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Another shot at history

Patralekha Chatterjee | 06th Jun 2013

Vaccines save lives. They al­so make his­tory. India’s triumphal announcement about Rotavac, the country’s first indigenously developed vaccine against rotavirus — the cause of severe diarrhoea in infants and young children — has created a huge buzz.

Can it create history by changing the narrative in a country where 100,000 children die of diarrhoea alone every year, and where an estimated 500,000 child deaths could have been prevented annually through vaccination? The jury is out.

First, the good news. Rotavac, with its low price and strong efficacy, is potentially a Brah­mastra in the battle for child survival. If it lives up to its promise, it will be joining the list of vaccines that have not only made history but also furthered diplomacy. Th­e­re is a fascinating precedent.

During the 1950s, when polio epidemics raged on both sides of the Iron Cur­tain, Soviet and US scientists collaborated to de­velop an oral polio vaccine though the erstwhile Soviet Union and the US were locked in a Cold War.

That vaccine helped era­dicate polio in many pa­rts of the wor­ld. In a 2001 article in the magazi­ne Fore­ign Poli­cy, Dr Peter Hotez, president of the Sabin Vac­ci­ne Insti­tute, pointed out  how “the dreadful natu­re of these epidemics” co­mpelled the Soviets to bre­ak their Cold War sile­nce in 1956 when th­ey realised that “they co­uld no longer afford the comfort and sustenance that ideology provided”.

Soviet virologists subsequently collaborated with US researcher Albert Sabin to develop a “live” polio vaccine that improved upon the one developed by Jonas Salk in 1954. To this day, “many Americans are astonished to learn that the Sabin polio vaccine was introduced into the US only after its safety and efficacy had first been tested on millions of Soviet children,” wrote Hotez.
Rotavac, too, is a product of a global partnership — one between Ind­ia and the US.

The idea of an Indian rotavirus vaccine surfaced in the mid-1980s, when Indian scientists discovered un­u­sual strains of rota­virus that infected newborns in hospital nurseries, but didn’t make th­em sick. Dr M.K. Bh­an, paediatrician and former secretary, depa­rt­ment of biotechnology, was one of the scientists working at the All-India Institute of Medical Sci­e­n­ces (AIIMS) who discovered one of these strains, called 116E, during routine diagnostics of newborns in Delhi.

Dr Bhan got diarrho­eal expert Dr Roger Gla­ss, then working at the rotavirus laboratory of the US’ Centre of Dise­ase Control and Preven­tion (CDC), to join in the study of the strain. Subsequently, more institutions and experts from India and the US came together to take the research forward.

Th­ese included the de­partment of biotechnology, the Indian Co­u­ncil of Medical Rese­arch, the Indian In­stitute of Scie­nce, AIIMS, the National Institute of Immu­no­logy, the Soci­ety for Applied Studies, the Hyderabad-based Bh­a­rat Biotech Inter­na­tional Ltd. From the US, there was Stanford University’s School of Me­dicine, the National Institute of Health, CDC and PATH, an international NGO.

Last month brought news that cheers. Rota­vac had cleared the crucial three-clinical trial stage — designed to assess the effectiveness of a new drug and its va­l­ue in clinical practice — and is now awaiting clearance by the Dr­ug Controller General of In­d­ia (DCGI). Once the DCGI clears it, the vaccine will be marketed by Bharat Bio­tech at Rs 54 per dose.

Im­ported equi­va­lents co­st ne­arly Rs 1,000 per do­se. But celebrations should not prevent us from ac­kno­w­ledging the hard facts. Vaccine manu­factu­ring and delivery in this country continue to face numerous challen­g­e­s.

India’s vaccine manufacturers export vaccin­es to more than 150 cou­n­tries. But millions of Indian children remain unimmunised. Many die from vaccine-prev­e­ntable diseases because they could not be rea­ch­ed. But there are other problems which impact health outcomes. A tel­ling example is the acute shortage of the yellow fever vaccine.

The director of Kasauli’s Central Research Institute (CRI), which used to ma­ke the low-cost yellow fever vaccine, told a re­porter last month that for the last one-and-a-half years, CRI has not been able to come out with the vaccine beca­use a freezer-drier (used to preserve the vaccine) has been out of order.

All sorts of reasons have been cited to explain the delay in fully reviving this public sector unit. To tide over the crisis, India imported a large stock of the yellow fever vaccine in 2011. Now that stock is running out and travellers going to yellow fever endemic countries have been left with no choice but to buy the vaccine from private centres.

The problems in Kasa­uli bring to the fore ano­ther sticky issue — good manufacturing pra­c­tic­es. In 2007, three public sector vaccine-manufacturing units from India came under a cloud on account of non-compliance of good manufacturing practices. The Wor­ld Health Organi­sa­tion suspended their manufacturing licences.

A sub­sequent assessment showed that remedial measures had been ta­ken and attempts were made to re-start the uni­ts, but it is happening in a lackadaisical manner though a parliamentary standing committee has recommended pumping in more funds into these PSUs so that India has enough stocks of low-cost vaccines. The latest fiasco over yellow fever vaccines, however, suggests that few lessons have been learnt.

Then there are the last mile constraints. Distri­bu­tion of vaccines is ha­mpered by factors like an inadequate cold cha­in (temperature-control­led supply chain). In ma­ny states, maintaining vaccine stocks at health clinics is tough because of frequent power outages. Strengthening cold-chain facilities for storage and transport of the vaccines needs to be a top priority if vaccines are to reach remote are­as within the country.

Back to vaccines and history. India has eradicated small pox. It has been declared polio-free, thanks to sustained vaccination. There is no reason why vaccines ca­n­not make history aga­in in India. Now is the time to step up efforts to strengthen every weak link in the chain, from vaccine manufacturing to the last mile in delivery, to achieve immunisation’s full potential. The buzz around Rota­vac offers a great opportunity to do just that.

The writer focuses on development issues in India and emerging economies

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