Research Profile - Protecting the public trust: Transparency in vaccine development

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Blockbuster vaccines to tackle cancer, HIV and chronic illnesses like asthma and diabetes are on the horizon, the next best hope for improving public health and increasing longevity. Medical breakthroughs alone, however, won't ensure that vaccines succeed.

At Dalhousie University in Halifax, medical anthropologist Janice Graham and her team are studying three new vaccines and the regulatory and communications challenges in ensuring they reach the people who need them. By examining the scientific, clinical and policy decisions involved in developing and disseminating the H1N1 pandemic influenza vaccine, the HPV vaccine against infection that can lead to cervical cancer, and the roll-out of the meningococcal A vaccine in Burkina Faso, the Halifax researchers explore different regulatory processes to glean lessons they can apply on a global scale.

"In a globalized world, immunology, infectious diseases and vaccines have no boundaries," says Graham. "Yet it is essential that we must work too within a national regulatory environment."

Many factors contribute to the safety, efficacy and quality of new vaccines, and the public's willingness to be immunized, she points out.

"We need to be spending a lot more time building capacity and capabilities within the structures of public health , the vaccine registry and delivery system, the information system, and what people know, understand and can feed back about our public healthcare system."

Graham's work will result in recommendations for the development of Canada's public, private, and public-private vaccine sectors, whose networks and relationships she is studying.

In the case of the H1N1 pandemic vaccine, the Halifax team studied the development of the new vaccine and its roll out in real time, as the pandemic hit. The researchers observed that multiple health-care delivery systems across provinces led to communications mishaps, such as confusion about who could get vaccinated in different jurisdictions and uneven access to the vaccine across the country.

Examining the federal government's decision to allocate $300 million to Canadian provinces to roll out Merck & Co. Inc.'s Gardasil vaccine against HPV for young girls led the researchers to explore the issue of public confidence in this vaccine, distrust of pharmaceutical companies, and the need to make the vaccine licensing and regulatory process in Canada transparent.

"Our vaccines are very safe (in Canada), but we were clearly unable to translate that safety to the public," says Graham. "The public isn't confident; people don't necessarily trust what's going on or the added value of immunization."

That lack of confidence led many parents to question the need for the vaccine, and its safety, and fuelled rumours about the company's "true" motivations in aggressively promoting Gardasil, Graham's team observed.

In Burkina Faso, Graham studies the development of the conjugate meningitis A vaccine, after a $70-million donation from the Bill and Melinda Gates Foundation in 2001. Before the Gates Foundation put up the money, the pharmaceutical industry was uninterested in creating a vaccine, despite the great need, because neither patients nor the nations of sub-Saharan Africa could pay for high-cost immunizations.

Once Gates made money available, the Serum Institute of India Ltd. developed a vaccine for fifty cents per dose – compared with the $20 or $30 a dose that pharmaceutical companies previously said they needed to charge to be profitable.

"My sense is that they (the Serum Institute) were able to do it because they didn't have shareholders to account to," says Graham. "Shareholders are really looking at short-term quarterly profits and that's what drives Pharma."

Graham's research has led her to note the need for a broader public discussion into why vaccinology has become an industrial science fuelled largely by private money, rather than a public investment. The polio vaccine, she points out, was a public initiative created with public money.

Given the likely advent of increasingly specialized vaccines targeted to individual DNA for everything from asthma to cancer, the cost of vaccines will probably continue to increase, limiting their distribution, Graham says.

She is concerned about a future where vaccines are marketed at individuals solely for the purpose of making money for manufacturers. That motive will, in turn, undermine the public's willingness to be immunized, she fears.

"I'd hate to see something that has always been a public good eroded through concerns about public confidence and trust."

Graham's on-going research will result in a series of recommendations for regulators that will stress the importance of transparent vaccine decision-making processes, better communication by public health authorities, so people know where public health clinics are and where they can get vaccinated, and the need for a national vaccine registry, so patients and healthcare professionals can track immunization rates.

She also stresses the responsibilities of national vaccine companies to share what they produce, in an era where infectious disease knows no borders.

Finally, Graham emphasizes that "you cannot separate political issues from the scientific issues around vaccines."

"I'd hate to see something that has always been a public good eroded through concerns about public confidence and trust."
Dr. Janice Graham, Dalhousie University