Vac­cine In­dus­try los­ing skill?

BioSpectrum (India) - - BIO EDIT - Milind Kokje Chief Ed­i­tor [email protected]­

News re­ports since the last one month re­gard­ing the Po­lio vac­cine are, least to say, dis­turb­ing. They ac­tu­ally raise very se­ri­ous con­cerns as they pose a threat of a likely vac­cine con­tam­i­na­tion.

Some batches of oral po­lio vac­cine have been found to be con­tam­i­nated with po­lio type-2 virus. Its pres­ence ap­pears to be a se­ri­ous threat to pub­lic health be­cause this strain has been erad­i­cated world­wide. Hence its re-emer­gence is a se­ri­ous prob­lem. Some vac­cine vials con­tain­ing type-2 virus were ad­min­is­tered to chil­dren in Ma­ha­rash­tra, Ut­tar Pradesh and Telangana. The in­ci­dent came to light when sur­veil­lance re­ports from Ut­tar Pradesh showed signs of virus in stool sam­ples of some chil­dren in Ut­tar Pradesh. So, on sus­pi­cion when vac­cine sam­ples were sent for test­ing the re­ports con­firmed con­tam­i­na­tion of some batches.

Med­i­cal ex­perts fear that the virus may mu­tate and could lead to vac­cine re­lated Po­lio cases. The govern­ment health ma­chin­ery and the reg­u­la­tory has swung into its usual ac­tion of pre­cau­tion, in­quiry and ac­tion. A case has been filed against Ghazi­abad based Biomed, which man­u­fac­tured the vac­cine. It has also been asked to stop pro­duc­ing, dis­tribut­ing and sell­ing the vac­cine.

The states have been asked to trace the chil­dren who have been given the con­tam­i­nated vac­cines. As pre­cau­tion­ary mea­sures all the chil­dren in the ar­eas from the three states where con­tam­i­nated vac­cines were sup­plied are be­ing ad­min­is­tered with In­ac­ti­vated Po­lio Virus (IPV) in­jec­tions. But, the prob­lem is the coun­try has wit­nessed short­age of IPV in­jec­tions dur­ing the last two years. The govern­ment will have to en­sure smooth sup­ply and it is very cru­cial now. The Po­lio sur­veil­lance teams in the three state have also stepped up mon­i­tor­ing of all chil­dren in these ar­eas and a close watch has been kept on them for any symp­toms.

Still, a very cru­cial ques­tion is how this strain en­tered into the vac­cine. The Global Com­mis­sion for the cer­ti­fi­ca­tion of Po­liomyeli­tis Erad­i­ca­tion said on Septem­ber 20, 2016 that type 2 has been erad­i­cated from the world. Just prior to that the In­dian govern­ment had or­dered all man­u­fac­tur­ers to com­pletely de­stroy all traces of the strain by April 25, 2016. The ques­tion is that whether Biomed had re­tained the strain? If so, the sub­se­quent ques­tions are how it re­tained it and how it pass through the reg­u­la­tory mech­a­nism. An in­quiry has been or­dered for the same.

Even a pos­si­bil­ity of the virus com­ing through the key start­ing ma­te­rial (KSM) is also be­ing ex­am­ined. A team from the drug reg­u­la­tory vis­ited In­done­sia’s PT Bio Farma. It sup­plies KSM to In­dian com­pa­nies to pro­duce vac­cine. PT Bio Farma is one of the largest sup­pli­ers of po­lio and measles bulk vac­cine in the world. The com­pany, with WHO pre­qual­i­fi­ca­tion, pro­duces at least 1.4 bil­lion doses of oral po­lio vac­cines to meet the global de­mand.

This in­ci­dent takes us back to the re­cent episode where the Chi­nese vac­cine maker Chang­sheng Biotech re­called batches of ra­bies vac­cines from across the globe, in­clud­ing In­dia. On ac­count of that the Chi­nese au­thor­i­ties have slapped a fine and as­set seizures to­tal­ing a whop­ping $1.3 bil­lion on Chang­sheng.

In­dia with its sus­tained cam­paign & ef­forts in the last few years has erad­i­cated Po­lio. The last Po­lio cases de­tected in In­dia were in 2011. After that when no sin­gle case was re­ported for con­sec­u­tive three years, in 2014, WHO of­fi­cially an­nounced In­dia Po­lio free. Even now, both WHO and UNICEF have pro­vided re­lief by say­ing that the risk of chil­dren get­ting vac­cine de­rived po­lio virus was min­i­mal due to the rou­tine im­mu­ni­sa­tion cov­er­age.

But, for peo­ple such words of com­fort are no re­lief, par­tic­u­larly when their chil­dren’s health is at stake. Ex­perts feel that there are sev­eral pos­si­ble and un­pre­dictable out­comes of the de­vel­op­ment and the au­thor­i­ties should pre­pare them­selves to face the worst. That is most wor­ri­some news and a very se­ri­ous chal­lenge be­fore the health au­thor­i­ties.

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