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H1N1 VACCINE

"Recently there has been publicity about some in the media representing all different kinds of opinions and viewpoints who are giving out incorrect information out about the flu and seasonal and H1N1 vaccination.

Many health reporters and bloggers around the country, as well as doctors on television, have raised some concerns about non medical folks dispensing inaccurate information that could result in a lot of people getting sick. You can find some of their posts below. Here at flu.gov, we want to make sure that Americans have the facts about the flu.

Below we debunk some myths that were recently promoted by TV personality Bill Maher. Former Senate Majority Leader Dr. Bill Frist, who as a guest on Maher's show, flagged some of these during the program. We will continue to update you when we get word of more misinformation. Additional flu myths and facts can be found here.

Myth: The flu shot injects “a disease into your arm.”

Fact: Both the seasonal and 2009 H1N1 flu shots are inactivated vaccines that contain killed/inactivated influenza virus. The nasal spray H1N1 vaccine contains a live, but weakened form of the virus that does not cause flu illness. These vaccinations are the best protection against contracting the seasonal and 2009 H1N1 flu.

Myth: Healthy people are not vulnerable to dying from the new 2009 H1N1 virus.

Fact: Both healthy people and people with underlying conditions, such as asthma and diabetes and other chronic diseases, are vulnerable to the 2009 H1N1 flu. CDC studies have shown that about 70 percent of people who have been hospitalized with this 2009 H1N1 virus have had one or more medical conditions previously recognized as placing people at “high risk” of serious seasonal flu-related complications. That leaves 30% of those hospitalized in the previously healthy category. The 2009 H1N1 flu has especially affected young people ages 5 to 24. A recent study of by the New England Journal of Medicine of 272 hospitalized H1N1 patients showed that although 60% of the children who were hospitalized had an underlying condition, the remaining 40 percent had no underlying condition. Since April, 81 children who contracted 2009 H1N1 flu have died.

Myth: Pregnant women should not get the 2009 H1N1 flu vaccine.

Fact: Pregnant women, even ones who are healthy, are at risk from medical complications from the seasonal and 2009 H1N1 flu. The CDC study of 1,400 adults who were hospitalized with 2009 H1N1 flu showed that 6 percent were pregnant. Click here for more information on pregnant women and the flu."

Source: U.S. Food and Drug Administration (FDA)

"Influenza A (H1N1) 2009 Monovalent Vaccines Questions and Answers

Provide Protection Against Influenza Disease Caused by Pandemic (H1N1) 2009 Virus

September 15, 2009 What is the U.S. Food and Drug Administration (FDA) announcing?

FDA has approved supplements to existing vaccine licenses to protect against the pandemic (H1N1) 2009 influenza virus. The Influenza A (H1N1) 2009 Monovalent vaccines contains an A/California/7/09-like virus. Information on the Influenza A (H1N1)2009 Monovalent Vaccine approvals. Is this vaccine part of the seasonal influenza vaccine that is recommended every year?

No, this is a stand-alone monovalent vaccine and is separate from the seasonal influenza vaccine. Will the seasonal influenza vaccine provide protection against the 2009 H1N1 influenza virus?

No. Although the currently licensed seasonal trivalent influenza vaccines contain an H1N1 subtype, their subtype differs from the 2009 H1N1 influenza virus, which is a new virus strain that has never before circulated among humans. The 2009 H1N1 influenza virus is not the same as previous or current human seasonal influenza viruses and seasonal influenza vaccine does not provide protection against the 2009 H1N1 influenza virus. Do I still need to get the seasonal influenza vaccine?

Yes, it is still important that those individuals for whom seasonal influenza vaccine is recommended receive it. According to the U.S. Centers for Disease Control and Prevention (CDC), between 5 and 20 percent of the U.S. population are infected with seasonal influenza each year. More than 200,000 people are hospitalized from its complications and about 36,000 people die. Vaccination is the best protection against influenza and can prevent many illnesses and deaths. Since influenza viruses change almost every season, there is always a possibility of a less than optimal match between the vaccine and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications. What information did FDA use to support approval of the Influenza A (H1N1) 2009 Monovalent influenza vaccines?

Vaccines used in the United States must be licensed by FDA. FDA approved these vaccines as a strain change to each manufacturer’s FDA-approved seasonal influenza vaccine. Each of the manufacturers will make the Influenza A (H1N1) 2009 Monovalent vaccines using its well-established, licensed egg-based manufacturing process that is used for seasonal influenza vaccine.

There is considerable experience with seasonal influenza vaccine development and production and influenza vaccines produced by this technology have a long and successful track record of safety and effectiveness in the United States. The safety and effectiveness demonstrated for seasonal influenza vaccine also support the licensure of the Influenza A (H1N1) 2009 Monovalent vaccines produced using the same process as for seasonal vaccine.

Clinical studies of the Influenza A (H1N1) 2009 Monovalent vaccines are ongoing. FDA will be assessing information from these studies to determine the optimal dose of the vaccine based on immunogenicity data (the levels of antibodies produced).

The Influenza A (H1N1) 2009 Monovalent vaccines will undergo the same rigorous testing and lot release procedures that are in place for seasonal influenza vaccines. Does FDA know at this time how many doses individuals should receive?

Currently available data suggest that children 6 months to 9 years of age have little or no evidence of protective antibodies to the pandemic (H1N1) 2009 virus (MMWR 2009; 58(19) 521-524, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5819a1.htm). Based on these data, children 9 years of age and younger should be administered 2 doses of the monovalent pandemic (H1N1) 2009 virus vaccine. Adults should be administered 1 dose, as should children and adolescents 10 years of age and older, as we expect that they will respond similarly to adults. Clinical studies are underway and will provide additional information about the optimal number of doses. Will the vaccine be available with and without a preservative?

Yes. As with the seasonal influenza vaccines, the Influenza A (H1N1) 2009 Monovalent vaccines will be available in formulations that contain thimerosal, a mercury-containing preservative, as well as preservative-free formulations. Is thimerosal safe when used as a preservative in vaccines?

Yes. A high standard of safety is expected by FDA. We are aware of the concerns that some people have regarding thimerosal in vaccines. The vast majority of research conducted in the U.S. and around the world does not support an association between thimerosal in vaccines and autism. Since 2001, no new vaccine licensed by FDA for use in children has contained thimerosal as a preservative, and all vaccines routinely recommended by CDC for children under six years of age have been thimerosal-free, or contain only trace amounts, except for some formulations of influenza vaccine. Are the Influenza A (H1N1) 2009 Monovalent vaccines safe?

The Influenza A (H1N1) 2009 Monovalent vaccines are manufactured and tested using the same processes used for the seasonal vaccine. Many millions of doses of seasonal vaccine have been distributed every year for many years, and seasonal vaccines have a well-established safety profile. As for seasonal vaccines, safety will also be monitored as part of the vaccination program (see below). What are the expected side effects of the Influenza A (H1N1) 2009 Monovalent vaccines?

The expected side effects will be similar to those of the seasonal vaccine, potentially including a mild fever, body aches, and fatigue for a few days after the vaccine, and soreness at the injection site. The most common side effects seen with administration of the nasal vaccine include runny nose or nasal congestion in recipients of all ages, fever more than 100 degrees Fahrenheit in children two to six years of age, and sore throat in adults. As with any medical product, serious adverse events may occur. People who have a severe (life-threatening) allergy to chicken eggs or to any other substance in the vaccine should not be vaccinated. How will the Influenza A (H1N1) 2009 Monovalent vaccines be monitored for safety?

FDA and CDC will closely monitor the safety of the Influenza A (H1N1) 2009 vaccines. FDA is collaborating with CDC, HHS, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the Influenza A (H1N1) 2009 vaccination program. Efforts are underway to establish a robust network to share information in real-time. The network will build on the well established Vaccine Adverse Event Reporting System and Vaccine Safety Datalink by integrating capabilities from the Department of Defense, the Department of Veterans Affairs, the Center for Medicare and Medicaid Services, State, Territorial, Tribal, and local public health and medical, and private sector healthcare entities. FDA is also engaged with international regulatory partners on pharmacovigilance planning efforts. What makes up the Influenza A (H1N1) 2009 Monovalent vaccines?

The Influenza A (H1N1) 2009 monovalent vaccines are manufactured using the same approved processes used to produce the seasonal influenza vaccines. Ingredients used during the manufacture of influenza vaccines include substances to help prevent bacterial contamination, to inactivate or “kill” the viruses, and stabilizers to prevent the vaccine from changing. Vaccines that are packaged in multi-dose vials use a preservative to prevent contamination. The Influenza A (H1N1) 2009 Monovalent vaccines are made from a single influenza virus strain that is an A/California/7/09-like virus. For the injectible vaccines, or shots, the virus is inactivated, using the same processes the manufacturers use for seasonal influenza vaccines. The vaccine administered via nasal spray contains a live, attenuated virus.

People who have a severe (life-threatening) allergy to chicken eggs, or to any other substance in the vaccine, should not be vaccinated. When will the vaccine be available?

Although approved by FDA, initial lots of the vaccines may not be immediately available until the end of September to mid-October, when manufacturers complete production and testing. What can be done to prevent getting infected with the 2009 H1N1 influenza virus?

* Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it. * If a tissue is not available cough or sneeze into your elbow. * Wash your hands often with soap and water, especially after you cough or sneeze. You should wash your hands as long as it takes to sing “Happy Birthday” twice. * Avoid touching your eyes, nose or mouth. Germs spread this way. * Try to avoid close contact with sick people."

Vaccine Press Release

September 21, 2009,

The following vaccine article is a press release by the US Department of Health and Human Services:

"Early Results: In Children, 2009 H1N1 Influenza Vaccine Works Like Seasonal Flu Vaccine

Early results from a trial testing a 2009 H1N1 influenza vaccine in children look promising, according to the trial sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Preliminary analysis of blood samples from a small group of trial participants shows that a single 15-microgram dose of a non-adjuvanted 2009 H1N1 influenza vaccine — the same dose that is in the seasonal flu vaccine — generates an immune response that is expected to be protective against 2009 H1N1 influenza virus in the majority of 10- to 17- year-olds eight to 10 days following vaccination. These results are similar to those recently reported in clinical trials of healthy adults. Younger children generally had a less robust early response to the vaccine.

"This is very encouraging news," says NIAID Director Anthony S. Fauci, M.D. "As we had hoped, responses to the 2009 H1N1 influenza vaccine are very similar to what we see with routinely used seasonal influenza vaccines made in the same way. It seems likely that the H1N1 flu vaccine will require just one 15-microgram dose for children 10 to 17 years of age. The 2009 H1N1 influenza virus is causing widespread infections among children, so these are welcome results."

The ongoing NIAID-sponsored trial began in mid-August at five sites nationwide. The trial is assessing the safety and immune responses to one and two doses of either 15 micrograms or 30 micrograms of vaccine. Data from the trial is being compared for three age groups: children 6 months to 35 months old; 3 to 9 years old; and 10 to 17 years old.

The preliminary results are based on blood samples taken eight to 10 days after the first vaccination. Immune responses were strongest among the oldest children, those 10 to 17 years old. In this group of 25 children, a strong immune response was seen in 76 percent who received one 15-microgram dose of vaccine. The immune responses in children nine years old and younger were not as strong. Among 25 volunteers aged 3 to 9 years old, a strong immune response was seen in 36 percent of those given 15 micrograms of vaccine. In the youngest group, 20 children between 6 months to 35 months old, a single 15-microgram dose of vaccine produced a strong immune response in 25 percent of recipients.

"These results are not unexpected and are both similar to what is seen with seasonal influenza vaccines and consistent with what we and our colleagues at the Food and Drug Administration anticipated," notes Dr. Fauci.

Study investigators are also collecting blood samples from the volunteers approximately three weeks after both the first and second injections. It is anticipated that the immune response to the 2009 H1N1 influenza vaccine will be similar to that of seasonal influenza vaccination and will continue to rise for several weeks following vaccination, says Dr. Fauci. The study is being closely monitored by the trial physicians and staff as well as by an independent safety monitoring committee.

The vaccine being tested in this trial is manufactured by Sanofi Pasteur in Swiftwater, Pa., in the same manner as its licensed seasonal vaccine, which is used every year in millions of children, and is the same formulation recently licensed by the FDA to protect against 2009 H1N1 influenza. Like inactivated seasonal influenza vaccines, the vaccine contains a purified part of a killed virus and cannot cause flu."

transcript from CDC podcast September 2009

"2009 H1N1 ACIP Vaccination Recommendations

This podcast is presented by the Centers for Disease Control and Prevention. CDC – safer, healthier people.

Welcome to this CDC influenza podcast. In this podcast, Dr. Tony Fiore from CDC's Influenza Division discusses vaccination recommendations made by the Advisory Committee for Immunization Practices (ACIP) for the new 2009 H1N1 influenza virus. The 2009 H1N1 flu is sometimes called novel H1N1 or swine flu, and the World Health Organization calls it the pandemic H1N1 2009 virus.

This podcast discusses only 2009 H1N1 influenza vaccination recommendations. For ACIP recommendations regarding seasonal influenza vaccination, listen to the Podcast "Seasonal Influenza 2009-2010: ACIP Vaccination Recommendations" at www.cdc.gov/podcasts.

In the spring of 2009, a new and very different influenza A H1N1 virus emerged to cause illness in people. This virus is spreading worldwide and the World Health Organization has declared an influenza pandemic. The virus is so different from seasonal influenza A H1N1 viruses that have spread in people over the past 30 years that the seasonal flu vaccine is not expected to protect against this new virus.

A vaccine to protect against 2009 H1N1 influenza is currently in production and it is anticipated that vaccine will be ready for the public during the 2009-2010 flu season. This 2009 H1N1 vaccine is not intended to replace the seasonal flu vaccine. Many people will be recommended to get both vaccines to protect against influenza illness this season.

ACIP advises the Centers for Disease Control and Prevention on vaccine issues. In July, 2009 the committee made recommendations on the use of vaccine for the control and prevention of 2009 H1N1 influenza. The committee considered several factors, including current disease patterns; who is most at-risk for severe illness, hospitalization or death; how much vaccine is expected to be available; and when the vaccine is expected to be available.

The committee recommended that vaccination efforts focus on five key populations. The key populations include those who are at higher risk of disease or complications, those who are likely to come in contact with 2009 H1N1, and those who could infect young infants who cannot be vaccinated themselves. The ACIP has recommended that when vaccine becomes available, immunization programs and providers should focus first on vaccinating as many people as possible in the following five groups:

• pregnant women,

• people who live with or provide care for children younger than 6 months of age,

• health care and emergency medical services personnel,

• people between six months through 24 years of age, and

• people from the ages of 25 through 64 who are at higher risk because of chronic health disorders such as asthma, diabetes, or a weakened immune system.

These groups total approximately 159 million people in the United States.

Once the demand for vaccine for these groups has been met, the next group to be vaccinated includes everyone from the ages of 25 through 64 years. Unlike seasonal flu, people 65 or older appear to be less at risk of infection with the 2009 H1N1 virus than younger people. However, once vaccine demand among younger age groups has been met, programs and providers should offer vaccination to people 65 or older.

The 2009 H1N1 vaccine is not intended to replace the seasonal flu vaccine. It is an additional influenza vaccine for this influenza season. Many people will be recommended to get both vaccines. So the best advice is, get the seasonal flu vaccine as soon as it is available in your community, and if you are in one of the recommended groups, get the 2009 H1N1 vaccine when it becomes available.

And remember that in addition to vaccination, there are other actions everyone should take to help prevent the spread of flu. This includes coverings coughs and sneezes with a tissue; washing hands often with soap and water, especially after coughing or sneezing; and staying home when sick with flu-like symptoms except to seek medical care. People who become severely ill or have a medical condition that places them at high risk for flu-related complications and develop flu-like symptoms, including fever or chills and cough or sore throat, should consult with a healthcare provider. They might need to be treated with influenza antiviral medicines. High risk medical conditions include asthma, diabetes, or heart and lung disease. For more information on 2009 H1N1, visit www.cdc.gov/h1n1.

For the most accurate health information, visit www.cdc.gov or call 1-800-CDC-INFO, 24/7."

H1N1 vaccine

May 2, 2009

Source: World Health Organization

Vaccines for the new influenza A(H1N1)