Pregnancy

More and more vaccines are being recommended for pregnant women. And to think, less than 10 years ago, we would not even recommend a Tylenol or anti-histamine to someone who is pregnant! This is not a good suggest. Everything that goes into the mother has the potential for causing a toxicity for the baby. SAY NO to vaccines while prenatal!

July 9, 2015 – Improving influenza and Tdap vaccination during pregnancy: A cluster-randomized trial of a multi-component antenatal vaccine promotion package in late influenza season (full text) “The intervention package did not significantly improve antenatal influenza or Tdap vaccine coverage. More research is needed to determine what motivates women remaining unvaccinated against influenza late into the influenza season to get vaccinated. Future research should quantify the extent to which clinical interventions can bolster a provider’s recommendation for vaccination. This study is registered with clinicaltrials.gov, study ID NCT01761799.”

May 11, 2015 Tdap in Every Pregnancy: Circling the Wagons Around the Newborn (pdf) “The CDC currently recommends that every person 11 years of age and older should have received 1 dose of Tdap, but by 2012 a pitiful 14.2% of people aged $19 years had received Tdap. The anticipated birth of a child is a good opportunity to ensure that everyone who will have contact with the infant has received recommended pertussis vaccines. The strategies together can complete a circle of protection around newborns.”

April 27, 2015 Influenza vaccination during pregnancy: A systematic review of fetal death, spontaneous abortion, and congenital malformation safety outcomesFetal death outcomes for women in later pregnancy ranged fromOR 0.34 to 2.95 with 95% confidence intervals crossing or below the null value.Spontaneous abortion less than 24 weeks ranged from HR 0.45 to OR 1.23, with 95% confidence intervals crossing or below the null value. Congenital malformations for women vaccinated during their first trimester ranged from OR 0.67 to 2.18 and imprecise confidence intervals crossed the null value. Included in this review were some high quality studies, although overallthe studies have a high risk of selection and confounding bias.”

April 27, 2015 Influenza and pertussis vaccination coverage in pregnant womenA documented vaccination coverage of 42.8% for influenza and 39.2% for pertussis was observed. Taking into account doses which were not documented, but administered according to the expectant mother, coverage for influenza would increase to 62% and for pertussis to 46%. The most important reasons for non-vaccination were the absence of a recommendation by medical staff (9.6%) and delay in vaccination (8.4%). The GP was the most important vaccinator. Pregnant women with a lower education and those with a foreign origin were more vulnerable for non-vaccination.”

April 14, 2015 – Declining newborn intramuscular vitamin K prophylaxis predicts subsequent immunisation refusal: A retrospective cohort study “Records for 3575 babies were examined. Ninety-two per cent of infants received intramuscular, and 5% received oral vitamin K. An increased risk ratio for non-immunisation of 14.1 (95% confidence interval 7.8–25.9) for babies whose parents declined vitamin K was identified. Receiving oral vitamin K was also associated with subsequent non-immunisation, with a risk ratio of 3.5 (95% confidence interval 1.7–7.3).”

March 4, 2015 – Pregnancy Does Not Attenuate the Antibody or Plasmablast Response to Inactivated Influenza Vaccine “Inactivated influenza vaccine (IIV) is recommended during pregnancy to prevent influenza infection and its complications in pregnant women and their infants. However, the extent to which pregnancy modifies the antibody response to vaccination remains unclear, and prior studies have focused primarily on hemagglutinin inhibition (HI) titers.”

February 21, 2015 – Quantification of Vaccine-Induced Anti-Pertussis Toxin Secretory IgA Antibodies in Breast Milk: Comparison of Different Vaccination Strategies in Women. “Both antibody analytes were measured in breast milk samples of lactating women obtained eight to nine weeks postpartum to compare different maternal pertussis vaccination strategies: vaccination during pregnancy, shortly after or at delivery (cocoon), less than 5 years before delivery or more than 5 years before delivery.”…”Conclusion: Vaccination against pertussis in the second/third trimester of pregnancy or immediately postpartum significantly increased the levels of anti-pertussis toxin sIgA in breast milk.

February 18, 2015 – Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy “In the U.S., while many vaccines are approved for use in adults and most are not contraindicated for use in pregnant women, no vaccine is licensed for use specifically during pregnancyAmong the perceived obstacles hindering the clinical development of vaccines for use in pregnancyregulatory issues are frequently cited. One aim of this article is to address the perceived regulatory obstacles. General concepts and regulatory considerations for clinical safety and effectiveness evaluations for vaccines indicated for use during pregnancy will be discussed. This discussion is not intended to establish data requirements or to articulate agency policy or guidance regarding specific vaccine products.”

December 26, 2014 – Relevance of Age at Diagnosis to Prevention of Late-Onset Group B Streptococcal Disease by Maternal Immunization.“Among 248 infants with late-onset group B streptococcal (GBS) disease from 1993 through 2012, approximately two-thirds (63%) had a gestation of at least 35 weeks and 72% of these became ill within 6 weeks of life (median 27 days), suggesting that third trimester maternal GBS immunization could substantially reduce the late-onset GBS disease burden in the United States.”

September-October 2014 Placental transfer and concentrations of cadmium, mercury, lead, and selenium in mothers, newborns, and young children “Finally, this study investigated the association between metal burden and preterm birth and low birthweight. We found significantly higher levels of Hg in maternal and cord plasma and RBCs in preterm or low birthweight births, compared with term or normal birthweight births. In conclusion, this study showed that maternal exposure to these elements was widespread in the BBC, and maternal–fetal transfer was a major source of early life exposure to Hg, Pb, and Se.”

September 19, 2014 – CDC MMWR Influenza Vaccination Coverage Among Pregnant Women — United States, 2013–14 Influenza Season “Women with the following reported characteristics had lower influenza vaccination coverage than other women within each comparison stratum: those aged 18–24 years, with education less than a college degree, not married, reporting no medical insurance, not working for wages, living below the poverty threshold, reporting no high-risk conditions associated with increased complications for influenza, reporting fewer than six visits to a clinician since July 2013, and having a negative attitude towards efficacy and safety of influenza vaccination or not being concerned about influenza infection. Vaccination coverage increased from 2012–13 to 2013–14 for Hispanic women, non-Hispanic women who reported race other than white or black, women aged 25–34 years, and women with greater than a college degree (Table 1).”

August 20, 2014 The association between age and the development of respiratory syncytial virus neutralising antibody responses following natural infection in infants “The disease incidence estimates presented in Fig. 1b, suggest that in order to have the greatest impact on disease burden, infants should be vaccinated prior to the period of greatest risk of disease, at about 2 months of age. However the poor response to natural infection in infants under the age of 4 months suggests that such infants are unlikely to mount strong neutralising antibody responses to live vaccines. Nonetheless, the data presented suggest that vaccination of infants aged 4 months and above is likely to provide substantial benefit. To protect very early infants at the period of greatest risk, there is need to explore alternative strategies such as maternal vaccination. The boosting of the titre of trans-placentally transferred antibody will increase the duration of infant protection and delay the age of first infection, at which time infection is less likely to result in severe disease. Comment: Live vaccines are not given to an infant 4 months and under. For profit sake, and also masking adverse events while the infant is still in the womb seems to be the direction the vaccine industry is heading more and more.

August 6, 2014 A single immunization with inactivated H1N1 influenza vaccine formulated with delta inulin adjuvant (Advax™) overcomes pregnancy-associated immune suppression and enhances passive neonatal protection “We therefore wished to test whether addition of Advax™, a polysaccharide adjuvant based on delta inulin, to an inactivated influenza vaccine (A/H1N1/PR8) administered during pregnancy would safely enhance vaccine immunogenicity and thereby provide improved protection of pregnant mothers and their newborns.”…”This study shows that Advax adjuvant was safe when administered with influenza vaccine during pregnancy and provided protection of pups via enhanced breast milk transfer of anti-influenza antibodies, not seen with administration of unadjuvanted vaccine.” Comment: See more info on the Advax Adjuvant here

July 31, 2014 Personal attitudes and misconceptions, not official recommendations guide occupational physicians’ vaccination decisionsThe attitude towards vaccination most strongly affects whether occupational physicians recommend the measles, mumps, and rubella (MMR) vaccination: physicians with less positive attitudes recommend MMR to HCP in a more restricted way. A more positive attitude towards vaccination also relates to fewer misconceptions. Occupational physicians’ knowledge and attitude further influence the extent to which pregnant HCP receive vaccinations against influenza. Knowledge about official recommendations does not influence the recommendation of influenza vaccination for pregnant women. Conclusions Reasons for vaccination gaps in HCP might have their roots in occupational physicians’ incomplete knowledge of vaccination recommendations. Attitudes, which are related to misperceptions, also influence which vaccinations are recommended to HCP. Official recommendations, and not personal attitudes and misconceptions, should guide occupational vaccination behavior.

July 2, 2014 – Evaluation of the Impact of a Pertussis Cocooning Program on Infant Pertussis Infection. “Conclusions: Postpartum immunization and cocooning did not reduce pertussis illness in infants <= 6 months of age. Efforts should be directed towards increasing Tdap immunization during pregnancy, combined with cocooning, to reduce life-threatening young infant pertussis.” Comment: So vaccinated pregnant women? Some information from the FDA on this subject. “The FDA is continuing its efforts to reduce the exposure of infants, children, and pregnant women to mercury from various sources. Discussions with the manufacturers of influenza virus vaccines (which are now routinely recommended for pregnant women and children 6-23 months of age) regarding their capacity to potentially increase the supply of thimerosal-reduced and thimerosal-free presentations are ongoing.” View here

May 23, 2014 – Optimizing benefits of influenza virus vaccination during pregnancy: Potential behavioral risk factors and interventions “However, as in the general population, a relatively high proportion of pregnant women and their infants do not achieve protective antibody levels against influenza virus following maternal vaccination. Behavioral factors, particularly maternal weight and stress exposure, may affect initial maternal antibody responses, maintenance of antibody levels over time (i.e., across pregnancy), as well as the efficiency of transplacental antibody transfer to the fetus. Conversely, behavioral interventions including acute exercise and stress reduction can enhance immune protection following vaccination. Such behavioral interventions are particularly appealing in pregnancy because they are safe and non-invasive. The identification of individual risk factors for poor responses to vaccines and the application of appropriate interventions represent important steps towards personalized health care.”

April 1, 2014 – Breastfeeding after maternal immunisation during pregnancy: Providing immunological protection to the newborn: A review “All of the studies in this review that measured disease specific antibodies in breast milk (n = 8 papers), stressed the beneficial effect of maternal vaccination during pregnancy on the amount of disease specific sIgA in breast milk. Only a few studies demonstrated a potential protective effect, particularly with influenza vaccines.”

February 12, 2014 – Protecting the Family to Protect the Child: Vaccination Strategy Guided by RSV Transmission Dynamics (pdf) “Another consideration is that maternally‐derived antibodies against RSV can help protect the infant from infection, but may also dampen the endogenous response to neutralization‐sensitive antigenic sites on viral surface glycoproteins, and thus diminish vaccine immunogenicity. In addition to logistical and immunological factors that make implementation difficult and efficacy uncertain there are other features of the neonate that may complicate the vaccine development pathway from a safety or regulatory perspective. One is that there are more idiosyncratic rare adverse events in the neonate including apnea that may be difficult to distinguish from vaccine‐ associated events. Also, the small airway of the neonate increases the likelihood of obstructive events and leaves a relatively small therapeutic window, especially for vaccines administered into the airway, or those that may initially increase the inflammatory response to subsequent infection. This may have been part of the pathogenesis of the enhanced disease syndrome associated with a formalin‐inactivated whole virus vaccine tested in the 1960s, particularly evident in the youngest age group.

February 2014 Vaccinations Given During Pregnancy, 2002–2009 “In the VSD, 669,695 pregnancies and 141,389 vaccinations were identified. Trivalent inactivated influenza (TIV) was the most commonly administered vaccination (174.1 doses per 1000 pregnancies) and was most often administered during the 2nd and 3rd trimesters. The most common vaccines in the “consider if indicated” category were tetanus–diphtheria (6.1 per 1000) and hepatitis B (3.7 per 1000). Contraindicated vaccination was infrequent, and the majority of these were measles–mumpsrubella (MMR) (1.2 per 1000); varicella (1.0 per 1000); and live-attenuated influenza vaccine (LAIV) (0.3 per 1000). Both “consider if indicated” and contraindicated vaccines were more frequently administered during early pregnancy.

January-February 2014 Staff versus Physician Vaccine Protocols for Influenza Immunization During Pregnancy “In this retrospective observational report, a nurse-driven protocol did not improve vaccination rates across varying practice sites. Thus, a simple protocol change to staff alone offering vaccine is unlikely to improve rates of maternal influenza vaccination. Additional studies looking at interventions to increase the number of pregnant women vaccinated against influenza are needed.”

September 27, 2013 – Influenza Vaccination Coverage Among Pregnant Women — United States, 2012–13 Influenza Season “Of 6,633 women who entered the survey, 2,198 were determined to be eligible, and 2,047 (93.1%) completed the survey”…”Vaccination coverage among women with a negative attitude toward the efficacy of influenza vaccination was 9.8%, compared with 64.2% among those with a positive attitude. Women with a negative attitude towards the safety of vaccination had lower coverage than those with a positive attitude (13.0% versus 65.6%), and those with no concern about influenza infection had lower coverage than those with concern about influenza infection (47.1% versus 52.8%) (Table 1). The outcomes regarding attitudes were similar whether using responses to the composite scores or the individual questions.”

June 2013 – Vaccination against RSV: Is maternal vaccination a good alternative to other approaches? “The maternal immunization strategy is highlighted, but also vaccination in the youngest infants and specific risk group immunization strategies are evaluated in this paper. Key factors such as the seasonality of RSV disease, interference of maternal antibodies and the immaturity of the infants’ immune system are addressed.”

May 8, 2013 Gestational exposure to yellow fever vaccine “Neither maternal signs of toxicity nor alterations in physical development and reflex ontogeny of the offspring were observed in any of the groups. Data from behavioral evaluation indicated that yellow fever vaccine exposure induced motor hypoactivity in 22-day-old females independent of the day of exposure; and in 60-day-old male and female pups exposed at GD 10. Moreover, 22-day-old females also presented with a deficit in habituation memory. Altogether, these results indicate that in utero exposure to the yellow fever vaccine may induce behavioral alterations in the pups that may persist to adulthood in the absence of observed maternal toxicity or disruption of physical development milestones or reflex ontogeny.”

April 30, 2013 – Identifying pregnancy episodes, outcomes, and mother–infant pairs in the Vaccine Safety Datalink “The need for research on the safety of vaccination during pregnancy is widely recognized. Large, population-based data systems like the Vaccine Safety Datalink (VSD) may be useful for this research, but identifying pregnancies using electronic medical record (EMR) and claims data can be challenging.”

April 18, 2013 – Altered Response to A(H1N1)pnd09 Vaccination in Pregnant Women: A Single Blinded Randomized Controlled Trial “Our study suggests the immune response to the 7.5 µg MF59-adjuvanted Focetria® H1N1pnd09 vaccine in pregnant women may be diminished compared with non-pregnant women.”… “TFT is employed by Novartis Vaccines. The nested vaccine study is funded by Novartis Vaccines and Diagnostics GmbH, Marburg, Germany, who provided vaccines and funding as an unrestricted institutional grant.”

April 12, 2013 – Cost–benefit analysis of hospital based postpartum vaccination with combined tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) “If including direct medical costs only, the strategy would not generate net savings from a health care system perspective. Annual incidence of pertussis in birth mothers and Tdap efficacy exhibited substantial impact on the model as shown in one-way and two-way sensitivity analyses.

April 2013 – Predictors of Seasonal Influenza Vaccination During Pregnancy “Even after adjusting for significant baseline characteristics, we found that at least one item from each domain of the Health Beliefs Model was predictive of subsequent vaccination. Specifically, women who perceived they were susceptible to influenza, that they were at risk of getting seriously ill from influenza, that they would regret not getting vaccinated, and who trusted recommended guidelines about influenza vaccination during pregnancy were more likely to get vaccinated. Women who were concerned about vaccine side effects were less likely to get vaccinated.”

April 2013 – Improving Influenza Vaccination Rates in Pregnancy Through Text Messaging: A Randomized Controlled Trial “Text messaging prompts were not effective at increasing influenza vaccination rates among a low-income, urban, ambulatory obstetric population. Ongoing efforts are needed to improve vaccine uptake among pregnant women unsure about or unwilling to receive influenza vaccination.”

December 17, 2012 Theory-based predictors of influenza vaccination among pregnant women. “Between 2009 and 2012, the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) conducted a prospective cohort study of influenza vaccine safety among pregnant women in the US and Canada that oversampled vaccinated women.”

December 15, 2012
 – 2009 Pandemic Influenza A Virus Subtype H1N1 Vaccination in Africa—Successes and Challenges “From February through November 2010, 32.2 million doses were delivered to 34 countries in Africa. Of the 19.2 million doses delivered to countries that reported their vaccination activities to WHO, 12.2 million doses (64%) were administered. Population coverage in these countries varied from 0.4% to 11%, with a median coverage of 4%. All countries targeted pregnant women (median proportion of all vaccine doses administered [mpv], 21% [range, 4%–72%]) and healthcare workers (mpv, 9% [range, 1%–73%]).”

November 26, 2012 
– Translating vaccine policy into action: A report from the Bill & Melinda Gates Foundation Consultation on the prevention of maternal and early infant influenza in resource-limited settings (full text) “One randomized clinical trial in Bangladesh found that women who received TIV in pregnancy were 36% less likely to develop febrile respiratory illness. Several maternal influenza vaccine trials with laboratory-confirmed endpoints among the women and their infants are planned or are ongoing, including trials funded by the Gates Foundation in Mali, Nepal, and South Africa.”…”Despite existing recommendations for the use of some vaccines during pregnancy, SAGE has noted that pregnancy was a commonly cited contraindication to a wide range of vaccines, but indicated that in many cases this was precautionary and not evidence-basedSAGE therefore requested that the WHO Global Advisory Committee on Vaccine Safety (GACVS) review the safety of vaccines in pregnancy, and this work is ongoing. Additional efforts to address other barriers to maternal immunization are discussed below.”

November 21, 2012 – Impact of the 7-Valent Pneumococcal Conjugate Vaccine on Invasive Pneumococcal Disease in Infants Younger Than 90 Days in England and Wales “Young infants have benefited from PCV7 through indirect (herd) protection. Given that a third of cases occurred within 48 hours of birth, further studies should focus on risk factors for IPD in pregnancy and strategies to prevent mother-to-child transmission.” Comment: Influenza and Tdap vaccines are already recommended for pregnant women. It sounds like the Pneumococcal vaccine will be next.The developmental phase of a fetus is highly vulnerable to external toxicity. The epigenetic patterns evolve during the first 18 months of life, meaning, the genetic patterns that are expressed as an adult start at conception. Injecting pregnant women with toxic vaccines is going to create monumental health catastrophes for years to come. This should go down in history as crimes against humanity.

November 21, 2012Group B streptococcus vaccination in pregnancy: Moving toward a global maternal immunization program.Implementation of the administration of these high priority vaccines during routine prenatal care would result in a maternal immunization program

November 2012 Translating vaccine policy into action: A report from the Bill & Melinda Gates Foundation Consultation on the prevention of maternal and early infant influenza in resource-limited settings. “For the first time, SAGE recommended pregnant women should be made the highest priority for inactivated seasonal influenza vaccination. However, the variable maternal influenza vaccination coverage in countries with pre-existing maternal influenza vaccine recommendations underscores the need to understand and to address the discrepancy between recommendations and implementation success. We present the outcome of a multi-stakeholder expert consultation on inactivated influenza vaccination in pregnancy. The creation and implementation of vaccine policies and regulations require substantial resources and capacity. As with all public health interventions, the existence of perceived and real risks of vaccination will necessitate effective and transparent risk communication.”

October 24, 2012
Maternal Pertussis Vaccination: Protecting Neonates From Infection – “This strategy strives to immunize all adults (with tetanus, diphtheria, and pertussis vaccine [Tdap]) who currently have or anticipate having close contact with neonates to form a protective “cocoon” of pertussis immunity around the newborn.”

September-October 2012 Safety Update on Vaccination during Pregnancy “Prophylactic vaccinal administration against infections should be assessed with caution due to the little amount of available data. Its use will depend on the vaccine’s composition and known side effects, the stage of pregnancy, as well as the benefit for the mother and the child to born, and her clinical history. Whatever the vaccine’s nature, its administration never justifies a therapeutic abortion; its evolution must be closely followed to cover the occurrence of complication.”

September 27, 2012 Comparison of VAERS fetal-loss reports during three consecutive influenza seasons: Was there a synergistic fetal toxicity associated with the two-vaccine 2009/2010 season? “Capture–recapture demonstrated that the VAERS database captured about 13.2% of the total 1321 (95% confidence interval (CI): 815–2795) estimated reports, yielding an ascertainment-corrected rate of 590 fetal-loss reports per million pregnant women vaccinated (or 1 per 1695). The unadjusted fetal-loss report rates for the three consecutive influenza seasons beginning 2008/2009 were 6.8 (95% CI: 0.1–13.1), 77.8 (95% CI: 66.3–89.4), and 12.6 (95% CI: 7.2–18.0) cases per million pregnant women vaccinated, respectively. The observed reporting bias was too low to explain the magnitude increase in fetal-demise reporting rates in the VAERS database relative to the reported annual trends. Thus, a synergistic fetal toxicity likely resulted from the administration of both the pandemic (A-H1N1) and seasonal influenza vaccines during the 2009/2010 season.”

September 2012 Liability and maternal immunization: in utero injury claims in the VICP. (full text) “The issue of whether in utero injuries are afforded such protections, vis á vis compensation by the National Vaccine Injury Compensation Program (VICP) under the Vaccine Act, has not definitively been resolved by the courts. (full text) “Short of a decision by the Court of Appeals for the Federal Circuit or a statutory amendment by Congress specifically addressing this issue, the uncertainty remains.”…”In addition to in utero injuries, questions have also been raised about whether the Vaccine Act would allow claims for stillbirths or miscarriages. One case involving a miscarriage resulted in dismissal. In Spates v. Sec’y of HHS, a mother alleged that the MMR vaccine she received while pregnant caused her to miscarry and sought compensation for her own injuries (the miscarriage) and a death benefit on behalf of her unborn child. A judge of the CFC upheld the decision by a special master that the petitioner had failed to demonstrate that a vaccine caused her miscarriage, resulting in denial of compensation for the mother’s own injuries.  As for the request for the death benefit, the special master issued an order to show cause why the request for the death benefit should not be dismissed, noting that a petitioner seeking death benefits under the VICP must be the legal representative of the deceased under state law and explaining that under New York state law, “a lawsuit for death damages for a fetus is noncognizable.”  The petitioner subsequently withdrew her claim for the death benefit, and the issue of whether a claim could be pursued on behalf of a miscarriage was not resolved.”

September 2012 Influenza immunization during pregnancy: US regulatory perspective. (full text) “Several postmarketing initiatives are ongoing to obtain maternal and infant safety and immunogenicity data on US-licensed inactivated influenza vaccines used in pregnant women. The Food and Drug Administration is revising its pregnancy labeling regulations to improve the characterization and communication of risks of drugs and biologics used during pregnancy. To obtain a specifically labeled indication for use of an influenza vaccine during pregnancy, adequate and well-controlled prelicensure studies are needed to obtain data on the product’s safety and effectiveness and to demonstrate protection of the mother and/or infant against influenza illness.

September 2012Assessing the safety of influenza immunization during pregnancy: the Vaccine Safety Datalink (full text) “The studies that are described in this article represent the VSD’s first large scale efforts to evaluate the safety of vaccines that are administered during pregnancy. These studies will be well-powered to detect both common and relatively rare events after influenza vaccination. We will also provide needed data on the safety of first trimester vaccination. The quality of the VSD data files and the validity of the use of these files for conducting vaccine safety research has been well-established.”

September 2012 Safety of influenza immunization during pregnancy for the fetus and the neonate (full text) “Categories B and C are used to indicate a lack of sufficient data to make a clear designation; the combination of human and animal studies indicates that there is either little risk or that the risk is substantially outweighed by the benefit of the drug. The fifth category, X, indicates demonstrated risk to the fetus, with risks from the drug outweighing any potential benefits. Inactivated influenza vaccines currently are classified in categories B and C (Table 2). This classification primarily is due to the fact that prelicensure data on influenza vaccine safety and effectiveness during pregnancy is virtually nonexistent because of strict research ethics guidelines that govern the participation of pregnant women, who are considered a vulnerable population. Moreover, existing data from observational studies often do not reach the standard for studies that are considered in the determination of the Food and Drug Administration pregnancy categories. Thus, the current classification of influenza vaccines is indicative of a lack of available data to demonstrate vaccine safety in pregnancy rather than a lack of adequate safety data per se, which is balanced against the existing knowledge base of the benefit of influenza vaccine to pregnant women. Proposed revisions to the current labeling system are currently under consideration.

August 17, 2012 – Failure of the vaccination campaign against A(H1N1) influenza in pregnant women in France: Results from a national survey “The vaccination campaign resulted in poor vaccination coverage, strong social inequalities, and no special protection for pregnant women at the highest risk of complicationsThese findings provide essential information for the organization of future vaccination campaigns.”

July 11, 2012
Pneumococcal vaccination during pregnancy for preventing infant infection “They compared 23-valent pneumococcal polysaccharide vaccine with control vaccine. All women received a single injection of pneumococcal or control vaccine (where used). The women’s mean gestational age at the time of immunization was between 27 and 38 weeks, where stated. Only two trials with 241 pregnancies reported on neonatal infections. This was not enough information to say whether pneumococcal vaccination during pregnancy led to fewer infant infections. Two trials with 146 pregnancies reported on infant nasal carriage of pneumococci (pneumococcal colonization), which was not enough evidence to show an effect in reducing colonization at two to three months of age or six to seven months of age.”

July 9, 2012 – Monitoring seasonal influenza vaccination coverage among pregnant women in the United States “Influenza vaccination coverage among pregnant women improved from 11% during the 2001-2002 influenza season to approximately 38% measured by BRFSS and 50% measured by internet panel surveys during the 2010-11 influenza season. Coverage varied by state, ranging from 26% to 68% among the states participating in PRAMS in 2009-10. Provider recommendation increased a women’s likelihood of vaccination nearly 6-fold. Despite increases in influenza vaccination coverage among pregnant women, approximately half remain unvaccinated.”

June 8, 2012 – Influenza vaccination uptake amongst pregnant women and maternal care providers is suboptimal  “Influenza vaccination rates in pregnant women are low, reflecting inadequate patient education despite most maternity care providers indicating that they would routinely recommend influenza vaccination. Increasing influenza vaccination uptake by women in pregnancy will require better education of both women and maternity care providers.” Comment: Pregnant women are advised to take no additional medications, including over-the-counter pain and fever medications, and yet, they are being told to get a flu shot, which contains formaldehyde, animal cells and in some cases, mercury.

May 28, 2012 – A public-professional web-bridge for vaccines and vaccination: User concerns about vaccine safety “Questions about pregnant women had 5.01 higher odds of asking about safety than people not belonging to any risk group. Older questioners (>50 years) were less likely to ask about vaccine safety compared to younger questioners. Questions made after vaccination or related to influenza (including H1N1) or travel vaccines were also associated with a higher likelihood of asking about vaccine safety. These results identify risk groups (pregnant women), population groups (older people) and some vaccines (travel and influenza vaccines, including H1N1) where greater efforts to provide improved, more-tailored vaccine information in general and on the Internet are required.

May 8, 2012 – Neonatal Vaccine-Strain Varicella Zoster Virus Infection 22 Days after Maternal Post-Partum Vaccination Infection with vaccine-strain varicella zoster virus was confirmed by genetic analysis. The mother had no post-vaccination rash nor did other contacts have rash or recent vaccination. Potential means of transmission to the infant are explored. Comment: This article shows the virus CAN cross the placenta and infect the fetus. Why are they vaccinating pregnant women with the chickenpox vaccine, a live-virus vaccine?

March 27, 2012– Notice: Development of Animal Models of Pregnancy To Address Medical Countermeasures for Influenza in the “At Risk” Population of Pregnant Women: Influenza as a Case Study; Public Workshop “Specifically, this workshop will address experimental design issues inselecting the most appropriate animal model that mimics human pregnancy. The goal is to use this model to evaluate how pregnancy changes the pharmacokinetics of anti-influenza drugs in animals and compare those changes to the changes that are known to occur in human pregnancy. The data obtained from using this model may enhance the knowledge base needed to extrapolate the effects of pregnancy on other medical countermeasures.” Comment: This study is a look at how pregnancy impacts the efficacy of a vaccine.

February 2012 – Vaccine model of antiphospholipid syndrome induced by tetanus vaccine “Successful induction of anti-phospholipid syndrome (APS) in two different non-autoimmune prone mouse strains, BALB/c and C57BL/6, was achieved by tetanus toxoid hyperimmunization using different adjuvants (glycerol or aluminium hydroxide), and different adjuvant pretreatments (glycerol or Complete Freund’s Adjuvant.”  Comment: Anti-phospholipid syndrome is a disorder in which the immune system produces antibodies against certain normal proteins in your blood. Anti-phospholipid syndrome can cause blood clots to form in arteries or veins as well as pregnancy complications, such as miscarriages and stillbirths. The VAERS database showed that in the two years preceding the CDC’s recommendation for all pregnant women to be vaccinated against influenza and H1N1, 7 miscarriages per year were reported as attributable to vaccination. In 2009, that number rose to 178. By using this formula, it was estimated that 1588 miscarriages (within a range of 946 to 3587) in 2009 were associated with pregnant mothers who were vaccinated with the H1N1 or combined influenza shot. I wonder if it was due to APS, and no one thought to look? The Mayo Clinic reports, “no cure for antiphospholipid syndrome, but medications can be effective in reducing your risk of blood clots.” No Cure? Don’t cause it in the first place!

November 8, 2011 Inflammatory responses to trivalent influenza virus vaccine among pregnant women Trivalent influenza virus vaccination elicits a measurable inflammatory response among pregnant women. There is sufficient variability in response for testing associations with clinical outcomes. As adverse perinatal health outcomes including preeclampsia and preterm birth have an inflammatory component, a tendency toward greater inflammatory responding to immune triggers may predict risk of adverse outcomes, providing insight into biological mechanisms underlying risk.”

March 2, 2010 –  Overall and subgroup analyses of pregnancy outcome* by permutation tests of whether rate of miscarriage in HPV vaccine arm is greater than in hepatitis A vaccine arm “Overall and subgroup analyses of pregnancy outcome* by permutation tests of whether rate of miscarriage in HPV vaccine arm is greater than in hepatitis A vaccine arm”…”The difference was not significant (13.7% in HPV vaccine arm, 9.2% in hepatitis A vaccine arm”

October 2009 – H1N1 Influenza in Pregnancy Cause for Concern (pdf) “Venous thromboembolic events have also been noted in other case reports 3 and deserve special attention in the pregnant and postpartum critically ill patient as physiologic hypercoagulability compounded by immobilization predisposes these patients to this complication.”

June 2009 – Mitochondrial dysfunction, impaired oxidative-reduction activity, degeneration, and death in human neuronal and fetal cells induced by low-level exposure to thimerosal and other metal compounds Thimerosal-induced cellular damage as evidenced by concentration- and time-dependent mitochondrial damage, reduced oxidative–reduction activity, cellular degeneration, and cell death in the in vitro human neuronal and fetal model systems studied.”

January 2008 – Evaluation of developmental neurotoxicity of polysorbate 80 in rats.  “The developmental neurotoxicity of polysorbate 80 (PS80) was evaluated. Rats were given drinking water containing polysorbate 80 (PS80) [at a range of concentrations] on day 0 of pregnancy through day 21 after delivery. Pregnant rats were allowed to deliver spontaneously. Potential adverse effects of pre- and post-natal exposure on the development and function of the nervous system in offspring of rats given PS80 were examined. Maternal body weight was lowered at 7.5%. Number of pups born was lowered at 7.5%. Histopathological examinations of the brain revealed no toxicological changes. Lowered body weight was observed in male and female offspring.

Summer 2006 – Influenza Vaccination During Pregnancy: A Critical Assessment of the Recommendations of the Advisory Committee on Immunization Practices (ACIP)  “Only 11% of the 1,659 pregnant subjects had serological evidence of the illness; none had detectable influenza A-specific IgM. There was also no evidence for transplacental transmission of influenza virus, or autoantibody production in influenza-complicated pregnancies. Influenza infection had no significant impact on labor outcomes, health of the newborn, or maternal wellbeing.

August 2006Influenza Vaccination During Pregnancy: Opinions and Practices of Obstetricians in an Urban Community “This study suggests that the preferences of obstetricians regarding timing of influenza vaccination of pregnant women differ from the Advisory Committee on Immunization Practices (ACIP) recommendations. While these preferences may affect vaccine implementation among pregnant women, obstetricians have practical and valid concerns that should also be considered in developing vaccine education and guidelines.”

May 2004 – The evidence for the safety of thiomersal in newborn and infant vaccines. “There is an increased sensitivity of the fetal brain to mercury whether it is ethyl or methyl mercury. While there is no evidence to support the contention, it is at least theoretically possible that very low birth weight premature infants may be at increased risk from thiomersal-containing vaccines.”

March 2001 – Live virus vaccination near a pregnancy: flawed policies, tragic results “Vaccination of women with live virus vaccines around conception has always been contraindicated by the Center for Disease Control and Prevention (CDC) and the vaccine manufacturer because of potential risks to the fetus. Nevertheless this dangerous practice occurs and is associated with maternal health problems and a very high incidence of early-onset autism in the children.”

1987 – Neurotoxicity of monosodium-l-glutamate in pregnant and fetal rats  “Monosodium-l-glutamate given subcutaneously to pregnant rats caused acute necrosis of the acetylcholinesterase-positive neurons in the area postrema… These observations raise the possibility of transplacental poisoning in human fetuses after the consumption of glutamate-rich food by the mother.”

1984 – Prenatal monosodium glutamate (MSG) treatment given through the mother’s diet causes behavioral deficits in rat offspring. “The present study reports various developmental and behavioral changes in the offspring of rat dams that received monosodium glutamate (MSG) in the drinking water all through the second and third trimesters of pregnancy. Three main effects were observed in the MSG exposed offspring: (1) juvenile obesity; (2) reduced general activity levels; (3) a specific type of learning disability in discrimination learning involving choice between simultaneously present positive and negative stimuli.”

April 1971 Inadvertent Rubella Virus Vaccination during PregnancyThis subject and one other reported symptoms consistent with vaccine-virus infection. In both women the attenuated virus was isolated from conceptuses collected 69 and 28 days respectively after immunization. Attempts at virus isolation were negative on specimens from the remaining six women. Histologic changes in placenta or decidua consistent with rubella infection were detected in the two virus-positive cases and in one negative case. These data underscore the need for caution in vaccinating postpubertal women.”