Award for 2018 from the Tech­nol­ogy De­vel­op­ment Board, Gov­ern­ment of In­dia. This award on in­no­va­tive tech­nolo­gies, suc­cess­fully de­vel­oped and com­mer­cial­ized from In­dia was be­stowed on ROTAVAC, by the Pres­i­dent of In­dia Ram Nath Kovind. ROTAVAC, a Bharat Biotech vac­cine that pro­tects against di­ar­rhoea be­came the first in­dige­nously de­vel­oped vac­cine to be in­cor­po­rated in the gov­ern­ment-spon­sored im­mu­niza­tion cam­paign this year. Be­sides, Bharat Biotech has re­ported that its typhoid vac­cine, Typ­bar TCV, has shown 87 per cent ef­fi­cacy in tri­als. Cur­rently, the com­pany is work­ing on the phase I clin­i­cal tri­als for its chikun­gunya vac­cine.

“High in­vest­ments in R&D and prod­uct de­vel­op­ment, com­bined with 10-15 years of li­cen­sure make vac­cine de­vel­op­ment a painstak­ing ven­ture. Visu­al­is­ing re­turn on in­vest­ments is quite daunt­ing with vac­cines hav­ing pro­longed and highly de­tailed reg­u­la­tory pro­ce­dures world­wide. Although the

fu­ture for vac­cine re­search in In­dia is par­tially de­pen­dent on new tech­nolo­gies, the com­pa­nies need to have the pa­tience for long term in­vest­ments and re­search and de­vel­op­ment”, shares

Dr Kr­ishna Ella, CMD, Bharat Biotech.

This year also saw a strate­gic deal be­ing signed be­tween Panacea Biotec and Serum In­sti­tute of In­dia (SII) for a fully liq­uid six-in-one vac­cine. Un­der the col­lab­o­ra­tion, SII will be al­lowed to make and sell fully liq­uid Whole cell Per­tus­sis (wP) and Salk-based In­jectable Po­lio Vac­cine (IPV) based Hex­ava­lent vac­cine (DTwP-HepB-Hib-IPV) de­vel­oped and com­mer­cialised by Panacea Biotec, touted to be the first of its kind. Both vac­cine com­pa­nies in­tend to get this wP-IPV-based Hex­ava­lent Vac­cine in­tro­duced in the gov­ern­ment’s Na­tional Im­mu­ni­sa­tion Pro­gramme. Other de­vel­op­ing coun­tries are also on the radar through stake­hold­ers, in­clud­ing gov­ern­ments, the World Health Or­gan­i­sa­tion, the Global Al­liance for Vac­cines & Im­mu­ni­sa­tion (GAVI), the Bill and Melinda Gates Foun­da­tion (BMGF) and other United Na­tion agen­cies.

Back in 2017, SII had launched two new vac­cine prod­ucts - Ro­tasiil and Rabishield for ro­tavirus caus­ing di­ar­rhoea and ra­bies re­spec­tively. The newly de­vel­oped Rabishield anti-ra­bies im­munoglob­u­lin is the world’s first re­com­bi­nant ra­bies mon­o­clonal an­ti­body to pre­vent Ra­bies, a fa­tal disease which is es­ti­mated to cause two deaths ev­ery hour in In­dia. Rabishield has been de­vel­oped in re­search part­ner­ship with Mas­sachusetts Med­i­cal School, USA. Ro­tasiil ro­tavirus vac­cine is the world’s first ther­mostable pen­tava­lent Ro­tavirus vac­cine con­tain­ing the G9 strain to help pre­vent the spread of ro­tavirus which causes di­ar­rhoea mostly in ba­bies. Cur­rently, SII is work­ing on de­vel­op­ing vac­cines against pneu­mo­nia, chikun­gunya and en­teric dis­eases.

“The main chal­lenge the In­dus­try is fac­ing in vac­cine de­vel­op­ment is cap­i­tal in­ten­sive na­ture of de­vel­op­ment and long ges­ta­tion pe­riod. To sus­tain through this along with tech­no­log­i­cal com­pli­ca­tions and le­gal frame­work, is quite a task. In fact clin­i­cal trial per­mis­sions and pro­to­col is also equally chal­leng­ing as tech­nol­ogy. For the com­ing years, new tech­nolo­gies are re­quired for car­ry­ing out an­a­lyt­i­cal work and test­ing of vac­cines”, elab­o­rates Dr SD Ravetkar, Ex­ec­u­tive Director, Serum In­sti­tute of In­dia. Join­ing the league of vac­cine R&D,

Sun Phar­ma­ceu­ti­cal In­dus­tries Ltd has en­tered into a col­lab­o­ra­tion with the In­ter­na­tional Cen­tre for Ge­netic En­gi­neer­ing and Biotech­nol­ogy (ICGEB), New Delhi to de­velop a novel dengue vac­cine tar­geted against all four serotypes of dengue virus (DENV). Sun Pharma is fund­ing and sup­port­ing fur­ther de­vel­op­ment of the vac­cine can­di­date while ICGEB will be grant­ing Sun Pharma ex­clu­sive rights and li­censes for de­vel­op­ment and com­mer­cial­i­sa­tion of this vac­cine glob­ally. “A ma­jor prob­lem with dengue is that as it has four types -DENV-1, DENV-2, DENV-3 and DENV-4 and it is quite pos­si­ble that a per­son may get in­fected with one type first and later have a se­condary in­fec­tion with an­other type. The drug we are work­ing on has been val­i­dated in an­i­mals and is ready to un­dergo all the man­dated safety and tox­i­c­ity tests as per ex­ist­ing reg­u­la­tions. It is de­rived from a plant called Cis­sam­pe­los pareira Linn (Cipa). It has been

patented in 17 coun­tries across the world. This agree­ment with Sun Pharma will help us to pro­duce the world’s first botan­i­cal drug against dengue”, high­lights

Dr Naveen Khanna, Se­nior Sci­en­tist, ICGEB.

“Vac­cine de­vel­op­ment is not at all an easy process. Chal­lenges sur­round­ing vac­cines are of­ten spe­cific to the vac­cine in­volved and can vary from a com­pet­i­tive land­scape to main­tain­ing cold chain right upto the time of ad­min­is­tra­tion and time-to-mar­ket since bi­o­log­i­cal prod­ucts typ­i­cally have shorter shelf life com­pared to tra­di­tional pharma prod­ucts. Vac­cine man­u­fac­tur­ing has mul­ti­ple chal­lenges but com­pa­nies should con­tinue to in­vest in find­ing so­lu­tions to en­sure we can sup­ply life-sav­ing vac­cines pro­duced at a high qual­ity while main­tain­ing af­ford­abil­ity”, ex­plains

Dr Ma­hesh Bhal­gat, Ex­ec­u­tive Director and COO, Shan­tha Biotech­nics.

An­other prom­i­nent player in the vac­cine mar­ket, Zy­dus Cadila, has re­cently re­ceived ap­provals from the Drug Con­troller Gen­eral of In­dia (DCGI), Cen­tral Drugs Stan­dard Con­trol Or­ga­ni­za­tion (CD­SCO) and the Cen­tral Drug Lab­o­ra­tory (CDL) to mar­ket its Te­trava­lent In­ac­ti­vated In­fluenza vac­cine for sea­sonal flu, Vax­iFlu - 4. With this, Zy­dus Cadila will be­come the first In­dian pharma com­pany and sec­ond in the world to launch a Te­trava­lent In­ac­ti­vated In­fluenza vac­cine. The vac­cine pro­vides pro­tec­tion from the four in­fluenza viruses- H1N1, H3N2, Type B (Bris­bane) and Type B (Phuket).

“Disease preven­tion is the key to pub­lic health in both the de­vel­op­ing and the de­vel­oped world

and vac­cines have the po­ten­tial to im­prove the qual­ity of life in both spec­trums. In coun­tries such as In­dia, there is a press­ing need for low cost, high qual­ity vac­cines that can ad­dress health­care chal­lenges”, shares Pankaj R. Pa­tel, Chair­man and Managing Director, Zy­dus Cadila.

Gov­ern­ment’s role

One of the pri­mary forces that is stim­u­lat­ing the vac­cine mar­ket growth in In­dia is the in­creas­ing in­vest­ments in re­search and de­vel­op­ment (R&D) by gov­ern­ment fund­ing agen­cies like the Depart­ment of Biotech­nol­ogy, the In­dian Coun­cil of Med­i­cal Re­search, and the Min­istry of Health and Fam­ily Wel­fare. The In­dian Coun­cil of Med­i­cal Re­search (ICMR) has en­tered into an agree­ment to col­lab­o­rate on vac­cine re­search and de­vel­op­ment with South Korea based in­ter­na­tional vac­cine de­vel­op­ment or­gan­i­sa­tion In­ter­na­tional Vac­cine In­sti­tute (IVI). Through this part­ner­ship, In­dia will com­mit $5,00,000 (Rs 3.20 crore) an­nu­ally for a stake in IVI.

“Un­der ICMR’s lat­est part­ner­ship, vac­cine can­di­dates de­vel­oped in IVI labs could be brought to In­dia and given to one of the In­dian com­pa­nies for fur­ther de­vel­op­ment. IVI may also fa­cil­i­tate fur­ther global test­ing of vac­cine can­di­dates de­vel­oped in In­dian labs by link­ing de­vel­op­ers here with global part­ners. The part­ner­ship is fur­ther ex­pected to help with ca­pac­ity build­ing for clin­i­cal tri­als within In­dia as well. The MoU is also ex­pected to help sup­port com­pa­nies like Bharat Biotech, which has com­pleted phase I clin­i­cal tri­als of its chikun­gunya vac­cine and has ex­pressed the need for sup­port in con­duct­ing phase II and

III tri­als for the can­di­date”, points out Dr Soumya Swami­nathan, DDG, Pro­grammes, World Health Or­gan­i­sa­tion.

The Depart­ment of Biotech­nol­ogy (DBT) has made con­certed ef­forts in the area of vac­cine re­search and de­vel­op­ment since its in­cep­tion in 1986-87 through the Task Force on Med­i­cal Biotech­nol­ogy, Indo-US Vac­cine Action Pro­gramme (VAP), Na­tional Tech­nol­ogy Mis­sion on Im­mu­ni­sa­tion and Na­tional Jai-Vi­gyan Mis­sion on Sci­ence and Tech­nol­ogy for the gen­er­a­tion of new and im­proved vac­cines and more re­cently through the Vac­cine Grand Chal­lenge Pro­gramme (VGCP).

“Malaria Vac­cine De­vel­op­ment Pro­gramme (MVDP) is a con­sor­tium of DBT, ICGEB, Malaria Vac­cine Ini­tia­tive (MVI), PATH, EMVI and WHOTDR. MVDP was es­tab­lished as an in­de­pen­dent so­ci­ety in July 2010. It takes vac­cine projects up to proof of con­cept and ef­fi­cacy stud­ies (Phase II) and turns them over to com­pa­nies for Phase III trial and com­mer­cial­i­sa­tion. Over­all ob­jec­tive of the pro­gramme is to pro­mote the de­vel­op­ment of vac­cines against P. fal­ci­parum and P. vi­vax malaria by lever­ag­ing the ba­sic sci­en­tific work done by ICGEB and other sci­en­tific groups. Then Vac­cine and In­fec­tious Disease Re­search Cen­tre (VIDRC) of THSTI was set in early 2009 as one of the niche cen­tres of the newly es­tab­lished Trans­la­tional Health Sci­ence and Tech­nol­ogy In­sti­tute (THSTI). The aim of VIDRC is to study in­fec­tious dis­eases and pathogens with a view to de­velop ef­fec­tive vac­cines and ther­a­peu­tics”, ex­plains

Dr Renu Swarup, Sec­re­tary, DBT.

DBT has also been fund­ing re­search on Tu­ber­cu­lo­sis (TB) for the past two decades with fo­cus on vac­cine de­vel­op­ment, among oth­ers. A num­ber of novel ap­proaches for gen­er­at­ing vac­cines against TB have been iden­ti­fied at ICGEB, Delhi Univer­sity South Cam­pus, New Delhi, Univer­sity of Hy­der­abad, In­dian In­sti­tute of Sci­ence, Ben­galuru, to name a few.

“In terms of vac­cines, In­dia has pro­gressed from be­ing one of the world’s top vac­cine man­u­fac­tur­ers to be­come an emerg­ing player in the R&D of vac­cines. The DBT is sup­port­ing TB ini­tia­tives in a ma­jor way by set­ting up Re­gional Prospec­tive Ob­ser­va­tional Re­search for Tu­ber­cu­lo­sis (Re­PORT) In­dia Con­sor­tium un­der the aegis of Indo-US Vac­cine Action Pro­gramme, to en­hance or build, com­bined bio­med­i­cal and clin­i­cal re­search ca­pac­ity in In­dia. It is a mat­ter of pride that In­dia makes more than 60 per cent of the world’s vac­cines and are in the right di­rec­tion to be­come a hub for vac­cine R&D as well”, states Dr Ashutosh Sharma, Sec­re­tary to the Gov­ern­ment of In­dia, Depart­ment of Sci­ence and Tech­nol­ogy (DST).

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