Wednesday, November 25, 2020

COVID-19 vaccines and ethically problematic cell lines [Updated]

Update 11/25/2020, 10:17 am - I have expanded the moral analysis in the second half of the post and have tried to express my own views a bit more strongly and clearly.

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This is a complex subject.  I will do my best to unpack it, and also will share some initial views.  Disclaimer: I am neither a scientist nor a moral theologian.  

All of us presumably have been buoyed in recent weeks by public announcements of the development of three different vaccines to protect us from COVID-19.  News reports have focused on the promising efficacy of all three vaccines, each currently in Phase 3 clinical trials, developed respectively by Pfizer/BioNTech, Moderna and AstraZeneca/University of Oxford.  Pfizer already has applied for the US government's Operation Warp Speed emergency approval to begin distributing its vaccine to the public.  The other two are expected to follow suit quickly.

These three are not the only COVID vaccines in development, but they are leading a crowded field of contenders in the race to receive government approval and begin widespread distribution.  The Charlotte Lozier Institute (CLI) has identified over 100 vaccine research and development initiatives around the world; this chart lists 32 of them, including their clinical-phase status.

Media accounts have focused on the efficacy of these three drugs, the relative complexity of taking them (all three products will require two doses, spaced several weeks apart), the logistics of distributing and storing them, and how members of the public will be prioritized for vaccination until production and distribution have ramped up.  

Until this week, I was not aware of ethical concerns about these vaccine initiatives.  I am not referring to the debunked claims of the so-called anti-vaxxers.  Rather, concerns have been raised that the design, development, production and/or testing of these vaccines may rely on cell lines from aborted fetuses.  

Those concerns were expressed in a letter sent this past April to the commissioner of the US Food and Drug Administration (FDA).  The letter was signed by four Catholic bishops, each of whom heads a relevant committee from the United States Conference of Catholic Bishops (USCCB).  Other signatories include leaders of health care, bioethics and pro-life organizations, some Catholic, some not.   From the letter:

We are aware that, among the dozens of vaccines currently in development, some are being produced using old cell lines that were created from the cells of aborted babies. For example, Janssen Pharmaceuticals, Inc. has a substantial contract from the U.S. Department of Health and Human Services (HHS) and is working on a vaccine that is being produced using one of these ethically problematic cell lines. Thankfully, other vaccines such as those being developed by Sanofi Pasteur, Inovio, and the John Paul II Medical Research Institute utilize cell lines not connected to unethical procedures and methods.

Broadly speaking, it seems there are three possible ways that these problematic cell lines can be involved in the development of a vaccine:

  • Design and development of the product
  • Production of the product
  • Lab tests on the product
This diagram, produced by CLI, shows that, of these three broad areas, the final vaccine product is directly dependent on the first two (design/development and production), while the final product is only indirectly dependent on the third (lab tests).


As we will see below, for purposes of moral analysis this distinction between a direct dependency and an indirect dependency is significant.

CLI has produced a chart which summarizes the level of ethical concern for these three dependencies for 32 vaccines under development.  Here is a table which recaps CLI's analysis for the Pfizer, Moderna and AstraZeneca vaccines:


As you can see, none of the three vaccines gets a perfect ethical score in this analysis, but Pfizer and Moderna do considerably better than AstraZeneca. 

It's worth noting that, of the 32 initiatives CLI analyzes, only one, CureVac, would get a Green (ethically acceptable) score in all three columns.  CureVac is not considered in this post because the vaccine is not as far along in its clinical trials (still in Phase 1/Phase 2).  Some other entries in the CLI chart are Green in the first two columns, but no color code is assigned in the Lab Tests column.  No explanation is given for the Lab Tests for those products not being rated; it may be because the CLI authors have not been able to identify the lab test techniques for those products; or because the initiatives themselves are not far enough along in the development process to have reached the Lab Test stage.  So it is at least possible that other vaccines could eventually reach the market which would be Green across all three columns.  But the timetable for the general availability of those products isn't known yet.  They could still be many months away from receiving government approval, and they may never reach the marketplace for one reason or another.

Michael O'Loughlin at America Magazine reported this week that two American bishops, who apparently have seen the same or similar analysis to what is presented in this post, made public statements which were intensely critical of pending vaccines:

Bishop Joseph Strickland, the head of the Diocese of Tyler, Tex., tweeted on Nov. 16: “Moderna vaccine is not morally produced. Unborn children died in abortions and then their bodies were used as ‘laboratory specimens’. I urge all who believe in the sanctity of life to reject a vaccine which has been produced immorally.” Bishop Strickland is also listed as a speaker at an online anti-vaccination conference this fall, giving a talk entitled “Rejecting the Culture of Death to Embrace the Sanctity of Life.”

On the same day as Bishop Strickland’s tweet, Bishop Joseph Brennan, head of the Diocese of Fresno, said in a video, “I won’t be able to take a vaccine, brothers and sisters, and I encourage you not to, if it was developed with material from stem cells that were derived from a baby that was aborted, or material that was cast off from artificial insemination of a human embryo.”

O'Loughlin reports that, possibly in response to these two bishops' statements, 

...the U.S. Conference of Catholic Bishops distributed a memo to all U.S. bishops stating that at least two of the vaccines are considered ethically sound. The memo also reminded bishops that church teaching allows for even the widespread use of vaccines whose origins are considered ethically unsound when other treatments are unavailable.

The memo, which O'Loughlin apparently has seen but not been given permission to publish, came from Bishop Kevin Rhoades of Fort Wayne-South Bend, who leads the USCCB's doctrine committee, and Archbishop Joseph Naumann of Kansas City, who leads the USCCB's pro-life committee. 

The memo paragraph I've quoted here makes two separate points which are worth considering individually:

  1. Rhoades and Naumann, in their capacities as heads of the committees on doctrine and pro-life activities respectively, apparently have deemed two of the vaccines (Pfizer and Moderna) "ethically sound".  O'Loughlin reports that Rhoades and Naumann relied on a CLI report from May which categorized these two initiatives as "Ethically Uncontroversial"

  2. "... widespread use of vaccines whose origins are considered ethically unsound" can be acceptable "when other treatments are unavailable".  

To the first point: O'Loughlin notes the following:

“Neither the Pfizer nor the Moderna vaccine involved the use of cell lines that originated in fetal tissue taken from the body of an aborted baby at any level of design, development, or production,” reads the Nov. 23 memo...

The bishops’ memo states that some of the testing of the vaccines was done with what it called a “tainted cell line” but said the connection between the two vaccines and abortion is “relatively remote.”

“Some are asserting that if a vaccine is connected in any way with tainted cell lines then it is immoral to be vaccinated with them. This is an inaccurate portrayal of Catholic moral teaching,” the memo states.

The reference to "Catholic moral teaching" deserves to be further unpacked.  Rhoades and Naumann apparently are following the principle of remote cooperation to argue that whatever "taint" the Pfizer and Moderna vaccines may have acquired via their lab tests is sufficiently morally remote from consumers of the vaccines that we need have no serious qualms about receiving them.  As the CLI diagram pasted above shows, the final product is not directly dependent on the lab tests.  

The Holy See's Pontifical Academy for Life also has seconded Rhoades' and Naumann's judgment, in a tweet earlier this week:


It's worth noting that, while O'Loughlin doesn't report that Rhoades and Naumann wrote anything about the AstraZeneca vaccine, that one strikes me as more problematic because both the design and the production of the vaccine depended on cell lines derived from aborted fetuses, so there is a direct dependency.  

To the second point: as the color-coded table I have pasted above indicates, none of these three vaccines get "Green" boxes in all columns.  There will be no completely "untainted" alternatives available in the short term.  The choice in coming months for members of the public will be: receive the vaccines that are available; or don't get vaccinated.  I would argue for getting vaccinated, especially if the Pfizer or Moderna vaccines are available, as both have been deemed morally acceptable.  I consider the AstraZeneca vaccine to be more morally problematic.

But it's conceivable that, for at least some members of the public, the AstraZeneca vaccine may be the only one available.  It will take all three manufacturers several months to ramp up production to the point that their vaccines are widely available.  Until then, doses will need to be strictly allocated and prioritized for those who need them the most, and states are developing their criteria for prioritizing the doses.  As an illustration: my state, Illinois, has 12 million residents, virtually all of whom would be candidates for vaccination, but only 400,000 doses of the Pfizer vaccine will initially be sent to Illinois.   As the Pfizer vaccine requires two doses per patient, that means that only 200,000 Illinoisans will be able to be vaccinated immediately.  Probably that wouldn't be enough to cover even the health care workers in this state.  So states are going to have to exercise strict rationing.

So what should an ethically concerned person do if the only vaccine on offer is the AstraZeneca vaccine?  I would still argue for getting vaccinated.  Note the second criteria which O'Loughlin reports from the Rhoades and Naumann memo:

"... widespread use of vaccines whose origins are considered ethically unsound" can be acceptable "when other treatments are unavailable".

Thus, even the AstraZeneca vaccine, which the CLI analysis implies may be "ethically unsound", can be taken if it is the only vaccine on offer.

I have a certain degree of sympathy for Bishops Strickland's and Brennan's qualms - but only to a point.  Like them, I'd prefer not to take a vaccine which has any sort of abortion "taint" to it, even if only indirect.  O'Loughlin characterizes Strickland's and Brennan's critical public statements as "misinformation".  In my view, that is too strong a word.  As I've tried to illustrate here, all three of the vaccines on the verge of entering the marketplace have some sort of a connection to problematic cell lines. 

Even so, I don't support Strickland's and Brennan's statements.  I can't defend advising anyone not to take an available, safe, effective and morally permissible vaccine which will protect against COVID-19 infection.  We can't let the perfect be the enemy of the morally acceptable.  COVID-19 is not a rare and exotic disease; it is a world-wide pandemic which already has killed a quarter of a million Americans (and 1.5 million worldwide), and continues to spread rapidly in virtually every state.  The well-developed tradition of Catholic moral reasoning makes distinctions which permit the Pfizer and Moderna vaccines to be categorized as "morally sound"; and there could well be situations in which it is morally permissible to be vaccinated even by the AstraZeneca vaccine.  

27 comments:

  1. Is Bishop Brennan point that the way to be pro-life is to die to preserve it for the already dead?

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  2. This info about vaccines generally--lines developed from aborted fetuses--is the reason more than half the kids at The Boy's Catholic school were not vaccinated.

    I talked with the priest about this when The Boy was little. The Church long ago ruled that there was no complicity in abortion for parents who got the usual battery of vaccines. But many scrupulous Catholics continue to proclaim proudly that they don't inject their kids "with the bodies of little dead babies."

    Charity prevents me from accusing these people of a narcissistic and dangerous kind of scrupulosity the comes from anti-abortion hype. Moreover, anything done or not done in the name of being anti-abortion apparently absolved these people from any responsibility to stop the spread of disease to other people and their kids.

    Too bad there's not a vax for that.

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    1. AS I said in another post: there is no cure for stupid.

      Jean: you are a bad Catholic! You call them fetuses when the Real True Orthodox Catholics KNOW they are babies!!!!

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  3. Almost everything that we are involved with has many connections to past terrible moral decisions on the part of many people, e.g. theft of our land from Native Americans, wars, slavery, exploitation of third world populations and our own workers, and on and on..

    The emphasis on remote cooperation seems to me to be the psychological disease of scrupulosity, excessive concern over committing sin, combined with the spiritual disease of desiring to appear to be morally superior to everyone else.

    Many American bishops appear to be infected with these psychological and spiritual diseases.

    For example many bishops think they cannot appear to cooperate any way with Biden because of his unwillingness to impose Catholic morality on other people. They feel they have to deny him communion because if they did not then Catholics might think that bishops have become tolerant of abortion!

    Cardinal-elect Gregory, a very successful former president of the bishops, has placed some distance with the current president saying that he will work with Biden and sees no reason to deny him communion. Maybe Gregory will begin to provide some real leadership for the bishops.

    In recent weeks as I have begun to reflect on the Trump era, it has increasingly become clear that the problem is more than Trump, it is all the Republicans, Evangelicals and Catholics who have supported Trump who are the real problem.

    In past elections, I would not have been concerned very much if McCain or Romney had won. Sure McCain might have been more likely to lead us into war, or Romney may have been more likely to serve the rich than the poor. However their drawbacks are nothing in comparison to Trump who has been such a disaster for the nation, both domestically and internationally.

    I really have great difficulty in understanding how people could have and even continue now to support Trump, and have decided to increasingly question the psychological and spiritual health of those who do.

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    1. It used to give people pause if you pointed out that they were being "more Catholic than the pope." Now they just decide the pope is either misinformed or controlled by Mark Zuckerberg (see the Thomas More Society filing in the Wisconsin eletion case), George Soros or the communists.

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    2. Jack: In recent weeks as I have begun to reflect on the Trump era, it has increasingly become clear that the problem is more than Trump, it is all the Republicans, Evangelicals and Catholics who have supported Trump who are the real problem.

      That became clear to me a few months after he was elected in 2016. The problem is the trump voters - especially those who wear their religion on their sleeves. Trump's popularity with these voters is not the cause of this country's deep moral problems - his election was the symptom that revealed the extent of the moral cancer infecting our society.

      It appears that while this symptom may be checked for a while, Biden's election does not guarantee that the disease won't continue to spread and may yet kill our democracy.

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  4. As I understand it, the cells being used in most of the efforts to create a vaccine are HEK293 cells, from an abortion that happened back in the 1970s. It is a cell line which can be replicated endlessly, what is called an "immortal" cell line. No abortions would need to occur ever again to keep using this line. In a way it is similar to the HeLa cell line taken from cancer victim Henrietta Lacks in the 1950s. Which is still used in cancer research, and was the first human immortal cell line. A somewhat parallel situation exists, in that the original cells were obtained without the consent or knowledge of the patient or her family.
    Anyway, this whole thing was hashed out with the chicken pox vaccine, which some anti-vaxxers are still boycotting.
    In my view, "misinformation" on the part of these bishops is not too strong a word, because that is actually what it is. Objectively speaking, they are not being dishonest, because they sincerely believe what they are saying. But that doesn't prevent what they are saying from being misleading. BTW, these are some of the same people who are trying to throw the election results into question. Clergy ought to have to swear something like the Hippocratic oath, "first do no harm."
    Jean nailed it when she said, "Charity prevents me from accusing these people of a narcissistic and dangerous kind of scrupulosity that comes from anti-abortion hype."

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    1. "Objectively speaking, they are not being dishonest, because they sincerely believe what they are saying."

      I can think of cases where that is true, but I don't think it applies here. The bishops involved know as much about immunology as I know about Boolean Algebra but who throw a religious cloak over their ignorance and prescribe for everybody. They know -- or should, because of their office know -- that have no qualification to "believe" a damn thing about the subject on which they are pontificating. It seems to me, that is dishonest. It may be other things as well.

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  5. I don't think it is charity to allow bishops, priests and church ladies to continue to do harm so many people.

    I understand that it is far easier for me with my background both in mental health and spirituality to be frank and honest in challenging these people as to their psychological and spiritual health.

    Nevertheless the lives and health of other people living here and now are at stake. I can understand reluctance to defend one's person views when they differ from others. I have that too. However I have always been willing to challenge others who are engaged in harming others.

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    1. I had a lifetime of trying to reason with addicts, and as a mental health professional, you must know better than most of us that beating your head against a wall is about as effective.

      Catho-holics who are addicted to dead baby worship are on par with drunks and junkies.

      Certainly my views on abortion, execution, and euthanasia have changed over time, but not because of anything they ever said.

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    2. Changing anyone's beliefs, values, and behavior by trying to reason with them isn't helpful or productive.

      However one can change others people's behavior by changing their environment. I don’t know if this works for alcoholics or not, I have little experience there.

      For example I spent my career in the mental health system promoting the dignity and value of the mentally ill, not by challenging everyone to change their beliefs, but by behaving in ways toward the mentally ill and creating new environments in which their talents developed.

      We need to create environments in which bishops, priests and laypeople have alternatives to the PTB who are promoting unhealthy psychological and spiritual thinking.

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  6. There might be other potential ethical issues involved in these vaccines that the bishops are missing in their preoccupation with fetal cell lines.

    One of them might be whether it's ethical for companies to develop a vaccine on the public dime and then sell it back to tell public at a profit.

    Another might be the way vaccine recipients will be prioritized.

    Still another could be which vaccines will be given to which populations. The Oxford vaccine seems to be cheapest--and least effective. Poor people, line up over there!

    And finally what happens if it turns out that one of these vaccines causes harmful side effects? Who's on the hook for dealing with that fallout?

    Any bishops concerned about that?

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    1. One thing I would be a little concerned about with the Oxford vaccine is that the delivery vector is a chimpanzee adenovirus which has been disabled. I assume they know what they are doing, but we've had a lot of bad experience with zoonotic diseases. Even though this one is basically just a cold virus.
      Another thing, which is likely to turn off more people than scruples about material cooperation are the reports that, while there haven't been serious side effects with the vaccine candidates nearest to public release, about 10% of people in the test groups have reported a day or so of feeling crappy. I don't want to feel crappy, but we expect our kids to put up with all kinds of needle sticks, soreness, and feeling fussy after inoculations. One of my granddaughters said, "Grandma, I had a flu shot today, and I didn't even cry!" My comment, "Oh, you are such a big brave girl!" I guess Grandma can also be a big brave girl in the interests of ending the pandemic and getting more personal freedom.
      Particularly of interest in distributing a vaccine in areas which don't have access to cold storage is an oral vaccine being developed by Vaxart in San Fransisco. It would be delivered by a pill. It isn't in stage 3 trials yet, but that seems promising.

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    2. Jean, America has had several articles related to your ethical concerns about who gets the vaccine etc. including a report on Pope Francis - "Pope Francis: Coronavirus vaccine must be for everyone, not just the wealthy"

      If you go to their website, just enter covid vaccine in the search box and it will come up with several articles.

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    3. Anne, thanks. Good to know that Catholics see this from a variety of ethical perspectives.

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  7. One thing that occurs to me about the cell line derived from cells from an aborted fetus back in the 70s. It was a grave injustice that he or she was not allowed and be born. But that life has meaning, because countless lives will have been saved because of his or her brief life in this world. That is said not to justify abortion, but to derive meaning from a tragedy.

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  8. Most likely, we won't have much control over which company's vaccines we get. They will be distributed wholesale, and whoever retails it will get it from their usual wholesaler, and if you usually go to CVS and it has AstraZeneca, you can spend a day on hold phoning around to find someone who has something else, or you can get shots of AstraZeneca.

    My primary tells me most doctors don't vaccinate in their office anymore. Additionally, there would be little sense in investing in a humongously cold freezer if you don't vaccinate patients by the hundreds.

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    1. Medicare has some very weird rules about vax, but usually it won't pay for them at the doc's office.

      The ultra cold vax seems destined for hospitals with deep freezers and their staff. I can't see Rite Aid or Wal-Mart offering that to the general public.

      Which ones your insurance company, Medicare, or Medicare D supplement will pay for will be all over the map. The rich will have choices, and the poor will have to settle for what they can get.

      One thing yet to be determined is which vax has the longest lasting protection. I don't think anyone knows how often people will have to get shots.

      Flu shots are effective for six months, which works fine for a disease that eases off in summer. Covid doesn't ease off in warm weather, and the idea of getting two shots that make you sick for a couple days every six months doesn't sound like a lot of fun.

      I expect a lot of tinkering will continue as the limitations of the vax become apparent. And I expect a lot of people will hold off until more is known.

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    2. The reason immunity doesn't last for flu shots is that the virus mutates frequently, "changes its coat". What I am reading about all the Covid vaccines is that they are targeting the spike protein, which is pretty stable. So hopefully even if there is a mutation there would still be immunity. Remains to be seen, I guess.

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    3. Kaherine, thanks. That explains the significance of tea spikes they keep talking about in reports I am hearing.

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  9. I think these bishops are very dangerous because they will encourage many Catholics not to get the vaccine. Jean above said that half the Boy classmates were not vaccinated. If a substantial percentage of people fail to take the vaccine it could still be around for a while.

    We want to take the vaccine to protect ourselves. However even if a vaccine is 90 percent effective there is still a chance of getting the virus if it is still out there because other people are not getting vaccinated.

    Just getting vaccinated will not allow me to go back to Church or shop, its only when the cases fall to zero for a month or more in my state will I feel safe. And they may not fall to zero if a fair number of people fail to get the vaccine.

    I think these bishops are harming people by their talk.

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    1. I agree about the bishops, Jack. Seems like they are pretty far out of their areas of expertise. Supposedly they want people to be able to come back to church as normal. That's not going to happen unless we get the virus under control.

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    2. Bishops should have their own advisers on their curia to advise on these complex topics. Every bishop should have expertise at hand for medical ethics. And in this case, the national conference has staff. It would be best if the bishops would speak with one voice- and it should be a voice of wisdom and discernment.

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  10. Something I didn't research, but back around 2007, President George W banned public funds from going to certain fetal lines for research purposes. So I wonder if those companies that got Operation Warp Speed money from the government are "ethically safe" by Catholic standards.

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    1. As I am understanding it, neither the Pfizer or Moderna vaccines used human cells at all in their development. They might have used some cell lines in in vitro testing though.
      That seems pretty remote.

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    2. According to CLI, neither Pfizer nor Moderna used any human cells, or any cells at all, in their design and development; their designs were done via computer simulation. Sounds pretty cool.

      Some other companies are using monkey cells or insect cells. Whether there are any human cell lines which were harvested via non-problematic means, I am not certain.

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  11. I see that Oxford/ AstraZeneca has hit a snag with their vaccine. Apparently some people were given half doses when they should have had full ones. Hopefully it can be straightened out.
    It's sounding like the US versions from Moderna and Pfizer have better efficacy.

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