Why Are Pharmaceutical Companies Gradually Abandoning Vaccines?

Paul A. Offit

Disclosures

Health Affairs. 2005;24(3):622-630. 

In This Article

Abstract and Introduction

During the past fifty years, the number of pharmaceutical companies making vaccines has decreased dramatically, and those that still make vaccines have reduced resources to make new ones. Pharmaceutical companies are gradually abandoning vaccines because the research, development, testing, and manufacture of vaccines are expensive and because the market to sell vaccines is much smaller than the market for other drug products. Congressional action could assure both a steady supply of existing vaccines and the promise of vaccines for the future.

Pharmaceuticalcompaniesarebusinesses,not public health agencies; they are not obligated to make vaccines. Events during the past fifty years have made the manufacture of vaccines more expensive and their sale less profitable. What follows here are case studies of two important vaccines, one for polio and the other for influenza, and the factors that either encouraged or discouraged their production.

In mid-1953, the National Foundation for Infantile Paralysis (the March of Dimes) was ready to test Jonas Salk's polio vaccine. Made by treating live polio virus with formaldehyde, the Salk vaccine was initially tested in 161childreninand around Pittsburgh.[1] When it was time to determine whether Salk's vaccine worked in a field trial involving hundreds of thousands of children, Basil O'Connor, the foundation's director, turned to the two largest vaccine makers in the United States: Eli Lilly of Indianapolis and Parke Davis of Detroit.[2] O'Connor realized that only pharmaceutical companies had the expertise, facilities, experience, and skill required to make that much vaccine. After the field trial proved successful—and the polio vaccine was ready to be sold to the public—three more pharmaceutical companies entered the field: Pitman-Moore of Zionville, Indiana; Wyeth Laboratories of Marietta, Pennsylvania; and Cutter Laboratories of Berkeley, California.[3] Between 1955 and 1962, physicians and public health agencies administered 400 million doses of polio vaccine across the United States, and the incidence of polio decreased by 90 percent.[4]

The commitment by five pharmaceutical companies to make polio vaccines in 1955 stands in sharp contrast to companies' lack of commitment to making influenza vaccines today. For 2003-04, drug companies made eighty-three million doses of influenza vaccine for the United States: forty-eight million doses were made by Aventis in Swiftwater, Pennsylvania, and thirty-five million doses, by Chiron in Liverpool, England.[5] Because the influenza epidemic of 2003-04 started early and because cases were particularly severe, the media broadcast stories daily of those who were hospitalized for and died of the disease. Demand for the flu vaccine quickly exceeded supply, and many people who wanted and needed the vaccine could not get it.

The flu vaccine shortage was repeated a year later. For 2004-05, Aventis made fifty-five million doses and Chiron made forty-eight million. But because of a manufacturing error, British regulatory authorities prohibited the sale of Chiron's vaccine. As a consequence, about thirty million fewer doses of influenza vaccine were available for 2004-05 than the year before. The U.S. Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and drug companies were all blamed for their inefficiencies, and during the presidential debate on 13 October 2004 between George W. Bush and John Kerry, each candidate accused the other of failing to provide the nation with needed influenza vaccine.

The flu vaccine shortages of 2003-2005 are just one example of what has been a steady, unrelenting series of vaccine shortages.[6] Since1998,nine of twelve vaccines routinely recommended for young children have been in short supply: specifically, vaccines to prevent measles, mumps, rubella (German measles), varicella (chickenpox), tetanus, diphtheria, whooping cough (pertussis), influenza, and pneumococcal disease. All of these shortages have caused children to miss vaccines that they needed, and some children never caught up when the shortages were over.

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