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CDC Spells Out Process to Get Pandemic Vaccine to Patients
  MedPage Today
September 18, 2009
ATLANTA -- A minimum of 3.4 million doses of vaccine against H1N1 pandemic flu will be available in the first week of October, the CDC said.
Those doses -- all in the form of a live attenuated nasal spray vaccine -- may be supplemented by some injectable vaccine, according to Jay Butler, MD, the chief of the agency's 2009 H1N1 vaccine task force.
"Additional vaccine may be available as well," Dr. Butler told reporters, "but 3.4 (million) is the hard number that we have right now."
After the first week of October, additional vaccine will become available, he said, eventually reaching 20 million doses delivered each week until the end of the year.
Butler cautioned that getting the vaccine to patients is likely to be logistically challenging, especially in the first days. "The flow of vaccine the first week or two may be slower than what we would like," he said.
The U.S. has ordered 195 million doses of pandemic flu vaccine from five companies, and four of the vaccines have now been licensed by the FDA. (See FDA Approves H1N1 Vaccines)
To get them out, the government will use the same process employed by the Vaccine for Children program, which distributes medications to about 40,000 healthcare providers across the country, he said.
That network will be expanded by adding another 50,000 providers of various types.
But not all of those providers will have vaccine available for all patients immediately, he said. "There's not a sudden appearance of vaccine in 90,000 refrigerators around the country," Butler said.
The ordering process, he said, will begin with a request from a provider to the state health department, which will know from day to day how much vaccine is allocated to that state.
State allocations will be based on population.
The state authorities will do an initial triage to decide which orders will be filled, Butler said.
The orders will be transmitted daily to the CDC, which will collate them and transmit them to distributors by 5 a.m. the next day. They'll be filled and shipped within three business days, Butler said.
Meanwhile, the flu season is well under way -- and earlier than usual, according to Daniel Jernigan, MD, deputy director of the CDC's influenza division.
Jernigan said flu -- all of it pandemic H1N1 -- is being reported in all 50 states, with 21 seeing widespread activity.
"It's a very strange thing for us to see that amount of influenza at this time of year," he said -- about twice the level that would usually be reported.
On the other hand, he said, while there is an increase in children and young adults needing hospital care, it still has not reached the levels usually seen later in a normal flu season.
Dr. Jernigan urged people to get the seasonal flu vaccine, which is now available, and to take the usual preventive precautions, including hand hygiene, covering coughs, and staying home if ill.
FDA Approves H1N1 Vaccines
MedPage Today
September 15, 2009
WASHINGTON -- The FDA today approved four vaccines for pandemic H1N1 flu, and will begin distributing the vaccines nationally in a little more than a month.
The approval comes after several trials found that a single dose of the vaccines produces an immunogenic response just eight to 10 days after injection.
Approved are vaccines manufactured by Sanofi Pasteur, Norvartis, CSL Limited and MedImmune, according to an FDA release. All four companies manufacture seasonal flu vaccines as well.
"The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines," said Jesse Goodman, MD, FDA acting chief scientist, in a prepared statement.
The National Institutes of Health (NIH) released results last week from its trial of 2,800 healthy people. NIH researchers found that the vaccines made by Sanofi Pasteur produced a strong immune response in 96% of adults ages 18 to 64, and the CSL vaccines produced a robust immune response in 80% of adults ages 18 to 64. No adverse events were reported.
Trials published in the New England Journal of Medicine last week found the vaccines by CSL and Norvartis yielded similarly high immune responses and were safe.
Government officials said last week they're on track to begin vaccinating people between ages 18 and 64 in mid-October, and those people will likely have immunity before Halloween. Some predictive models suggest this fall's H1N1 pandemic will peak in October.
The approved vaccines include a nasal spray vaccine manufactured by MedImmune, which is indicated for active immunization of patients age two through 49 and a vaccine developed by CSL Limited, which provides active immunization of adults age 18 and older.
The other two approved vaccine are one developed by Novartis Vaccines and Diagnostics Limited, designed to provide active immunization for patients age four and older, and Sanofi Pasteur's vaccine which provides active immunization beginning at age six months.
The NIH recently began testing the vaccines among pregnant women, and should have results from its pediatric trial available next week.
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