H1N1 (Swine Flu) Vaccine Frequently Asked Questions for Health Care Providers
A summary of questions we've received from health care providers on H1N1
(swine flu) vaccine. We'll update this page regularly, so check back often for
the latest information.
These answers are only intended to address the current pandemic situation and
might change as the situation unfolds. They are not intended to be applied to
routine use during future flu vaccination efforts.
Vaccination of Pregnant and
Breastfeeding Women
Should providers vaccinate family members of a pregnant woman with the live,
attenuated intranasal H1N1 vaccine?
Yes, family and household members and other close contacts between the ages of 2
and 49 years, that are otherwise healthy and not pregnant, may receive the live,
attenuated intranasal H1N1 vaccine.
Should providers wait until the second trimester of pregnancy to give the
inactivated H1N1 vaccine to pregnant women?
Available data indicate that flu vaccine does not cause fetal harm or affect
fertility when given to a pregnant woman. Pregnant women and newborns are at
increased risk for flu complications, and all women who are pregnant or will be
pregnant during flu season should be vaccinated with inactivated H1N1 vaccine.
Vaccination can occur during any trimester of the pregnancy. Benefits of
vaccinating pregnant women usually outweigh potential risks from the vaccine.
If a pregnant mother receives the H1N1 vaccine, will the baby have some immunity
to the H1N1 virus after it is born?
After vaccination with seasonal flu vaccine, there may be passive transfer of
anti-influenza antibodies that might provide some protection from the vaccinated
woman to the newborn. At this time, there is no specific data available for H1N1
vaccine and passive transfer of antibodies from vaccination of pregnant women to
their newborns.
Can a pregnant health care worker administer the live, attenuated intranasal
H1N1 vaccine?
Pregnant health care workers may administer the live, attenuated intranasal H1N1
vaccine. No special precautions (like gloves and masks) are needed. Hands should
be washed or cleaned with waterless hand sanitizer before and after giving the
vaccine or having any direct contact with patients in a health care setting.
Can women who are breastfeeding receive the live, attenuated intranasal H1N1
vaccine or should they receive the inactivated H1N1 vaccine?
It is OK to give the live, attenuated intranasal H1N1 vaccine to women who are
breastfeeding.
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Vaccination of Health Care Workers
Can health care workers receive the live, attenuated intranasal H1N1 vaccine?
The Centers for Disease Control and Prevention’s guidelines on the live,
attenuated intranasal H1N1 vaccine and health care workers, including emergency
medical services personnel, say it’s OK to give the live H1N1 vaccine to health
care workers who are otherwise healthy and not pregnant through age 49 years.
This vaccine can also be given to health care workers with infants under six
months or other household contacts with immunodeficiency conditions.
Health care workers who are vaccinated with the live H1N1 vaccine should not
care for patients with severely weakened immune systems requiring protective
isolation for seven days after vaccination. Health care workers that take care
of people with lesser degrees of immunosuppression (people with diabetes,
healthy newborns or newborns in intensive care units, those taking long-term
steroids or people with HIV) can receive the live H1N1 vaccine.
Can a pregnant health care worker administer the live, attenuated intranasal
H1N1 vaccine?
Yes, pregnant health care workers may administer the live, attenuated intranasal
H1N1 vaccine. No special precautions (like gloves and masks) are needed. Hands
should be washed or cleaned with waterless hand sanitizer before and after
giving the vaccine or having any direct contact with patients in a health care
setting.
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Contraindications
Should patients with known egg allergies be given the H1N1 vaccine?
People who have had symptoms like hives or swelling of the lips or tongue or who
have experienced breathing problems after eating eggs should consult their
health care provider to see if they should get the vaccine. More information on
administering flu vaccine to asthmatic children with severe disease and egg
hypersensitivity can be found on the
American Academy of Allergy and Asthma & Immunology Web site and in the
Journal of
Pediatrics.
Is it safe to give the inactivated H1N1 vaccine to a patient with an allergy to
gentimicin?
Yes, it is safe to administer the inactivated H1N1 vaccine to a patient with an
allergy to gentimicin. The live, attenuated intranasal H1N1 vaccine does contain
gentimicin and should not be used for individuals with a gentamicin allergy.
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Timing, Dosage, and Administration
Can the seasonal flu vaccine and the H1N1 vaccine be given to patients at the
same time?
Yes, patients can be given the seasonal flu vaccine and H1N1 vaccine on the same
day. However, patients cannot get two nasal spray vaccines on the same day. A
seasonal flu nasal spray vaccine and an H1N1 nasal spray vaccine need to be
separated by at least four weeks. It is important to note that seasonal flu
vaccine is available now and patients shouldn’t wait until H1N1 vaccine becomes
available to get vaccinated. Patients should get vaccinated against seasonal flu
as soon as they can. Both influenza viruses can cause illness, hospitalizations,
and death. If a patient is at risk for pneumococcal pneumonia, vaccinate them
with pneumococcal vaccine to prevent flu complications.
Will two doses of H1N1 vaccine be needed?
Yes, but only for people under age ten. The U.S. Food and Drug Administration
(FDA) approved the use of one dose of H1N1 vaccine for those ten years or older.
Two doses create better protection in the less mature immune systems of younger
children. For that reason, the FDA approved two doses for children nine years
and younger. The FDA continues to test to be sure that the number of doses it
recommends for all age groups are effective.
If two doses are needed, how long after the first dose must children wait to
receive the second dose?
The minimum interval recommended for children 9 years and younger is at least 28
days between the first and second vaccination.
If a person receives two live, attenuated intranasal H1N1 vaccines and it is
less than 28 days, should one of the vaccines be repeated?
As little as 14 days (2 weeks) might be sufficient to allow for an appropriate
immune response. Therefore, an interval between the two types of live,
attenuated intranasal H1N1 vaccines may be acceptable, although an interval of
28 days is preferred. If the interval is less than 1-13 days, the vaccine more
recently administered should be repeated.
The age for two doses of vaccine is different for the seasonal flu vaccine (six
months through eight years) and the H1N1 vaccine (six months through nine years)
in the prescribing information from the manufacturers. Should the two doses for
H1N1 vaccine be given at the same ages and intervals as the seasonal flu
vaccine?
The Centers for Disease Control and Prevention recommends that clinicians follow
the guidance in the manufacturer’s prescribing information. For H1N1 vaccine,
administer two doses to children six months through nine years. People ten years
and older should receive one dose.
Can a child who requires two doses of H1N1 vaccine and who received the
first dose with the inactivated H1N1 vaccine complete the series with the live,
attenuated intranasal H1N1 vaccine, or vice versa?
When feasible, the same type of vaccine should be used in a two-dose
schedule, but mixed schedules are preferable to not completing the series. A
28-day interval between doses is recommended, but 21 days is acceptable. There
are limited data on mixed schedules.
If live, attenuated intranasal
seasonal flu vaccine and live, attenuated intranasal H1N1 vaccine are given at
the same time, do either of the doses need to be repeated? If so, when?
Live, attenuated intranasal seasonal flu vaccine and seasonal H1N1 vaccines
should not be administered at the same visit. Administration of both live virus
vaccines at the same time could result in reduced protection for one vaccine.
However, if both types of the vaccine are inadvertently administered at the same
visit, neither vaccine needs to be repeated.
Children from six months to nine years should receive two doses of H1N1
vaccine. What is the acceptable interval when using the inactivated H1N1 vaccine
and the live, attenuated intranasal flu vaccine?
The two doses of inactivated H1N1 vaccine should be separated by 28 days.
However, trials have often used a 21-day interval. Giving the two doses at least
21 days apart is safe. If the second dose of inactivated H1N1 vaccine is
separated by at least 21 days, the dose should be considered valid, although 28
days is preferred. If the two doses are not separated by 21 days, the second
dose should be repeated 28 days or more after the first dose (21 days is
acceptable). Trials of 2009 live, attenuated intranasal H1N1 vaccines have used
a 28-day interval between doses, so 28 days is the appropriate valid interval.
Can H1N1 vaccines be used outside of the Food and Drug Administration
(FDA)-approved age indications?
Whenever possible, vaccines should be administered in accordance with FDA
labeling. Vaccines approved for an age group have undergone required testing for
that age group. There are no known safety concerns with use of inactivated
vaccines in appropriate doses outside their labeled age indications. Data on
vaccine effectiveness when used outside of labeled age indications are limited.
Live, attenuated intranasal flu vaccine should not be used outside the approved
age indications (2-49 years) and inactivated vaccine should not be given to
infants younger than six months. However, clinicians may use inactivated H1N1
vaccines for persons aged six months and older outside their labeled age range
if a vaccine licensed for use in a particular age group is not available and the
need to provide vaccination is urgent. For instance, some H1N1 vaccines (for
example, the CSL product licensed for people 18 years and older and the Novartis
product licensed for children and adults four years and older) may be used if
the alternative would be for the child to not receive flu vaccine at that visit.
For children aged 6 through 35 months, 0.25 mL of a vaccine licensed for older
children or adults should be used. Use of vaccines outside approved indications
is a temporary measure that applies only to special circumstances faced during
the 2009 H1N1 pandemic and should be avoided, if possible.
Can a person who gets the H1N1 vaccine donate blood?
The Centers for Disease Control and Prevention does not make recommendations
regarding blood donation and receiving vaccines, except for the hepatitis B
vaccine. These rules are made by the Red Cross and other agencies. The Red Cross
indicates there is no waiting period to donate blood after receiving either a
seasonal inactivated or live, attenuated intranasal flu vaccine or the
inactivated or live, attenuated intranasal H1N1 vaccine. It also says that
donating blood will not make an individual more susceptible to influenza
disease, including H1N1. For more information, contact the
Red Cross
or the agency that is performing the blood donation activities.
Can a person who had a blood transfusion, blood products, or immune
globulin in the last year be given the live, attenuated intranasal H1N1 vaccine?
Yes, there are no contraindications for giving the live, attenuated
intranasal H1N1 vaccine to someone who had a blood transfusion, blood products,
or immune globulin within the last year.
Should we repeat the live, attenuated intranasal H1N1 vaccine if, during
administration, some of the dose ran out of the patient's nose or if the patient
sneezed immediately after getting the vaccine?
The Centers for Disease Control and Prevention has no specific guidance on
this issue. It is not recommended for the dose to be repeated if a person
sneezed after getting the vaccine. You may consider revaccination if half the
dose missed the nostril. This decision is left to your discretion.
Should someone who received other live virus vaccines (such as MMR,
varicella, or yellow fever vaccines) wait 28 days before receiving live,
attenuated intranasal H1N1 vaccine?
Yes, if someone received a live virus vaccine in the past four weeks, they
should wait 28 days before receiving the live, attenuated intranasal H1N1
vaccine. The live, attenuated intranasal seasonal flu vaccine and the live,
attenuated intranasal H1N1 vaccines should be separated by at least four weeks
because of concerns about competition between the two vaccine viruses. There is
no reason to defer giving the live vaccine if someone was vaccinated with an
inactivated vaccine or if they have recently received blood or other
antibody-containing blood products (like immuneglobulin).
Live virus oral vaccines (such as oral polio, rotavirus, or oral typhoid
vaccines) are not believed to interfere with each other if not given
simultaneously. These vaccines may be given at any time before or after each
other. Live virus oral vaccines may be given at any time before or after live
parenteral vaccines or live, attenuated intranasal influenza vaccines.
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Transmission of Live, Attenuated Intranasal H1N1 Vaccine
Since the live, attenuated intranasal H1N1 vaccine is given in the nose, is
it possible to spread the virus to others after getting the vaccine?
The virus has been weakened in the manufacturing process so that it cannot grow
well in human tissue. It also does not survive and grow in certain temperatures.
The virus can grow in the nose and throat. However, once the virus reaches the
lower respiratory tract, the warm temperature destroys it. Shedding of the virus
can occur for up to three weeks. Most adults stop shedding virus by the third
day. The virus is shed in low levels. Even if transmission were to occur, there
are not enough particles to make a person ill. And since it can’t grow in the
lower respiratory tract, the potential for transmission is rare. There have not
been any reports of transmission of live virus vaccine to vulnerable patients.
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Vaccine Storage and Handling
The manufacturer’s prescribing information for the CSL multi-dose vials
indicates that once the stopper is pierced, the multi-dose vials need to be
discarded in 28 days. Why is this different from the other influenza products
that can be used up until the manufacturer’s expiration date?
According to the manufacturer’s prescribing information, the recommendations for
discarding the products made by CSL are different from the other products of the
other manufacturer’s of H1N1 vaccines. The Centers for Disease Control and
Prevention was consulted and its experts recommend following the prescribing
information from CSL regarding discarding this product within 28 days of
piercing the stopper.
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Influenza Antivirals and Vaccination
Can a person on antiviral medications receive H1N1 vaccine?
The live, attenuated intranasal H1N1 vaccine should not be given until the
person has been off of flu antiviral drugs for 48 hours, or if there is an
expectation that the person will be placed on antivirals in the next 14 days.
Antiviral medications can lower or prevent vaccinated people from responding to
the vaccine. This only applies to antivirals for flu and does not apply to
antiviral therapy (like antivirals for herpes or varicella). Antiviral drugs can
be taken with the inactivated H1N1 vaccine.
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Lab Tests and H1N1 Vaccines
Can a person who has received the live, attenuated intranasal H1N1 vaccine
test positive on a rapid flu diagnostic test?
The live, attenuated intranasal H1N1 vaccine can cause a positive test result on
a rapid flu diagnostic test if a person has been vaccinated in the past seven
days. The test cannot differentiate between the live H1N1 vaccine and wild-type
flu viruses.
Should the H1N1 vaccine be recommended for people who have had a flu-like
illness since last spring?
People in the recommended target groups who had a flu-like illness but did not
have lab confirmation of H1N1 disease should be vaccinated. This includes people
who had symptoms without testing and people that may have had a rapid antigen
test that showed they had an “Influenza A” illness, but was not confirmed to be
the H1N1 influenza strain.
People who were not tested, but who became ill after being exposed, should not
assume they had H1N1 disease. People whose test confirmed they had H1N1 disease
should consult their primary care provider about vaccination. Someone who was
infected with H1N1 and who is not severely immunocompromised will likely have
some immunity to subsequent infection with the H1N1 virus. Vaccination of a
person with some existing immunity or those that are unsure if they had the
disease will not be harmful.
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Vaccine Safety
What is the procedure for reporting adverse reactions?
The Centers for Disease Control and Prevention and the Food and Drug
Administration will be closely monitoring any signs that the vaccine is causing
unexpected adverse reactions. Health care providers and patients can report
suspected adverse reactions through the
Vaccine Adverse Event Reporting System (VAERS).
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Last Update:
11/12/2009 03:11 PM
