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CDC: Pregnant Women and 2009 H1N1 Influenza (updated Sept 1, 2009)

thebes

Well-known member
http://www.cdc.gov/h1n1flu/clinician_pregnant.htm

This document provides updated, interim guidance on the use of influenza antiviral treatment of pregnant women who are sick with novel influenza A (H1N1). The highest priority message is to treat pregnant women with influenza-like illness as soon as possible; treatment should not be withheld pending results of testing for influenza, if testing is done. Influenza antiviral chemoprophylaxis recommendations have been updated to be consistent with CDC recommendations for chemoprophylaxis for high risk groups. Finally, infant feeding recommendations have been updated to reflect current mask use guidance and the need for a cautious approach to preventing infection in infants, even though clinical data are lacking. Recommendations are interim, based on current knowledge of the H1N1 outbreak in the United States, and may be revised as more information becomes available.

On this Page
Background
Clinical presentation
Treatment and chemoprophylaxis
Other ways to reduce risk for pregnant women
Infant feeding considerations

Background
Human infections with a novel influenza A (H1N1) virus that is easily transmissible among humans were first identified in April 2009. Severe illnesses among pregnant woman and infants have been reported in this outbreak although the epidemiology and spectrum of illness among pregnant woman and infants are not fully understood at this time and are under investigation.

However, evidence that influenza can be more severe in pregnant women is available from observations during previous pandemics and from studies among pregnant women who had seasonal influenza. An excess of influenza-associated deaths among pregnant women were reported during the pandemics of 1918?1919 and 1957?1958. Adverse pregnancy outcomes have been reported following previous influenza pandemics, with increased rates of spontaneous abortion and preterm birth reported, especially among women with pneumonia. Case reports and several epidemiologic studies conducted during interpandemic periods also indicate that pregnancy increases the risk for influenza complications for the mother and might increase the risk for adverse perinatal outcomes or delivery complications.

Clinical presentation
Pregnant women with novel influenza A (H1N1) virus infection would be expected to present with typical acute respiratory influenza-like illness (e.g., cough, sore throat, rhinorrhea) and fever. Other symptoms can include body aches, headache, fatigue, vomiting and diarrhea. Many pregnant women will go on to have a typical course of uncomplicated influenza. However, for some pregnant women, illness might progress rapidly, and might be complicated by secondary bacterial infections including pneumonia. Fetal distress associated with severe maternal illness can occur. Case reports of adverse pregnancy outcomes and maternal deaths have been associated with severe illness. Ideally, pregnant women who have suspected novel influenza A (H1N1) virus infection should be tested for influenza. However, treatment should not be delayed pending results of testing and treatment should not be withheld in the absence of testing. This is because antiviral treatment is most effective when started as early as possible after the onset of symptoms (i.e. within the first 2 days). Testing is not available in many instances and, when available, results of novel H1N1 testing often take several days. Clinicians should be aware of circulation of H1N1 in their area and not wait for test results to initiate influenza treatment in women who have symptoms consistent with influenza illness.

Treatment and chemoprophylaxis
Early treatment with influenza antiviral medications is recommended for pregnant women with suspected influenza illness. Clinicians should not wait for test results to initiate treatment since these medications work best if started as early as possible after illness onset. The currently circulating novel influenza A (H1N1) virus is sensitive to the neuraminidase inhibitor antiviral medications zanamivir (Relenza?) and oseltamivir (Tamiflu?), but is resistant to the adamantane antiviral medications, amantadine (Symmetrel?) and rimantadine (Flumadine?). Oseltamivir is given orally and results in systemic absorption; by contrast, zanamivir is given by inhalation and results in lower systemic absorption. Oseltamivir and zanamivir treatment and chemoprophylaxis regimens recommended for pregnant women are the same as those recommended for adults who have seasonal influenza. Pregnancy should not be considered a contraindication to oseltamivir or zanamivir use. Pregnant women appear to be at higher risk for severe complications from novel influenza A (H1N1) virus infection, and the benefits of treatment or chemoprophylaxis with oseltamivir or zanamivir outweigh the theoretical risks of antiviral use. Although a few adverse effects have been reported in pregnant women who took these medications, no relation between the use of these medications and those adverse events has been established. More information on influenza antiviral medications is available at: CDC Interim Guidance on Antiviral Recommendations for Patients with Novel Influenza A (H1N1) Virus Infection and Their Close Contacts.

Treatment Recommendations
Pregnant women with influenza-like illnesses should receive empiric antiviral treatment. Because of its systemic activity, the drug of choice for treatment of pregnant women is oseltamivir. Recommended duration of treatment is five days. Treatment should not be delayed while waiting for the results of viral testing. As is recommended for other persons who are treated, antiviral treatment should be initiated as soon as possible after the onset of influenza symptoms, with benefits expected to be greatest if started within 48 hours of onset, based on data from studies of seasonal influenza. However, data from studies on seasonal influenza indicate benefit for hospitalized patients even if treatment is started more than 48 hours after onset. Thus, antiviral medications are recommended for high risk persons, including pregnant women, presenting for care more than 48 hours after illness onset, particularly for those who require hospitalization


Chemoprophylaxis Recommendations
Post exposure antiviral chemoprophylaxis can be considered for pregnant women who are close contacts of persons with suspected or laboratory confirmed novel influenza A (H1N1) virus infection. The drug of choice for prophylaxis is probably zanamivir because of its limited systemic absorption. However, respiratory complications that may be associated with zanamivir because of its inhaled route of administration need to be considered, especially in women at risk for respiratory problems. For these women, oseltamivir is a reasonable alternative. Recommended duration of chemoprophylaxis is for 10 days after the last known exposure to novel influenza A (H1N1). In situations where multiple exposures are likely to occur, such as within families, the total length of chemoprophylaxis for a pregnant woman may depend on clinical considerations. Close monitoring for influenza like illness in exposed pregnant women is recommended.


Fever Treatment
One of the more well-studied adverse effects of influenza is its associated hyperthermia. Studies have shown that maternal hyperthermia during the first trimester doubles the risk of neural tube defects and may be associated with other birth defects and adverse outcomes. Limited data suggest that the risk for birth defects associated with fever might be mitigated by antipyretic medications and/or multivitamins that contain folic acid. Maternal fever during labor has been shown to be a risk factor for adverse neonatal and developmental outcomes, including neonatal seizures, encephalopathy, cerebral palsy, and neonatal death. Even though distinguishing the effects of the cause of fever from the hyperthermia itself is difficult, fever in pregnant women should be treated because of the risk that hyperthermia appears to pose to the fetus. Acetaminophen appears to be the best option for treatment of fever during pregnancy.

Table 1 below is extracted from the guidance on influenza antiviral medications. Additional information on influenza antiviral medications can be found at recommendations.

Table 1. Antiviral medication dosing recommendations for treatment or chemoprophylaxis of novel influenza A (H1N1) infection
(Table extracted from IDSA guidelines for seasonal influenza.) Agent, group Treatment Chemoprophylaxis
Oseltamivir
Adults 75-mg capsule twice per day for 5 days 75-mg capsule once per day

Zanamivir
Adults Two 5-mg inhalations (10 mg total) twice per day for 5 days Two 5-mg inhalations (10 mg total) once per day


Other ways to reduce risk for pregnant women
There is no vaccine available yet to prevent novel influenza A (H1N1) virus infection; however, the risk for novel influenza A (H1N1) virus infection might be reduced by taking steps to reduce the chance of being exposed to respiratory infections. These steps include:

Frequent hand washing.
Minimizing contact with sick individuals.
Having ill persons stay home (except to seek medical care).
Having ill persons cover coughs.
Avoiding, whenever possible, crowded settings in communities having outbreaks of novel influenza A (H1N1) virus.
And using facemasks and respirators correctly if they are used (see Interim Recommendations for Facemask and Respirator Use to Reduce Novel Influenza A (H1N1) Virus Transmission).


Infant feeding considerations
Infants who are not breastfeeding are more vulnerable to infection and hospitalization for severe respiratory illness than infants who are breastfeeding. Women who are not ill with influenza should be encouraged to initiate breastfeeding early and feed frequently. Ideally, babies should receive most of their nutrition from breast milk. Eliminate unnecessary formula supplementation, so the infant can receive as much maternal antibodies as possible

Infants are thought to be at higher risk for severe illness from novel influenza A (H1N1) infection and very little is known about prevention of novel H1N1 flu infection in infants. If possible, only adults who are not sick should care for infants, including providing feedings. The risk for novel influenza A (H1N1) transmission through breast milk is unknown. However, reports of viremia with seasonal influenza infection are rare, which suggests that the risk of virus crossing into breast milk is also probably rare. Sick women who are able to express their milk for bottle feedings by a healthy family member should be encouraged to do so. Antiviral medication treatment or prophylaxis is not a contraindication for breastfeeding.

Careful adherence to hand hygiene and cough etiquette is critical, especially for sick women who do not have anyone to help with infant care while they are ill. Women with influenza-like illness are recommended to use facemasks when providing infant care and feedings (see Interim Recommendations for Facemask and Respirator Use to Reduce Novel Influenza A (H1N1) Virus Transmission).

Instruct parent and caretakers on how to protect their infant from the spread of germs, like novel influenza A (H1N1) virus, that cause respiratory illnesses:

Practice hand hygiene and cough etiquette at all times
Keep the infant away from persons who are ill and out of crowded areas.
Limit sharing of toys and other items that have been in infants' mouths. Wash thoroughly with soap and water any items that have been in infants' mouths.
 
Re: CDC: Pregnant Women and 2009 H1N1 Influenza (updated guidance: Sept 1, 2009)

Re: CDC: Pregnant Women and 2009 H1N1 Influenza (updated guidance: Sept 1, 2009)

2009 H1N1 Influenza Vaccine and Pregnant Women

September 1, 2009, 10:00 AM ET
General Public


Q: Why does CDC recommend that pregnant women receive the 2009 H1N1 influenza vaccine?
A. It is important for a pregnant woman to receive the 2009 H1N1 influenza vaccine as well as a seasonal influenza vaccine. A pregnant woman who gets any type of flu is at risk for serious complications and hospitalization. Pregnant women who are otherwise healthy have been severely impacted by the 2009 H1N1 influenza virus (formerly called ?novel H1N1 flu? or ?swine flu?). In comparison to the general population, a greater proportion of pregnant women infected with the 2009 H1N1 influenza virus have been hospitalized. In addition, severe illness and death has occurred in pregnant women. Six percent of confirmed fatal 2009 H1N1 flu cases thus far have been in pregnant women while only about 1% of the general population is pregnant. While hand washing, staying away from ill people, and other steps can help to protect pregnant women from influenza, vaccination is the single best way to protect against the flu.


Q: Is there a particular kind of flu vaccine that pregnant women should get? Are there flu vaccines that pregnant women should not get?
A. There are two type of flu vaccine. Pregnant women should get the "flu shot"? an inactivated vaccine (containing fragments of killed influenza virus) that is given with a needle, usually in the arm. The flu shot is approved for use in pregnant women.
The other type of flu vaccine ? nasal-spray flu vaccine (sometimes called LAIV for ?live attenuated influenza vaccine)?is not currently approved for use in pregnant women. This vaccine is made with live, weakened flu viruses that do not cause the flu). LAIV (FluMist?) is approved for use in healthy* people 2-49 years of age who are not pregnant.

Q. Will the seasonal flu vaccine also protect against the 2009 H1N1 flu?
A. The seasonal flu vaccine is not expected to protect against the 2009 H1N1 flu. Similarly, the 2009 H1N1 influenza vaccine will not protect against seasonal influenza.

Q. Can the seasonal influenza vaccine and the 2009 H1N1 influenza vaccine be given at the same time?
A. It is anticipated that seasonal flu and 2009 H1N1 vaccines may be administered on the same day but given at different sites (e.g. one shot in the left arm and the other shot in the right arm). However, we expect the seasonal vaccine to be available earlier than the 2009 H1N1 influenza vaccine. The usual seasonal influenza viruses are still expected to cause illness this fall and winter. Pregnant women and others at increased risk of complications of influenza are encouraged to get their seasonal flu vaccine as soon as it is available.

Q: Is the 2009 H1N1 influenza vaccine safe for pregnant women?
A: Influenza vaccines have not been shown to cause harm to a pregnant women or her baby. The seasonal flu shot (injection) is proven as safe and already recommended for pregnant women. The 2009 H1N1 influenza vaccine will be made using the same processes and facilities that are used to make seasonal influenza vaccines.

Q: What safety studies have been done on the 2009 H1N1 influenza vaccine and have any been done in pregnant women?
A: A number of clinical trials which test 2009 H1N1 influenza vaccine in healthy children and adults are underway. These studies are being conducted by the National Institutes of Allergies and Infectious Diseases (NIAID). Studies of 2009 H1N1 influenza vaccine in pregnant women are expected to begin in September.

Q: Does the 2009 H1N1 influenza vaccine have preservative in it?
A: There is no evidence that thimerosal (used as a preservative in vaccine packaged in multi-dose vials) is harmful to a pregnant woman or a fetus. However, because some women are concerned about exposure to preservatives during pregnancy, manufacturers will produce preservative-free seasonal and 2009 H1N1 influenza vaccines in single dose syringes for pregnant women and small children. CDC recommends that pregnant women may receive influenza vaccine with or without thimerosal.

Q: Can the 2009 H1N1 influenza vaccine be given at any time during pregnancy?
A: Yes.

Q: How many 2009 H1N1 influenza vaccine shots will be needed?
A: Some people, including pregnant women, may need two doses. We will know more about the number of doses once data from the clinical trials are available.

Q. What will be the recommended interval between the first and second dose if two doses are needed?

A. This will not be known until clinical trial data are available. We anticipate that 21-28 days will be needed between the first and second doses.

Q: Should the 2009 H1N1 influenza vaccine be given to someone who has had an influenza- like illness since between April and now? Do I need a test to know if I need the vaccine or not?
A. There is no test that can show whether a person had 2009 H1N1 influenza in the past. Many different infections, including influenza, can cause influenza-like symptoms such as cough, sore throat and fever. In addition, infection with one strain of influenza virus will not provide protection against other strains. People for whom influenza vaccine is recommended should receive the 2009 H1N1 vaccine, even if they had an influenza-like illness previously. It is not necessary to test a person who previously had an influenza-like illness. People for whom the 2009 H1N1 influenza vaccine is recommended should receive it, even if they have had an influenza-like illness previously, unless they can be certain they had 2009 H1N1 influenza based on a laboratory test that can specifically detect 2009 H1N1 viruses. CDC recommends that persons who were tested for 2009 H1N1 influenza discuss this issue with a healthcare provider to see if the test they had was either an RT-PCR or a viral culture that showed 2009 H1N1 influenza. There is no harm in being vaccinated if you had 2009 H1N1 influenza in the past.

Q: What are the possible side effects of the 2009 H1N1 influenza vaccine?
A. The side effects from 2009 H1N1 influenza vaccine are expected to be similar to those from seasonal flu vaccines. The most common side effects following vaccination are expected to be mild, such as soreness, redness, tenderness or swelling where the shot was given. Some people might experience headache, muscle aches, fever, nausea and fainting. If these problems occur, they usually begin soon after the shot and may last as long as 1-2 days. Like any medicines, vaccines can cause serious problems like severe allergic reactions. However life-threatening allergic reactions to vaccines are very rare. In 1976, an earlier type of swine flu vaccine was associated with cases of a severe paralytic illness called Guillain-Barre Syndrome (GBS) at a rate of approximately 1 case of GBS per 100,000 persons vaccinated. Some studies done since 1976 have shown a small risk of GBS in persons who received the seasonal influenza vaccine. This risk is estimated to be no more than 1 case of GBS per 1 million persons vaccinated. Since then, flu vaccines have not been clearly linked to GBS. GBS has a number of different causes, and GBS can occur in a person who has never received an influenza vaccine. The potential benefits of influenza vaccination in preventing serious illness, hospitalization, and death substantially outweigh these estimates of risk for vaccine-associated GBS.
Anyone who has a severe (life-threatening) allergy to eggs or to any other substance in the vaccine should not get the vaccine. People should always inform their immunization provider if they have any severe allergies, if they?ve ever had a severe allergic reaction following flu vaccination, or if they have ever had GBS.

Q. Can the family members of a pregnant woman receive the nasal spray vaccine?
A. Pregnant women should not receive the live nasal spray influenza vaccine but family and household members and other close contacts of pregnant women (including healthcare personnel) who are 2 through 49 years old, healthy* and not pregnant may receive live nasal spray vaccine.

Q. Can a pregnant healthcare worker administer the live nasal influenza vaccine?
A. Yes. No special precautions are (such as gloves) are necessary. Hands should be washed or cleaned with waterless hand sanitizer before and after administering the vaccine or having any direct contact with patients in a health care setting.
Healthcare Providers


Q. Where can healthcare providers obtain 2009 H1N1 influenza vaccine?
A. The CDC will be distributing the 2009 H1N1 influenza vaccine to each state. If healthcare providers want to provide H1N1 vaccine directly to their patients, they can contact their local health department to obtain H1N1 vaccine. Information to direct providers interested in obtaining vaccine to appropriate public health contacts in their state is available.

Q. How will healthcare providers obtain other supplies necessary for vaccination?
A. The vaccine will be distributed with a kit which will contain needles, syringes, sharps containers and alcohol swabs.

Q. How much does the vaccine cost?
A. The vaccine will be provided free; however, healthcare providers may bill for vaccine administration.

Q. If a pregnant woman delivers before receiving her second dose of vaccine, should she still receive the second dose?
A. Yes. In addition to protecting her from infection, infants less than 6 months old will not be able to be vaccinated so it is recommended that everyone who lives with or provides care for infants less than 6 months of age receive both the seasonal influenza vaccine and 2009 H1N1 influenza monovalent vaccine to provide protection for the infant.
One recent study conducted in Bangladesh, assessed the effectiveness of influenza immunization for mothers and their young infants. Inactivated influenza vaccine reduced proven influenza illness by 63% in infants up to 6 months of age. This study confirmed that maternal influenza immunization is a strategy with substantial benefits for both mothers and infants.

Q. Where can healthcare providers get more information about the 2009 H1N1 influenza vaccine?
A. Information is continually updated at http://www.cdc.gov/h1n1flu/vaccination/


http://www.cdc.gov/H1N1flu/vaccination/pregnant_qa.htm
 
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