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Tdap Vaccinations for All Pregnant Women in Brazil Mandated in Late 2014

pregnant in brazil

In October 2014, the Brazilian Ministry of Health’s Epidemiological Surveillance Center “Prof. Alexandre Vranjac” (CVE) in São Paulo, Brazil published a “technical report” on the diphtheria, tetanus and pertussis vaccine (Tdap).1 In that report, the CVE stated that the Tdap vaccine would be included in Brazil’s National Vaccination Schedule for pregnant women.

Considering the epidemiological situation of the [pertussis] disease and the need to protect the mother-child pair, the Tdap vaccine will be incorporated into the National Vaccination Schedule for pregnant women and health professionals (anesthesiologist, gynecologist, obstetrician, neonatologist, pediatrician, nurse, and nursing technician) who care for newborns in maternity wards and nurseries/neonatal ICUs.1 

A retrospective study published in the journal BMC Infectious Diseases in 2015 highlights the growing incidence of pertussis (whooping cough) in Brazil from 2007 to 2014. Using data obtained from case notification forms, the study identified a total of 80,068 “suspected cases” of pertussis in Brazil during that seven-year period.2 Another study published in Autopsy Case Reports last year cited the increasing number of deaths from pertussis in Brazil in recent years, particularly in 2013.3

In 2013, 109 pertussis-related deaths were reported—a number 7-fold higher than the average number of deaths reported annually in the period from 2001 to 2010. More than 80% of the deaths occurred in infants younger than 3 months of age.3

It is understandable that the Brazilian government was concerned about the upward trend in pertussis infections. By the end of 2014, following the October report from the CVE, the Brazilian Ministry of Health announced the introduction of the Tdap vaccine for all pregnant women in the country,3 and the Brazilian National Immunization Program (NIP) had begun the vaccinations.2 The policy change had been expected for many months. Earlier in 2014, at a meeting of the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE), the group had written in a background paper…

[Brazil] will recommend Tdap in the routine immunization programme for pregnant women from 2014 onward.4 .

The CVE report recommended the Tdap vaccine be given to women between the 27th week and 36th week of their pregnancy, and that it could also be administered up to 20 days prior to the expected date of birth.1 The report specified the Tdap produced by GlaxoSmithKline (GSK) of the United Kingdom as the one to be used. GSK has a technology transfer agreement with Brazil’s Butantan Institute for the production of the Tdap vaccine5 in Brazil.

The CVE report listed the following ingredients in the GSK/Butantan Institute Tdap vaccine:

  • Diphtheria toxoid—not less than 2 International Units (IU)
  • Tetanus toxoid—not less than 20 International Units (IU)
  • Bordetella pertussis antigen
  • Pertussis toxoid—8 mcg
  • Filamentous haemagglutinin—8 mcg
  • Pertactin—2.5 mcg
  • Adsorbed hydrated aluminum hydroxide (Al (OH ) 3) and aluminum phosphate (AlPO4)
  • Excipients: aluminum hydroxide , aluminum phosphate , sodium chloride and water for injection. Contains formaldehyde residues, polysorbate 80 and glycine1

GSK’s Tdap product is internationally known under the brand name Refortrix® or, more commonly, Boostrix®), and it has been licensed in Brazil for more than a decade.6 In addition to the ingredients listed above for Boostrix, the following growth medium and process ingredients are used in manufacturing the vaccine:

  • modified Latham medium derived from bovine casein
  • Fenton medium containing bovine extract
  • formaldehyde
  • Stainer-Scholte liquid medium
  • glutaraldehyde
  • aluminum hydroxide7

According to GSK, neither the safety nor effectiveness of Boostrix have been established in pregnant women.8 The package insert for Boostrix reads:

A developmental toxicity study has been performed in female rats at a dose approximately 40 times the human dose (on a mL/kg basis) and revealed no evidence of harm to the fetus due to BOOSTRIX. Animal fertility studies have not been conducted with BOOSTRIX. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, BOOSTRIX should be given to a pregnant woman only if clearly needed.8

Despite this cautionary information, the Brazilian government has been vaccinating tens of thousands, if not hundreds of thousands, of pregnant women in its country during the past year. A large portion of these pregnancies are occurring in Brazil’s northeastern region, notably in the state of Pernambuco—the country’s fastest growing population center.9 10


References:

1 Centro de Vigilância Epidemiológica “Prof. Alexandre Vranjac” (CVE). INFORME TÉCNICO–VACINA DIFTERIA, TÉTANO E COQUELUCHE (dTpa). cve.saude.sp.gov.br October 2014.
2 Guimarães LM, Neves da Costa Carneiro EL, Carvalho-Costa FA. Increasing incidence of pertussis in Brazil: a retrospective study using surveillance dataBMC Infect Dis2015; 15: 442.
3 Palazzi Sáfadi MA. Pertussis in young infants: a severe vaccine-preventable diseaseAutops Case Rep April-June 2015; 5(2): 1-4.
4 World Health Organization (WHO). WHO SAGE pertussis working group: Background paper, SAGE April 2014. WHO.int April 2014.
5 Instituto Butantan. vaccines. Butantan.gov.br.
6 de Carvalho AP, Pereira EMC. Acellular pertussis vaccines for adolescentsJ PediatrJuly 2000; 82(3).
7 Vaccine Ingredients and Manufacturer Information. CarProCon.org
8 GlaxoSmithKline (GSK). Package Insert for Boosterix. us.GSK.com
9 Bevins V. Brazil’s historically poor northeast finally gets its boom. Los Angeles Times May 24, 2012.
10 Sells H. Brazil’s Northeast Emerging as Economic Powerhouse. CBN News July 23, 2012.

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11 Responses to “Tdap Vaccinations for All Pregnant Women in Brazil Mandated in Late 2014”

  1. Patty

    Is it true that around the same time Brazil mandated that all babies be born by C-section? I heard that from a US doctor.

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  2. pat nalin

    BUTANTAN, the company in Brazil which manufactures their tdap vaccine touts its success in introducing “a powerful vaccine adjuvant” and “an innovative production of whole-cell pertussis vaccine” on its website. Check out their NEW PRODUCT DEVELOPMENT if you need something to keep you awake at night!

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  3. Kris Huygen

    See a recent paper by Walls T et al in BMJ Open:
    A cohort of 403 infants whose mothers had received Tdap vaccine, followed for more than 12 months in New Zealand.

    MAIN OUTCOME MEASURES:

    Gestational age at birth, growth parameters, congenital anomalies, immunisation status and timeliness of immunisation, development of pertussis infection.

    RESULTS:

    There were no significant differences in birth weight, gestational age at birth, congenital anomalies or infant growth as compared with baseline population data. Infants of mothers who had received the vaccine were more likely to receive their vaccinations on time during infancy. No cases of pertussis occurred in this cohort despite high rates of disease in the community. We have not found any adverse events attributable to vaccine exposure.

    CONCLUSIONS:

    These data add to the growing pool of evidence that the administration of Tdap vaccine during pregnancy is an appropriate strategy for reducing the burden of pertussis in infants.

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    • Albert Donnay

      But the NZ version was not made in Brazil by Butantan with a more powerful adjuvant! This has so far been used only in Brazil, which is why it is the most likely cause of the microcephaly.

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  4. anonimo

    zika is fraud. 4000 cases of microcephaly this number reduced to 270 zika suspects and only 8 confirmed with zika with microcefaliar
    cases of zika is the northeast region of Brazil. There decades in Africa and has no reporting microcefaliar in Africa.

    Brazil has 205 million people on average have less 300 cases. US averages 2500 to 25,000 per year. 86% of the cases concentrated northeastern Brazil and not in the whole Brazil which in northeast signal is concentrated where more cases of zika and microcefaliar in Brazil and which has more cases of anomaliar where transgenic mosquitoes were played.
    “Workers Party” PT “which is the feminist movement and the government is interested in legalizing abortion in general Brazil ……. they will get in the coming months in the Supreme Court with federal safety mandate to legalize abortion by the Supreme because the national congress did not pass. the same government that prohibits pilular cancer not expect anything else, since the voters of Rousseff believe she’s doing good of Brazil.
     
     The President of Brazil Dilma wants to use combat the mosquito that transmits dengue and zika etc …. to distract the people, because your government is in the news involved in several corruption scandals involving members of his party and allies arrested for corruption and the process impeachment in the coming months. use mosquito fight to distract the people, but many Brazilians have already agreed to it.

    website 1
    http://www.bbc.com/portuguese/noticias/2016/01/160126_zika_stf_pai_rs

    site 2 http://www.bbc.com/portuguese/noticias/2016/02/160201_zika_aborto_temporao_rs

    site 3
    http://g1.globo.com/ac/acre/noticia/2016/02/ministro-defende-opcao-de-aborto-em-caso-de-fetos-com-microcefalia-no-ac.html

     of Rio Grande do Sul The government suspended on Saturday (13) the use of water for human consumption pyriproxyfen larvicide used to stop the development of mosquito larvae Aedes aegypti, the transmitter zika virus. The product is manufactured by Sumitomo Chemical.

    http://g1.globo.com/ac/acre/noticia/2016/02/ministro-defende-opcao-de-aborto-em-caso-de-fetos-com-microcefalia-no-ac.html

    science site belying Humbug zika:
    http://www.csmonitor.com/World/Global-News/2016/0205/Research-suggests-more-fear-than-fact-behind-Zika-threat

    Video 1 https://www.youtube.com/watch?v=8ABzc_P4JeM
    Video 2 https://youtu.be/ioQDBl1KSxU?t=58s

      

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  5. Leigh

    I have done a lot of research into this issue as a former RN, who is concerned. Problems I have seen is that the Zika testing is not accurate (has to be done at 4-7 days of exposure/problems with other flavavirus) False positives on all 4 tests. New Wyss Institute test is not confirmed accurate either. AND first 2 women were NOT positive for zika but later found it in miscarriage tissue(other women), and amniotic fluid tested at the Oswaldo Cruz Foundation. I heard about the vaccine issue so I searched that angle also. The new pregnancy requirements peaked my interest , as well as the possible MMR booster (live rubella) taken (as recommended by CDC for month or several month before pregnancy) mixed with possible new Dtaplow or Plow. ( changed from prior vaccine) Cannot get vaccination records, etc. Anyway , the syndrome rash,fever(BOOSTRIX or other vaccines) (described by women in Medscape article who also stated they blamed the vaccine(s) (Dr. Melo ) who found the problem of increasing microcephaly, is also the same for the infant (eye problems, hearing problems, microcephaly, etc.) as is the congenital rubella syndrome. Guillion-barre is also a KNOWN side effect of vaccines ( product insert info. from the companies)Something new happened here IMHO. I wish I was tech saavy, or had an investigator.!! I hope for the sake of these women, their loved ones, and all women being cajoled into vaccinations (while pregnant) will think twice! I was always told to tell women to take NO MEDS at all during pregnancy as you could be allergic!! Some places to check:: INOVIO- Clinicaltrials.gov. SUS Brazil health systems. Paraguay new outbreak of GBS!! Public Health Reports The National Vaccine Advisory Committee June 11,2014″Reducing Patient and Provider Barriers to Maternal Immunizations” approx. page 14 on AFIX(incentives for providers) to know why Obgyn’s are pushing these!!!

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