Vaccine Supply

PneumoADIP is working to ensure that developing countries are willing to introduce pneumococcal vaccine, the donor community is willing to finance it, and manufacturers are ready and able to produce the doses needed.

Pneumococcal Vaccine Pipeline

The pneumococcal vaccine pipeline contains a number of projects are in varying stages of development from pre-clinical to the last stages of clinical development that occur just before licensure.  These projects come from a wide range of developers including multi-national pharmaceutical/vaccine companies, emerging market vaccine suppliers, biotechnology firms, and some projects that are still in academic laboratories.

Pneumococcal Conjugate Vaccines

One product, Prevenar® (Wyeth), first licensed in the US in 2000, is now recommended for use by the WHO, allowing it to be procured by UNICEF, making it available to GAVI eligible countries.  Prevenar, contains 7 important pediatric serotypes and is available in pre-filled syringes.  It will be used in the Gambia and Rwanda beginning in 2009.  Additional developing countries, however, are planning to introduce 10- and 13- valent which provide extended protection and do not require as much storage space or have special disposal considerations of the current product.

In March, 2009, GlaxoSmithkline’s 10-valent pneumococcal conjugate vaccine, Synflorix(TM), received European Commission authorization, paving the way for product introductions to begin in Europe. Prequalification is expected soon after in 2009.  This vaccine will include the serotypes in the currently available 7-valent but add serotypes 1, 5, and 7F which often cause a considerable amount of disease among children in developing countries.    The vaccine uses a novel carrier protein which has been shown to confer protection against otitis media caused by non-typeable Haemophilus influenzae.    It is a liquid formulation that is expected to be supplied in 2-dose vials without a preservative to GAVI eligible countries.

Wyeth has filed for fast-track approval in the US and submitted for approval in Europe for their 13-valent pneumococcal conjugate vaccine and is expected to be prequalified in 2010.  This 13-valent formulation will include all the serotypes in the 10-valent plus serotypes 3, 6A, and 19A.  It is a liquid formulation that is expected to be supplied in single dose vials.

Several emerging market manufacturers have pneumococcal vaccine programs in early stages.  A licensed vaccine from these programs is not likely before 2015.

Alternative Pneumococcal Vaccines

An alternative approach to pneumococcal vaccination involves creating a vaccine based on a few protein antigens that appear on all or nearly all pneumococci.  This approach may get around the need to make conjugate vaccines with many serotypes by stimulating immunity to these “common proteins”.  The leading candidate common protein vaccine is being developed by Intercell AG (based in Vienna, Austria).  According to their website they expect to begin the first phase 1 trial of the vaccine candidate in 2008.  It is possible that if this development process goes swiftly that a vaccine could be licensed between 2014 and 2015.

Strategic Demand Forecast

In 2003, the GAVI Alliance (GAVI) funded the Pneumococcal Vaccines Accelerated Development and Introduction Plan (PneumoADIP) at Johns Hopkins Bloomberg School of Public Health to improve child health in developing countries by accelerating the development and introduction of new vaccines against pneumococcal disease. One of PneumoADIP’s goals was to ensure an affordable and sustainable supply of pneumococcal vaccines for GAVI-eligible countries1. To enable vaccine suppliers, global donors, and countries to make informed decisions about pneumococcal vaccine supply, financing, and adoption, respectively, PneumoADIP developed a strategic demand forecast.

To read the full report, click here.

Updated: 1 April, 2009