When British authorities declined the vaccine for meningitis B (a rare but harsh disease affecting babies) on grounds it was not cost-effective the move triggered an outcry (photo by Christopher Lance via Flickr)

Vaccines: world needs new approach, more transparency, say researchers

“We can’t just have a group of clever people go off into a room and make a decision," says Natasha Crowcroft

A group of University of Toronto researchers is urging the world’s health authorities to overhaul the way vaccine decisions are made and communicated, saying such decisions should no longer be made behind closed doors. 

The decision by government authorities to include new vaccines on their countries’ schedules should be open to public consultation and input, and the process should allow greater prominence to ethical considerations, they argue.
 
Babies today receive far more protection from disease through vaccination than children in previous generations, and the diseases that are targeted by newer vaccines are now relatively rare, said Natasha Crowcroft, associate professor in U of T's department of laboratory medicine and pathobiology. As a result, decisions about whether to schedule additional vaccines are more difficult and require more than just scientific input  – and the traditional, closed-door method of deciding whether a new vaccine should be used is outmoded. 
 
“Anything that undermines confidence in immunization is a bad idea,” said Crowcroft, who is also chief of infectious diseases at Public Health Ontario. “We can’t just have a group of clever people go off into a room and make a decision. That process doesn’t work anymore.”
 
In a paper published Jan. 30 in the British Medical Journal, Crowcroft, along with Professors Ross Upshur and Shelley Deeks of U of T's Dalla Lana School of Public Health, calls for an internationally agreed-upon framework to provide clarity about the pros and cons of adding new vaccines to the schedule. 
 
“Every country is facing the same decision,” Crowcroft said. “It has to be international because we’re all in this together. Disease can’t be turned back at the border. And every country is struggling with the same issue – there’s a crucial chunk missing from the decision-making process which undermines public confidence.”
 
The way in which British health authorities handled the decision against introducing a new vaccine in 2013 underscores the need for change, according to the authors. Authorities announced they were declining the vaccine for meningitis B, a rare but harsh disease affecting babies, because it was not cost effective – triggering a public outcry.
 
While it may have seemed easiest to put it in strictly economic terms, in reality the initial decision to turn down the vaccine was far more complex, involving safety and effectiveness considerations, said Crowcroft. But the public never understood the nuances because such decisions are made behind closed doors. In the British case, this lack of transparency led to conspiracy theories, including the idea that industry had unduly influenced the proceedings.
 
The authors also believe that bio-ethicists should be involved in the decision-making process early on, when the risks and benefits of a new vaccine are being weighed. Ethical considerations, such as the opportunity cost of spending health care dollars on vaccinations, should be integral to the assessment of the medical evidence and economic benefit of an immunization, they argue. 
 
The paper can be viewed at http://www.bmj.com/content/350/bmj.h308

Heidi Singer is a writer with the Faculty of Medicine at the University of Toronto.

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