Is a Clinical Trial of 42 Days Enough to Establish Vaccine Safety?

In the 1960s and early 1970s many babies were sacrificed to produce the rubella vaccine. Hysterotomy was performed on women who chose to have an elective abortion in order to provide fetal tissue. The research took place over a period of years.

This rubella vaccine (included in the MMR) was approved in the U.S. by the FDA in 1979. The approval was based on study groups, comparing 3 different preparations of the live attenuated rubella virus for effectiveness. The 834 children receiving the MMR were followed for 42 days. Just 42 days to assess the safety for administering to all toddlers. 

Why was there such a dramatic efforts to develop this vaccine? In 1964-65 there was an epidemic of rubella in the U.S. that caused birth defects in pregnant women. Dr. Stanly Plotkin isolated the rubella virus from aborted fetal tissue. 

Currently, the virus strain (RA 27/3) found in the rubella vaccine most commonly used around the world was developed by Dr. Stanley Plotkin and colleagues at the Wistar Institute.19 The RA27/3(rubella abortus,twenty-seventh fetus, third tissue extract) virus strain was obtained from a female human fetus in a series of twenty-seven abortions in the United States:

Scientific research was devoted to producing a vaccine. The first vaccine was developed from kidney cells from a monkey. But a couple of researchers at the Wistar Institute in Pennsylvania were pursuing a vaccine that could be grown on human cells. 

Abortion was illegal in the United States at that time, so fetal tissue was provided by Dr. Sven Gard of the Karolinska Institute Medical School in Stockholm, Sweden.4 Dr. Erling Norrby, who later served as chairman of the department of virology and dean of the medical faculty at the Karolinska Institute, was a graduate student there during this period. He dissected many of the aborted fetuses.

For the initial research the Wistar Institute received dissected tissue from 19 elective abortions done in Sweden. Finland was also participating in the research (35 women had abortions by hysterotomy for one study). 

Timo Vesikari wrote about his part in rubella research. in late 1966, I was incredibly lucky to meet Antti Vaheri (later Professor of Virology) who had just returned to Finland from the Wistar Institute in Philadelphia with all the latest knowledge in rubella research . . . An important open question was whether the live attenuated vaccine would cross placenta same way as wild type rubella virus. The crucial study was to be done in Finland, away from potentially damaging publicity in the US, with Dr. Fred Robbins, a Nobel Laureate, as the godfather of the project. Under the seniors I was to do much of work: vaccinate pregnant women prescreened to be seronegative for rubella and scheduled to have a legal abortion a week or two later. The plan was to isolate rubella (vaccine) virus from the products of conception and, in fact, we succeeded in doing that.

A healthy pregnancy of a married couple was selected by Dr. Sven Gard for the abortion–the female fetus that would provide the line of cells, WI-38, for the rubella vaccine.

This vaccine developed off of aborted fetal cells is part of the measles-mumps-rubella vaccine. The hysteria about the measles has renewed public controversy over the MMR. Even though there is no current concern about rubella, this combination vaccine is the only one available for the measles in the U.S.

Years of research and a multitude of abortions led to the rubella portion of the vaccine. Researchers have a lot invested in this vaccine. Perhaps too much invested?

The concern about rubella was the possible effect that the virus could have on a developing fetus–effects on the heart, eyes, brain–multiple organs. There was great concern about the effect on a growing fetus.

You would expect that there would be similar concern about the possible effects of the live attenuated vaccine on a toddler. At 15 months a child’s immune system is still developing.

In 1979 the FDA approved the combined vaccine for all children based on study groups that inoculated healthy children, age 10 months to 8 years, with three different forms of the rubella vaccine. The focus was on the effectiveness of the vaccine. Children that participated in the study could not have an allergy to eggs or chicken and had to be free of a sensitivity to neomycin.

834 healthy children of various ages were given the MMR vaccine. Some of the children developed fevers and a variety of complaints. They were followed for 42 days and no more–even though some continued to have symptoms. The usual phase III of clinical trials lasts much longer.

The documentation of the studies done during a 4 month period in 1978 were obtained by RFK jr. and Del Bigtree via a FOIA request. You can access the study here.

The controversy over the MMR vaccine remains today because parents are observing side effects in their children that are not being acknowledged by the medical community.

In 1986 Congress passed a law to prevent any law suits against the pharmaceutical companies when a child was injured by a vaccine. No lawsuits, no investigation, no discovery. The only recourse that a parent has is to petition the vaccine court (which is conducted by the federal government). If a parent can supply sufficient documentation of death or disability due to the vaccine, the parents receive a payment from the government. To date the vaccine court has paid out more than 4 BILLION dollars.

Dear reader, please understand that there are legitimate spiritual and medical concerns about the MMR vaccine. In addition to adequate safety testing for pharmaceutical products, informed consent, discussion of risks and benefits of any medical procedure, and religious liberty must be part of health care.

Leiva, Rene M.D. “A Brief History of Human Diploid Cell Strains” National Catholic Bioethics Quarterly 6.3 (Autumn 2006), 443-451

Vaheri, Antti; Oker-Blom, Nils; Vesikari, Timo; Seppala, Markku “Isolation of Attenuated Rubella-Vaccine Vaccine Virus from Products of Conception and Uterine Cervix” New England Journal of Medicine 286(20) 1071-4. June 1972

Vesikari, Timo “From Rubella to Rota Virus, and Beyond” Human Vaccines and Immunotherapies; 11(6): 1302-1305. June 2015

Department of Health, Education and Welfare, Public Health Service, Food and Drug Administration. Reference Nos 76-316, 77-303, 77-304

photo courtesy of Arek Socha at pixabay.com

Two Different Viewpoints on Faulty Vaccines

On July 27ththe Wall Street Journal published an article titled China’s Vaccine Scandal. Parents in China have led protests on behalf of their children. I read through the article noting several paragraphs.
     Over the past couple of weeks parents in China have learned that a compulsory public-health program injected an unknown number of children with substandard vaccines. They are understandably furious.  . . .
     Chinese are particularly angry because similar cases have happened in recent years, followed by promises to crack down. In 2010 and 2013 hundreds of children were hospitalized and several died from faulty vaccines. Chinese companies have used official connections to avoid accountability for producing a range of defective products that kill and maim.

Today, July 31st, The New York Times published an article titled Angry Parents Protest in China Over Bad Vaccines for Children. The tone and conclusion of this article was a little different. Here are a few paragraphs:
     The protest followed reports this month that hundreds of thousands of children across China had been injected with faulty vaccines for diptheria, tetanus and whooping cough. . . .
     While the vaccines were not harmful, officials say, they left children at risk of contracting illnesses that they should have been protected against. . . .
     Public officials say that the problems at the two companies [pharmaceuticals] could lead to a broader backlash against vaccines in China, where an aggressive immunization effort in recent decades has helped eliminate polio and drastically reduce the spread of other diseases.

These two articles demonstrate different perspectives on the same situation. Vaccine safety is extremely important issue. I pray that the government in the United States would look carefully at vaccine safety. The pharmaceuticals have been relieved of any liability for harm to children. Who is going to make sure that profit doesn’t become more important than the health of children?

Required Vaccine Safety Reports Were Not Done

Parents have differing opinions about childhood vaccines. That is okay. I am a nurse and my children received the recommended vaccines in the 1980s and 1990s. But my daughter had vaccine reactions and eventually developed fibromyalgia.

Because of my family’s experience with vaccine reactions I support informed consent and parent involvement in decisions about vaccines.

It is good to understand the history behind our current vaccination program. In 1986 the National Childhood Vaccine Injury Act was passed. So many lawsuits were taking place because of vaccine injuries that pharmaceuticals were relieved of any liability. Instead the government would compensate for vaccine injuries. More than 3.7 billion dollars has been paid out through this program.

Robert F. Kennedy has spent years researching vaccines, the ingredients in vaccines and the impact on childrens’ health. He looked at the law that was passed in 1986 and realized that the law included a mandate for improved  vaccine safety. The law required that the department of Health and Human Services submit reports to congress regarding the studies done and progress made for safer vaccines.

In August of 2017 a FOIA request was made for these reports. The result of the FOIA request for these reports has been made public. The reports cannot be found. It appears that they were never done.

Today the prompt for Five Minute Friday is: DONE

Moms for Vaccine Safety

At the beginning of the 19th century, in the city of Chicago, the health of young children  was in  perilous condition. The health of both women and children needed focused attention.

In 1916, for example, Chicago’s death rate for children under 2 years of age was 141.4 per 1,000 live births, as compared with 129.3 for Detroit, 88.3 for Philadelphia, 58.1 for New York and 49.4 for Boston.

“Enteritis under 2” remained as one of the top ten causes of death reported by the Illinois state Board of health each year from 1902 to 1913, and dramatic increases in childhood diarrheal diseases continued to be identified in the hot summer months.*

 Lack of proper sanitation and hygiene contributed to the illness. Malnutrition was another factor. The educated women in Chicago responded to this health crisis. Women from Hull House, the Chicago Women’s Club, women physicians and social workers became involved.

A broad coalition of public health practitioners, social welfare advocates, and women’s rights supporters argued that a sound and democratic future depended on mother’s ability to produce and maintain a robust citizenry.**

Since that time improved sanitation, indoor plumbing, purified water, pasteurization of milk and improved hygiene have made a difference. Public health classes on infant care and nutrition have benefited young mothers.

In addition, the discovery of antibiotics to treat infections has saved lives. These wonderful medicines were eventually overused. Doctors have learned that not every ear infection should be treated with antibiotics. When antibiotics are overprescribed they lose their effectiveness: bacteria become resistant and increasingly difficult to treat.

Is the same thing happening with the heavy use of vaccines?     Is  the  immune system—intricately designed by God—being impaired by too many vaccines?

VAXXED: A Powerful Message
Photo by Naypong@FreeDigitalPhotos.net

Currently 1 in 68 children has been diagnosed with the autism spectrum. Children have more allergies and are being diagnosed with immune system disorders. It is shocking that research data indicating a relationship between the MMR vaccine and autism was destroyed. Click here for a news article.

The number of vaccines recommended for children by age six has dramatically increased. If you count up the doses of each type of vaccine, there are 39 to be administered by age six.  Click here for the recommended vaccine schedule.

Each vaccine injection contains adjuvants. These are additions like mercury and aluminum, which stimulates the immune system to respond. What is the cumulative effect of these additives? We are concerned about mercury in the environment—and yet it is injected into the bodies of young children? Click here for an interview with Robert Kennedy Jr. regarding his research into mercury in vaccines.

Vaccines should be evaluated by their benefits and risks. Why does an infant need to receive a vaccine (hepatitis B) for a sexually transmitted disease? Click here for a school nurse’s concern about the hepatitis B vaccine.

A group of researchers, doctors and parents are working together for the robust health of children in the United States.    A petition  for  vaccine  safety is available on-line.

Click here to join the voices of many others who have concerns about vaccine safety.

*Lynne Curry, Modern Mothers in the heartland: Gender, Health and Progress in Illinois, 1900 – 1930, Columbus, Ohio: Ohio State University Press, 1999. p. 19.

**Ibid. p.1

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When You’re in the Middle You Need to Pray

Today I am joining Kate Motaung for Five Minute Friday:  We write fast and free, for five minutes flat. The prompt is MIDDLE.

Middle of the Grandchildren

In the photo above my husband and I are sitting in the middle of our grandchildren. This is a wonderful place.

In our extended family we are in the middle of youth and aging. My mother is gradually drifting away as dementia progresses. This is hard. Our family is facing change.

As a nation we are in the middle, between the current administration and the next.   Next week we will have a new president, but divisiveness in our country continues.   We are in a period of change. How will it work out?

There is bright spot. The new administration is planning to take a careful look at the controversial issue of vaccines. As a grandmother (and nurse) I am concerned about the health of children. I am encouraged that Robert Kennedy Jr. will be leading a commission on vaccine safety.     Vaccines have their place, but are children receiving too many, too soon?

You can read about my experience and concern regarding the MMR here.

In all periods of change we need to pray for wisdom, pray for our families, pray for our nation, pray for our government leaders.

Do not be anxious about anything, but in everything by prayer and supplication with thanksgiving let your requests be made known to God. Philippians 4:6

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