At a meeting described as "urgent" today in Atlanta, Georgia, the Advisory Committee on Practices immunization Practices (ACIP) recommended that the launch of the US government vaccination program against the virus H1N1, 09.
15 member ACIP, which advises the Ministry of Health and social services ( HHS), said that because it will probably be a limited amount of vaccine at the start of the season the traditional flu this fall, five groups of people should be placed at the head of the line. In addition to people who have underlying conditions that put them at an increased critical illness risk swine flu, other more priority groups are pregnant women, anyone between 6 months and 24 years, the people who live with children under 6 months (who can not be vaccinated themselves), and healthcare workers and emergency personnel.
estimated that this initial target population up to 159 million people. HHS now predicts it will have more than 0 million doses in October. Each dose contains 15 micrograms of the product, and that may not be enough vaccine if, as many expect, two doses are needed to establish a protective immune response. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases at the US Centers for Disease Control and Prevention, a division of HHS, said that many questions remain about the demand for the vaccine and the dose ultimate required per person.
Schuchat, during a press conference, noted that HHS recommendations call for 280 million Americans to get vaccinated against the vaccine against the "seasonal" flu, but in recent years, about 0 million chose to take it. "Pretty clearly, if we use the seasonal flu [vaccine] demand and uptake as our kind of waiting, we can have lots of vaccine right away," Schuchat said. "On the other hand, there is much uncertainty with this particular virus. We do not know exactly what the supply or demand will at some point in any community. "
To complicate matters, the vaccine can be prepared and approved by the Food and Drug Administration before clinical trials testing different doses of the vaccine have been completed, she said." Clinical trials give us information that is useful, but there are other decisions to be taken in the future "that will have to take into account the circumstances, said Schuchat." the National biodefense Science Board, which advises the HHS preparedness group, actually recommended to go ahead without waiting for clinical trials at-least to a certain quantity of vaccine. It is a serious issue that we currently deliberating. "
Given the uncertainties about supply and demand, Schuchat noted that ACIP also came with a" just-in-case prioritization group "of about 41 million people. This group would limit the availability of vaccines for certain health care workers and emergency personnel, and the age limit would fall to 4; under 18 with underlying risk factors would also be eligible.
Current recommendations do address the thorny issue of adjuvants that may be needed to stimulate immunity to viral antigens in the vaccine or stretch the amount of product that can be manufactured from a limited amount of antigen. Security issues regarding the use of adjuvants may delay approval of vaccines containing them, said Schuchat. "We assess the need for adjuvants, but our work plans are now that we expect not to need them."
Vaccine manufacturers also intend to use thimerosal in some vaccines. This mercury containing preservative has been removed from many other vaccine after public concerns grew of potential harm to children. Schuchat said vaccine without thimerosal will be available. But she also stressed that the ACIP and CDC usually do "not express a preference for thimerosal-free, based on science about this component."
HHS usually accepts the recommendations of the ACIP. "These recommendations will be promptly investigated by the CDC," said Schuchat. And urged national and local health authorities to start making preparations for the H1N1 vaccine.
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