Meningitis Vaccine Project Introduces Meningococcal Vaccine for Africa

Emergency mass vaccination campaigns are difficult to implement quickly and effectively. Photo credit: Monique Berlier/PATH.In the United States, meningitis is thought of as an extremely rare disease. It usually appears in the news when a college student has fallen ill, amid reminders by public health officials that a meningococcal vaccine can protect against diseases caused by Neisseria meningitidis bacteria, including meningitis. In 2008 (the most recent year for which data are available) only about 1,100 total cases of meningococcal disease were reported in the United States, and meningitis cases were only a fraction of that number.

In other parts of the world, however, meningitis takes a much larger toll. In Sub-Saharan Africa, an area that spans from Senegal to Ethiopia is called the “meningitis belt” because of the epidemic waves that occur there, some lasting as long as three years. The largest epidemic wave in history led to more than 25,000 meningitis deaths from 1996 to 1997. In 2009 alone, more than 88,000 cases were reported. Now, a new vaccine developed specifically for use in Africa offers hope that future epidemics may be prevented.

A region-specific challenge

Overcrowding, poor living conditions, and droughts all contribute to the rise of epidemics in the meningitis belt. Among the cases of meningitis in these epidemics, the vast majority—80 to 85%—are caused by a single group of meningococci bacteria: Group A.

There are multiple meningococcal vaccines that prevent meningitis from Group A meningococci. Two conjugate vaccines and two polysaccharide vaccines that include Group A protection, as well as protection against three other groups, are used in the United States. The conjugate vaccines are recommended as a routine immunization for children and adolescents between the ages of 11 and 18. None of these vaccines, however, are ideal for long-term prevention of meningitis in Africa.

Polysaccharide vaccines are typically ineffective in young children, and only provide protection for a short time (typically two to three years). In regions where performing repeated large-scale vaccinations is extremely difficult, only a conjugate vaccine can significantly reduce meningitis epidemics by providing longer-lasting immunity with a single dose. Yet the existing vaccines are far too expensive for use in Africa’s meningitis belt, with an at-risk population of hundreds of millions of people.

Global collaboration

In 2000, a group of global health leaders gathered together by the World Health Organization (WHO) determined that a meningitis vaccine could be developed specifically for use in Africa: a low-cost vaccine that would focus solely on the Group A bacteria responsible for the majority of meningitis cases there. The Bill & Melinda Gates Foundation provided a ten-year grant for what would become the Meningitis Vaccine Project (MVP).

The MVP, a collaboration between WHO and the Program for Appropriate Technology in Health (PATH), faced an immense challenge: develop, test, license and distribute a conjugate vaccine to protect against Group A meningococci. The idea is daunting on its own, but MVP faced an additional hurdle. After meeting with African public health officials, they realized that any vaccine they developed would have to cost less than USD $0.50 per dose to be a viable option for Africa. In comparison, a single dose of the conjugate vaccines used in the United States costs between $80 and $100.

To call it a lofty goal would be charitable. But by 2002, the MVP had not only found a way to produce exactly the conjugate vaccine that Africa needed, but to do it for less than fifty cents per dose.

The power of developing nations

In order to develop a vaccine from scratch, the Meningitis Vaccine Project faced three major challenges: obtaining the raw materials needed to create the vaccine; obtaining the technology to turn the raw materials into a vaccine; and finding a vaccine manufacturer that could produce it, all at low cost.

They began by partnering with a vaccine manufacturer in a developing country: the Serum Institute of India, whose executive director Dr. S.V. Kapre said that the challenge of manufacturing a vaccine for the developing world inspired the company’s efforts to do so at the lowest possible cost.

Next came the raw materials: first, the Group A antigen needed to generate immunity against the bacteria, and second, the protein tetanus toxoid to which the antigen would be conjugated. Binding these two materials together generates greater protection against meningitis than the Group A antigen alone. (For more about how conjugate vaccines are made, see our article on Different Types of Vaccines.) Both the Serum Institute and Synco BioPartners of Amsterdam provided raw materials for the project.

The last component needed proved to be the most challenging: obtaining the technology to transform these raw materials into a vaccine. This technology can’t be found in a textbook or manual. It’s closely guarded intellectual property: techniques used by biologics companies to develop their products.

Fortunately for MVP, scientists at the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research had recently developed a new conjugation method—one that would be feasible for the African vaccine. Working with the U.S. National Institutes of Health, MVP was able to obtain the technology for the Serum Institute to use at a very low cost.

A decade of effort

Just five years after the first gathering to discuss developing a meningitis vaccine for Africa, the vaccine was ready for its phase 1 clinical trial. This trial was completed in India, and the vaccine was shown to be both safe and able to generate an immune response against Group A meningococci. In 2009, based on data from additional clinical trials, MVP officially requested licensure of the vaccine from the Drugs Controller General of India and asked WHO for prequalification of the vaccine for use in Africa.

WHO prequalification guarantees that a vaccine meets standards for quality, safety, and efficacy. It also involves the use of vaccine vial monitors (VVMs) on the final product vials—stickers that change color when exposed to heat that would damage the vaccine. This allows people administering the vaccine to easily check whether it has been stored at a safe temperature throughout its journey from the manufacturing plant to the patient. In the meningitis belt, where extremely hot weather and poor travel conditions combine to make temperature-controlled vaccine transport a serious challenge, these stickers are a simple way to monitor the viability of a vaccine.

WHO granted prequalification status to the African meningitis vaccine, called MenAfriVac, on June 23, 2010. The final cost of development: less than 10% of the $500 million typically required to create a new vaccine.

The final cost per dose: $0.40.

The fruits of a 10-year labor

Starting today, December 6, people across the meningitis belt will receive MenAfriVac. This will be a historical first: in the more than 200 years since the world’s first vaccine was developed, not a single one has been specifically designed for use, or even first introduced, in Africa.

The potential impact of the planned vaccination campaigns is difficult to overstate. A 2008 study found that a single case of meningitis immediately costs African families the equivalent of three to four months of their disposable income. The long-term costs may be much larger, as about a fourth of those who survive meningitis are left with permanent injury—including deafness, loss of a limb, or brain damage—that leaves them less able to contribute to the family’s income. Preventing even a single case of the disease can also prevent serious financial hardship for an entire family.

Together, WHO and PATH plan to administer the vaccine throughout 25 different African countries, reaching 250 million people between the ages of 1 and 29. The first efforts will be focused in Mali, Niger, and Burkina Faso, and will target 33 million people.

The conjugate vaccine will not only provide individual protection against meningococcal meningitis, but will reduce the transmission of the bacteria and—it’s hoped—result in herd immunity against the disease.

PATH is updating a “Notes from the Field” collection on their website during the final weeks before MenAfriVac is distributed. Follow the efforts here:

http://www.path.org/menafrivac/notes-countdown.php

More information on MenAfriVac is available at the Meningitis Vaccine Project’s website:

http://www.meningvax.org/

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