Pharma Companies Partner in Vaccine Development and Manufacturing

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-01-12-2012, Volume 8, Issue 1

The pharmaceutical majors advance vaccines for the developing world.

Vaccines represent an important way to reduce disease burden in the developing world and are part of many global health initiatives. Public–private sector collaborations, in particular, are an important tool and have been the recent focus of renewed commitments by pharmaceutical companies.

Pfizer strengthens commitment
In December 2011, Pfizer reported that it has entered into a second supply agreement that will broaden and extend its participation in supplying vaccines for pneumococcal disease to children and infants in the developing world. Pfizer will supply up to a total of 480 million doses of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine ([13-valent, adsorbed]) through 2023, which builds on its original commitment announced in March 2010 to supply up to 300 million doses of the vaccine under the auspices of the Advance Market Commitment (AMC) for pneumococcal vaccines.

The AMC, an innovative program piloted by the GAVI Alliance, is a public–private approach to health funding designed to create a sustainable marketplace, ensure an affordable and stable supply of pneumococcal vaccines at a discounted price, and stimulate the development and expansion of manufacturing capacity for vaccines specifically for the world’s poorest countries. The agreements for supply of pneumococcal vaccines have been financed by GAVI, five donor countries (i.e., Italy, the United Kingdom, Canada, the Russian Federation, and Norway) and the Bill and Melinda Gates Foundation.

“Pfizer is proud to broaden and extend access to our vaccine to advance public health,” said Mark Swindell, president of vaccines at Pfizer, in a Dec. 13, 2011, company press release. “Public-private partnership programs like the AMC are vital to accelerating the availability of affordable vaccines, faster than ever before, to those children who are most vulnerable. We are proud to help protect even more children at risk for the potentially devastating consequences of pneumococcal disease, which claims more young children lives than any other vaccine-preventable disease.”

In December 2010, Pfizer’s 13-valent pneumococcal conjugate vaccine was introduced into the childhood immunization program of Nicaragua, the first developing country to launch a program under the auspices of the AMC. “Prevenar 13 was introduced into the childhood immunization program of a developing country within one year of its launch in the United States and European Union, a historic precedent given the average 10–15 year lag between the introduction of newer vaccines in developed versus developing countries,” said Swindell in the release. “One year later, Prevenar 13 is now available in 14 of 16 countries that have launched pneumococcal immunization programs under the AMC. While there is much more work to be done, we are encouraged by this progress.”

To date, Prevenar 13 has been introduced into the national childhood immunization programs of the following GAVI-eligible countries: Benin, Burundi, Cameroon, Central African Republic, Democratic Republic of Congo, the Gambia, Guyana, Honduras, Malawi, Mali, Nicaragua, Rwanda, Sierra Leone, and Yemen.

GlaxoSmithKline increases partnership
GlaxoSmithKline (GSK) also announced in December 2011 that it has expanded its agreement with the GAVI Alliance for vaccines for preventing pneumococcal disease. Pneumococcal disease can lead to pneumonia, meningitis, and sepsis and is a leading cause of death in children under the age of five in developing countries.

Under a new agreement, GSK commits to provide an additional 180 million doses of its pneumococcal vaccine, Synflorix, to GAVI over the next 12 years to help expand immunization programmes against pneumococcal disease to 72 developing countries by 2023.The additional support builds on the 300 million doses that GSK committed to GAVI in March 2010 through the AMC. In total, up to 160 million children in developing countries could be protected with Synflorix against pneumococcal disease by 2023. The new commitment by GSK follows GAVI's recent decision to support the introduction of pneumococcal vaccination in an additional 18 countries, bringing the total number of countries currently supported by GAVI to 37 countries.

By stepping up our contribution of Synflorix to GAVI, we can help ensure there is enough pneumococcal vaccine available to meet the increasing demand across the world,” said Jean Stéphenne, chairman of GSK Biologicals, in a Dec. 16, 2011, GSK press release. “We are committed to playing our part in addressing healthcare challenges in developing countries, which includes adopting new strategies to help accelerate access to vaccines for diseases such polio, rotavirus, measles, and pneumococcal around the world. Vaccines are one the most effective ways to improve public health and the economical development of these countries. Increasing vaccination means more children will be able to live healthy lives." More than 90% of deaths due to pneumococcal disease occur in developing countries where children frequently do not have access to pneumococcal vaccination or early treatment, according to the GSK release


With its partnership with GAVI, GKS supplies more than 80% of its total vaccine volumes to developing countries. In June 2011, GSK made a new offer to supply its rotavirus vaccine, Rotarix, to GAVI at discounted prices to developed-world prices. It is estimated that more than half a million children worldwide die of rotavirus gastroenteritis each year, the equivalent of one child per minute worldwide, and it is responsible for the hospitalization of millions more. Rotavirus-related diarrhea and pneumococcal disease are two leading diseases among children in developing countries.

GSK has committed to provide the additional 180 million doses of Synflorix to GAVI at a small cost relative to developed-world prices. Synflorix helps protect against diseases due to pneumococcus. It contains 10 serotypes, three of which, serotype 1, 5, and 14, were required to be included in the vaccine for the AMC due to the high burden of invasive diseases caused by these serotypes in the developing world, according to the GSK press release. Over the next 12 years, GSK has committed to provide 480 million doses of Synflorix. To date, more than 12 million doses have been delivered in Ethiopia and Kenya. Kenya was the first African country to include pneumococcal vaccines in its national immunization program under the AMC. Ethiopia represents to date the largest introduction of pneumococcal vaccines under the AMC, according to the GSK release. GSK has invested more than $400 million in a dedicated manufacturing plant in Singapore that will produce several hundred million doses of the vaccine annually in the coming years. Synflorix was the first pneumococcal vaccine to receive World Health Organization (WHO) prequalification" for global use, a regulatory endorsement that is a precondition for participation in the AMC, notes GSK.

GAVI expands scope
In November 2011, responding to demand from developing countries, the GAVI Alliance reported it will take the first steps toward the introduction of human papillomavirus (HPV) and rubella vaccines in developing countries. GAVI reported that if negotiations to secure a sustainable price from manufacturers are successful and countries can demonstrate their ability to deliver the vaccines, up to two million women and girls in nine countries could be protected from cervical cancer by 2015, according to a Nov. 17, 2011, GAVI press release.

Responding to projected demand from 30 countries and WHO recommendations, the board of the GAVI Alliance also agreed to open a funding window for vaccines against the rubella virus, which threatens pregnancies and child health. The plan is to reach 588 million children by 2015. “These two initiatives have huge potential impact for women and families in the developing world,” said Seth Berkley MD, CEO of GAVI, in the GAVI press release. GAVI supports seven other vaccines.

The GAVI board also said it will consider funding a vaccine against Japanese encephalitis once an appropriate vaccine is prequalified by WHO. The GAVI board also said it looked forward to the development of an appropriate conjugate vaccine against typhoid. The board also reviewed progress on the roll out of pneumococcal and rotavirus vaccines, approved a new supply and procurement strategy, discussed new options for results-based funding and tailored solutions for countries with large numbers of unvaccinated children.

GAVI-funded rubella vaccines will be combined for easy delivery with measles vaccines in a single measles–rubella (MR) shot, supporting the global measles immunization effort. If contracted by pregnant women, rubella can lead to multiple severe birth defects that cause lifelong disabilities. Some 90,000 birth defects occur each year in GAVI-eligible countries, equivalent to 80% of the global burden, according to the GAVI press release.

Since GAVI began introducing support for pneumococcal vaccines in December 2010, more than three million children have been immunized, according to GAVI. Another 10 million are expected to receive the vaccine in 2012. By the end of 2012, an estimated 4.8 million additional children will have received the rotavirus vaccine, protecting them from rotavirus diarrhea, another leading cause of vaccine-preventable child mortality.

In November 2010, the GAVI Alliance Board approved a five-year;strategyto ensure the alliance delivers on its overall mission from 2011–2015. Full implementation of four strategic goals will see GAVI immunize about 240 million children by 2015 and prevent nearly four million future deaths. This includes the roll-out of pneumooccal and rotavirus vaccines to protect against pneumonia and diarrhea, as well as sustained progress in providing the pentavalent, meningitis and yellow-fever vaccines