Another shot at history

For more than a year, the yellow fever vaccine has not been manufactured because a freezer-drier to preserve the vaccine has been out of order

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 in 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 `54 per dose. Imported equivalents cost nearly `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 bulk 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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