CDC Stands by UNICEF Vaccines in Kenya

By Stefano Gennarini, J.D. | November 25, 2014

Following is a response of the U.S. Centers for Disease Control and Prevention to questions from C-Fam on the tetanus vaccination in Kenya sponsored by WHO and UNICEF. The questions are based on the reasons for suspicion that the vaccination program might  be a “disguised” population control program given by the Kenya Cathoolic Doctors Association and the Kenyan bishops.

Tetanus (lockjaw) is a life-threatening disease caused by Clostridium tetani bacteria, the spores of which are widespread in the environment, especially in soil and dust. Tetanus bacteria enter the body through open wounds (including those associated with labor and delivery and cutting of the umbilical cord). Small pricks and scratches have been associated with tetanus, although the disease is more common when there are infections of deeper puncture wounds, bites, cuts, burns and ulcers. Tetanus disease is caused by the action of a neurotoxin produced by the bacteria that affects the nervous system and can be fatal if left untreated.

Tetanus can be prevented by the administration of TT vaccine, which induces specific antitoxins. To prevent maternal and neonatal tetanus, TT needs to be given to the mother before or during pregnancy. Antibodies formed in the mother’s body following vaccination are passed on to the baby providing several months of protection after birth. Clean delivery and cord care also should be ensured to further protect mothers and newborns from exposure to tetanus and other infections.

In 1989, the World Health Assembly resolved to eliminate neonatal tetanus (NT- tetanus in the first month of life) as a public health problem throughout the world.  Subsequently elimination of maternal tetanus was added to the goal and the global program was renamed the Maternal and Neonatal Tetanus Elimination (MNTE) Initiative.  A key strategy to achieving the elimination goal is to provide TT vaccination to women of reproductive age either through routine services during pregnancy or campaigns focused on women living in areas where routine services do not reliably reach them. Promotion of clean deliveries and umbilical cord care are the other main strategies to achieve elimination.  Implementing these strategies resulted to a 90% worldwide decline in the number of newborns dying from tetanus between 1988 (787,000 estimated deaths) and 2010 (58,000 estimated deaths).

Have you ever come across this kind of tetanus vaccination regime before? Is it medically feasible?

Tetanus toxoid (TT) campaigns have successfully decreased the incidence of maternal and neonatal tetanus and is used in areas where health care is limited and women of reproductive age are not generally receiving TT during primary health care. Maternal and neonatal tetanus has been eliminated as a public health concern in countries and areas where campaigns have been conducted, along with efforts to provide TT to all women of childbearing age during other healthcare contacts and to provide clean deliveries for all births.

Could the same kind of immunity be reached with only a single shot?

A single dose of tetanus toxoid (TT) does not reliably confer immunity but serves to prime the body for the production of antibody following two or more doses. Because immunity may wane over time, multiple doses of TT are needed to protect women and children for years. An accumulative schedule of five doses of TT protects mothers for their lives and their children during the reproductive years.

According to UNICEF five shots of tetanus vaccinations are recommended by the Kenyan Health Ministry in order to guarantee immunity from tetanus for life. Is this realistic?

There are no absolutes, but no tetanus deaths have been reported in persons who completed primary tetanus immunization and five doses to women appear to protect infants born to these women throughout their reproductive life.

Had you ever heard of birth control shots or fertility regulating vaccines? Does any such thing exist?

No. There is not, and never was, human chorionic gonadotropine (HCG) in any Tetanus Toxoid (TT) vaccine used for tetanus prevention – not in UNICEF-supplied TT/Td/DTP nor in any WHO prequalified tetanus toxoid-containing vaccine procured directly by governments or the private sector.

The rumor that TT vaccine used by immunization programs has been contaminated with HCG to reduce women’s fertility arose with the 1994 publication of a report on a small clinical trial in India of a contraceptive vaccine composed of HCG coupled to tetanus toxoid (serving as a carrier protein and adjuvant).  WHO was in no way connected with this trial.  In addition, the experimental vaccine used in the trial was created by the researchers for that study and was in no way related to vaccine produced by commercial suppliers.

The presence of HCG in the Mexican and Philippine tests of TT conducted in 1994 was clearly shown by subsequent lab tests to be below the limits of accuracy of the test kits used and was probably related to interference from the adjuvant and preservatives used in the vaccine. The findings of the Mexican and Philippine tests were called “an artifact rather than a true value” by Professor Salvatore Mancuso of the Vatican’s Catholic University of the Sacred Heart.  Six independent labs in five countries ran tests on TT from seven different manufacturers, including those supplying the four countries affected directly by the controversy. All the tests were negative for presence of HCG. Global Programme for Vaccines and Immunization (GPV) director Dr Jong-Wook Lee declared in a WHO statement issued in July 1995 that the rumors “are completely false and are totally without any scientific basis”. The rumors are “categorically denied by the Governments responsible for administering the vaccine, by the vaccine manufacturers, by UNICEF (which provides much of the TT vaccine used in the world) and by the World Health Organization”. [Milstein J, Griffin PD, Lee JW. Damage to Immunisation Programmes from misinformation on contraceptive vaccines. Reprod Health Matters 1995; 3:24-28.

Would it be even possible to combine the tetanus vaccine with hCG to obtain a combined tetanus and birth control vaccination?

Because of the adjuvants and preservative contained in tetanus toxoid, it is unlikely that hCG could remain active in a vial of TT. In addition, all vaccines and toxoids are produced in facilities that are under strict quality control conditions and accredited (pre-qualified) by the World Health Organization’s Vaccines and Biologics Department. UNICEF only purchases vaccines and toxoids made by pre-qualified manufacturers.

The CDC also forward us to the following resources:

Tetanus toxoid and spontaneous abortions: is there epidemiological evidence of an association? The Lancet, Volume 348, Issue 9034, 19 October 1996, Original Text

Nicolas Catindig a, Grace Abad-Viola a, Florante Magboo a, Ma Concepcion Roces a, Manuel Dayrit , http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(05)64442-X/fulltext#article_upsell

Damage to Immunisation Programmes from misinformation on contraceptive vaccines.  Milstein JM, Griffin PD, Lee JW. Reproductive Health Matters 1995; 3:24-28. Scanned copy available at http://www.who.int/immunization_monitoring/milstien.pdf

Tetanus Toxoid Controversy Philippines – http://www.docstoc.com/docs/87508949/WHO-FACT-SHEET

Annex I: The Rumour Campaign against TT in the Philippines

Submitted by dheimann on July 18, 2002. From: Combatting Antivaccination Rumours: Lessons Learned from Case Studies in East Africa (Excerpted, with permission, from the unpublished report, “Deadly diseases, deadly vaccines, or deadly rumours?” by L. Luwaga, R. Wellington, and J. Clements)http://www.comminit.com/node/1545

 

COMBATTING ANTIVACCINATION RUMOURS: LESSONS LEARNED FROM CASE STUDIES IN EAST AFRICA: http://www.path.org/vaccineresources/files/Combatting_Antivac_Rumors_UNICEF.pdf

 

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