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Sanofi Wins U.S. Approval for First Bird Flu Vaccine (Update3)
http://www.bloomberg.com/apps/news?pid=20601085&sid=alzxwotcLliw&refer=europe
April 17 (Bloomberg) -- Sanofi-Aventis SA won U.S. approval
for the first vaccine to protect against bird flu even though
the shot may protect less than half of the people inoculated.
The U.S. government already has bought millions of doses of
Sanofi's vaccine for its emergency stockpiles. The shots are
worth having until more effective products can be developed,
FDA officials said.
``We feel that as part of pandemic preparedness,
it would be best to have a licensed vaccine,''
said Norman Baylor, director of the FDA's Office
of Vaccines Research and Review, in a conference call today.
``This is sort of an interim measure.''
`This Simplifies Things'
``Patients would have to sign some kind of waiver,'' Schaffner said
today in a telephone interview. ``This simplifies things enormously
because now it's a licensed product.''
The U.S. has bought more than 6 million doses of the
vaccine and has indicated that it would like 20 million doses,
Hosbach said in a telephone interview today. The vaccine won't
be sold commercially.
Some of the Sanofi shots that have been bought have already
begun to lose their effectiveness.
The Health and Human Services Department said in November that
almost a fifth of the shots in its storehouse had begun to
lose potency. As a result, the stockpile now contains enough
vaccine to fully immunize 3 million people against H5N1,
down from the 3.75 million that could have been protected
when the shots were new.
Sanofi Wins U.S. Approval for First Bird Flu Vaccine (Update3)
http://www.bloomberg.com/apps/news?pid=20601085&sid=alzxwotcLliw&refer=europe
April 17 (Bloomberg) -- Sanofi-Aventis SA won U.S. approval
for the first vaccine to protect against bird flu even though
the shot may protect less than half of the people inoculated.
The U.S. government already has bought millions of doses of
Sanofi's vaccine for its emergency stockpiles. The shots are
worth having until more effective products can be developed,
FDA officials said.
``We feel that as part of pandemic preparedness,
it would be best to have a licensed vaccine,''
said Norman Baylor, director of the FDA's Office
of Vaccines Research and Review, in a conference call today.
``This is sort of an interim measure.''
`This Simplifies Things'
``Patients would have to sign some kind of waiver,'' Schaffner said
today in a telephone interview. ``This simplifies things enormously
because now it's a licensed product.''
The U.S. has bought more than 6 million doses of the
vaccine and has indicated that it would like 20 million doses,
Hosbach said in a telephone interview today. The vaccine won't
be sold commercially.
Some of the Sanofi shots that have been bought have already
begun to lose their effectiveness.
The Health and Human Services Department said in November that
almost a fifth of the shots in its storehouse had begun to
lose potency. As a result, the stockpile now contains enough
vaccine to fully immunize 3 million people against H5N1,
down from the 3.75 million that could have been protected
when the shots were new.
