Will USA's rushed swine flu vaccine be safe?

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US rushing swine flu vaccine clinical trials July 28, 2:30 PM

As the swine flu contnues to rapidly move across the globe, the World Health

Organization has stopped asking governments to report new cases, claiming the

effort is too great now that the disease has become so widespread. Instead, the

focus is on developing strategies for preventing what some experts fear will be

a new, more serious outbreak of swine flu in the fall and winter months just

when seasonal flu arrives.

Pharamceutical companies are rushing to develop a vaccine by early fall.

Clinical trials have already started in Australia. Canadian trials will begin by

September or early October. Federal health officials announced that the first US

clinical trials will begin in August and will be conducted in what Dr.

S. Fauci, director of the National Institute of Allergy and Infectious Disease

described as " a two month compressed time frame " in which about 2400 volunteers

will be tested. The initial tests will be of vaccines made by Sanofi-Pasteur, a

European company, and CLS Biotherapies, an Australian company that has supplied

seasonal flu shots in the US for years. A third company, Novartis, is conducting

separate trials for FDA licensing.

Adult volunteers for the clinical trials will be recruited at 8 separate sites

including Emory University in Atlanta, the University of land School of

Medicine in Baltimore, Vanderbilt University in Nashville, Baylor College of

Medicine in Houston, Children's Hospital Medical Center in Cincinnati, Group

Health ative in Seattle, the University Iowa in Iowa City, and St. Louis

University.

Initial studies will determine whether one or two 15-microgram doses of A/H1N1

swine flu vaccine are needed to produce an immune response in healthy adult

volunteers (18 to 64 years) and elderly people (65 years and older).

The doses will be given 21 days apart. If there are early indications that the

vaccines are safe, similar trials in healthy children (six months to 17 years)

will begin. According to Fauci, later tests may include pregnant women, who are

at higher risk for swine flu complications.

Vaccines will be given to different sets of volunteers before, after or at the

same time as the seasonal flu vaccine. Every volunteer will be monitored for

negative side effects including allergic reactions to the chicken eggs that the

vaccines are grown in.

Researchers will also look out for Guillain-Barré syndrome , a rare reaction to

any vaccine which can cause fever, serious nerve damage and muscle weakness. The

1976 vaccination of 40 million people after a swine flu outbreak in Fort Dix, N.

J., was halted after some people developed the syndrome. However, the vaccine

was never proved to be the cause. According to a 2009 worldwide literature

review, approximately one person in 100,000 develops Guillain-Barré syndrome for

unknown reasons. Unfortunately because the US vaccine trials are so small, it is

unlikely to pick up such a rare side effect. " You'd have to vaccinate several

hundred thousand or millions of people to do that, " Fauci said.

In addition to checking for adverse reactions, volunteers will have their blood

tested about three weeks after the shot to see if antibodies to the virus have

developed. Those with high levels of antibodies to the specific strain should be

immune to the infection or at the very worst, get only a mild case of the flu if

exposed to it.

Once these trials are completed and the vaccine is determined to be safe and

effective, health officials can then make specific recommendations as to how to

conduct a vaccination program and who should be vaccinated.

Assuming things go according to schedule, the hope is to have as many as 160

million doses ready in the US by mid October and then 80 million doses a month

later. Depending on how much vaccine is available and assuming most individuals

will require two shots, it could take until March to vaccinate the full U.S.

population of 300 million people.

None of the first trials will test a vaccine containing an adjuvant, which is an

additive -generally an oil-water emulsion- that stimulates the immune system to

react more strongly and helps to stretch the number of doses of vaccine needed.

Adjuvants are common in veterinary vaccines and tend to cause more side effects.

They are not now used in flu shots in the United States. But they are " not off

the board, " Fauci said. " We've developed a mix-and-match protocol for them, but

we want to see the data on vaccine safety first. " According to a report from

Reuters, the U.S. Health and Human Services Department has contracted for 120

million doses of adjuvant which they might use if the flu mutates into a more

dangerous form and the demand for more shots than are available results.

Federal advisers plan a meeting tomorrow to discuss who should receive the

vaccination

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