The right kind of investment for India
According to Dr. Keith Klugman who helped develop the pneumococcal conjugate vaccine, immunisation is critical for reducing lakhs of preventable deaths caused by pneumonia
Shalini Sharma and Shibu Kumar Tripathi Delhi
A report published last year by the International Vaccine Access Center (IVAC) at the Johns Hopkins Bloomberg School of Public Health stated that India has the highest number of deaths caused by pneumonia among children in the world. Three lakh children died an untimely death due to the disease in 2016. Although the mortality rate amongst children has gone down by at least 60 percent between 2000 and 2015, there is still a lot of work that needs to be done to ensure that all Indian children are safeguarded from preventable causes of death. The lamentable fact is that many of the childhood fatalities caused by pneumonia in India are preventable. The leading type of pneumonia in India among children aged 1-59 months is caused by pneumococcus, and can be prevented with pneumococcal conjugate vaccines (PCV). PCV is currently available in the Indian private market but, since it costs between Rs. 3,800 and Rs. 2,200 per dose, it remains out of reach for a large section of the population. Thus, there is need for wider, more equitable access to PCV across the country. This year, the Government of India is preparing to introduce PCV into the Universal Immunisation Programme (UIP) and provide it free of cost to families and children over three phases. PCV will be rolled out in three states in the first phase: Himachal Pradesh, Uttar Pradesh and Bihar.
Hardnews spoke to Dr. Keith Klugman, Director for Pneumonia, Bill & Melinda Gates Foundation, who helped develop PCV, about the efficacy of the vaccine and its role in bringing down the deaths caused by pneumonia in India.
You helped develop the PCV vaccine. Could you tell us about your experience?
The very first pneumococcal conjugate vaccine was developed to protect against the strains that infect children in America. It was a seven-valent vaccine, meaning it included the seven most common strains found in the US. The most common strains in developing countries were not included in that vaccine. I was working in South Africa and was very interested in researching pneumococcal disease. I put out a challenge to pharmaceutical companies saying that if a firm made a vaccine that included serotype 1—it is the most important serotype but is not common in the US—I will find the funding to do a vaccine trial and show the efficacy of the vaccine. Pfizer came up with one such vaccine. The Pfizer vaccine never became a commercial product but we were able to include in it serotypes 1 and 5, which were not included in the US vaccine. We recruited 40,000 children in South Africa and did a randomised control study of the 20,000 children who received the vaccine. We proved that the vaccine was protecting against pneumonia and antibiotic resistance. And that helped to make the case for a global vaccine.
In a developing country like India, how does the existing socio-economic situation worsen the burden of the disease?
Pneumonia is the number one cause of death among children in the world but it is not something that people think or talk about much. You don't really think about children dying of pneumonia in developed countries because it is treatable and preventable. However, if children are malnourished, they are at a great risk of dying from pneumonia. If you get pneumonia, your lungs fill up with fluid— that's the body’s inflammatory cell response and it means you can't get oxygen. The normal response of the body when you can't get oxygen is to breathe faster. The problem with breathing faster is that it takes energy. So, if a child is malnourished and has to breathe faster, after a day of fast breathing they get exhausted. Breathing fast is almost like an exercise. Eventually, if they don't get any treatment and the onslaught of the disease continues, their bodies give up and the children die.
The PCV rollout is a very important step. We were not anticipating that India would introduce this vaccine before 2020. This was because India generally only introduces vaccines if there's an Indian supplier of the vaccine. However, money has now been made available via donor funding to India for introducing PCV. It’s great because it gives an opportunity for children in India to be protected against a deadly disease.
Could you please tell us about PCV? How does it work and how is it different from other vaccines that are already part of the national immunisation programme?
Essentially, the cause of pneumococcal pneumonia is a bacterium called pneumococcus. Pneumococcus has a capsule around it that is made of carbohydrate sugar. And the problem is that there are many different kinds of pneumococcal capsules — more than 90. It was shown some years ago that if you are given the sugar capsule as a vaccine, you can make anti-bodies that protect you from that specific strain. To make a vaccine with 90 different strains would be economically impossible. But around 72 percent of all the pneumococcal disease and strains that exist in India can be countered with a vaccine that has about 10-13 of these strains. So, this particular vaccine that is being rolled out in India has those 13 sugars in it. One of the many benefits of this vaccine is that it not only protects the infants who receive the vaccine but it protects the entire community in which they live as well.
How effective is this vaccine?
It's highly effective against the strains that are included in the vaccine. There have been a number of clinical trials all over the world, including those conducted in Africa, America, Asia and Europe, and they have all shown efficacy between 85 percent and 100 percent against the strains included in the vaccine.
India already has a vaccination basket which includes the pentavalent vaccine. Why is there a need to introduce a new vaccine at the moment?
Amongst the vaccines that India offers through the UIP is the pentavalent vaccine, a five-in-one vaccine, which includes a vaccine against something called Haemophilus influenzae type b (Hib). Hib is the second major bacterial cause of pneumonia in children. So, if we say that the pneumococcus is responsible for about 40%Hib is responsible for about 20 percent of pneumonia deaths. But at the moment, there isn't anything in the existing vaccination schedule protecting against pneumonia, other than Hib. Having said that, there are other vaccines that are given. For instance, kids who have measles may get pneumonia and die. So the measles vaccine can protect against pneumonia but there is no specific vaccine that protects against pneumonia-causing pathogens, barring Hib and PCV.
This vaccine has also been introduced in a number of developing countries. How has it affected the pneumonia burden in these countries?
There’s a global vaccine alliance called Gavi. It has made pneumococcal vaccines available in developing countries at an affordable price. With the help of Gavi, PCV has already been rolled out in Pakistan, Bangladesh and Nepal. The vaccine has had a major impact on pneumonia and mortality rates in those settings.
The PCV is an expensive vaccine. How can it be made cheaper?
India is working on developing an indigenous product. Once that vaccine is ready, PCV won’t be this expensive because it will be manufactured on a large scale, specifically for India. And the idea is that the government will pay for it. That’s the promise for the future and people should expect politicians to make important, lifesaving vaccines available under the Universal Immunization Programme. And that’s something they should consider when they go to vote. I must say that the priority for vaccination with the current government has been extraordinary.
How cheap do you think the generic version of PCV will be in comparison to its counterparts?
I am hoping for a significant cut in prices, maybe about two-thirds.
In a state like Bihar that has just 39 percent immunisation coverage, how will the government attempt to increase the number of people opting for vaccination?
It is very important to increase coverage overall because once you reach a coverage of 60 percent with a vaccine like PCV, then you reduce transmissions so that all kids are protected, including the ones who are unimmunised. So, the Bill and Melinda Gates Foundation is working with NGOs and the government to help strengthen India’s vaccination programme. Historically, in many countries that have poor health systems, the vaccination system is often a good place to start. The government of India has set a target of achieving 90 percent vaccination coverage by 2020. What India needs to do is measure the progress as it goes ahead.
As of now, the vaccine will be introduced in 3 states. After that what can be expected?
Immediately after that, the roll out will be extended to two more states: Rajasthan and Madhya Pradesh. We are anticipating that in 2019, there should be a government tender for this vaccine for the whole country.
Antibiotic resistance is an emerging health issue all over the world. How do you think the PCV is going to combat this?
The strains of pneumococcus which are antibiotic resistant are, in fact, the same strains that are included in the current vaccine. Most of the strains that have shown resistance are in the 10 or 13 strains included in the vaccine. And there’s good evidence from developed and developing countries that not only do the resistant strains go down because transmission stops but, because you get less infection, antibiotic use diminishes as well. So, the PCV in fact reduces antibiotic resistance.