The development of a shingles vaccine without the use of aborted fetal cell lines is prompting Catholic leaders to encourage ethical development of other immunuzations

By Jennifer Brinker | jbrinker@archstl.org | twitter: @jenniferbrinker

Within the scientific community, they’re known as WI-38 and MRC-5.

But these human stem cell lines, had they been allowed to develop as God intended them, might have been known as Michael and Lisa.

Two babies aborted in the 1960s — Michael and Lisa were top names of the time — were used to produce stem cell lines as a prime ingredient in several popular children’s vaccines in the United States, including rubella (the R in MMR), hepatitis A and varicella (chickenpox).

Many people have been long unaware of the connection between vaccines and human cell lines from aborted babies. Because vaccines play a valuable part in the protection of public health — some deadly diseases, such as polio and diphtheria, have either been eradicated or nearly extinguished in the United States — the “how” of vaccines creation has understandably taken a back seat in the conversation on vaccinations.

Last October, the U.S. Food and Drug Administration approved a shingles vaccine that does not use aborted fetal cell lines. Shingrix, developed by GlaxoSmithKline, was hailed by the U.S. bishops as an opportunity to encourage vaccine manufacturers to create other vaccines in an ethical manner.

“As recommended by the Pontifical Academy for Life in 2005, a long-term solution lies in working to ensure that future vaccines and other medicines are not based on cooperation with practices that demean human life,” wrote Archbishop Allen Vigneron, chair of the Committee on Doctrine, and Cardinal Timothy Dolan, then-chairman of the Committee on Pro-Life Activities, in a letter in May to fellow bishops. Additionally, the bishops’ Pro-Life Secretariat sent a similar communication to diocesan respect life directors and state Catholic Conference directors in July.

The Catholic Medical Association and National Catholic Bioethics Center issued a joint letter in April to the bishops, calling the new shingles vaccine “a significant development for building a culture of life in America.” The organizations also encouraged bishops, leaders and Catholics in the pews to remember their duty to use vaccines not linked to abortion when they are available; encourage Catholic health care systems to use purchasing power to create a market for the development of more vaccines not linked to abortion; and express gratitude to GSK for making a vaccine without aborted fetal cell lines and encourage them to develop other vaccines in a similar method.

WI-38 and MRC-5 cell lines

• WI-38 (bit.ly/2MqVLdY): This cell line was developed in July 1962 from lung tissue taken from a female fetus aborted at about three months gestational age.
• MRC-5 (bit.ly/2MadnOd): This cell line was developed in September 1966 from lung tissue taken from a male fetus aborted at 14 weeks old.

Archbishop Robert Carlson, who recently received his first dose of Shingrix, praised the recent development, noting that “this opens up exciting possibilities. I’m grateful to GlaxoSmithKline and the researchers who brought us this development, and I hope similar alternatives for other vaccines will be pursued by medical researchers and pharmaceutical companies.”

He also noted that Catholic doctors and health care systems play an important role in the discussion, too, and encouraged Catholics to ask their doctors about ethically created vaccines.

“I don’t see any reason why Catholic doctors and hospital systems shouldn’t get behind this from the point of view of distribution,” he said. “It’s another avenue for them to be consistently pro-life. We’re going to have to put pressure on Catholic hospitals and doctors not to ignore this.”

Living values, making accommodations

Rudy Probst learned about the connection between abortion and vaccines on Catholic radio. So when he and his wife, Linda, had their first child, Isaac, in February, they began researching how they could minimize the number of vaccines with aborted fetal cell lines that their child would receive.

Whether or not to vaccinate was not a question. The Probsts, members of St. Gabriel Parish in south St. Louis, understood the importance of immunizations from a public health and safety standpoint. But could they minimize the vaccines with aborted fetal cell lines? As they discovered, in some cases the answer was yes, and in others, no.

At Isaac’s first pediatrician visit, the couple was given a CDC-recommended vaccination schedule. Their doctor was initially hesitant when they asked if accommodations could be made to use other vaccines not created with aborted fetal cell lines. But as Rudy Probst described their next visit, “when she followed up with people in her practice who were more aware of it, they figured out a way to accommodate it.” The Probsts did not forgo any vaccinations.

Rudy Probst said the decision came down to “the importance of being pro-life and trying to live our values. In doing the research, I can’t support that if I know it’s there. If there’s not an alternative, it’s unconscionable to me to think about that, particularly now having a child.”

Linda Probst said it’s about “wanting to live out our values as much as we can. We’re just trying to follow the Catholic Church’s teachings.”

Dr. Elizabeth Abraham, a pediatrician in south St. Louis, noted that most of her patients “have no idea” about the connection between abortion and vaccines. Several years ago, she developed a vaccination schedule that minimizes the number of vaccines with aborted fetal cell lines, but also adheres to the CDC recommendations for immunizations. There are no “alternatives” at 12 months and 4 years old, she noted, when children typically receive MMR, varicella and Hepatitis A vaccines.

One of her challenges is finding time to talk to parents about this, as routine visits are typically short and to the point. She also has to balance that with not knowing where parents might fall on the abortion issue. Abortion is not an easy topic to talk about, she added.

“Any physician is required to hand out vaccine information statements,” she said. “That’s informed consent about each vaccine. But the part that’s missing is that people may have an ethical objection, and it needs to be on there.”

Abraham also faces the challenge of parents who do not want to vaccinate their children for various other reasons. “There’s a lot of misinformation on the internet,” she said. “The duty to vaccinate outweighs personal decisions — these diseases have real risks. You put other babies at risk. You need to inform your conscience that these diseases are still here and this is necessary and safe.”

Catholic duty

The Vatican has long held that the use of vaccines with aborted fetal cell lines are morally permissible if no other alternative exists. In 2005, the Pontifical Academy for Life wrote that vaccines that do not have an alternative are necessary in order to “avoid a serious risk not only for one’s own children but also … for the health conditions of the population as a whole — especially for pregnant women.”

But with that comes a responsibility to urge drug manufacturers and health care providers to promote ethically created vaccines. The Pontifical Academy for Life also wrote that there is a “duty to take recourse to alternative vaccines (if they exist), putting pressure on political authorities and health systems so that other vaccines without moral problems become available.”

In 2008, the Congregation for the Doctrine of the Faith noted in “Dignitatis Personae” that there are differing degrees of responsibility. “…For example, danger to the health of children could permit parents to use a vaccine which was developed using cell lines of illicit origin, while keeping in mind that everyone has the duty to make known their disagreement and to ask that their health care system make other types of vaccines available,” it noted. “Moreover, in organizations where cell lines of illicit origin are being utilized, the responsibility of those who make the decision to use them is not the same as that of those who have no voice in such a decision.”

From an ethical standpoint, the issue goes far beyond vaccines and into the use of human cell lines in research and development, said John Brehany, an ethicist and director of institutional relations at the Philadelphia-based National Catholic Bioethics Center.

“What we tend to get from the world of research medicine is that we have to do this — we must benefit from abortion to produce the cures we need,” Brehany said. This has come up in other areas, such as the use of human embryonic stem cells for research, which became a central issue on a 2006 ballot initiative in Missouri.

Brehany noted that in 2009, scientists gave public testimony in appealing for federal funding for embryonic stem cell research, and they cited a precedent of using fetal tissue from elective abortions for the rubella and varicella vaccines. In 2015, when a series of undercover videos showed Planned Parenthood officials discussing the sale of fetal body parts, scientists noted that obtaining tissue from abortion was indispensable, and pointed to its use in the production of vaccines, Brehany added.

The Shingrix vaccine “shows that no, you can do good without (abortion),” he said. “It takes time and costs money, but a lot of things take time and cost money. We have to address the underlying principle and that is, are we willing in a sense to affirm and endorse and continue without change, or are we willing to recognize there is a OVERSET FOLLOWS:problem and we don’t want to continue on this path and find a way to undo that?”

The science of vaccine development takes years, decades to complete

From antigens to licensing, the making of a vaccine can take years, decades

BY JENNIFER BRINKER | jbrinker@archstl.org | twitter: @jenniferbrinker

Graphics by Abigail Witte

Dr. Daniel Hoft, director of Saint Louis University’s Center for Vaccine Development, answered these questions via email about the science of vaccine development.

How are vaccines developed? What is the scope of the work and general timeline for development?

The process of creating a vaccine can take decades and cost millions of dollars. The United States is very particular about its vaccine research and it is well regulated. Scientists follow a series of standardized steps that start with laboratory and animal studies and continue with at least three phases of clinical trials done in humans for vaccines that seem promising.

In a nutshell, the basic science and pre-clinical stages of research typically take three to six years and identify promising antigens (a toxin or foreign substance that induces an immune response in the body, including production of antibodies) to prevent or treat a disease and test them in tissues, cells and animals.

Clinical research in humans starts with testing the vaccine candidate in small groups of 20-80 people for Phase 1 trials and moving to thousands or tens of thousands of people for Phase 3. Clinical trials study the safety of the investigational vaccine, the type of immune response it triggers, dosage, frequency and method of delivery and possible side effects. The overall time frame for all three phases of clinical trials can take decades and cost hundreds of millions of dollars. (See related graphic.)

Is it possible to take a vaccine like Shingrix (for adult shingles) and modify it as a varicella vaccine (a children’s vaccine for chickenpox), seeing that they are the same virus?

It’s not as easy as it sounds and we wouldn’t know the answer without extensive testing. One vaccine (chickenpox) is a live virus vaccine and the other (shingles) is a recombinant protein-based vaccine. There is no guarantee you could make an effective chickenpox vaccine from the Shingrix vaccine. It would have to go through the vaccine development process outlined above that includes pre-clinical and clinical research and that takes decades. You would have to start over.

Scientifically speaking, what challenges are present to creating a vaccine without the use of aborted fetal cell lines?

One challenge is whether the vaccine — either a live vaccine or a vaccine that is recombinant in nature — can replicate in other cell lines. Each cell is different in its capacity to support viral replication, which is necessary to make a vaccine. Not all cell lines are interchangeable and the way you make your vaccine can have a big impact on whether it works. There are different reasons that it may not work to use other cell lines to produce vaccines for different diseases. There may be production problems and a mutation could occur that makes the vaccine less effective.

Basic science:

To start the process, scientists conduct basic laboratory research, typically for two to four years, to identify antigens, such as weakened viruses or bacterium or other pathogens, that could prevent or treat a disease.

Pre-clinical:

The process then moves onto pre-clinical research, which studies vaccine candidates in cultures of cells or tissues or in animals. The one- to two-year process assesses the safety of the investigational vaccine and whether it is likely to provoke an immune response. This gives scientists an idea if how the human immune system might respond to the vaccine.

IND application:

If the vaccine candidate seems promising in the pre-clinical phases of research, an industry sponsor applies to the FDA for licensure as an Investigational New Drug (IND). The sponsor describes the research thus far and proposes human studies, which are approved by the Institutional Review Board of the facility, which often is a university, that will conduct a clinical trial. The FDA has 30 days to make a decision. If an IND application is granted, clinical trials — scientific testing in people — begin. Clinical trials can’t move forward unless an IND application is granted.

Phase 1 clinical trial:

Phase 1 vaccine trials typically include between 20 and 80 people, and are the first studies in humans. They are designed to check the safety of the vaccine candidate and if and what kind of immune response it triggers. It can take up a year or two to get protocol approvals and conduct the research at a cost that ranges from a few hundred thousand dollars to a million.

Phase 2 clinical trial:

If a vaccine has promising Phase 1 results, it moves into Phase 2 testing. This research includes several hundred people and is randomized (some people get the vaccine candidate and others get a placebo.) These tests assess safety, if the vaccine provokes an immune response, and specifics such as dosing, frequency of immunizations and delivery of the vaccine (for instance, as a nasal spray or under the skin injection). This phase can take one to two years at a cost of tens of millions of dollars, depending on the complexities involved.

Phase 3 clinical trial:

Promising vaccine candidates move onto phase 3 clinical trials, where they are tested in thousands, sometimes tens of thousands of people. By having such a large pool of subjects, researchers can better check for safety — side effects may emerge that are rare, but previously undetected in smaller groups. They check efficacy of the vaccine and look at the immune response the vaccine triggers. Phase 3 clinical trials typically take three to five years, research that costs $100 million or more.

Post clinical trials:

If after extensive testing that involves many thousands of people, the vaccine is found to be safe and effective, the company that developed the vaccine applies to the FDA for a license. The FDA inspects the manufacturing facility and approves the vaccine’s label before this is granted. If the FDA licenses the vaccine, it is then produced so people can be immunized. Even after the vaccine is licensed, the FDA will continue to make sure manufacturing facilities are up to speed and periodically can test lots of the vaccine to make sure they are pure, safe and effective. In addition, patients, their family and friends, and health care providers can voluntarily report any possible adverse reaction to a vaccine to the Vaccine Adverse Event Reporting System (VAERS). The CDC monitors and investigates the adverse events. Finally, the CDC and WHO conduct ongoing evaluations of disease outbreaks to ensure the vaccine is working and hasn’t lost potency.

— Dr. Daniel Hoft

>> Resources

• Pontifical Academy for Life response to inquiry on ethical use of vaccines: bit.ly/2AQgNBp
• Immunization schedule that minimizes the use of abortion-related cell lines (note: the schedule adheres to the CDC recommendations for immunizations): bit.ly/2OS1Gu3
• Dignitatis Personae (read paragraphs 34-35): bit.ly/1ry3mL5
• USCCB on vaccines: bit.ly/2tdvohh
• National Catholic Bioethics Center on the use of vaccines: bit.ly/2nkbcJQ
• FDA list of approved vaccines for use in the United States (includes links to each vaccine and its ingredients): bit.ly/1CUe2rF
• Message on the shingles vaccine from the USCCB Secretariat for Pro-Life Activities (includes sample letters to send to health care providers and drug manufacturers): bit.ly/2M9Bc8Q