NVIC Vaccine News


By Barbara Loe Fisher
Published June 01, 1996 in Infectious Diseases & Vaccines

"When it happens to you or your child, the risks are 100%"

Published by the National Vaccine Information Center

Barbara Loe Fisher, Editor

Vol. 2 No.2 June 1996


National Vaccine Information Center and Washington Office on Haiti Call On FDA to Release All Records and Raw Data on Experiment

In an experiment to find out if they could give a high potency Edmonston Zagreb measles vaccine to babies as young as four months old in order to overwhelm their natural maternal antibodies and replace them with vaccine-induced antibodies, medical researchers at the Centers for Disease Control (CDC) and Johns Hopkins University injected thousands of babies in the Third World with the experimental vaccine that reportedly caused chronic immune suppression and the deaths of an unknown number of babies. With the help of Kaiser Permanente, more than 1500 six month old black and Hispanic babies in inner city Los Angeles were enrolled in the experiment starting in June 1990. The study was halted in October 1991 after repeated reports from vaccine trial sites in Africa that girl babies were dying in higher than expected numbers six months to three years after vaccination.


CDC Admits Informed Consent Violations - CDC director David Satcher admitted in a June 17 Los Angeles Times article that a National Institutes of Health (NIH) investigation of the 1990-91 Los Angeles study found that informed consent regulations had been violated because the parents were not told their babies would be injected with an experimental vaccine that had never been licensed by the FDA for use in America. Both Kaiser and the CDC have denied that any of the Los Angeles babies were harmed by the high potency EZ vaccine but did admit that one child, who received a standard potency EZ vaccine, died from a bacterial infection they maintain is unrelated to the vaccination.

The high potency EZ measles experiments began at four major sites in the mid-1980's including Haiti, the Senegal, Guinea Bissau and Mexico. Other trials followed in Cameroon, Gambia, Bangladesh, Togo, Iran, New Guinea, Peru, Rwanda, Sudan, South Africa, Egypt, Philippines, Uzbekistan, Thailand, Zaire and Los Angeles. Primary funding came from the U.S. Agency for International Development (USAID) and the World Health Organization (WHO). In Haiti, infants were given the experimental vaccine at 10 to 500 times the usual dose levels. In a June 1996 article in Journal of Infectious Diseases, Johns Hopkins researchers report that infants with the highest antibody responses to high titer measles vaccine have the most profound immune suppression.

HIV Positive Babies Enrolled - Some of the infants in both Haiti and Zaire were HIV positive and already enrolled in a long term HIV study. They were deliberately included as part of the study design in order to evaluate the effects of vaccines in HIV positive infants. When study results were finally published in late 1993, deaths occurring in the HIV positive babies were left out of the mortality figures. It is unknown exactly how many of the vaccinated HIV-positive babies died, although at least 100 of the Haitian HIV-positive babies reportedly died.

Warnings Ignored - The measles vaccine experiment was only stopped two years after the director of one of the African sites warned the WHO and CDC experiment leaders in April 1990 that African mortality data raised a red flag about the high titer EZ vaccine. His reports were first ignored and then discounted and he was replaced as a principal investigator. After his mortality data was dismissed as incorrect for more than a year, with support from colleagues at Harvard, he published the mortality data in The Lancet in October 1991. WHO then called for all the sites to submit mortality data for independent analysis. The CDC has stated that enrollment for the LA study was halted in October 1991.

CDC Knew It Was An Experiment - In the LA Times article, the CDC's chief Satcher referred to the failure to tell the parents in LA that the EZ vaccine was experimental as a "little mistake" and not a deliberate attempt to deceive them. Kaiser maintains that the failure to inform the parents was an administrative "oversight." However, CDC grant announcements in 1989 clearly state that the vaccine trials are "experimental, developmental, test and research work."

Vaccine Antibodies Only Temporary - Since the early 1980’s, the WHO, CDC and Johns Hopkins researchers had been working on a way to vaccinate babies by six months of age with measles vaccine. This became even more important in the late 1980's when measles cases started to increase in the U.S. and around the world with cases atypically occurring in infants under a year of age and in older children. The "one measles shot will make you immune for life" theory that had prevailed in medical circles was shattered as it became obvious that antibodies induced by the live virus measles vaccine do not provide permanent immunity like natural antibodies created after recovery from the natural disease. It also became obvious that now babies at special risk for measles infection were under one year old, born to young mothers who had been vaccinated and could not transfer maternal antibodies to protect their babies in the first vulnerable year of life. During the 1989-91 measles epidemic, the largest increase in measles cases was in infants under one year old.

In a 1990 meeting of the National Vaccine Advisory Committee there was also discussion that the unexpected rise in measles cases raised the question of whether, during the previous two decades of mass vaccination, the wild measles virus had evolved into a more deadly strain. But in January 1991, the National Vaccine Advisory Committee issued a White Paper to Congress that blamed the "measles epidemic" not on the measles vaccine's failure or the mass vaccination campaign's effect on the natural epidemiology of the disease but on "failure to deliver vaccine to vulnerable preschool children on schedule." Shortly afterwards the CDC and American Academy of Pediatrics recommended that all American children get a second dose of measles vaccine at Kindergarten or at Junior High School entry.

Trying To Wipe Out Maternal Antibodies - The biggest problem for public health officials vaccinating large populations of very young infants is that some of the infants have maternal antibodies to protect them from measles in the first year of life. These infants do not respond to the vaccine until they are older when maternal antibody levels have dropped. That is why the measles vaccine licensed for use in America is recommended to be routinely given to children at 15 months of age or older in order to maximize chances for a vaccine-induced antibody response. And that is why the EZ vaccine researchers used a high dose in the experiment - to see if it could overwhelm natural maternal antibodies. This will not be a problem in the future, according to an article published in the January 1996 issue of Pediatrics by the CDC, Johns Hopkins and Kaiser researchers, because in the future all mothers will have been vaccinated and won't have maternal antibodies to give to their infants and so all babies will be candidates for measles vaccination from birth.

This means that public health officials plan to use mass vaccination to eliminate natural measles antibodies from the human race, which are permanent, and replace them with vaccine-induced antibodies, which are temporary. Repeated doses of the vaccine will undoubtedly be given from birth to try to keep vaccine antibodies high in everyone.

Call for Public Inquiry - The National Vaccine Information Center and the Washington Office on Haiti have issued a joint request under the Freedom of Information Act for all government data on the EZ measles vaccine experiments in the U.S. and the Third World. In Los Angeles, the African American community has founded a group called Los Angeles Coalition Against Racist Child Experimentation and is networking with NVIC and the Washington Office on Haiti.

"The parents in inner-city LA were not told what it meant to subject their babies to a dose of measles vaccine many times stronger than normal," said NVIC Co-Founder & President Barbara Loe Fisher. "They weren't told that measles vaccine can cause brain inflammation and death. Their human rights were violated - rights protected by the Nuremberg Code and the Declaration of Helsinki and U.S. federal laws created to protect human subjects in medical experiments. It is just another example of vaccine researchers and public health officials willing to sacrifice the lives of individuals without their consent because they have decided the ends justify the means."

Worth Cooley-Prost, a biomedical research consultant and director and past president of Washington Office on Haiti, added, "Haiti has been an offshore laboratory for drug research for decades. "What is really frightening about this experiment is that the WHO was ready to buy 250 million doses for Third World babies. Millions would have died but nobody would have realized the vaccine was to blame because six months to three years passed before the babies died. The investigator who found the mortality problem had a very hard time convincing the other researchers to take it seriously. And the vaccine was slated for use in inner city infants in the U.S. We came very close to a huge, hidden disaster."



In a classic example of how a drug company in search of a market for a new vaccine creates that market with the help of the CDC, black children in Memphis, Tennessee eligible for free vaccines under the Vaccines for Children Program (VFC) program are being targeted for mandatory vaccination with the newly licensed high potency pediatric hepatitis A vaccine. A group of Memphis parents, protesting the forced vaccination of black children without the informed consent of their parents, have filed a $500 million lawsuit against vaccine maker SmithKline Beecham, the county health department and school board citing civil and religious rights violations.

Poor Sanitation The Cause - In February 1985 the FDA gave the nod to SmithKline Beecham to market Havrix, the first adult and pediatric hepatitis A vaccines for use in America. Six months after the license was issued, former U.S. Surgeon General Everett Koop announced a public education campaign on the risks of hepatitis A and the need for Americans traveling to countries with poor sanitation who may come into contact with contaminated food and water to get the vaccine.

Most People Recover - Hepatitis A is a viral disease affecting about 10 million people worldwide with only about 143,000 cases in the U.S. It causes jaundice, diarrhea, fatigue, appetite loss and stomach pain but, with proper medical care, most people fully recover and are left permanently immune to the disease. Rarely, it leads to chronic liver disease. While poor sanitation is the primary cause, like hepatitis B, the disease can also be spread by coming into contact with an infected person's blood or other body fluids and waste products.

Drug Company Lobbyists in Memphis - In January 1996, SmithKline Beecham sent lobbyists to Tennessee and persuaded state legislators to support introduction of a bill in the State House that would mandate that children be fully vaccinated against hepatitis A before being allowed to attend kindergarten, nursery school, daycare or Head Start in counties with "epidemics" of hepatitis A. An epidemic was defined in the bill as 50 cases per 100,000 residents. At this point, SmithKline Beecham was trying to get another license from the FDA to market a high potency hepatitis A vaccine for children between two and 18 years old.

CDC Awards Contract - On Jan. 30, SmithKline Beecham announced that the CDC had awarded them a contract to supply hepatitis A vaccine under the Vaccines for Children Program (VFC). VFC guarantees federally funded vaccine supplies to states where there are high rates of vaccine-preventable disease for a defined group of children, i.e., those aged two to 18 who qualify for Medicaid, have no health insurance, are Native Alaskans or Native Americans, or get vaccinations at federally qualified health centers.

School System Issues Directive - On Mar. 8, the Memphis City School system sent out a memo to "Selected Principals" of 14 middle, junior high and senior high schools in Shelby County stating that the County Health Department has "determined that the Hepatitis A epidemic has not been stemmed," and that in cooperation with the health department, "no student, age 17 or under, will be allowed to continue enrollment without documentation of receipt of the Hepatitis shot. This also applies to graduating seniors." All but two of the targeted 14 schools contain a majority of black students. In the two predominately white schools, only those black students bused into those schools were required to get the vaccine. On April 2, SmithKline Beecham announced the FDA had licensed their higher potency pediatric hepatitis A vaccine.

Parents Protest - In mid-April, when school officials started to enforce the new vaccination requirement, a group of black parents protested, asking why only black children between the ages of two and 18 were being targeted and why cafeteria workers handling food and other adults were not being required to be vaccinated. They also protested the fact that the health department and school officials were picking and choosing which religions the children could belong to qualify for religious exemptions to vaccination. The parents reported that no information was given to the students or parents describing possible adverse reactions, contraindications or how to report reactions.

Lawsuit Filed - When it became obvious that health department and school officials were not going to allow parents the right to informed consent to vaccination of their children, the protesting parents filed a $500 million lawsuit against SmithKline Beecham, the health department and school board on April 29 and eventually filed for several temporary restraining orders in federal court on grounds of civil rights and religious freedom violations. Later a federal court judge issued several orders stating that all Shelby county children, not just black children, had to get hepatitis A vaccine and that parents had the right to be advised of their right to religious exemption. In mid-May, another memo from the school system went out to principals stating that "high schools will place a priority on tracking down every single senior needing the vaccine" and barring students from graduation or summer school if they have not been vaccinated or obtained an approved exemption.

Governor Signs Bill - Finally, in May the Governor of Tennessee signed the bill mandating hepatitis A vaccine in targeted communities in the state. By the second week in June, teenagers were coming forward with reports of reactions to their hepatitis A shots. Some students reported school officials signed their consent to vaccinate forms or the students forged their parents signatures after feeling pressure from school officials to get vaccinated. The protesting parents went back to federal court to ask for a requirement that parents be present when vaccinations are given. On June 22 and 29, the protesting parents stood outside community centers where other parents were lining up with their children, who qualify for VFC to get free hepatitis A vaccinations, and handed out literature about side effects and contraindications.

Taxpayer Group Slams VFC - In late June, Citizens Against Government Waste (CAGW) called on Congress to repeal the Vaccines for Children (VFC), charging that it was "poorly thought out and has already started to show signs of gross mismanagement." CAGW said the Government Accounting Office (GAO) has found that vaccine cost is not a major barrier to getting children vaccinated and charged that the nine month old VFC program giving out free vaccine has already cost the federal government more than $1 billion. HHS Secretary Shalala and the Children's Defense Fund have been vocal supporters of the program.

Side Effects Not Minor - SmithKline Beecham's product insert for Havrix lists a variety of reported adverse events including headache in 14% of adults and 5% of children and fatigue, nausea, fever, and swelling in up to 10% of recipients. Diarrhea, vomiting, jaundice, convulsions, encephalopathy, neuropathy, Guillain-Barre syndrome, multiple sclerosis and other more serious conditions have also been reported. The insert states that "Havrix has not been evaluated for carcinogenic potential, mutagenic potential or potential for impairment of fertility" and "it is also not known whether Havrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity" and "at present the duration of protection afforded by Havrix has not been established. Therefore it is unknown if the protection provided to immunized children will last until adulthood."

NVIC and Parents Network - The National Vaccine Information Center is networking with the Tennessee parents protesting violation of their civil, religious and human right to informed consent to vaccination. "If they get away with it in Tennessee," said one Memphis parent, "they will get away with it in every state."


In late April, a sixteen year old Milwaukee, Wisconsin boy was handcuffed, stripped and jailed overnight because he hadn’t shown public school or county health officials proof that he had gotten a second MMR (measles-mumps-rubella) shot. The busy mother of Jacob Kallas, a divorced mother of five who owns her own business and ignored repeated court orders to provide her son’s school with proof of vaccination, was quoted in an AP story as saying "I didn’t realize we were in such a police state. We’re talking about a really good kid who’s freaking out because he’s in jail." Jacob was reportedly stopped by police while driving his mother’s van, which had expired license plates. When a routine police check found he was wanted on a juvenile warrant [for failure to vaccinate] issued by Ozaukee County, he was thrown in jail and taken in shackles to court the next morning before finally being released to his mother.

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