Chrome 2001
.
The Trusted Source InteliHealth Aetna InteliHealth Aetna InteliHealth
Enter Drug Name . Enter Search Term
     
. .
. .
.
Home
Health Commentaries
InteliHealth Dental
Drug Resource Center
Ask the Expert
Interactive Tools

InteliHealth Policies
Site Map
Diseases & Conditions Healthy Lifestyle Your Health Look It Up
Health News Health News
.
Associated Press

Manufacturers Brewing New Swine Flu Vaccine
July 23, 2009

WASHINGTON (AP) -- Attention is shifting to the world's five leading flu vaccine makers: How fast are they really producing swine flu vaccine, and just how do they plan to test that it works?

A meeting Thursday of the Food and Drug Administration's scientific advisers offers the first in-depth public progress report since U.S. scientists delivered the novel virus to manufacturers and asked them to turn it into usable vaccine.

They've succeeded to a degree. The National Institutes of Health on Wednesday called for a few thousand volunteers, from babies to the elderly, for studies to see if pilot batches are safe and protective. The first shots should go into adult volunteers' arms in early August, with child studies to follow quickly if there are no signs of immediate side effects.

Those government-directed studies -- and more that manufacturers will run -- are key as the government decides whether to offer swine flu vaccine to millions of Americans starting in mid-October, besides vaccinating against the regular winter flu. Health authorities in other countries are looking to the U.S. studies, too, as they make their own plans.

Assuming the studies show the vaccine is OK, a big question is how much will be available and when. Last week, the World Health Organization warned that production is going slower than predicted, with the strains now in use yielding only about half as much of the main vaccine ingredient as is usual.

Wednesday, London-based GlaxoSmithKline echoed that caution, saying it is "working as quickly as possible" but being hindered by those low yields.

"Some of us are skeptical that very much will be available by mid-October," said Dr. William Schaffner, a vaccine specialist at Vanderbilt University.

And the government has warned that any vaccination campaign will put higher-risk people in line for the first batches, as supplies gradually increase over time.

Manufacturers' vaccine studies are expected to largely mirror the NIH's plans: Volunteers will get two vaccinations, 21 days apart. By early September, the NIH should have blood tests showing how much immune protection the initial inoculation triggered, and if a low-dose or higher-dose version was needed. It will take another month to get information on the second inoculation.

Complicating the question: If plain vaccine doesn't spur enough protection or there isn't enough supply, manufacturers could add immune-system boosters called adjuvants. That will pose a dilemma as the U.S. has never approved a flu vaccine containing those ingredients, although they are widely used in vaccine given to older adults in Europe.

But there's little information on their safety in children and pregnant women. Dr. Anthony Fauci, the NIH's infectious disease chief, said it's highly unlikely that flu vaccine with an adjuvant would be part of a children's immunization campaign. Part of FDA's debate Thursday, however, is how to do additional testing of that combination in various age groups.

The NIH's first studies will use flu shots made by France-based Sanofi-Pasteur and CSL Ltd., which on Wednesday began a much smaller study of its vaccine in its home country of Australia.

Also yet to be studied are shots made by Glaxo and Swiss-based Novartis, and a nasal-spray flu vaccine from Maryland-based MedImmune.

Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

.
InteliHealth
. . . .
.
More News
InteliHealth .
.
General Health
Top News
This Week In Health
Addiction
Allergy
Alzheimer's
Asthma
Arthritis
Babies
Breast Cancer
Cancer
Caregiving
Cervical Cancer
Children's Health
Cholesterol
Complementary & Alternative Medicine
Dental / Oral Health
Depression
Diabetes
Ear, Nose And Throat
Eyes
Family Health
Fitness
Headache
Heart Health
HIV / AIDS
Infectious Diseases
Lung Cancer
Medications
Men's Health
Mental Health
Nutrition News
Multiple Sclerosis
Nutrition Guide
Parkinson's
Pregnancy
Prevention
Prostate Cancer
Senior Health
Sexual / Reproductive Health
Sleep
Tobacco Cessation
STDs
Stress Reduction
Stroke
Weight Management
Today In Health History
Women's Health
Workplace Health
.
.
.
.
InteliHealth

   
.
.   HONcode
.
Chrome 2001
Chrome 2001