05 H1N1 Flu Vaccine FAQs (Specific Information)
05.01 Vaccine Availability (Where/When)
05.02 Vaccine Recommended Populations/Targeted Groups
05.03 Vaccine Cost
05.04 Vaccine Safety
05.05 Ordering Vaccine
05.06 Vaccine Recall of Pediatric Pre-filled Syringes (Dec. 15, 2009)
05.07 Voluntary Recall of Nasal Spray Vaccine for H1N1 Flu (Dec. 22, 2009)
H1N1 flu vaccine should be available at many of the same places you would go to get your regular (seasonal) flu shots. This includes your doctor’s office, public health clinics, pharmacies, and other community locations - including schools in some California counties. We recommend that you call ahead to see if they have any vaccine.
You can use the flu vaccine locator, located on the Home page of the CDPH Web site.
You can also use text messaging to find your nearest H1N1 flu vaccination locations. Text the phrase “No Flu”, then a space, and then your ZIP code. Send this text to 30644. You will receive a text with flu information, including your nearest H1N1 vaccine locations.
The following link has phone numbers of local public health departments:
Local Health Service information:
Vaccine is now widely available throughout the state, including at most health departments, physicians’ offices, pharmacies and public health clinics.
The H1N1 vaccine will be manufactured in the same types available for the regular seasonal flu vaccine. That is:
Inactivated, preservative-free 0.25 ML pre-filled syringe
Children 6 month to 36 months
Inactivated, Preservative-containing 0.5 ML
Children age 3 and older, adolescents, and adults
Live, Attenuated 0.20 ML nasal sprayer
Children age 2 and older up to adults age 49
Inactivated, preservative-containing, multi-dose vials (5 mL)
Children age 6 months and older through adulthood
Inactivated, preservative-free 0.5 ML dose single dose vial or pre-filled syringes
Shipments of H1N1 vaccine are made based on vaccine availability and are shipped from a national distributor that works with the vaccine manufacturers. Multiple shipments are made weekly over several months as more vaccine becomes available.
Nasal spray H1N1 vaccine is made from a weakened live virus and is recommended for healthy persons aged 2 through 49 years.
Virtually everyone in the general public can benefit from the H1N1 vaccine. Because initial supplies may be limited, the CDC’s Advisory Committee on Immunization Practices (ACIP) has set national recommendations for initial vaccination for the early vaccine distribution when vaccine first becomes available. Providers in California should abide by these recommended groups, which are:
Health care workers and emergency medical responders
People caring for infants under 6 months of age
Children and young adults from 6 months through 24 years
People age 25 through 64 years with underlying medical conditions (like asthma or diabetes)
As the vaccine supply increases in the coming months, anyone who wants to be vaccinated should be offered H1N1 vaccination.
There is currently no requirement to provide proof that you or a family member has a chronic illness or, for women, that they are pregnant. Most flu shot clinics just ask their patients to “self-report” on these conditions.
The CDC recommends still getting both the seasonal and the H1N1 flu vaccines even if you have already had the flu. This is because you may not have had the exact flu virus strain in the vaccines or you have had another virus that is not the flu.
No. The H1N1 is completely voluntary for the general public and is NOT required for school-aged children to enroll in school. Only the military and some health care settings are requiring flu vaccination for their staff.
Seniors and healthy adults will be able to get the H1N1 vaccine a little later in the flu season. Current recommendations set by the CDC target the early vaccine supply to go to groups that have a higher risk of becoming infected with H1N1 and also a higher risk of influenza-related complications or death. Data indicates that people older than 64 years are less likely to become infected with H1N1 flu because they may have some immunity from an infection with similar strains that were circulating when they were younger. As vaccine supply increases, H1N1 vaccine should be made available to anyone who wants to be vaccinated. We recommend that you check with your doctor or public health clinic to find out when they plan to start vaccinating seniors with the H1N1 flu vaccine.
Teachers are not specifically prioritized for the H1N1 vaccine.
Current CDC recommendations target the early vaccine supply to go to groups that have a higher risk of influenza-related complications or death. This is expected to affect vaccine availability during October and November when supply is still limited.
Teachers who have a chronic health condition, like diabetes or asthma, should check with their doctor to get the vaccine as soon as it’s available since they may have a higher risk of flu complications if they do catch the flu.
Teachers who are healthy adults will be able to get vaccinated a little later in the flu season. As vaccine supply increases, H1N1 vaccine should be made available to anyone who wants to be vaccinated. We recommend that you check with your doctor or public health clinic to find out when they plan to start vaccinating healthy adults with the H1N1 flu vaccine.
Current recommendations target the early vaccine supply to go to groups that have a higher risk of influenza-related complications or death. This only expected to affect vaccine availability during October and November when supply is still limited. If you are traveling soon, check with your doctor to find out how soon you can get your H1N1 vaccine.
According to the CDC, Health-care personnel (HCP) include all paid and unpaid persons working in health-care settings who have the potential for exposure to patients with influenza, infectious materials, including body substances, contaminated medical supplies and equipment, or contaminated environmental surfaces. HCP might include (but are not limited to):
nurses and nursing assistants,
emergency medical service personnel
laboratory personnel and autopsy personnel
students and trainees
contractual staff not employed by the health-care facility, and
persons (e.g., clerical, dietary, housekeeping, maintenance, and volunteers) not directly involved in patient care but potentially exposed to infectious agents that can be transmitted to and from HCP.
The recommendations apply to workers in acute-care hospitals, nursing homes, skilled nursing facilities, physicians' offices, urgent care centers, and outpatient clinics, and to persons who provide home health care and emergency medical services. Emergency medical services personnel might include persons in an occupation (e.g., emergency medical technicians and fire fighters) who provide emergency medical care as part of their normal job duties. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0821a1.htm
The CDC’s Advisory Committee on Immunization Practices (ACIP) has set national recommendations for initial vaccination for the early vaccine distribution when vaccine first becomes available. The California Department of Public Health is following these national recommendations. Source: http://www.flu.gov/faq/vaccines/2004.html
Initial targets for vaccination are pregnant women; healthcare providers; caretakers of young infants less than 6 months of age; children and young people between the ages of 6 months and 24 years; also, adults less than 65 years with underlying medical conditions, such as heart problems, diabetes or neuromuscular disease.
People who are allergic to eggs should not get vaccinated. People who are allergic to latex will want to check with their provider since some vaccine comes into contact with latex. People should discuss any concerns with their health care provider.
The H1N1 flu vaccine is being offered free-of-charge by local public health departments at their flu clinics and by some private health plans. Some locations may charge an administrative fee. We recommend that you check ahead with your health care provider to learn about any possible fees.
The table indicates which vaccines you can take at the same time if they are indicated. Pneumococcal polysaccharide vaccine is recommended for those aged 65 years and older and those 2 years and older with certain chronic medical conditions. Pneumococcal conjugate vaccine is recommended for infants and young children.
If you get…
You can also take at the same time…
Seasonal flu spray
· H1N1 flu shot
· Pneumonia shot
H1N1 flu spray
· Seasonal flu shot
· Pneumonia shot
Seasonal flu shot
· H1N1 flu spray or shot
· Pneumonia shot
H1N1 flu shot
· Seasonal flu spray or shot
· Pneumonia shot
NOTE: You should not take the two different flu nasal spray vaccines (H1N1 and seasonal) at the same time. You must wait at least 14 days, or preferably 4 weeks between the two spray vaccines.
The side effects reported from the clinical trial are similar to those for the regular seasonal flu shot. The most common side effect is redness, swelling or tenderness at the injection site—basically a sore arm. The flu vaccine cannot give you the flu, this is a myth. If you are concerned about side effects or have felt any side effects after getting the H1N1 vaccine, we recommend that you contact the clinic where you got your vaccine immediately. You or your doctor can file a report. The most current vaccine safety information is available online at http://www.Flu.gov.
The H1N1 vaccine is being manufactured by the same companies that produce regular seasonal flu vaccine. The safety track record for seasonal influenza vaccine has been very good and so far, preliminary safety data from the clinical trials indicate that H1N1 vaccine will be not be any different.
National monitoring systems including Vaccine Safety DataLink and the Vaccine Adverse Events Reporting System (VAERS) are in place to continue monitoring the vaccine after it goes into distribution. The best place to get vaccine safety updates is at http://www.Flu.gov.
Clinical trial information shows that both the regular, injectable flu shot and the nasal spray vaccine provide very good protection against the H1N1 flu disease. The nasal spray vaccine is licensed only for healthy children and adults age 2 through 49 years old with no chronic health conditions like asthma or diabetes. Nasal spray vaccine also is not licensed for pregnant women. You can look up more information about the H1N1 vaccine safety and effectiveness at http://www.flu.gov.
The CDC recommends H1N1 vaccine and regular seasonal flu vaccine for all pregnant women. This is because pregnant women can get severely ill from a flu virus and could endanger themselves and their unborn child.
Millions of people, including pregnant women, have safely gotten flu shots for years. The H1N1 flu vaccine is basically a strain change and is made the same way seasonal flu vaccines are made each year.
Pregnant women should not be given the nasal spray form of the flu vaccine, only the flu shot given with a needle in the arm. You may get the flu shot during any trimester in your pregnancy. We recommend that you discuss this with your doctor to decide what’s right for you.
Flu shots this fall and winter will be available with or without thimerosal (a preservative that protects vaccines from contamination).
More information about flu shots and pregnancy can be found online at http://www.flu.gov.
The best place to check for H1N1 vaccine safety updates is at http://www.Flu.gov. The Centers for Disease Control and Prevention (CDC) also provides extensive vaccine safety information at : http://www.cdc.gov/h1n1flu/vaccination/safety_planning.htm.
Flu vaccines are generally considered safe for people taking other medications. However, we recommend that you talk to your doctor or pharmacist about possible interactions with any specific medications you or a family member is taking.
VAERS is the Vaccine Adverse Events Reporting System. The VAERS reporting system accepts reports from both health care providers and the public on adverse events associated with vaccines licensed in the United States. If you want to find out more about VAERS, or report a suspected vaccine adverse event, you can report it directly at: http://www.cdc.gov/vaccinesafety/vaers/.
VAERS is the Vaccine Adverse Events Reporting System. The VAERS reporting system accepts reports from both health care providers and the public on adverse events associated with vaccines licensed in the United States. If you want to find out more about VAERS, or report a suspected vaccine adverse event, you should contact the provider who gave you your vaccine or you can report a suspected vaccine side-effect online at: http://www.cdc.gov/vaccinesafety/vaers/.
The clinical trials data is expected to be available sometime during this fall. The best place to get vaccine safety updates is at http://www.Flu.gov.
Vaccine Information Statements (VISs) are information sheets produced by the Centers for Disease Control and Prevention (CDC) that explains vaccine benefits and risks. Federal law requires that a vaccine-specific VIS be handed out before each dose of a vaccine is given.
You can also find a copy of the new H1N1 flu vaccine VIS online at http://www.cdc.gov/vaccines/pubs/vis/default.htm#h1n1live. There are two separate VISs, one for the intranasal H1N1 vaccine and the other for the injectable (or inactivated) H1N1 vaccine. The VISs for the H1N1 vaccines are available in multiple languages.
CDC's Advisory Committee on Immunization Practices (ACIP) recommends that all children between 6 months and 18 years of age get the novel H1N1 vaccine. This is because there have been many cases of novel H1N1 influenza (flu) in children. They are also in close contact with each other in school and day care settings, which increases the likelihood of spreading the disease.
People who have a severe (life-threatening) allergy to chicken eggs or to any other substance in the vaccine should not be vaccinated.
Talk to your doctor before getting a flu shot if you:
Have ever had a severe allergic reaction to eggs;
Have ever had a severe allergic reaction to a previous flu shot; or
Have a history of Guillain-Barre Syndrome (GBS).
If you are sick with a fever when you go to get your flu shot, talk to your doctor or nurse about getting your shot at a later date. However, you can get a flu shot if you have a respiratory (breathing) illness without a fever; or if you have another mild illness.
Any person licensed to practice medicine in California is eligible to register for and order H1N1vaccine. Any entity such as a corporate community vaccinator, school health center, employee health program, or pharmacy is eligible—if they have a designated medical prescriber to complete the registration and ordering process. Registration is required to order; this includes VFC enrolled providers and local health departments. California’s centralized online ordering system at http://www.CalPanFlu.org.
Four lots of Sanofi Pasteur H1N1 vaccine were discovered to have lost their strength/potency after being shipped to health care providers.
The discovery was made during routine stability testing of vaccine.
The potency problem is specific to four lots of Sanofi Pasteur’s pediatric H1N1 vaccine in 0.25 mL pre-filled syringes.
The same vaccine packaged in other dosing forms, such as pre-filled syringes for older children adults, and multi-dose vials, continues to meet specifications.
This recall does not affect H1N1 vaccine produced by other manufacturers.
No. There are no safety concerns with these lots of H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency and safety.
Parents of children who received vaccine from the recalled lots do not need to take any action, other than to complete the two-dose immunization series if not already completed.
No. There is no need to re-administer a dose to those who received vaccine from these lots.
However, as is recommended for all H1N1 flu vaccines, all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response.
Children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.
Approximately 800,000 doses of vaccine in these lots were distributed to providers in the United States. Approximately 104,000 doses were distributed to providers in California.
No. The lots being recalled passed all quality controls and met all specifications before they were shipped.
The Centers for Disease Control and Prevention (CDC) has information on its Web site.
First, it is important to point out that the recall is not safety-related.
As part of its quality assurance program, the manufacturer of the nasal spray monovalent 2009 H1N1 flu vaccine, MedImmune, performs routine, ongoing stability testing of the vaccine.
Stability testing means measuring the potency of the vaccine over time to make sure it does not go below a pre-specified limit during the vaccine’s “shelf life.”
On December 18 and 21, the manufacturer notified CDC and FDA that the potency in 13 lots (about 4.7 million doses) of nasal spray vaccine had decreased below the pre-specified limit or were at risk of falling below that limit within the upcoming week. The vaccine was within the specified range at the time the vaccine was distributed. The slight decrease in potency should not affect how the vaccine works.
This recall does not affect H1N1 flu vaccine produced by other manufacturers.
However, a similar non-safety recall was conducted recently which involved lots of Sanofi Pasteur’s pediatric H1N1 flu vaccine in pre-filled syringes.
No. There are no safety concerns with these lots of H1N1 flu vaccine. All lots successfully passed pre-release testing for safety, purity and potency.
No. There is no need to re-administer a dose to those who received vaccine from these lots. Much of this vaccine has already been administered while fully potent and within specifications. The nasal vaccine is designed for healthy persons, aged 2-49.
Persons who received vaccine from the recalled lots do not need to take any special actions.
As is recommended for all H1N1 flu vaccines, all children younger than 10 years old should get the recommended two doses vaccine approximately a month apart.
Children younger than 10 years old who have only received one dose of the nasal spray vaccine should still receive a second dose of H1N1 flu vaccine.
Before they were shipped, the lots being recalled now passed all quality controls and met all specifications for safety, purity, and potency.
Vaccine from these 13 lots was distributed throughout the United States. More than a half million of the affected doses were distributed in California.
The Centers for Disease Control (CDC) has information on its Web site:
California Department of Public Health, Office of Public Affairs