Thursday, 30 April 2015

Pneumococcal Conjugate Vaccine (PCV), The Six-Year Journey from Ibadan to Lokoja


You should all please read this...

Nigeria launched the introduction of the pneumococcal conjugate vaccine (PCV)into its childhood immunization schedule in Lokoja, on December 22nd 2014. PCV prevents one of the deadliest bacterial causes of pneumonia, meningitis, blood infections and middle ear infections in children. Before now, only parents with the means could afford to vaccinate their children for thousands of naira in private clinics. But now, government is offering it for free to all kids. This is a big deal, so get excited!

PCV_launch_Nigeria
 A journey that began 6 years ago has finally come to a successful end. But it was not an easy ride. As I think about the road to this introduction, I remember all the twists and turns along the way and marvel at the tenacity and perseverance of the chief actors in this story.

In 2008, I was working for a Johns Hopkins project called Pneumo Adip, which was set up to accelerate the introduction of PCV into African and Asian countries. You may wonder why anyone needs a project to do that, right? Well, it turns out that having a vaccine that works is not enough to get countries to use it, unless the vaccine is for Ebola. I bet countries will scramble for an Ebola vaccine, if it comes. But then most diseases are not like Ebola. For more silent diseases like pneumonia, it takes concerted effort to make the decision makers recognize the burden of the disease, the value of the vaccine and the actions to take on it. For example, it took Nigeria 21 years to adopt the Haemophilus Influenza b (Hib) vaccine into our routine system. The first country to use Hib vaccine in their national program started in 1991, we started 2012.

I remember sitting in the Premier Hotel Ibadan during the 39th Annual General and Scientific Conference of the Paediatric Association of Nigeria (PANCONF) in January 2008. The halls were packed, the place was buzzing, the energy was infectious, pediatricians were milling around discussing how to save babies. I had come from Baltimore to field test a pneumonia diagnostic tool and discuss the prospect of Nigeria introducing PCV into the national immunization program.

At one of the session breaks, I cornered Dr. Abanida, then Director of Immunization at NPHCDA and asked him, “Doc, when are we going to introduce penta and PCV?” “Very soon” he replied, “We will apply for both vaccines this year”. This was an unexpected and pleasant surprise. I had predicted he would commit to only penta, but PCV as well? That was great. You see, it was no coincidence that we were coming late to the penta party when countries like Kenya had introduced the vaccine 8 year before. As a country, we had been preoccupied with battling polio, especially after the major polio vaccine rejection of 2004. In addition, our systems were weak. Indeed, before 2005, we would not have been able to apply for Gavi support for new vaccines even our immunization coverage was less than 50%, less than the required threshold. To get Gavi’s help, countries have to meet certain eligibility criteria and they have to formally apply and be approved for support.

Just as Dr. Abanida had declared, in April 2008, Nigeria tendered their first Gavi application for penta and PCV introduction support. In June 2008, the reviewers granted the application a conditional approval.

Disappointed but not deterred, in September 2008, the new vaccine application team led by Dr. Oteri, then Gavi desk officer at NPHCDA, responded to the conditions and queries from Gavi. But the second submission was rejected and the country was asked to re-apply. 
Three things then happened that delayed the process for the next two and half years. First, Gavi suspended all new vaccine applications due to internal processes and funding constraints. No country could apply for new vaccine support in 2009. Second, Gavi revised their new vaccine application policy, now requiring an immunization coverage rate of at least 70% instead of 50%. Third, Nigeria’s vaccine coverage dropped below 50% to 42% according to WHO-UNICEF estimate released in June 2010. This new drop caused Dr. Dorothy Esangbedo, then the President of the Pediatric Association of Nigeria, to lament bitterly and call for stronger action to shore up routine immunization.
Under the new policy and with the lower coverage, Nigeria could not re-apply in 2010. In fact, a workshop in August 2010 convened by NPHCDA to develop the third submission was truncated by the twin news that our coverage rate had dropped and Gavi coverage requirement had increased.
When Gavi began revising their policy, there had been talk and expectation in some quarters that countries such as Nigeria, who were already in the application process before the policy change, would be “grandfathered in”. That did not pan out. To help matters, Gavi delayed the implementation of the new coverage requirement by one year, which left Nigeria with one window of opportunity to apply in May 2011.

But there was one more hurdle to scale. Coverage estimates for 2010 had to be 50% or better. The National Immunization Coverage Survey (NICS), showed coverage to be 71% for 2010, but Gavi only recognizes the WHO/UNICEF estimates, which was still 42% and would only be updated in July. Nigeria needed the updated estimates to apply in May. The update would be two months late. What to do?
The emails and phone calls started going back and forth advocating for a solution. At IVAC we pushed for different options: allow Nigeria use the NICS to apply, allow a phased introduction, so that states that meet the coverage criteria can be supported to introduce the vaccine, while effort be made to raise coverage in the other states. Dr. Mohammad Ali Pate, then Minister of State for Health, was very vocal in his advocacy to find a solution. Eventually and exceptionally, Gavi allowed Nigeria to apply for penta and PCV in May 2011. Then in July 2011, penta was approved and PCV was conditionally approved. All decisions were subject to the 2010 WHO/UNICEF DTP3 coverage estimates being >50%.

After the July 2011 conditional approval for PCV, Nigeria worked on responding to the conditions attached to the approval by strengthening the cold chain system. Then, 15 months later, in October 2012, Gavi gave the final approval for a phased roll out of PCV to begin in 2013. However, due to global supply constraints and other operational issues such as strikes in the Nigerian health sector, the first child could not be vaccinated till December 2014.

I didn’t go for the launch, but my colleagues went, and it was gratifying to see the culmination of everyone’s effort. Big thanks should go to the NPHCDA, Gavi, UNICEF, WHO, Pediatric Association of Nigeria, CHAI and all other groups who have pushed hard to see this happen.

1stChild_PCV_in_Nigeria
Description: 1stChild_PCV_in_Nigeria
First Nigerian Child to receive the Free Pneumococcal Conjugate Vaccine
As I look at the grainy picture of baby Collins, who is the first child to be vaccinated, cry out in pain from the shots of the first PCV vaccination, I wish I could tell him,

“Baby, don’t cry, laugh instead, even though that injection is painful. You are getting a shot a life. Something that babies before you did not get, but thankfully those after you will receive. If we are able to immunize 87% of your fellow babies every year with this vaccine, we can save about 200,000 lives by 2020. Isn’t that something to laugh or even rejoice about? Yes indeed, it is cause for celebration. I only wish it didn’t take six long years for this to happen. Think of all the babies we could have saved in that time. Anyway, you are too young to understand all this. After all, what do you know? You are just a baby. You probably just want to suck you mother’s breast right now, forget all this noise and go to sleep. So I’ll let you be.”

Dr. Chizoba Wonodi (MBBS, MPH, DrPH),
Nigeria Country Programs Lead, Johns Hopkins International Vaccine Access Centre, 
Advisor, Saving One Million Lives Initiative, 
Advisor, Gavi’s Strategic Demand Forecast for vaccines.



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