Swine Flu: CDC Mixes H1N1, H5N1 Viruses in Tests
Q. When will the decision to administer vaccine be made?
A. For planning purposes, it should be assumed that vaccine will be administered beginning in the fall.
Q. When will vaccine shipping begin?
A. Planners should assume shipping of vaccine will begin mid-October, although there is a possibility that some vaccine will be available for shipping starting late September.
Q. How many manufacturers are producing vaccine?
A. Five manufacturers are producing vaccine for the U.S.: Sanofi Pasteur, Novartis, GSK, Medimmune and CSL.
Q. How will vaccine be shipped to projects areas (CDC Public Health Emergency Preparedness grantees)?
A. Vaccine will be shipped to clinics, offices, health departments, and other project area-designated sites which may include a mix of public health and private sector sites via centralized distribution. This is the same process that is used to ship vaccines for the childhood immunization program to immunization providers. CDC's centralized distribution mechanism will be substantially enhanced to provide capacity for this activity in addition to shipping of other vaccines.
Q. Will project areas (CDC Public Health Emergency Preparedness grantees) be able to limit the amount of vaccine they receive?
A. Yes, project areas will be able to determine what proportion of their allocation they wish to receive.
Q. How frequently will vaccine shipments arrive?
A. As details of distribution are finalized, CDC will communicate with states about the anticipated time period between placing vaccine orders and receiving shipments.
Q. How many sites can be designated as vaccine receiving sites?
A.One of the key benefits of using a centralized, third party distributor to support H1N1 vaccine distribution is that it allows distribution of doses to a much larger number of providers sites than would be feasible with direct manufacturer distribution. Thus, we will be able to serve a significantly larger provider base than the original state ship to sites, and are planning to be able to accommodate more providers than are currently served by the VFC program. More information, including any limitations in the number of vaccine receiving sites, will be shared with state planners as soon as it becomes available.
Q. Will vaccine be in multi-dose vials?
A. The majority of vaccine will be in multi-dose vials, the remainder in single dose syringes or nasal sprayers. The aim is to have enough vaccine in single dose syringes (i.e. preservative free) for young children and pregnant women.
Q. How will novel H1N1 vaccine be purchased?
A. Novel H1N1 vaccine will be procured and purchased by the federal government and made available for vaccinators at no cost. See section below titled “Vaccine administration fees” for information on cost of administration.
Vaccine Administration Fees
Q. Will insurance plans reimburse private providers for administration?
A. CDC asked America's Health Insurance Plans (AHIP) and on behalf of its members, AHIP provided this response:
"Every year health plans contribute to the seasonal flu vaccination campaign in several ways:
a) Health plans communicate directly with plan sponsors and members on the current ACIP recommendations and encourage immunization; they also provide information on where to get vaccinations, and who to contact with any questions.
b) Just as health plans have provided extensive coverage for the administration of seasonal flu vaccines in the past, public health planners can make the assumption that health plans will provide reimbursement for the administration of a novel (A) H1N1 vaccine to their members by private sector providers in both traditional settings e.g., doctor’s office, ambulatory clinics, health care facilities, and in non-traditional settings, where contracts with insurers have been established"
Q. Will private providers be able to charge patients for vaccine administration if they are uninsured?
A. Yes, providers may charge patients if they are uninsured. The administration fee cannot exceed the regional Medicare vaccine administration fee.
Q. Can persons be charged for vaccine administration in public health-organized large scale vaccination clinics?
A. There will be no administration fee for vaccination in public-health organized large scale vaccination clinics.
Q. How will vaccine be allocated among project areas (the CDC PHEP grantees)?
A. Vaccine will be allocated to each project area in proportion to its population (pro rata).
Q. Will there be a separate allocation for active duty DOD?
A. Yes, there will be a separate allocation for active duty DoD. It is not included in the project area allocations.
Q. Will there be a separate allocation for DoD dependants, retirees and civilian employees?
A.There is no separate allocation for these groups. Military facilities may be willing to vaccinate these groups, but will need to be allocated vaccine for these populations by the project areas.
Q. Will there be a separate vaccine allocation for IHS-served populations and other tribal communities?
A. There will be no separate allocation. States and local areas need to work with their tribal populations to ensure access to vaccine.
Q. Which ancillary supplies will be provided with vaccine?
A. HHS will provide needles, syringes, sharps containers and alcohol swabs.
Q. How will ancillary supplies be distributed?
A. Ancillary supplies will be distributed to the same project area-designated sites as vaccine. Plans for ensuring the distribution of these products are currently being developed.
Q. Will two doses of vaccine be required?
A.The U.S. Food and Drug Administration (FDA) has approved the use of one dose of 2009 H1N1 flu vaccine for persons 10 years of age and older. Data from trials among children are not available at this time, so dosing schedules for children are not yet known. Data from trials among children will be available soon. At this time, FDA has approved two doses for children 9 years of age and younger. Immunogenicity data for the 2009 flu H1N1 vaccine among adults is similar to that for seasonal influenza vaccines. If this is also the case among children, then it is likely that younger children will require two doses and older children will require one dose, as licensed. As with seasonal vaccine, children ages 6 months through 35 months get two doses of 2009 H1N1 flu vaccine that contains one-half the dose used for older children and adults.
Q. What will be the recommended interval between the first and second dose for children under 9 years of age?
A. This will not be known until clinical trials are complete. For planning purposes, planners should assume 21-28 days between the first and second vaccination.
Q. How much Thimerosal-free vaccine will be available?
A. It is anticipated that enough thimerosal-free vaccine in pre-loaded syringes will be available for young children and pregnant women.
Q. Will there be federal requirements to recall persons for their second dose, if a second dose is needed?
A. There will be no federal requirement to send out recall notices. Providing information on second dose at the time of the first dose, as well as using the media to disseminate this message will be the primary means of educating persons about who needs a second dose administered.
Q. Will it be necessary for the first and second dose to be the same product?
A. Ideally, first and second doses would be from the same product. However, practical considerations make this difficult to implement. Planners should assume they will be interchangeable.
Q. Can seasonal vaccine and novel H1N1 vaccine be administered at the same time?
A. Inactivated 2009 H1N1 vaccine can be administered at the same visit as any other vaccine, including pneumococcal polysaccharide vaccine. Live 2009 H1N1 vaccine can be administered at the same visit as any other live or inactivated vaccine EXCEPT seasonal live attenuated influenza vaccine
Q. Will vaccine be adjuvanted?
A. It is unlikely H1N1 vaccine will be adjuvanted. Definitive information will be available once clinical trial data are available.
Q. If vaccine is adjuvanted, how will it be formulated?
A. Formulation will vary by provider. For Novartis, vaccine may be preformulated with adjuvant. For CSL, GSK and Sanofi Pasteur, mixing of vaccine and adjuvant at the site of administration will be necessary. Specific information on storage requirements and procedures for mixing vaccine and adjuvant will be provided by CDC. Medimmune vaccine will not be adjuvanted.
Q. Will the vaccine be administered under EUA (Emergency Use Authorization)?
A. EUA will not be used for unadjuvanted vaccine if FDA licenses the vaccine under the current BLA (Biologics License Application) as a strain change.
Q. For whom will novel H1N1 vaccine be recommended?
A. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) met on July 29th to develop recommendations on who should receive the novel 2009-H1N1 vaccine when it becomes available, and to determine which groups of the population should be prioritized if the vaccine is initially available in extremely limited quantities. The committee recommended that vaccination efforts initially focus on 5 target groups: vaccination for pregnant women, people who live with or care for children younger than 6 months of age, healthcare and emergency medical services personnel, persons between the ages of 6 months through 24 years, and people ages 25 through 64 years who are at higher risk for novel H1N1 because of chronic health disorders or compromised immune systems. We do not expect that there will be a shortage of novel H1N1 vaccine, but flu vaccine availability and demand can be unpredictable and there is some possibility that initially, the vaccine will be available in limited quantities. So, the ACIP also made recommendations regarding which people within the groups listed above should be prioritized if the vaccine is initially available in extremely limited quantities. For more information see the CDC press release CDC Advisors Make Recommendations for Use of Vaccine Against Novel H1N1. Once the demand for vaccine for the prioritized groups has been met at the local level, programs and providers should also begin vaccinating everyone from the ages of 25 through 64 years. Current studies indicate that the risk for infection among persons age 65 or older is less than the risk for younger age groups. However, once vaccine demand among younger age groups has been met, programs and providers should offer vaccination to people 65 or older. (see http://www.cdc.gov/h1n1flu/vaccination/acip.htm)
Q. Will there be flexibility in how states implement the recommendations?
A. The recommendations are broad and allow for flexibility to accommodate local variability in vaccine needs and demands. Providers should be aware of and follow any additional guidance provided by their state or local health departments. If no additional guidance is provided at the state or local level, providers should vaccinate among the initial target group populations on a first come, first served basis.
Q. Given the potential for large amounts of vaccine available during the first month of vaccine shipments, are priority groups needed?
A. It is not expected that there will be a shortage of novel H1N1 vaccine, but availability and demand can be unpredictable, and there is some possibility that initially the vaccine will be available in limited quantities and priority groups may be needed.
Q. Will there be requirements regarding documentation of priority group membership?
A. There will be no federal requirements for vaccinators to require documentation of priority group status such as a doctor’s note documenting pregnancy or risk status.
NaturalNews - The mainstream media is engaged in what we Americans call "bald faced lies" about swine flu. It seems to be true with this issue more than any other, and it became apparent to me recently when a colleague of mine -- a nationally-syndicated newspaper columnist -- told me their column on natural defenses for swine flu was rejected by newspapers all across the country. Many newspapers refused to run the column and, instead, ran an ad for "free vaccine clinics" in the same space.
The media, it seems, is so deeply in bed with the culture of vaccinations that they will do almost anything to keep the public misinformed. And that includes lying about swine flu vaccines.
There are ten key lies that continue to be told by the mainstream media (MSM) about swine flu and swine flu vaccines.
Lie #1 - There are no adjuvants used in the vaccines
Lie #2 - The swine flu is more dangerous than seasonal flu
Lie #3 - Vaccines protect you from swine flu
Lie #4 - Vaccines are safe
Lie #5 – The vaccine isn’t mandatory
Lie #6 – Getting a vaccine shot is a good bet on your health
Lie #7 – The vaccine isn’t made with “attenuated live virus”
Lie #8 – Wash, wash, wash your hands (to avoid exposure)
Lie #9 – Children are more vulnerable to swine flu than adults
Lie #10 – There is nothing else you can do beyond a vaccine and Tamiflu...
VIDEO: Dr. Mercola Interviews Dr. Baylock On Vaccines
Reuters - The first U.S. roll-out of vaccines against the new swine flu virus will be 3.4 million doses of MedImmune's nose spray, the Centers for Disease Control and Prevention said on Friday.
The CDC's Dr Jay Butler said the vaccines would be distributed the first week of October.
"Initially we anticipate that 3.4 million doses of vaccine will be available," Butler told a telephone briefing.The United States has ordered 195 million doses of H1N1 swine flu vaccine from five companies -- MedImmune, a unit of AstraZeneca, Sanofi-Aventis, Australia's CSL, GlaxoSmithKline and Novartis.
"We anticipate being able to start receiving orders for the vaccine by early October," Butler added. The U.S. government is providing the H1N1 vaccine for free to about 90,000 distributors, including doctor's offices, retail chains and state health departments.
"We estimate that the amount of vaccine that will be available will increase through October," Butler said, adding that eventually delivery would rise to about 20 million doses a week.
It has recommended that about 160 million people, roughly half the population, get vaccinated first -- pregnant women, healthcare workers, children and people with chronic conditions such as diabetes or asthma who are most at risk of getting very ill from flu. There is no enforcement of this, however, and it will be up to the people giving the vaccine to decide who goes first.
MedImmune's vaccine is not approved for people with asthma, people over age 50 or very young children, mostly because it has not yet been tested widely in these groups. State health officials say that might affect who gets the first doses.
Some of the other vaccines contain thimerosal, a preservative that scientists say is safe but which worries some people, and the state of Washington, for instance, says infants and pregnant women may not be given thimerosal-containing vaccines, another factor that could affect distribution.
The CDC officials said they are racing to try to stay ahead of the virus, which is now active in all 50 states. It spread around the world to cause a pandemic within a few weeks in April and May.
"The flow of vaccine the first week or so may be slower than we like," Butler said.So far, the virus is causing moderate disease, with a death rate similar to that seen in seasonal flu. Every year, seasonal influenza kills between 250,000 and 500,000 people globally and around 36,000 in the United States.
But H1N1 may infect far more people than seasonal flu does, because so few people have any immunity to it. It also causes symptoms in a far younger age group than does seasonal flu, which is worse among the elderly.
"We expect that if the H1N1 (virus) remains the predominate strain, that more younger people might be affected than we have seen in the past," the CDC's Dr Daniel Jernigan said.
"There is some increase in the rate of hospitalization for younger children and for adults, but it is not up at the levels that we would see for seasonal flu."
He said it was very unusual to have so much flu spreading this time of year in the United States. It is usually more common in the United States from January to March.
"It's about twice as much, at least for what we would expect this time of year," Jernigan told the briefing.
"If you talk to doctors they will tell you, 'boy I am seeing a lot of flu for this time of year,'" he added.
WSJ's Health Blog - Public-health officials are breathing a small sigh of relief that the H1N1 swine flu virus hasn’t mutated to become more deadly since emerging last spring. But what are the chances it will?
To find out, scientists at the CDC recently launched experiments in the agency’s labs in which they infected ferrets with both the new H1N1 virus and the highly lethal H5N1 avian flu virus to see if they might “reassort” to create a new hybrid.
The scientists want to know whether a combination of the H1N1 virus -– highly transmissible, but not terribly deadly -– and the H5N1 flu virus could create an easily transmissible, deadly scourge.
The H5N1 virus has only sickened 440 people world-wide since 2003 and generally isn’t transmitted from one person to another. But it has killed 262, or about 60%, of those people, according to the World Health Organization.The two viruses could mix if they infected the same person simultaneously.
As the new H1N1 flu has spread, flu experts have kept a close eye on Egypt and parts of the world where human H5N1 infections are occurring too. The new H1N1 virus was also detected recently in turkeys in Chile, proving that it has the capacity to jump to birds, another potential source for reassortment.
The CDC scientists don’t have results of their lab experiments in ferrets yet, said Michael Shaw, associate director for laboratory science for the agency’s influenza division. While the experiments could produce viable combinations of the two viruses, the real question is whether any could create a virus that would spread, he said.
“Viability is one thing,” he cautioned. “Whether it’s easily transmissible is another.”Other experiments conducted so far suggest the new H1N1 virus isn’t terribly prone to doomsday changes. Viruses can change through either mutation of genetic material, or by reassorting with another flu virus. The new virus is lacking certain characteristics that would allow it to mutate to become more virulent, said Nancy Cox, chief of the CDC’s influenza division.
“It would be difficult for this virus to acquire some of those known virulence markers,” she said.As for reassortment, so far the new H1N1 virus hasn’t shown a penchant for mixing with other common flu viruses. In a research note published in late August on the web site PloS Currents: Influenza, scientists infected ferrets both with the new H1N1 virus and common seasonal strains of H1N1 and H3N2 flu. The new H1N1 pandemic virus didn’t reassort.
“Co-infection of seasonal and pandemic strains did not result in the rapid selection of reassortant viruses that either improved replication or transmission or exacerbated virulence,” they concluded. The federally funded study was led by scientists at the University of Maryland.Whatever any of the experiments show, CDC officials warn against drawing definitive conclusions.
“Influenza is really unpredictable,” Cox said.
USA TODAY — Scientists are racing to launch the first major trials of a multi-drug flu cocktail to see if it can prevent complications in high-risk H1N1 (swine flu) patients, researchers said Sunday.
All three of the drugs — amantadine, ribavirin and Tamiflu — are already on the market. All are mainstays of flu treatment that have lost much of their punch because of flu viruses’ ability to throw up new defenses against antivirals. But research reported Sunday suggests that doctors may be able to breach viruses’ defenses by using them together.
Researchers said the triple combination is broadly effective against many different flu viruses, even those resistant to one or more of the drugs in the combo. The most unexpected finding was that each drug appears to regain some measure of its effectiveness against resistant viruses when given with the other two drugs, said lead researcher Mark Prichard of the University of Alabama-Birmingham.
“We were frankly very surprised,” Prichard told participants at a meeting of the American Society for Microbiology.Secretary of Health Kathleen Sebelius on Sunday offered an upbeat vaccine report, saying on ABC’s This Week that some flu shots may arrive the first week of October, a few days earlier than expected.
Nancy Cox of the Centers for Disease Control and Prevention said the first shipments will be small and reserved for priority groups such as young people and pregnant women “as far as possible.” She said evidence that one shot offers protection was a big confidence-booster that prompted the government to speed up its timetable.
Tests of the triple-drug combo are underway in the Southern Hemisphere and are starting in the USA, Canada and Europe, said virologist Amy Patick of Adamas Pharmaceuticals in Emeryville, Calif. Adamas sponsored the tests using a fixed-dose mix of amantadine and ribavirin and Roche’s Tamiflu. Researchers will pit the combo against Tamiflu alone in 250 people at 40 medical centers.
Jon McCullers of St. Jude Children’s Research Hospital in Memphis said Adamas has asked him to take part. Doctors may now use combination therapy, he said, but so far they haven’t had to because in most cases Tamiflu alone is effective against swine flu which is still vulnerable to it.
Combo therapy will be most useful when swine flu develops resistance to Tamiflu or when more drug-resistant viruses begin to circulate, crowding swine flu out, he said.