The past few weeks, there have been a series of news reports coming out of China revealing that thousands of doses of improperly stored and expired vaccines for children and adults were illegally sold for millions of dollars on the black market by more than 100 people associated with Chinese companies and vaccination centers. The international scandal has raised a lot of questions about vaccines made in China, just as China has been trying to enter the global vaccine market while simultaneously dealing with setbacks related to vaccine quality control issues.
Most Americans do not understand that many pharmaceutical products, including vaccines, are not made in the United States and foreign pharmaceutical companies are not subject to U.S. Food and Drug Administration (FDA) quality control regulations. With no civil liability for vaccine injuries and deaths that occur in the U.S. for FDA licensed vaccines, Americans have a right to be concerned about vaccines made in China.
It was back in November 2011 that the Associated Press (AP) ran a story announcing the entry of China into the world vaccines market.1 The news was picked up by major newspapers and published as articles with titles such as “China Prepares for Big Entry into Vaccine Market”234 and “Could Your Vaccines Soon Be ‘Made in China?’”5 and “China to Enter World Vaccine Market Soon.”6
The AP report cited the announcement by the World Health Organization (WHO) in March 2011 that China had met “international standards for vaccine regulation” as a milestone in the process to that country’s entry into the market.”2
It opened the doors for Chinese vaccines to be submitted for WHO approval so they can be bought by U.N. agencies and the GAVI Alliance.2
The AP quoted Nina Schwalbe, who was then head of policy at the Global Alliance for Vaccines and Immunization (GAVI)—a public-private partnership organization that buys vaccines for more than 50 million children annually—as describing China’s entry as a “game changer.”2 Ms. Schwalbe, now principal adviser on health at UNICEF,7 added, “We are really enthusiastic about the potential entry of Chinese vaccine manufacturers.”2…