Tuesday, June 30, 2009

Branswell On The Adjuvant Controversy

 

# 3416

 

 

Memories of the Swine Flu vaccine debacle of 1976 run pretty deep among public health officials, and politicians, here in the United States.  Even those who are too young to actually have been a part of that event have certainly heard the cautionary tales.

 

For reasons still unexplained, a significant number of adverse side effects cropped up among people taking the vaccine.  Most notably, Guillain-Barré Syndrome (GBS), which causes a form of paralysis.

 

When the anticipated pandemic failed to arrive, officials were left with more dead and damaged people from the vaccine than from the swine flu.  

 

The lawsuits that followed, along with the political outfall, are well remembered to this day.   (For more information, see  Deja Flu, All Over Again)

 

All of this makes public health officials just a wee bit nervous when they contemplate another massive pandemic immunization drive.  Vaccine technology is better and more reliable today, of course, and so a repeat of 1976 isn’t considered likely.  

 

But that assumes we don’t do something different with this pandemic vaccine – like add an adjuvant. 

 

Adjuvants are chemicals that are added to vaccines to increase the recipient’s immune response, and can lower the amount of antigen needed in a vaccine.    In Europe, adjuvants have been approved for some vaccines given to those over 65 for years.

 

For a world facing a major pandemic vaccine shortage, adjuvants are an attractive option.   But not everyone is sold on the use of adjuvants, particularly for children and teenagers.

 

Helen Branswell picks up the story over this debate.  Follow the link to read it in its entirety.

 

 

Canada-U.S. may go different routes on pandemic vaccine production

 

By: Helen Branswell, THE CANADIAN PRESS

30/06/2009 2:50 PM | Comments: 0

 

TORONTO - Canada and the United States may go separate ways when deciding whether powerful boosting compounds called adjuvants should be added to swine flu vaccines, experts suggest.

 

Canada will likely use adjuvanted swine flu vaccine, says Dr. David Butler-Jones, head of the Public Health Agency of Canada.

 

But it is not a slam-dunk that regulatory authorities south of the border will clear adjuvanted flu vaccines for a U.S. mass vaccination campaign - if one takes place - this fall, some American experts say.

 

"The risk-benefit of using an adjuvant in a population in which you don't have a lot of data, i.e. younger people . . . has to be balanced against ... what's going on," says Dr. Anthony Fauci, head of the U.S. National Institute of Allergy and Infectious Diseases.

 

"What's going on in our summer here? In the Southern Hemisphere's winter there? All of those things are going to be playing into the decision of what you're going to use or not use."

 

Ultimately decisions on whether to license pandemic vaccines with adjuvants will be the job of each country's regulatory agency - Health Canada here and the Food and Drug Administration in the U.S.

 

They and sister agencies elsewhere will face tough decisions in the weeks ahead, decisions that will likely have to be made with less data than such bodies typically require for the licensure of new vaccines or drugs.

 

(Continue . . . )