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jeudi 1 décembre 2011

Influenza ( 2009 H1N1 ) & Pregnancy: Vaccination and Treatment

Swine Flu, Influenza A, H1N1 v, Pregnancy, High Risk, WHO, CDC, EMEA, FDA, Vaccination, 3rd Trimester, Antiviral,Tamiflu, Relenza, Breastfeeding

WHO, CDC, European experts have identified Pregnant Women as a high risk priority group for influenza A vaccination and antiviral treatment. Clinical studies and CDC data show a relatively high mortality in pregnant women due to 2009 H1N1 infection. Current recommendations call for starting the antiviral therapy in pregnant women as soon as possible and even before waiting for the confirmatory test for 2009 H1N1. CDC/WHO recommend continued breastfeeding during antiviral treatment.

Table des matières

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WARNINGS AND RECOMMENDATIONS
WHO, CDC
 
From Sanofi Aventis Image Library
 
Digital image model of 2009 H1N1 Virus
 
 
This is for information only. 
 
You are responsible for your own health and all decisions about your own health must be taken in consultation with your treating medical doctor/specialist and in accordance with national guidelines. 
A pregnant woman is highly susceptible to H1N1 infection and must take extra precautions (hand wash, soap, mask, minimize contact with infected persons) in minimizing the risk of exposure to the virus
Influenza A/2009 H1N1.
International (WHO, European) and National (CDC, UK, Swiss, Canada, Belgium French) recommendations are summarized here and links, RSS feeds and video links are provided for your information.
 
 
 

Injectable Vaccines

Intranasal Vaccine


EMEA Approval
http://www.emea.europa.eu/pdfs/human/pandemicinfluenza/60825909en.pdf

Information about pandemic influenza vaccines

Informations sur les vaccins contre la grippe pandémiqueInformazioni sui vaccini per l’influenza pandemicaInformācija par gripas pandēmijas vakcīnām

Celvapan
 
Visit the Agency's new Pandemic influenza (H1N1) website


  • Asthma Information for Patients and Parents of Patients (CDC, 15 Sep 2009)

  • Use of Influenza A (H1N1) 2009 Monovalent Influenza Vaccine in Pregnant Women


    •  
    FDA and EMEA have approved the emergency use of Tamiflu in pregnant women and babies less than 1 year old during Pandemic 2009 H1N1 outbreak and extended the shelf life of Tamiflu by 2 years (from earlier 5 to 7 years). Relenza can be used in patients not responding to Tamiflu. 



    [Ways to produce a flu vaccine chart]

    1 - Risks for pregnant women?

        The pregnant woman is more likely that another person getting the flu, but it is more likely to develop certain complications and particularly: 

    • Lung Infection Model pneumonia, this infection poses a significant risk to the mother and also to the fetus.
    • Respiratory Distress Syndrome
    • Risk of miscarriage
    • Risk of premature delivery

     Chest infection symptoms may appear late in the 2nd quarter and during the 3rd quarter, but they can also worsen during late pregnancy. 
            The risks of miscarriage are possible during the first months of pregnancy may be the complication of pulmonary infection. 
        According to some studies, contact the influenza A in late pregnancy may increase the risk through 4, see 5 of the emergence of cardiovascular complications for mother and cardiac events for the fetus. 
        In newborns, the infection of influenza A can be fatal.

        It should be noted however that these infections are very rare and do not pose particular risks.

    The Augusta Chronicle - Tom Corwin - ‎1 hour ago‎
    Less than 65 percent of health care workers and less than half of pregnant women got a flu shot last season, the Centers for Disease Control and Prevention reported Thursday, but both are still good increases over previous rates.


    2 - Important Risks for mother and child?


        Above 2nd, 3rd month of pregnancy and late pregnancy.


    2 months pregnancy
    cours.fse.ulaval.ca


    3 months pregnancy
    web.libre.or

    I Never Get The Flu

    Source: National Center for Immunization and Respiratory Diseases 
    Running Time: (1:01)Release Date: 12/15/2009http://www.cdc.gov/CDCTV/INever/index.html
    CDC Video Player. Flash Player 9 is required.
    CDC Video Player.
    Flash Player 9 is required.

    3 - Recommendations for pregnant women?


        a / pursue a completely normal life, whether family or social 
        In the case of symptoms, better stay home. 

        b / on hygiene, the same recommendations should be implemented, to recall: 

        Wash hands carefully with soap and water (at home it is best to use warm water and hand sanitizer). 
        Wash hands in all possible situations (sneezing, blowing your nose, back home ...) 
        A bottle containing disinfectant can find a place in a handbag, like any cosmetic product (perfume and other). 
        
        c / social behavior: coughing and sneezing or in the elbow, either inside the arm, rather than doing it in the interior of the hands. 
        Pay particular attention to items shared with others: work area, office furniture, computer .... 
    In case of contact the suspect, a visit to the doctor is required (for review and possible absorption). 


    4 - Recommendations for nursing women?


    Breastfeeding: Women who contacted the virus while they are breastfeeding "may" continue breastfeeding during their antiviral therapy.
     
    Wash hand before touching your baby
     
    Wear mask during breastfeeding and never cough or sneeze directly or in the direction of your baby.


    5 - Influenza symptoms:


    • Sudden fever (but can not quite too high)
    • Cough
    • Sore throat
    • Wheezing
    • Stiffness
    • Fatigue
    • Nausea, vomiting and diarrhea may also occur.

        If symptoms, consult a physician preference. 


    6 - Chronic conditions that may increase the risk of influenza complications in pregnant women (non-exhaustive list):


    • Cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis and asthma) ...
    • Diabetes mellitus or other metabolic diseases ...
    • Cancer, immunodeficiency, immunosuppression (due to underlying disease or treatment) ...
    • Kidney ...
    •  Anemia or hemoglobinopathy ...
     
    Text: Beware of H1N1 Fraudulent Products: More

    7 - Recommendations for immunizations in pregnant women:

        Should one or not vaccinate pregnant women, nursing women ?
        See the various recommendations by major countries on vaccination

    USA-CDC
    RECOMMENDATIONS CONCERNING THE ANTI-INFLUENZA VACCINATION AMONG PREGNANT WOMEN IN THE UNITED STATES 

    Pregnant women are at risk for complications from influenza, as all pregnant women and women who will be pregnant during the influenza season should be vaccinated.

    The American College of Obstetricians and Gynecologists (The American College of Obstetricians and Gynecologists) and the American Academy of Family Physicians (American Academy of Family Physicians) also recommended routine vaccination of all pregnant women.

    No preference was expressed for the use of an inactivated vaccine that does not contain thimerosal as a preservative.

    The use of live attenuated vaccine against influenza in pregnancy has not been approved.

    If you are pregnant or breastfeeding, it would be better to seek advice from your physician.

    Sources   : CDC,


    SWITZERLAND

    RECOMMENDATIONS FOR INFLUENZA VACCINATION AMONG PREGNANT WOMEN IN SWITZERLAND

    Some small studies indicate that pregnancy may increase the risk of serious complications from the flu.
    Researchers estimate that routine immunization of pregnant women would lead to a decrease of one or two hospitalizations per 1,000 pregnant women vaccinated.

    As the vaccine against influenza is inactivated (that is to say he is not alive), vaccination is theoretically safe for pregnant woman and her fetus.

    For these reasons the United States vaccination against influenza is recommended for all women who will be the second or third trimester of pregnancy during the season of the flu epidemic.

    However, public health authorities in Switzerland and most European countries and the World Health does not recommend routine vaccination of pregnant women, since data on this subject are still considered insufficient to make that decision .

    Moreover, generally avoids any drug or vaccine during pregnancy, especially during the first quarter.

    However, a woman who should be vaccinated against influenza because of a chronic condition may continue to benefit from this vaccination during pregnancy. Her baby at birth will have antibodies against the influenza virus that will provide at least partial protection for several weeks.

    Breastfeeding is not a cons-indication for vaccination against influenza.
    It poses no risk to the breastfeeding mother or her baby.

    Consequently, women in whom vaccination against influenza is indicated should continue to be vaccinated while breastfeeding.

    If you are pregnant or breastfeeding, it would be better to seek advice from your physician.
    FRENCH
     
    RECOMMENDATIONS FOR INFLUENZA VACCINATION AMONG PREGNANT WOMEN IN FRANCE

    In France, the Technical Committee on Immunization does not recommend the widespread vaccination of pregnant women against seasonal influenza in the absence of adequate data on efficacy and safety of this vaccine in this situation as well as the impact of influenza during pregnancy, both in the mother that the fetus:

    1 - however, he recalls that pregnant women with specific risk factors can be vaccinated against influenza during the second or third trimester and those at high risk of complications associated with influenza can be vaccinated regardless appropriate stage of pregnancy;

    2 - finally, for women without specific risk factors that give birth during the period of viral circulation, and whose child has risk factors, vaccination is recommended and should be practiced to motherhood.

    If you are pregnant or breastfeeding, it would be better to seek advice from your physician.

    Source   Guide vaccinations (France) 2008 edition
     


    Vaccine Facts

    There is no compulsory vaccination program in democratic countries.
    WHO experts have reviewed the safety of adjuvants in vaccines marketed in Europe and did not identify any safety concerns.
    Guillain Barré Syndrome GBS is an acute disorder of the nervous system and sometimes develops as a result of infections.
    Post marketing surveillance studies suggest that influenza vaccines may be sometimes associated with GBS at the rate of 1-2 person per million of person vaccinated.

    The 1956 Influenza vaccine in the USA led to 10 cases of GBS per million and was withdrawn from the market.
    The Institute of Medicine and CDC after careful review have discounted the link of vaccination (vaccines with mercury containing preservative thimerosal) in children to autism. The US courts have sided with IOM and CDC experts and rejected several vaccine injury claims.
    ( Maggon K. Industrial R&D paradigm shift to vaccines. Biotechnol J. 2009, 4, 458-461. Doi 10.1002/biot.200900042)

    If you are allergic to egg white or proteins, ask your doctor for a cell cultured or inhaled vaccine.
    Majority of new influenza vaccines do not contain the preservative thimerosal. If concerned, ask for a preservative free influenza vaccine.



    2009 H1N1 Influenza Vaccine and Pregnant Women 

    CDC Updated Guidelines



    CDC recommend that pregnant women receive the 2009 H1N1 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. 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.

    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.

    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.

    Influenza vaccines have not been shown to cause harm to a pregnant woman 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.

    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.

    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.

    CDC anticipate that 21-28 days will be needed between the first and second doses.

    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.

    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. Cell cultured (protein free medium) vaccines are available in Europe as alternative but not in USA. FluMist is approved only in the USA but is not approved for use in pregnant women and is not approved in Europe.
     
    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.

    Clinical review: Recommendations for the administration of influenza vaccine in children allergic to egg (15 Sep 2009)  BMJ
     
    Published 15 September 2009, doi:10.1136/bmj.b3680
    Cite this as: BMJ 2009;339:b3680

    Clinical Review

    Recommendations for the administration of influenza vaccine in children allergic to egg

    M Erlewyn-Lajeunesse, consultant in paediatric allergy 1, N Brathwaite, consultant in paediatric allergy2, J S A Lucas, honorary consultant in allergy and respiratory paediatrics, senior lecturer in child health1,3, J O Warner, professor of child health4

    Summary points

    Egg-free, mammalian culture based flu vaccines should be given preferentially to individuals allergic to egg
    If an egg-free vaccine is not available, only vaccines with a stated maximum egg content <1.2 µg/ml (0.6 µg per dose) should be used in individuals allergic to egg
      If egg based vaccine is administered to individuals with egg allergy, this should be done in a centre experienced in the management of anaphylaxis
      A single dose protocol is recommended for those with less severe egg allergy
      A two dose, split protocol can be used in those with anaphylaxis to egg or those with moderate or uncontrolled asthma

     
    Tips for non-specialists
    • Celvapan (Baxter), a pandemic A/H1N1 vaccine, and Optiflu (Novartis), a seasonal influenza vaccine are grown in a mammalian cell culture system and are egg-free
    • Other flu vaccines are prepared in hens’ eggs and may contain small amounts of egg protein
    • Individuals with severe egg allergy face a risk of anaphylaxis with flu vaccines that contain egg

    Cite this as: BMJ 2009;339:b3680


    Prevalence of influenza A and B antibodies in pregnant women and their offspring Journal of Clinical Virology View PDF
    Wutzler et al 2009 in 209 mothers and their neonates in Germany showed and confirmed active placental transport of maternal influenza antibodies during the third trimester. The prevalence of the anti influenza B virus antibodies was significantly higher in neonates than their mothers. New born babies have higher prevalence and concentrations of influenza A and B  antibodies than their mothers. Antibodies to measles, mumps, rubella, parainfluenza, varicella zoster, tetanus, pertussis and deptheria are actively transferred to neonates across the placenta during the third ptrimester period.
     Passive immunity to influenza in neonates is important since current vaccines are not indicated for babies less than 6 months old. Annual influenza vaccination may improve the protection of pregnant women and their off spring against influenza.
    BMJ
     BMJ Learning module: Swine flu vaccination - your questions answered (3) (22 Oct
    Best Practice topic: 2009 influenza A (H1N1) virus (27 Oct 2009)

    CDC

    • 2009 H1N1 Flu: Free Resources

    • Vaccine Safety Information

    • Vaccine Supply Status

    •  


      The burden of the disease in US    CDC Estimate


      CDC Estimates of 2009 H1N1 Cases and Related Hospitalizations and Deaths from April-November 14, 2009, By Age Group


      2009 H1N1
      Mid-Level Range*
      Estimated Range *
      Cases


      0-17 years ~16 million ~12 million to ~23 million
      18-64 years ~27 million ~19 million to ~38 million
      65 years and older ~4 million ~3 million to ~6 million
      Cases Total ~47 million ~34 million to ~67 million
      Hospitalizations    
      0-17 years ~71,000 ~51,000 to ~101,000
      18-64 years ~121,000 ~87,000 to ~172,000
      65 years and older ~21,000 ~15,000 to ~29,000
      Hospitalizations Total ~213,000 ~154,000 to ~303,000
      Deaths    
      0-17 years ~1,090 ~790 to ~1,550
      18-64 years ~7,450 ~5,360 to ~10,570
      65 years and older ~1,280 ~920 to ~1,810
      Deaths Total ~9,820 ~7,070 to ~13,930
      * Deaths have been rounded to the nearest ten. Hospitalizations have been rounded to the nearest thousand and cases have been rounded to the nearest million. Exact numbers also are available.

      Vaccine Safety & Availability

      Pandemic pharmacovigilance weekly update

      Pandemic H1N1 pharmacovigilance 


      Vaccine Recalls in the US: These recalls were due to the decline in the potency of some batches of the 2009 H1N1 vaccine during testing. The antigen may be sticking to the walls of the syringe or container. No safety issues are involved and the slight drop in antigen does not alter clinical immune response in vaccinated persons.

      Sanofi Aventis Pasteur has recalled 4 batches of pediatric prefilled syringes (about 800,000 doses) as the the level of antigen was below specifications during routine antigen analysis.

      Astra Zeneca (MedImmune) has recalled 4.7 million doses (13 lots) of its Nasal spray Vaccine as the potency of the vaccine was lower than the predetermined specifications during its routine testing


      Status at 24 March 2010


      This update by the European Medicines Agency (EMA)

      WHO has reported 16800 deaths from H1N1 pandemic and the disease had spread to 213 countries and territories.
      The disease killed 2840 victims in Europe.

       
      A total of 14015 ADRs were reported, a vast majority were non serious

      There were 2078 serious cases due to 2009 H1N1 infections in Europe.

      The benefit/risk ratio of pandemic vaccines and antivirals remains positive and no serious adverse event has been reported so far.
      About 50 million persons (544000 pregnant women) have been vaccinated in the European Union. Over 165 million doses of the vaccines were distributed

      The reported adverse reactions with the 3 approved vaccines (Celvapan, Focetria and Pandemrix) have been as expected, mild and reversible 
      symptoms such as fever, nausea, headache, allergic reaction, injection site pain and swelling. 
       
      There were 130 cases related to abortion (57), stillbirth (11), Premature labor and baby (11) and 13 other pregnancy related outcomes. The normal rate of fofoetal mortality in EU is 2.6 to 9.1 per 1000 births and abortions/miscarriage is 12-15%. Thus the total number of cases reported with vaccines are within normal background range of the population.

      There were 49 cases of Guillain Barre Syndrome and 1 case of Miller Fischer Syndrome (variant of GBS) were reported in relation to pandemic vaccines were reported to the EMEA. Considering that 42 million persons were vaccinated and these are considered normal background rates of GBS (1.1-1.8 per 100,000 persons). Multiple sclerosis 13 cases were reported, 2 on Focetria and 9 with Pandemrix. Out of 13 cases, 9 were with preexisting MS which flared up and 2 were within a short span after vaccination.
       

      Vaccine/AntiviralDoses Distributed  millionPersons injected/treated  millionAdverse Drug reactions
      Reports                  No ADRs      		Serious ADRs
      Celvapan9.1659000518                         -21 eye disorders
      Focetria366.52947                       52286 facial palsy, 6 intra uterine deaths, 4 deaths
      Pandemrix1122910547                       5 thrombocytopenia, 5 hearing loss, 3 seizures, 1 delayed hypersensitivity, 1 death,
      26 deaths underlying causes
      Tamiflu
      		21.11058                       2 deaths

       


      Background cases in General population

      Fetal deaths  4-5 per 1000 deliveries
      Facial palsy  29-36 per 100000
      GBS Syndrome 2 per 100000
      Thrombocytopenia 5-10 per 100000

      Deaths

      Most of the deaths reported after vaccinations were due to underlying risk factors
      or chronic diseases.

      High risk of hospitalizations and fatalities in children and pregnant women.


      Close Monitoring Required

      Eye disorders
      Seizures linked to poorly controlled epilepsy 
      Delayed hypersensitivity reaction
       
       
      Updated  CDC Estimates from April 2009 – February 13, 2010 for 2009 H1N1 infections USA

      Using the same methodology CDC has again updated the estimates to include the time period.
      • CDC estimates that between 42 million and 86 million cases of 2009 H1N1 occurred. The mid-level in this range is about 59 million people infected with 2009 H1N1.
      • CDC estimates that between about 188,000 and 389,000 H1N1-related hospitalizations occurred. The mid-level in this range is about 265,000 2009 H1N1-related hospitalizations.
      • CDC estimates that between about 8,520 and 17,620 2009 H1N1-related deaths occurred. The mid-level in this range is about 12,000 2009 H1N1-related deaths.
       
       

      FDA/CDC Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD).

      March 24, 2010


      FDA and CDC are assessing H1N1 vaccine safety on a continuing basis and have published a detailed report describing the safety profile of H1N1 vaccines in the United States (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm58e1204a1.htm). 

      About 127 million doses of the H1N1 vaccine were shipped and 86 million persons vaccinated with 91 million doses. This report analyzes the safety data after 11.3 million doses of live, attenuated monovalent vaccine (LAMV) for intranasal administration and 34.9 million doses of monovalent, inactivated, split-virus or subunit vaccines for injection (MIV) were distributed. As noted in the report, FDA and CDC evaluated 10172 reports of adverse events submitted to VAERS.
       
      The analysis of VSD data was based on 438,376 people vaccinated with H1N1 vaccines (323,345 MIV and 115,031 LAMV) in 
      managed-care organizations in the VSD as of November 24. No substantial differences between H1N1 and seasonal influenza vaccines were noted in the proportion or types of serious adverse events reported. No increase in any of the pre-selected adverse events under surveillance, such as Guillain-Barré syndrome, has been seen in VSD data. There were 6% or 553 reports of serious adverse events including 40 deaths. preliminary investigations fail to account for a common cause of deaths or linkage to vaccination. There were 56 reports of Guillian Barre Syndrome, each week, 80-160 cases of GBD are reported in US.

      According to the January 22, 2010 update of FDA and CDC vaccine safety monitoring activities, as of January 15, 2010, the total number of doses of H1N1 vaccines distributed was 127 million and the vast majority (93%) of adverse events reported to VAERS were classified as "non-serious" (e.g., soreness at the vaccine injection site). Weekly updates on FDA and CDC vaccine safety monitoring activities are available through the VAERS web site (http://vaers.hhs.gov/resources/h1n1update#top). 

      The National Vaccine Advisory Committee (NVAC) created the H1N1 Vaccine Safety Risk Assessment Working Group to review 2009 H1N1 vaccine safety data. This working group of outside experts conducts regular, rapid reviews of available data from the federal safety monitoring systems and presents them to NVAC and federal leadership for appropriate policy action and follow-up available at (http://www.hhs.gov/nvpo/nvac/index.html).

      To date, our experience with the H1N1 influenza vaccination program has met high safety expectations, based on the track record of the licensed seasonal vaccines, including live attenuated and inactivated vaccines. We are also collaborating with other agencies around the world to share our vaccine safety information and experiences. Should any safety concerns arise, we will evaluate them thoroughly and bring them to the public’s attention quickly. 

      VAERS Summary:

       As of December 30, 2009, 99.3 million doses of 2009 H1N1 vaccine had been shipped to vaccination providers in the United States.
       As of December 30, 2009, VAERS had received 7326 adverse event reports following 2009 monovalent H1N1 vaccination.
       The vast majority (94%) of adverse events reported to VAERS after receiving the 2009 monovalent H1N1 vaccine are classified as “non-serious” (e.g., soreness at the vaccine injection site).
       Of the 10172 reports, 636 (6%) were reports that were classified as “serious” health events (defined as life threatening or resulting in death, major disability, abnormal conditions at birth, hospitalization, or extension of an existing hospitalization)*.
       The percentage of reports involving what would be considered serious health events is not different between 2009 H1N1 and seasonal influenza vaccines. Additionally, no new or unusual events or pattern of adverse events have emerged.
       Among the 440 reports of serious health events, there were 51 reports of death. Preliminary findings do not indicate a common cause or pattern (such as similarities in age, gender, geographic location, illness surrounding death, or underlying medical conditions) to suggest that these deaths were associated with the vaccine. 
       VAERS has received 103 reports of Guillian-Barré syndrome (GBS), for which follow-up assessments are underway. In the United States, about 80-160 cases of GBS are expected to occur each week, regardless of vaccination.


      VAERS Limitations

       When reviewing data from VAERS, please keep in mind what the system is designed to do and what it is unable to do:
      o VAERS is a national reporting system, in which reports are submitted voluntarily by people who think an adverse event occurred after vaccination. VAERS does not solicit reports in any systematic way from all people who have been vaccinated. Reports can be submitted by anyone, including healthcare providers, patients, or family members. Because of this feature, VAERS reports may and often do include incorrect and incomplete information. VAERS reports often lead to more complete follow-up and review of medical records.
      o VAERS staff follow-up on all serious and other selected adverse event reports and obtain additional medical, laboratory, and/or autopsy records when available. As a result of the follow-up/review process, coding terms (e.g., serious or non-serious) for individual VAERS reports may change based on the information received. These changes are reflected in the weekly updates of VAERS data in the WONDER database. VAERS data in WONDER should be used with caution because numbers and conditions are often updated. Events reported in VAERS should not be viewed as evidence that the vaccine directly caused the event. Data does not infer causality. Further investigation is warranted.
      o Underreporting, or failure to report events, is also one of the main limitations of VAERS. Serious medical events are more likely to be reported than minor events.
      o Most importantly, VAERS cannot determine cause-and-effect. VAERS accepts all reports without regard to whether or not the event was caused by the vaccine. The report of an adverse event to VAERS does not mean that a vaccine caused the event. It only indicates that the event occurred sometime after administration of the vaccine. Proof that the event was caused by the vaccine is NOT required in order for VAERS to accept the report.
      o No reports are deleted from VAERS. Therefore, it is possible to have more than one VAERS report on an individual case (e.g., a physician and a patient may have filed separate reports for the same case).
       
       
      -

      CDC Releases 2009 H1N1 Vaccine Schedules

      Children aged 6 months to 9 years should receive 2 doses of 2009 H1N1 vaccine 4 weeks apart to have sufficient levels of protective antibodies.
      References and Links :

      • H1N1 Flu (Swine Flu): Resources for Pregnant Women






      See also

      The Lancet
    • First published trials of specific pandemic vaccines with ECDC comment - Immune responses after one or two doses of monovalent unadjuvanted and adjuvanted influenza A (H1N1) 2009 vaccines (ECDC, 15 Sep 2009)

    • Get Seasonal Flu Vaccinations Now, Health Officials Urge Americans

    • U.S. Vaccination Coverage of 70% Could Curb Pandemic H1N1

    • H1N1 Trials Begin for Pregnant Women

    5. Update on Influenza A (H1N1) 2009 Monovalent Vaccines.
      Centers for Disease Control and Prevention (CDC).
      MMWR Morb Mortal Wkly Rep. 2009 Oct 9;58(39):1100-1.
      PMID: 19816398 [PubMed - in process]
    6. Hospitalized Patients with 2009 H1N1 Influenza in the United States, April-June 2009.
      Jain S, Kamimoto L, Bramley AM, Schmitz AM, Benoit SR, Louie J, Sugerman DE, Druckenmiller JK, Ritger KA, Chugh R, Jasuja S, Deutscher M, Chen S, Walker JD, Duchin JS, Lett S, Soliva S, Wells EV, Swerdlow D, Uyeki TM, Fiore AE, Olsen SJ, Fry AM, Bridges CB, Finelli L; the 2009 Pandemic Influenza A (H1N1) Virus Hospitalizations Investigation Team.
      N Engl J Med. 2009 Oct 8. [Epub ahead of print]
      PMID: 19815859 [PubMed - as supplied by publisher]
    7. Oseltamivir susceptibility in south-western France during the 2007-8 and 2008-9 influenza epidemics and the ongoing influenza pandemic 2009.
      Burrel S, Roncin L, Lafon ME, Fleury H.
      Euro Surveill. 2009 Sep 24;14(38). pii: 19334.
      PMID: 19814958 [PubMed - in process]
    8. Tamma PD, Ault KA, Del Rio C, Steinhoff MC, Halsey NA, Omer SB. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol. 2009 Oct 20. [Epub ahead of print] PubMed PMID: 19850275.
    9. Eisen DP, McBryde ES. Avoiding Guillan-Barré Syndrome following swine origin pandemic H1N1 2009 influenza vaccination. J Infect Dis. 2009 Nov 15;200(10):1627-8. PubMed PMID: 19857155.
    10. Zhu FC, Wang H, Fang HH, Yang JG, Lin XJ, Liang XF, Zhang XF, Pan HX, Meng FY, Hu YM, Liu WD, Li CG, Li W, Zhang X, Hu JM, Peng WB, Yang BP, Xi P, Wang HQ, Zheng JS. A Novel Influenza A (H1N1) Vaccine in Various Age Groups. N Engl J Med. 2009 Oct 21. [Epub ahead of print] PubMed PMID: 19846844.
    11. Kramarz P, Ciancio B, Nicoll A. Seasonal and pandemic influenza vaccines for the elderly and other risk groups: a review of available data. Pol Arch Med Wewn. 2009 Oct;119(10):654-9. PubMed PMID: 19847142.

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    1. Editorial
      Published at www.nejm.org September 10, 2009 (10.1056/NEJMe0908224)
       
      Pandemic Influenza Vaccine Policy — Considering the Early Evidence
      Kathleen M. Neuzil, M.D., M.P.H.
    Experience with traditional seasonal vaccines tells us that the immune responses in older children, pregnant women, and immunocompetent adults with chronic conditions are roughly similar to those of healthy nonpregnant adults.  Immunogenicity data in young children are critical to guide policy decisions.
     
    In our current global situation, in which demand for influenza vaccine greatly exceeds supply, dose-sparing strategies are needed.Fewer or partial doses and the use of adjuvants can all contribute to increased global vaccine supply.
     
    Both vaccines tested have generally acceptable side-effect and adverse-event profiles, with pain or tenderness at the injection site being the most common adverse event observed. It is reassuring that the manufacturing process for these vaccines is identical to that used for seasonal vaccines, which have a strong record of safety.
     
    Although concerns linger about the association of the 1976 swine influenza vaccine with the Guillain–Barré syndrome, the syndrome was rare, with approximately 1 case for every 100,000 persons vaccinated. A plan for robust and comprehensive safety surveillance should be in place to detect uncommon events rapidly during the upcoming vaccination campaigns, so that risk–benefit ratios can be reassessed.
     
    Additional studies are ongoing that will address the immunogenicity of live-attenuated vaccines, and additional inactivated vaccines, in various age groups and on various schedules and in combination with seasonal influenza vaccines. The desire to see all the available data must be balanced with the need to deploy vaccine quickly to reduce morbidity associated with the pandemic. Likewise, the need to make timely decisions must be balanced with thoughtful, transparent debate and openness to changing direction as new data emerge.
     
     
    In a recent paper published in CMAJ, Tanake et al state that the use of the two antivirals Tamiflu and relenza is compatible with breast feeding. Limited data show that Tamiflu is not a teratogen and thus it can be used during pregnancy as the information about Relenza is not available.
     
    Toshihiro Tanaka, Ken Nakajima, Atsuko Murashima, Facundo Garcia-Bournissen, Gideon Koren, and Shinya Ito
    Safety of neuraminidase inhibitors against novel influenza A (H1N1) in pregnant and breastfeeding women
    Can. Med. Assoc. J., Jul 2009; 181: 55 - 58 ; doi:10.1503/cmaj.090866


    Other items recommended to read:

    Health News

    Israeli woman in 39th week of pregnancy dies of swine flu



    First US H1N1 vaccines will be nasal spray - CDC
    ....''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 ''
    19th Septemeber----TIMES OF INDIA US
    21st September.... 
    latimes.com  

    '' Each year, influenza results in thousands of deaths in our community, and the H1N1 flu has demonstrated that it affects children, young adults and pregnant women more severely than the general population.''

    Vaccines in general are well-accepted by the majority of parents, children and adults because they have an exemplary safety record and have played an important role in eliminating diseases that were once common. Despite the strong opinions of a small minority, it is important to remember that vaccines are required to meet high safety standards, and there are no data to support that they cause harm.''


    INDIA
    Important Contact Numbers:
    Outbreak Monitoring Cell (Control Room,
    NICD): 011-23921401 EMR Control room (Ministry of Health and
    family Welfare: 011- 23061469
    Important Websites:
    www.mohfw.nic.in; www.nicd.in


    Medical professionals : If you see Influenza like illness (ILI) , please inform 1075 (Toll free or call 1800-11-4377)
    Please see website : htpp://www.mohf.h1n1.nic.in


    health and family welfare ministry :India


    Summary  of 2009 H1N1 Risk for pregnant women


    Your risk of getting infected with H1N1       4 out of 100 ( vs 1 out of 100 in normal population)
    Risk of death from H1N1 infection               6 out of 1000 (vs 1.5 out of 1000 in normals)  

    Risk of GBS due to vaccine                         1 out of 1 million
    CDC data:  Out of 700 cases of 2009 H1N1 in pregnant women, 100 patients were hospitalized and 28 patients died (both mother and fetus).
    It is your choice what type of risk you are willing to choose.   
    Added on November 3, 2009  New links and CDC Data KM ( Salim & Minoo)
    CDC Recommendations

    What Pregnant Women Should Know About H1N1 Virus

    Flu Vaccination Locator. People at risk should get the H1N1 vaccine as soon as possible. Click here for more info.
    • Pregnant women and recently pregnant women are a priority group for the H1N1 (Swine) flu vaccine. More…

    • You should get vaccinated against both seasonal and H1N1 flu. More…

    • There are some steps you can do to protect children under 6 months old. More…

    • If you have H1N1 flu, you should stay home, follow your doctor’s orders, and watch for signs that you need immediate medical attention. More…

    • Antiviral medications can be given to pregnant women. Take direction from your doctor regarding medications and treatment. More…

    • Breastfeed your infant because breast milk passes on antibodies from the mother to a baby.More…

    • Follow available guidance if you are pregnant and work in schools and healthcare settings. More…

    • If you are a health care worker, pregnant, and must continue to work, follow these guidelines. More…

    • Emergency medical care may become necessary. Know the signs. More…

    • Antiviral dosage recommendations have been issued for post-exposure prevention and treatment of H1N1 flu. More…


    Protect Your Unborn Child

    If you are pregnant, you should get vaccinated against H1N1 as soon as possible. Your vaccination can potentially protect your unborn child from infection. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP)has recommended that H1N1 vaccination efforts focus on five groups. One of those groups is pregnant women and recently pregnant women. Use our Flu Shot Locator to get vaccinated where you live. Note that pregnant women should not receive the nasal-spray flu vaccine LAIV (FluMist®)

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    After Pregnancy

    Anecdotal reports suggest that women who have given birth, similar to pregnant women, might be at increased risk for severe complications and death from 2009 H1N1 influenza.



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    Vaccinations: Seasonal and H1N1

    There are separate vaccines for seasonal flu and H1N1 flu viruses.  You should get vaccinated against both viruses.
    • Pregnant women and recently pregnant women are one of the priority vaccination groups recognized by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).

    • You should get the seasonal flu shot and the H1N1 flu shots as soon as possible. Use our Flu Shot Locator to get vaccinated where you live. Note that pregnant women should not receive the nasal-spray flu vaccine LAIV (FluMist®)

    • Flu vaccines are available in different settings, such as vaccination clinics organized by local health departments, healthcare provider offices, and schools, and other private settings, such as pharmacies and workplaces.

    Initial Results Show Pregnant Women Mount Strong Immune Response to One Dose of 2009 H1N1 Flu Vaccine
    CDC Advisors Make Recommendations for Use of Vaccine Against Novel H1N1.

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    Protect Your Newborn

    Flu vaccine has not been approved for use in babies under 6 months old.  However, there are some things you can do to help protect your baby:
    • Keep your infant out of crowded areas and away from people who are sick.

    • Avoid 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.

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    What To Do If You Get Sick

    Don’t panic. If you have flu-like symptoms, contact your doctor.  Doctors are getting guidance on the proper medications and treatment to use with pregnant women that will not harm your baby.
    • If you are sick, stay home (except to get medical care) and limit contact with others.

    • Treat a fever right away with acetaminophen (Tylenol®). It is the best over-the-counter treatment of fever in pregnancy.

    • Drink plenty of fluids to replace those you lose when you are sick.

    • If you are not sick but have close contact with someone who has H1N1 flu or is being treated for exposure to H1N1 flu, ask your doctor whether you need treatment with antivirals to reduce your chances of getting the flu.
         

    Differences in Recommendations 


    WHO

    WHO expert panel recommends a single dose of 2009 H1N1 vaccine for all subjects including children. WHO endorses use of already approved adjuvents in pandemic vaccines and has recommended the use of nasal spray live attenuated vaccine FluMist 2009 H1N1 for pregnant women.


    CDC/FDA

    Although adjuvents are considered safe, the adjuvent containing pandemic vaccines were not approved in the US. Recommends 2 dose schedule for children 6 months to 9 years old. The live virus containg nasal spray FluMist is not recommended for pregnant women and children less than 2 years of age.


    ECDC/EMEA

    Has not approved the use of live attenuated virus containing nasal spray FluMist in Europe. Adjuvents containing vaccines (As04 and MF059) are approved. Recommends 2 dose schedule of the pandemic flu vaccine for all inspite of clinical studies showing immuno protection with one dose of vaccine. This may be a way to cover European experts and politicians who ordered 2 dose of vaccine per person?

    The NIAID sponsored trial of pandemic flu vaccine in 50 pregnant women showed robust immune response after a 15 mcg dose of the 2009 H1N1 vaccine. There were no serious adverse events linked to the vaccine. 
     
    anglais - English
    Salim Djelouat
    Professor Medical Analyses and Medical bacteriology / Scientific Author / knolAuteur
     






     

     


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