In early March, Robert Daum and other US-based infectious-disease experts will gather in a Silver Spring, Maryland, hotel to choose the influenza strains that vaccine makers should target for the 2015-16 flu season.
It’s an annual guessing game of sorts, one backed by data but also plagued with uncertainty. And when the guesses don’t match the reality, as happened this past year, it can mean a dismal and deadly flu season.
“We’ll do the best we can,” said Daum, a Chicago doctor who heads the Food and Drug Administration (FDA) advisory committee that makes the recommendations. But “the virus is smarter than we are at this point. I don’t know of any disease that plagues us more. It’s very, very frustrating and a very inexact science … We do it with varying luck, and I think the luck is mostly the virus’s whim.”
As it does each year, the group will pore over surveillance information from around the globe, hear presentations from government researchers and weigh recommendations from the World Health Organisation. The experts will cast their votes for the four specific flu strains – two each from the “A” and “B” types of the virus – that manufacturers should focus on making in the coming season’s vaccine. Then, they will wait and hope.
Daum said he suspects he’ll leave feeling the way he so often has in the past – head hanging, discouraged, wishing there was a more reliable way to protect people from the yearly scourge of the flu.
Despite constant tracking and surveillance of the virus in labs across the world and the work of hundreds of experts at universities, for the World Health Organisation (WHO) and agencies such as the Centers for Disease Control and Prevention (CDC), picking the correct flu strains still involves a measure of good fortune. Every few years, experts miss the mark.
“It’s inherently hard,” said Anthony Fauci, director of National Institute of Allergy and Infectious Diseases at the National Institutes of Health. “The one thing the flu is, is unpredictable.”
Global health experts had barely finished making their predictions last year when one of the strains they chose, a virulent type of H3N2 influenza, began to morph. “No sooner than the wheels started turning than we started to see a glimpse of a different H3N2 emerging,” Fauci said. This “drift”, as experts call it, rendered the current vaccine far less effective than initially expected.
In a typical year, when the strains chosen match well with the vaccine produced, people who get flu shots are on average about 60% less likely to become so sick that they require a visit to a doctor, according to the CDC. Although the agency has not yet published figures for the current season, officials say the numbers this year are likely to be far lower because of the changing nature of the H3N2 virus.
Such viral drift has been a persistent problem, although less devastating than the “antigenic shift” that occasionally occurs, creating an entirely new strain that leaves much of the population largely defenceless. That’s what led to the 2009 flu pandemic.
Still, in recent days, this flu season in the US has officially crossed into epidemic territory and could prove particularly severe; the CDC said that 43 states are experiencing “high or widespread” flu activity, with a growing number of hospitalisations and deaths. And the worst could lie ahead.
A big part of the challenge each year is timing. Vaccine manufacturers face a constant race to create and churn out enough doses to distribute throughout the country ahead of the annual flu season.
“It can’t just be done overnight,” said David Greenberg, vice-president and chief medical officer at Sanofi Pasteur, which produces about 65m doses of flu vaccine each year. “It’s a very busy process.”
Every February, the WHO identifies which strains in the northern hemisphere are most likely to wreak havoc the following flu season; the FDA’s recommendations, which historically align with the WHO’s, come soon afterward. After that, drugmakers develop formulations for each strain, and regulators ensure vaccines from numerous manufacturers are safe and similarly potent. “Standardisation is critical,” said Jerry Weir, director of the FDA’s Division of Viral Products.
Manufacturers also must produce and package millions of doses and distribute them to physicians’ offices and pharmacies in time for vaccinations to begin in the fall, ahead of the flu season.
The perpetually tight timeline forces experts to make choices about the next flu season even before the current one has faded. It’s an educated guess, for sure, that includes data about which strains have dominated in recent years and which are picking up in the southern hemisphere and likely to migrate north. But until better predictive models, universal flu vaccines or significantly faster manufacturing processes come along, the element of guesswork remains. So does the frustration when the call turns out wrong.
“Of course, there’s disappointment,” said Gillian Air, a biochemistry professor at the University of Oklahoma Health Sciences Center who has served for the past four years on the FDA’s advisory committee on vaccines. “We’ve done the best we can with the data that’s available … The trouble is, we can’t predict what’s going to happen.”
She and other experts responsible for identifying strains to target as part of the effort to lessen deaths, hospitalisations and general misery caused by the flu approach the assignment with a mixture of determination and exasperation: determination to make the best call possible; exasperation at the limitations of trying to outwit an ever-changing virus.
Air was there last February, when the group met inside Building 31 on the FDA’s campus in White Oak, Maryland. After a day full of data and presentations and detailed questions about which variations of the flu were likely to strike the United States many months in the future, it was time to vote on which four strains to choose.
“I must marvel at how many human beings are gathered in this room to understand the behaviour of a little tiny virus,” said Daum, the Chicago doctor and the committee’s chairman.
“And we don’t get it,” one participant chimed in. Daum agreed. “So here we are.”
This article appeared in Guardian Weekly, which incorporates material from the Washington Post
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