Follow up on Sanofi-Pasteur avian flu vaccine.

The FDA has approved an avian flu vaccine for government stockpiling, such as we discussed in Human Technology Manufacturing Platforms. It is not being sold or distributed at this time, and it is not the PER C.6 based vaccine. It is the one grown in embryonated chicken eggs, (see paragraph 11 of the manufacturer’s label found here) and thus does not raise the moral problems associated with the one based on PER C6. The FDA approval is here:

Product Approval Information Sanofi Pasteur Inc. Influenza Virus Vaccine, H5N1

However, to quote the final paragraph of the document found here, “With the support of FDA, the U.S. National Institutes of Health and other government agencies, Sanofi-Pasteur and other manufacturers are working to develop a next generation of influenza vaccines for enhanced immune responses at lower doses, using technologies intended to boost the immune response.” That “next generation” vaccine is based on PER C6.

ADDRESS OF HIS HOLINESS BENEDICT XVI

For your conveinience, I have cut and pasted this in its entirety. Its available

here.

BENEDICT XVI

ADDRESS
ADDRESS OF HIS HOLINESS BENEDICT XVI
TO THE PARTICIPANTS IN THE GENERAL ASSEMBLY
OF THE PONTIFICAL ACADEMY FOR LIFE
Clementine Hall

Saturday, 24 February 2007




Dear Brothers and Sisters,

It is a true joy for me to receive the Members of the PontificalAcademy for Life in this Audience, held on the occasion of the 13th General Assembly, and those who are participating at this Congress on the theme: "The Christian conscience in support of the right to life".

I greet Cardinal Javier Lozano Barragán, the Archbishops and Bishops present, brother priests, the Congress speakers and all of you, gathered from various countries. I greet in particular, Archbishop Elio Sgreccia, President of the PontificalAcademy for Life, whom I thank for the kind words addressed to me and for the work he does together with the Vice-President, the Chancellor and the Board of Directors who carry out the delicate and vast tasks of the PontificalAcademy.

The theme to which you have called the participants' attention, and therefore also that of the Ecclesial Community and of public opinion, is very significant: the Christian conscience, in fact, has an internal need to nourish and strengthen itself with the multiple and profound motivations that work in favour of the right to life.

It is a right that must be sustained by all, because it is the first fundamental right of all human rights. The Encyclical Evangelium Vitae strongly affirms this: "Even in the midst of difficulties and uncertainties, every person sincerely open to truth and goodness can, by the light of reason and the hidden action of grace, come to recognize in the natural law written in the heart (cf. Rom 2: 14-15) the sacred value of human life from its very beginning until its end, and can affirm the right of every human being to have this primary good respected to the highest degree. Upon the recognition of this right, every human community and the political community itself are founded" (n. 2).

The same Encyclical recalls that "believers in Christ must defend and promote this right, aware as they are of the wonderful truth recalled by the Second Vatican Council: "By his Incarnation the Son of God has united himself in some fashion with every human being' (Gaudium et Spes, n. 22). This saving event reveals to humanity not only the boundless love of God who "so loved the world that he gave his only Son' (Jn 3: 16), but also the incomparable value of every human person" (ibid.).

Therefore, the Christian is continually called to be ever alert in order to face the multiple attacks to which the right to life is exposed. In this he knows that he can count on motives that are deeply rooted in the natural law and that can therefore be shared by every person of upright conscience.

In this perspective, above all after the publication of the Encyclical Evangelium Vitae, much has been done to make the subject matter of these motivations better known in the Christian community and in civil society, but it must be admitted that the attacks on the right to life throughout the world have broadened and multiplied, also assuming new forms.

The pressures to legalize abortion are increasing in Latin American countries and in developing countries, also with recourse to the liberalization of new forms of chemical abortion under the pretext of safeguarding reproductive health: policies for demographic control are on the rise, notwithstanding that they are already recognized as dangerous also on the economic and social plane.

At the same time, the interest in more refined biotechnological research is growing in the more developed countries in order to establish subtle and extensive eugenic methods, even to obsessive research for the "perfect child", with the spread of artificial procreation and various forms of diagnosis tending to ensure good selection.

A new wave of discriminatory eugenics finds consensus in the name of the presumed well-being of the individual, and laws are promoted especially in the economically progressive world for the legalization of euthanasia.

All of this comes about while, on another front, efforts are multiplying to legalize cohabitation as an alternative to matrimony and closed to natural procreation.

In these situations the conscience, sometimes overwhelmed by the powerful collective media, is insufficiently vigilant concerning the gravity of the problems at play, and the power of the strongest weakens and seems to paralyze even people of good will.

For this reason it is necessary to appeal to the conscience, and in particular, to the Christian conscience. The Catechism of the Catholic Church tells us, "Conscience is a judgment of reason whereby the human person recognizes the moral quality of a concrete act that he is going to perform, is in the process of performing or has already completed. In all he says and does, man is obliged to follow faithfully what he knows to be just and right" (n. 1778).

From this definition it emerges that the moral conscience, to be able to judge human conduct rightly, above all must be based on the solid foundation of truth, that is, it must be enlightened to know the true value of actions and the solid criteria for evaluation. Therefore, it must be able to distinguish good from evil, even where the social environment, pluralistic culture and superimposed interests do not help it do so.

The formation of a true conscience, because it is founded on the truth, and upright, because it is determined to follow its dictates without contradictions, without betrayal and without compromises, is a difficult and delicate undertaking today, but indispensable.

Unfortunately, many factors hinder this undertaking. In the first place, in the current phase of secularization, called post-modern and marked by disputable forms of tolerance, not only is the rejection of Christian tradition growing, but distrust for the capacity of reason to perceive the truth also distances us from the taste for reflection.

According to some, for individual conscience to be unbiased it must free itself both from references to tradition and those based on human reason.

Hence, the conscience, which as an act of reason aims at the truth of things, ceases to be light and becomes a simple screen upon which the society of the media projects the most contradictory images and impulses.

One must be re-educated to the desire to know authentic truth, to defend one's own freedom of choice in regard to mass behaviour and the lures of propaganda, to nourish passion for moral beauty and a clear conscience. This is the delicate duty of parents and educators who assist them; and it is the duty of the Christian community with regard to its faithful.

Concerning the Christian conscience, its growth and nourishment, one cannot be content with fleeting contact with the principal truths of faith in infancy, but a programme of accompaniment is necessary along the various stages of life, opening the mind and the heart to welcome the fundamental duties upon which the existence of the individual and the community rest.

Only in this way will it be possible to prepare youth to comprehend the values of life, love, marriage and the family. Only in this way can they be brought to appreciate the beauty and the sanctity of the love, joy and responsibility of being parents and collaborators of God in giving life.

In the absence of a continuous and qualified formation, the capacity for judgment of the problems posed by biomedicine in the areas of sexuality, new-born life, procreation, and also in the way to treat and care for patients and the weaker sectors of society, becomes even more problematic.

It is certainly necessary to speak about the moral criteria that regard these themes with professionals, doctors and lawyers, to engage them to elaborate a competent judgment of conscience, and if need be, also a courageous objection of conscience, but an equal need rises from the basic level for families and parish communities in the process of the formation of youth and adults.

Under this aspect, next to Christian formation, whose aim is the knowledge of the Person of Christ, of his Word and Sacraments in the itinerary of faith of children and adolescents, one must consistently fuse the discourse on moral values that regard the body, sexuality, human love, procreation, respect for life at every moment, at the same time with valid and precise motives, reporting behaviour contrary to these primary values.

In this specific field the work of priests must be opportunely flanked by the commitment of lay educators, also specialists, dedicated to the duty to guide the ecclesial reality with their knowledge enlightened by faith.

Therefore, I ask the Lord to send among you, dear brothers and sisters, and among those dedicated to science, medicine, law and politics, witnesses endowed with true and upright consciences in order to defend and promote the "splendour of the truth" and to sustain the gift and mystery of life.

I trust in your help dearest professionals, philosophers, theologians, scientists and doctors. In a society at times chaotic and violent, with your cultural qualifications, by teaching and by example, you can contribute to awakening in many hearts the eloquent and clear voice of conscience.

The Second Vatican Council teaches us that "man has in his heart a law inscribed by God. His dignity lies in observing this law, and by it he will be judged" (Gaudium et Spes, n. 16). The Council has offered wise directives so that "the faithful should learn to distinguish carefully between the rights and the duties which they have as belonging to the Church and those which fall to them as members of the human society", and "they will strive to unite the two harmoniously, remembering that in every temporal affair they are to be guided by a Christian conscience, since not even in temporal business may any human activity be withdrawn from God's dominion" (Lumen Gentium, n. 36).

For this very reason the Council exhorts lay believers to welcome "what is decided by the Pastors as teachers and rulers of the Church", and then recommends that "Pastors... should recognize and promote the dignity and responsibility of the laity in the Church. They should willingly use their prudent advice" and concludes that "[m]any benefits for the Church are to be expected from this familiar relationship between the laity and the Pastors" (cf. Lumen Gentium, n. 37).

When the value of human life is at stake, this harmony between the magisterial function and the committed laity becomes singularly important: life is the first good received from God and is fundamental to all others; to guarantee the right to life for all and in an equal manner for all is the duty upon which the future of humanity depends. The importance of your study meeting emerges also from this perspective.

I entrust the work and the results to the intercession of the Virgin Mary, whom the Christian tradition hails as the true "Mother of all the living". May she assist and guide you! To seal this wish I willingly impart to all of you, to your families and collaborators, the Apostolic Blessing.



© Copyright 2007 - Libreria Editrice Vaticana





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Week in Review 22-28 April 2007

First designer babies to beat breast cancer

(Please note that this article is in the “Life and Style” section of the UK’s TimesOnLine. That pretty much says it all, I think.)
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Gardasil:

HPV vaccine concerns give legislatures pause

Do we really want to go down the path of vaccinating children against deficits of moral intelligence and willpower?

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A new study by Michels on the abortion / breast cancer link is seriously flawed, said the Coalition on Abortion/Breast Cancer.

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Gonzales v. Carhart:

Can't we agree this is reprehensible?

The Auth Cartoon

5 New Things The High Court Did

US Supreme Court Rescinds Former Rulings on Abortion Laws in Missouri and Virginia

Planned Parenthood Organizes Protests in Favour of Gruesome Partial Birth Abortion Procedure

Activists ready for abortion bill fight

PJB- Abortion is Back – in 2008

Aborted alive in the UK vs. U.S.

Mexico City Lawmakers Pass Abortion Bill

'No abortions, no exceptions,' in sight
Georgia group aims for constitutional amendment in 2008

Dutch Abortion Boat Granted License for International Abortions

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Gay marriage evil, abortion terrorism: Vatican

Judge: Catholic Position Against Homosexual Adoption Justifies Government Hostility Towards Church

Democrats Refuse Religious Freedom Amendment to Hate Crimes Bill

Christians in bull's-eye in new 'hate crimes' plan

Hate Crime Update- Pastors- Act Now or Prepare for Jail

Ban on 'mom' and 'dad' considered – again

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From the National Catholic Bioethics Center:

FAQ on the Persistent Vegetative State

IVF and the conjugal act: the proper cause of procreation.

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Watering-Down Catholic Education has Made it Indistinguishable from the Secular - thus Dispensable

Ontario Public School Boards Call for Elimination of Catholic Separate System

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Secret postal rate hike: Democracy at stake?

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Brazil's Catholics for a Free Choice Housed in Building owned by Catholic Religious Order

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HIV Vaccine Pre-clinical Toxicology Testing

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Ethanol causes more smog?

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F.C.C. Moves to Restrict TV Violence

(I have nothing good to say about television; it serves no useful purpose and we’d be far better off without it. Its main function in society it to keep the mass of people financially enslaved by saturating them with consumerism, sexually enslaved by saturating them with increasingly blatant pornography, and intellectually enslaved by eliminating independent thought.)

Human Technology Manufacturing Platforms Part V: What Happens Now?

At the beginning of this series I stated that the question of the correct moral response to vaccines manufactured from cell lines derived from aborted babies was no longer confined to simply the parents of small children. We have seen that this is true; using just the pandemic flu and seasonal flu vaccines as examples, the question will quite soon apply to virtually everyone. Likewise, we have seen that the "vaccination question" really isn't a question about just vaccinations. The moral problems presented by the use of human cell lines from aborted babies are going to be attached to an ever growing number of diverse therapeutic regimens: I believe that the day is not too far away where it will be easier to define what in medicine is not tainted by this evil, rather than what is, for this sort of corruption is going to invest itself in every aspect of the medical enterprise if we allow it to. Nevertheless, the issue was raised in the context of pediatric vaccinations, and it is to pediatric vaccinations that we shall now return.

The Vatican paper does a good job at clarifying some issues regarding parental involvement with the evil of the original abortions, but it is, perhaps, a little too nuanced, and this has led to extensive, and occasionally acrimonious, disagreement within the Catholic press. The study appears to set a threshold for parental refusal of the vaccine at "no significant risk," a threshold which not easily defined. Regarding varicella, refusing the WI-38-based vaccine may indeed involve "no significant risk." It is arguable that there should not even be a mass varicella vaccination campaign: the introduction in the U.S. of required mass immunization against varicella was controversial in when VARIVAX was introduced in 1995, and remains so now. Indeed, outside of the United States, only one nation - Germany - requires universal varicella vaccination as of 2005.[1] Analysis by the Public Health Service for England and Wales concluded in 2003 that, "routine infant varicella vaccination is unlikely to be cost effective and may produce an increase in overall morbidity."[2] Nevertheless, the U.S. Advisory Committee on Immunization Practices recommended universal pediatric immunization with VARIVAX in 1996, the year after the vaccine was introduced. These recommendations were expanded in 1999 to include vaccination requirement prior to daycare or school.[3] Currently the requirement for a second VARIVAX vaccination is under consideration, essentially a “booster shot”, due to the problem of waning immunity as the child who was immunized matures to adulthood. Varicella, while innocuous in children, is a serious and potentially life-threatening illness in adults, and it is possible that we have traded relatively mild childhood morbidity for more serious future problems as the artificially immunized population ages. The point is this: one can easily argue that abstaining from the varicella vaccine as an "objection of conscience" is the right thing to do, since physicians and governmental public health departments don't even agree on whether it should be used universally or not. Regarding rubella, the situation is more complicated. It could be the case that the vaccine is currently unnecessary in the United States, but this is only because of the low level of endemic rubella currently, which in turn is due to the high level of immunity, much of which is supplied by the vaccine (or it's non-tainted predecessors). Were immunization levels to drop the disease might reappear. In addition, even though rubella is at a low level in the United States, it's still pretty widespread in the world, and given the high level of international travel it's not unreasonable to posit that an un-immunized American child could, on an overseas trip, catch rubella, and then transmit it to an unimmunized mother and from there to the unborn child.[4] So, rubella's a little less clearcut regarding "significant risk." Finally, when - not if - the MRC-5 derived polio vaccine replaces the current polio vaccine, the parent will have the choice of cooperating with the evil (the document does not say the parent is not cooperating with evil, only that the level of cooperation is remote, and excusable) or exposing their child to a very real and very devastating illness.

The document does enable us to evaluate the actions of those involved in the production and distribution of these products. We noted above that the document considers three categories of people: makers, marketers/distributors, and users. Parents and physicians were in the last category, and we discussed them earlier. It is those in the first two categories we now look at. The document says that the activity of those involved in "the preparation, distribution and marketing of vaccines produced as a result of the use of biological material whose origin is connected with cells coming from foetuses voluntarily aborted" is "as a matter of principal, morally illicit."[5] If the activity of the original Merck, Karolinska Institute and Wistar researchers back in the early 1960's was illicit - and I do not see how it could not have been - it is even more true of the activities of the researchers at University of Leiden who developed PER.C6, Crucell N.V., the company developing and marketing this human technology manufacturing platform, and those fifty or more companies licensing this "platform." It would also be especially true of the U.S. Department of Health and Human Services, which is pouring hundreds of millions of dollars of U.S. taxpayer money into, specifically, the PER.C6 based influenza vaccine program being developed by Crucell and Sanofi, even though licit alternatives are available - conventional egg based vaccines, and/or animal cell culture vaccines.

The main drawback of the Vatican paper is that it doesn't address the larger reality that exists. As noted above, the document uses phrases such as "temporary basis" and "vaccines for which there are not yet acceptable alternatives," suggesting that the authors believe this issue to be temporary, confined to a relatively small group of parents who worry about such things, and likely to resolve itself. Though not explicitly stated, one gets the impression that the authors of the Vatican study believe that, perhaps, the pharmaceutical companies didn't know the source of their cell cultures, or were unwitting accomplices in the development of these lines. Further, this line of reasoning might go, now that the manufacturers know the true source of these lines, they will distance themselves from the evil, and pursue righteous alternatives. The reality is that pharmaceutical manufacturers and biotechnology companies are driving full speed ahead on the development and implementation of human technology manufacturing platforms, aided and abetted by taxpayer dollars, because such technologies are laden with profit, both current and future. These people know what they are doing, and they are not going to stop. We are not at the sunset of a dead end aberration which involves only a handful of parents agonizing over whether it is right to vaccinate their children with immoral vaccines; we are at the dawn of a whole new world utilizing human technology, a world where this technology will intertwine itself with every aspect of medicine.

In developing a coherent response to this looming moral disaster, two points are worth considering. First, when considering the problem, substitute "vaccines and therapies made from cell lines derived from Jewish concentration camp victims killed decades ago" for "vaccines and therapies made from cell lines derived from fetuses aborted decades ago." This is not hyperbole. If the Church considers these two acts, murder of concentration camp prisoners and murder of unborn babies, morally equivalent - and I believe the Church does - then it does not matter who was killed, or when they were killed, or why they were killed. Deliberate killing of innocents - murder - is proscribed by the Church. If it is morally admissible under some circumstances (e.g., remote passive material cooperation under moral coercion) to utilize the products whose origins lie in the murder of unborn children, then likewise it should be morally admissible to use the same product under the same circumstances if their origins lay in the murder of concentration camp victims, or any other group of murdered innocents one might imagine. Perhaps the Church might teach that would be admissible to use these vaccines even if derived from murdered concentration camp victims, and perhaps the Church might teach that it would not be. But whatever the Church would teach, I should think it should be the same for any group of murdered innocents.

The second factor to consider is this: the use of cell lines developed from aborted babies in manufacturing vaccines (or anything else) strikes me as no different, conceptually, from using embryonic stem cells for all the various things they might be used for. The only difference, really, is that the fetal cell lines are already in use, while the stem cell applications are still pretty much hypothetical. But in both cases you have an unborn child being killed and disassembled for useful parts, nothing more. The Pontifical Academy for Life document entitled "Declaration on the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells" states that use of stem cells, or cells differentiated from them, is illicit.[6] Since the hypothetical "product" of the embryonic stem cell is the differentiated cell, it does not seem to be too much of a stretch to conclude that the Church is heading in the direction of stating that using the "products" derived from embryonic stem cells is immoral, because their origin is immoral. I am unable to discern a significant conceptual distinction between products from embryonic stem cells and products from fetal cell lines.

As the Ghost of Christmas Yet to Come said to Ebenezer, "These are scenes of things which might yet be." As a nation, we chose the evil fork in the road when we legalized contraception in 1965; and took the next evil fork with abortion in 1973. Initially, though, abortion "rights" were somewhat limited; we came to the fork labeled "unlimited abortions" in 1993. Today, the US has the most liberal abortion laws on the planet (with the possible exception of China), and since we live in a county where we can abort a baby for no reason whatsoever and up until the moment her entire head is out of the birth canal, why fuss about babies whose abortions produce something good and useful? We chose the evil road then, and now, like an ever branching tree, the choices before us are multiplying faster and faster, and are more and more bewildering: embryonic stem cell research, cloning, euthanasia, doctor assisted suicide, vaccines and cancer therapies whose origins are in dead babies; the list grows with a dull, constant pounding. This paper has been about yet another fork, just one of many: do we allow ourselves to embark on the use of human technology manufacturing platforms, or do we not? They are not necessary, we can develop these things - vaccines, monoclonal therapies, what have you, without them. We can still choose the moral path, even at this late date. We can start to climb down from this tree. What, then, will we decide?

Endnotes:
[1] "Varicella zoster virus vaccination policies and surveillance strategies in Europe." Eurosurveillance, Euro surveill 2005;10(1):43-5; published online Jan 2005. www.eurosurveillance.org
[2] Brisson, M. "Varicella vaccination in England and Wales: cost-utility analysis." Arch Dis Child 2003; 88:862-869. My emphasis. The reason for increased morbidity is due to zoster in later years as the vaccine acquired immunity wanes.
[3] “Prevention of Varicella: Update Recommendations of the Advisory Committee on Immunization Practices (ACIP).” Morbidity and Mortality Weekly Report Reports and Recommendations Vol. 48, No. RR-6, 28 May 1999. It's worth noting here that ACIP, and even the 1998 WHO position paper on varicella (online at www.who.int, go to "vaccine position papers") notes that the primary reasons for universal varicella vaccination in the "developed world" are economic - "lost workdays.". In other words, in the US, most parents work. If the children get chickenpox, somebody has to stay home to take care of them.
[4] This situation was outlined in the "Moral reflections" document in footnote 15. The footnote put the moral responsibility for any damage to the hypothetical unborn child on the parents who didn't have their own child immunized. The footnote didn't indicate whether the unimmunized pregnant mother had any responsibility, such as to ensure she was protected against rubella by, for example, gamma globulin injections, which would protect her during the susceptible period of her pregnancy and do not have any moral problems associated with them..
[5] "Moral reflections," ibid. My emphasis.
[6] Pontifical Academy for Life, "Declaration on the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells" 25 August 2005. See in particular page 5 where the full text reads, "The third ethical problem can be formulated thus: Is it morally licit to use ES cells, and the differentiated cells obtained from them, which are supplied by other reasearchers or are commercially obtainable? The answer is negative..." The text does not make any distinction as to who is doing the 'using,' researcher or clinician. Further, the title of the document makes it clear that the authors intend the conclusions to cover both research and therapeutic uses of stem cells. Available at numerous websites including www.priestforlife.org/magisterium/00-08-25stemcells.htm

Feast days of the week 29 April - 5 May, A.D. 2007 (1962 liturgical calendar).

SECOND PART OF THE LITURGICAL YEAR: THE EASTER CYCLE (MYSTERY OF THE REDEMPTION).
II. EASTERTIDE[i]

Sunday, 29 April, 2007
Third Sunday after Easter (II)
"'Let us shout with joy to God; let us sing a psalm to His Name.' because our Lord Jesus Christ is risen again and has given His life for us."
Epistle: I Peter 2:11-19.
Gospel: John 16:16-22.

St. Peter of Verona, Martyr (III)
“St. Peter of Verona was a famous preacher of the Dominican Order. From childhood he was conspicuous for his refutation of heretics and his singular innocence. He longed to die for the faith, and his prayer was heard. A.D. 1252.”
Epistle: II Timothy 2:8-10; 3:10-12.
Gospel: John 15:1-7.

Monday, 30 April, 2007
St. Catherine of Sienna, Virgin, Doctor (III)
“St. Catherine of the Order of St. Dominic, led a life of great penance. She received the stigmata, but at her urgent prayer they did not show externally; she died A.D. 1380.”
Epistle: II Corinthians 10:17-18; 11:1-2.
Gospel: Matthew 25:1-13.

Tuesday, 1May, 2007
St. Joseph the Worker, Spouse of the Blessed Virgin Mary, Confessor (I)
"Work, imposed on man as a penalty, is transformed into a blessing through his communion with the life and work and death of Jesus Christ, a communion effected by the active part he takes in the Sacrifice and Communion of the Mass – with St. Joseph as model and patron. This Feast was instituted by Pope Pius XII in 1956."
Lesson: Colossians 3:14, 15, 17, 23, 24.
Gospel: Matthew 13:54-58.

Wednesday, 2 May, 2007
St. Athanasius, Bishop, Confessor, Doctor of the Church (III)
"Bishop of Alexandria, St. Athanasius opposed Arius with admirable zeal. He has left us several works in defense of the divinity of Christ. He suffered frequent persecution. He died A.D. 373."
Epistle: II Corinthians 4:5-14.
Gospel: Matthew 10:23-28.

Thursday, 3 May, 2007
Ferial (IV)
Epistle: I Peter 2:11-19.
Gospel: John 16:16-22.

Ss. Alexander I, Eventius, & Theodolus, Martyrs; and Juvenal, Confessor (Comm.)
Epistle: I Peter 1:3-7.
Gospel: John 15:5-11.

Friday, 4 May, 2007
First Friday
St. Monica, Widow (III)
“St. Monica first converted her pagan husband, and then, by her tears and unceasing prayers, her son St. Augustine, who is regarded as one of the greatest Doctors of the Western Church. She died A.D. 387.”
Epistle: I Timothy 5:3-10.
Gospel: Luke 7:11-16.

Saturday, 5 May 2007
First Saturday
St. Pius V, Pope, Confessor (III)
"St. Pius V of the order of Preachers, was a Pope of great sanctity. His pontificate was one of the most glorious. He enforced obedience to the decrees of the Council of Trent and revised the Missal and the Breviary. He died A.D. 1572."
Epistle: I Peter 5:1-4, 10-11.
Gospel: Matthew 16:13-19.

[i] Remarks are abstracted from The Daily Missal and Liturgical Manual, from Editio Typica of the Roman Missal and Breviary, 1962
(Baronius Press Limited, London, 2004, in conjunction with the Fraternal Society of St. Peter, www.baroniuspress.com)

Human Technology Manufacturing Platforms Part IV. The Flu Vaccine.

In the first three installments, we covered a lot of ground. First, we looked at the "pediatric vaccination question"; specifically, those vaccines in the U.S. pediatric immunization series which are manufactured using cell lines derived from aborted babies. In the second installment, we looked at "levels of cooperation", and what the Vatican has to say about the matter. In the third installment, we were introduced to what is, to my mind, the most important and ominous component of this entire topic: the use of cell lines derived from aborted babies as human technology manufacturing platforms; that is, 'platforms' on which any number of drugs and vaccines can be developed. In this part, we will see how the use of human technology manufacturing platforms is expanding rapidly, and will quite soon come to affect us all. First, it will come via the flu vaccines.

"Seasonal flu" is the usual, well, seasonal, flu that people get, usually caused by a strain of Influenza A or Influenza B. It's the one they give the shots for. There's an Influenza C as well, but it's so mild nobody worries about it. Currently there are 2 types of A (H1N1 and H3N2) and 1 type of B which circulate worldwide and cause seasonal flu. "Pandemic flu" is an outbreak which spreads worldwide, and can be a public health disaster. Some Type A strains occur in swine, horses, and other animals; but wild birds can carry any strain, and the avian strains H5 and H7 are particularly virulent. Pandemics are caused only by strains of Influenza A, and some thirty pandemics have been recorded in the past several centuries (every ten to fifty years or so), with three having occurred in the 20th century: the 1918-1919 "Spanish flu", the 1957-1958 "Asian flu" and the 1968-1969 "Hong-Kong flu". There have also been a couple of false alarms: who remembers the "swine flu"? In the 20th century, the 1918 flu was the horrific one, causing more deaths worldwide in a few months than World War I did in four years. The "Asian" and "Hong-Kong" pandemics were far, far milder. There is some evidence to suggest that the 1918-1919 pandemic occurred when an avian flu strain became capable of infecting humans, which brings us to the current "avian flu." The avian Influenza A strain H5N1 first crossed into a human in southern China in1997, with an outbreak in Asian nations in 2003. Currently, about 177 persons have been infected worldwide with H5N1, with 98 fatalities.[1] It has been noted that, given the potential exposure of millions of people in southeast Asia to H5N1, clinical disease in humans remains at this time a rather rare event. The concern among public health officials is that the genes of H5N1 could "mix" - reassort - with a human strain of Influenza A, thus leading to increased infectivity and a pandemic. Please note: the potentiality of H5N1 to reassort and become the etiology of an Influenza A pandemic is just that, a potential. It is, apparently, a very real potential, so it is prudent for governments to be addressing the issue, but it is, nevertheless, a potential. At least one other avian flu strain - H7N1 - seems to exhibit similar potential.

Regarding the vaccines used for the "seasonal flu," all that are in current use are developed using viral strains grown in embryonated hen's eggs. Each year the most likely candidate A strains as well as the B strain are selected, viruses grown in the eggs, and 15 micrograms of viral antigen put in each dose. The process from strain selection to final product takes six to eight months, and, due to the nature of hen's eggs, is time and labour intensive: each egg must be individually inoculated. Currently there are multiple manufacturers for the seasonal flu vaccine. Cell culture techniques are generally acknowledged as superior to using hen's eggs, and please take note that cell cultures using Madin-Darby Canine Kidney (MDCK) or Vero (African green monkey kidney) are approved for human vaccine production, and have the same benefits as those listed for PER.C6: greater production capability, less risk of transmission of avian flu virus (after all, H5N1 is a disease of poultry) and decreased labour requirements.[2] In addition, there are numerous other strategies for developing a vaccine rapidly enough, and in sufficient quantities, to confront a pandemic. This is crucial to keep in mind as we move through the discussion which follows: PER.C6 or some other human cell line is not a requirement to address the threat of an influenza pandemic with H5, or any other strain. There are other ways. The U.S. Department of Health and Human Services plans to phase out use of the egg-based vaccine, and replace it with the cell culture- based vaccine[3]. It further appears to be the case that this would be true for both the "seasonal" flu vaccine, as well as a "pandemic flu vaccine stockpile." The reasons are those noted previously: increased flexibility, less cumbersome manufacture, and higher antigenicity. The question is, will it be a cell line derived from animals, or from aborted babies?

Sanofi-Pasteur is the vaccine division of the French conglomerate Sanofi-Aventis Group, based in Lyons, France. The U.S. corporate headquarters are in Swiftwater, PA. In May, 2004, the National Institute of Allergy and Infectious Disease (NIAID, a branch of the National Institutes of Health, which in turn is under the auspices of the U.S. Department of Health and Human Services) awarded Sanofi a contract to develop 8000 doses of investigational H5N1 vaccines. These were presumably egg-based doses. In November, 2004, HHS announced that it had awarded Sanofi another $10 million to develop egg production facilities to ensure a continuous supply of eggs in the event of a pandemic or vaccine shortage.[4] This represented the third agreement between HHS and Sanofi to develop a pandemic influenza vaccine response; this third agreement, in addition to the up front $10 million, had options giving a total potential value of $41 million.[5] So far, so good; this all appears to be appropriate groundwork for egg based H5N1 vaccines in the event of a pandemic. However, on 1 April 2005, Sanofi Aventis Group announced that it had been awarded a $97 million contract by the United States Health and Human Services Department "...to speed production process for new cell culture influenza vaccines in the US..."[6] The contract is to both develop the PER.C6 vaccine, and design and develop a new U.S. PER.C6 cell culture manufacturing facility to be located in Swiftwater, PA. The same press release repeated the two main advantages of human cell culture over the usual conventional influenza viral culture medium of chicken eggs already cited in the literature: (1) the cell culture technique decreases the start up time for a new viral culture from four weeks to three, and (2) it eliminates the need for all those eggs. In September, 2005, Sanofi was awarded another $150 million to manufacture vaccine in bulk form at the Swiftwater location. Although unspecified in the press release, this is presumably the egg based vaccine.[7] Finally, at the same time as the initial May, 2004 contract, another vaccine manufacturer, Chiron (Emeryville, CA and Marburg, Germany) was also awarded a contract by DHHS for production and clinical testing of an H5N1 vaccine.[8] Now, this is important: the Chiron investigational vaccine is based on a cell line, the Madin Darby Canine Kidney (MDCK) cell line mentioned above. The Chiron vaccine is in U.S. Phase I/II study, and has completed a second Phase III European study.[9] So, like Sanofi, Chiron is rapidly developing a cell culture based vaccine. But, Chiron is using an animal line, MDCK. Sanofi is using PER.C6. Sanfoni-Pasteur's avian influenza (H5N1) is lagging behind the Chiron MDCK vaccine; Sanofi's will enter clinical trials in Norway in the Spring of 2006.[10] Perhaps the extra boost from U.S. DHHS dollars will help them out.

Another biotechnology company, Vaxin, based in Birmingham, Alabama, announced a license agreement with Crucell on 13 September, 2004, to use the PER.C6 cell line to develop vaccines against influenza, anthrax, respiratory syncytial virus (RSV), and other unspecified diseases.[11] The influenza vaccine is especially interesting; unlike the Sanofi product discussed above, the Vaxin product is to be an inhaled flu vaccine developed on the PER.C6 line.[12] The vaccine is already in Phase I clinical trials, and full FDA approval is anticipated in 2009. To date, Vaxin has been awarded $10 million in Federal funds to develop this product.[13]

In addition to the influenza vaccines, I offer a short and far from complete miscellany of companies and vaccines here. The Aeras Global TB Vaccine Foundation of Bethesda, Maryland, contracted with Crucell $2.9 million to develop a new tuberculosis vaccine using PER.C6 to replace the old BCG TB vaccine (not used in the United States).[14]

The PER.C6 cell line is being used in the development of Merck's HIV-1 vaccine; this licensing agreement was actually the first for the cell line between Crucell and a major vaccine manufacturer, in 2001.[15] The research moved into Phase I clinical trials in 2002,[16] and it was recently announced that the candidate vaccines will move into "the next phase of clinical trials in the near future."[17]
Crucell and the Walter Reed Army Institute of Research have signed an agreement to evaluate PER.C6 for the development of vaccines against Japanese encephalitis, dengue fever, and West Nile fever viruses.[18]

At this point, a pause for a brief summary is in order. Currently, the following human cell lines derived from aborted babies are in use: WI-38, MRC-5, and PER.C2. The following vaccines use them: rubella (WI-38, as well as the viral strain originally grown out of RA27/3), varicella (WI-38, MRC-5), hepatitis A (MRC-5), rabies (MRC-5), and polio (MRC-5). Rabies and polio have alternative vaccines currently available. Rubella once had alternatives; in fact prior to the introduction of Merck’s WI-38/RA 27/3 based vaccine, there were no fewer than three rubella vaccines licensed and in use in the U.S. market. One was based on a duck embryo cell culture, one on a dog kidney culture, and one on a rabbit kidney culture.[19] They were withdrawn from the U.S. market after the introduction of MERUVAX, although at least two remain licensed by the FDA and could be “brought back on the market tomorrow.”[20] Vaccines utilizing human cell cultures which are currently under development, or entering clinical trials include smallpox (MRC-5), influenza A (PER.C6), influenza B (PER.C6), "avian flu" vaccines (PER.C6), tuberculosis (PER.C6), respiratory syncytial virus (PER.C6), HIV-1 (PER.C6), anthrax (PER.C6) and various encephalopathic viruses (PER.C6). This list is not inclusive, and discusses only vaccines.

As is appropriate for a versatile manufacturing platform, in 2002 the PER.C6 line was "launched (into) commercial production of fully human monoclonal antibodies,"[21] something totally divorced from vaccine production. This "launch" consisted of a formal collaboration between Crucell and the Dutch biotechnology company DSM Biologics, which develops biopharmaceutical products. The biopharmaceutical product market segment is currently EURO 30 billion and is growing about 20% annually;[22] in 15 to 20 years it is projected to reach USD $200 billion. "PER.C6 has the potential to become the technology of choice for an attractive part of that market."[23] "Biopharmaceuticals" is roughly synonymous with another biotech buzzword, "monoclonal antibody (Mab) therapeutics." Mab's are becoming increasingly used in cancer therapies, as they are antibodies directed at specific antigens found on the malignant cells. They attach to the antigens, and activate compliment-mediated and cell-mediated cytotoxicity, resulting in death or arrest of the malignant cells.[24] They are, in effect, "magic bullets" targeted at specific malignant cells, and thus have high specificity with minimal side effect profiles. Currently there are over a dozen monoclonal antibody therapies in clinical use, against certain forms of breast cancer and certain stomach cancers, certain leukemias, and certain lymphomas. I have observed the effects of a couple of these therapies; they are, truly, remarkable. In addition, there is what has been described as a "bulging pipeline" of new Mab's against an even broader array of cancers as well as chronic autoimmune inflammatory diseases with high morbidity such as rheumatoid arthritis and ulcerative colitis. As far as I can tell, none of the existing Mab's were developed using human cell lines, but Crucell as well as numerous other biotech companies are aggressively pursuing Mab development using human lines such as PER.C6.[25] Interestingly, it is not just anticancer therapies where Mab's have potentialities; they may prove useful in infectious diseases as well. Research is underway looking at Mab therapies for severe acute respiratory syndrome (SARS, caused by a coronavirus)[26] and rabies,[27] among others. All of the Mab therapies are amenable to development on human cell lines, though human cell lines such as PER.C6 are not required. Animal lines such as Vero or MDCK work as well (and are generally the ones which are used in the research papers). Finally, PER.C6 is being actively developed as a platform for various gene therapies. Like Mab's, this is a field which will be simply exploding in the very near future.

Next week: What happens now?

Endnotes.
[1] This synopsis on the flu developed from www.answers.com and the on-line encyclopedia Wikipedia, www.wikipedia.com. In addition, the Kamps et. al. Influenza Report 2006 is an outstanding reference, available as a free PDF download at www.influenzareport.com
[2] Influenza Report 2006 Chapter 6, "Vaccines," see section entitled "Vaccines and technology and development." The author of the chapter, Dr. Korsman, does not list PER.C6 in his chapter, but only the animal cell lines.
[3] Fauci, A. "Race against time." Nature Vol. 435:423-424, 26 May 2005.
[4] "Secretary Thompson Announces Contract To Secure Future Egg Supply For Flu Vaccines." HHS Press Office, 9 Nov 2004, www.dhhs.gov/news/press/2004pres/20041109a.html
[5] "Aventis and U.S. Department of Health and Human Services Enter into Third Pandemic Influenza Vaccine Agreement." Aventis Press Release, 9 November 2004, Sanofi-Aventis
[6] "Sanfoni pasteur awarded $97 million HHS contract to accelerate cell-culture pandemic influenza vaccine development." Sanfoni Aventis "Press Room" Year 2005, www.en.sanfoni-aventis.com
[7] "Sanofi Pasteur Delivers More H5N1 Vaccine For U.S. Government Pandemic Initiatives." Sanofi-Aventis Press Release, 6 February 2006 See also the press release of 15 September 2005.
[8] "Questions and Answers, H5N1 Avian Flu Vaccine Trials, Question 3.: What vaccines are being tested?" National Institute of Allergy and Infectious Diseases, National Institutes of Health March 2006, at www3.niaid.nih.gov/news/newsreleases/2005/H5N1QandA.htm
[9] "Chiron Initiates U.S. Phase I/II Study of Influenza Cell Culture Vaccine." Chiron News, 25 October 2005
[10] "High-volume avian influenza vaccine a step closer." in-PharmaTechnologist.com, 14 October 2005.
[11] "Crucell and Vaxin Announce PER.C6 Licensing Agreement." 13 Sep 2004, Birmingham. www.vaxin.com
[12] "Revolutionary Flu Vaccine in Development by Vaxin, Inc.: Vaxin Technology Utilizes Cell Culture for Manufacturing." Press release, 11 October 2004, www.vaxin.com
[13] "Federal funding is key to vaccine producer Vaxin." Birmingham Business Journal, Vol. 21, No. 43, 22 Oct 2004
[14] "Aeras partners with Crucell to develop TB vaccine." Press Release, 24 March 2004, Leiden, The Netherlands. www.aeras.org News and Events.
[15] United Business Media, op cit.
[16] "Crucell: preliminary Phase I data of PER.C6-derived HIV vaccine encouraging." Press release, Bionews,/Medicine/Immunotechnology 05 March 2002, Biotechnology Investment Today, Ltd. www.investinbiotech.com/pressroom
[17] "PER.C6-produced HIV vaccine to advance to next phase of clinical trials." NewsRx, "AIDS Weekly" section, 20 September 2004, www.newsrx.com/newsletters/AIDS-Weekly
[18] "Crucell and WRAIR sign CRADA to evaluate PER.C6(R) Technology for Development of Flavivirus Vaccines." Market Wire News, 22 December 2005, www.marketwire.com
[19] Maxcy-Rosenau-Last Public Health, pg. 95.
[20] Aborted Fetal Cell Lines, footnotes 24 & 25.
[21] ibid, Crucell, "Corporate History"
[22] "Biotech Alliance of DSM Biologics & Crucell - for faster preparation of new medicines at lower cost." Biotech Industry General Issues press release, 19 December 2002, www.investinbiotech.com
[23] Quote from Leendert Staal, president of DSM, found in "Crucell/DSM push PER.C6 technology forward." in-Pharmatechnoligist.com on line pharmaceutical news, 23 December 2005, www.in-pharmatechnologist.com/news
[24] Fishelson, Z. "Obstacles to cancer immunotherapy: expression of membrane complement regulatory proteins (mCRPs) in tumors." Molecular Immunology 40(2-4):109-123, Sep. 2003.
[25] "First milestone achieved in Centocor-Crucell Agreement for CD46 human antibodies against cancer." Medicine/Biotherapeutics 1 February 2002, www.investinbiotech.com/pressroom
[26] ter Meulen, J. et al. "Human monoclonal antibody as prophylaxis for SARS coronavirus infection in ferrets." Lancet 363(9427):2139-41, 26 Jun 2004. See also van den Brink, E. et al. "Molecular and Biological Characterization of Human Monoclonal Antibodies Binding to the Spike and Nucleocapsid Proteins os Severe Acute Respiratory Syndrome Coronavirus>" Journal of Virology 79(3):1635-1644, Feb. 2005.
[27] Goudsmit, J. et al. "Comparison of an anti-rabies human monoclonal antibody combination with human polyclonal anti-rabies immune globulin." Journal of Infectious Diseases 193(6):796-801, 15 Mar 2006.

Feast days of the week 22-28 April, A.D. 2007 (1962 liturgical calendar).

SECOND PART OF THE LITURGICAL YEAR: THE EASTER CYCLE (MYSTERY OF THE REDEMPTION).[1]
II. EASTERTIDE

Sunday, 22 April, 2007
Second Sunday after Easter (II)
"This Sunday is often called Good Shepherd Sunday: the Gospel tells us of the Good Shepherd. Jesus is indeed the Good Shepherd of our souls. He came to give His life for us."
Epistle: I Peter 2:21-25.
Gospel: John 10:11-16.

Ss. Soter and Caius, Popes, Martyrs (III)
"St. Soter was martyred in the second century under Marcus Aurelius A.D. 174, and St. Caius was put to death A.D. 296."
Epistle: I Peter 5:1-4, 10-11.
Gospel: Matthew 16:13-19.

Monday, 23 April, 2007
Ferial (IV)
Epistle: I Peter 2:21-25.
Gospel: John 10:11-16.

St. George, Martyr (Comm.)
"St. George, of an illustrious family, having reproached Diocletian for his cruelty, was subjected therefore to atrocious torments and was finally beheaded A.D. 304. He is venerated as the patron of Christian soldiers, and is the Patron of England."
Epistle: II Timothy 2:8-10; 3:10-12.
Gospel: Matthew 10:26-32.

Tuesday, 24 April, 2007
St. Fidelis of Sigmaringen, Martyr (III)
"St. Fidelis was at first 'the Advocate of the poor'. He then entered the Order of Friar Minors, preached the Word of God, and was stabbed to death by Protestant soldiers A.D. 1622."
Lesson: Wisdom 5:1-5.
Gospel: John 15:1-7.

Wednesday, 25 April, 2007
Greater Litanies (V)
"ROGATION DAYS: Earthquakes and other calamities afflicted the diocese of Vienne in Dauphiny (France) in the fifth century, and St. Mamertus, who was bishop of that Diocese, instituted a penitential procession with public supplications on the Monday, Tuesday and Wednesday before Ascension Day. In 816, Pope Leo III introduced it into Rome, and soon after it became a general observance throughout the Church.

The Litany of the Saints, the Psalms and Prayers sung during the Procession on these days are supplications: hence the name of Rogation Days (rogare, to ask) applies to them. The object of these rogation supplications is to appease the anger of God and avert the scourges of His justice, and to pray for the harvest.

A similar function is observed on April 25th, on the feast of St. Mark, but this is of Roman origin. It is called the Greater Litanies in contrast to the Lesser Litanies of the Rogation days; but in practice there is no difference between them, except that the Rogations may be transferred by the Bishop of the Diocese to three other continuous (sic) days which are more convenient according to local custom or need."
Epistle: James 5:16-20.
Gospel: Luke 11:5-13.

St. Mark the Evangelist (II)
"St. Mark was a disciple of St. Peter and the author of the second Gospel under the inspiration of the latter. He was martyred at Alexandria A.D. 80.

The Procession of the Greater Litanies, followed by the Rogation Mass, has no connection with the Feast of St. Mark as such. If St. Mark's Day is transferred, the Procession still takes place on April 25 unless Easter occurs that day, in which case the Litanies are observed the following Tuesday."
Lesson: Ezechiel 1:10-14.
Gospel: 10:1-9.

Thursday, 26 April, 2007
SS. Cletus and Marcellinus, Popes, Martyrs (III)
"St. Cletus, the third pope, was martyred under Domitian A.D. 91. St. Marcellinus was beheaded under Diocletian A.D. 304."
Epistle: I Peter 5:1-4, 10-11.
Gospel: Matthew 16:13-19.

Friday, 27 April, 2007
St. Peter Canisius, Confessor, Doctor (III)
"Peter Kanis, born at Nigmegen in Holland, after brilliant studies at Cologne and Louvain, entered the Company of Jesus, of which he is one of the chief glories. The wisdom of his controversy, his eloquent preaching, his instructive writings (for example the first Catechism) caused him to be called the Hammer of Protestantism. He died at Fribourg in Switzerland, A.D. 1597."
Epistle: II Timothy 4:1-8.
Gospel: Matthew 5:13-19.

Saturday, 28 April 2007
St. Paul of the Cross, Confessor (III)
"St. Paul all his life had a burning love for Jesus. He founded the Congregation of Passionists. He and his brethren were preaching 'the mystery of the Cross and of devotion to the Passion.' He died A.D. 1775."
Epistle: I Cor 1:17-25.
Gospel: Luke 10:1-9.

[1] Remarks are abstracted from The Daily Missal and Liturgical Manual, from Editio Typica of the Roman Missal and Breviary, 1962
(Baronius Press Limited, London, 2004, in conjunction with the Fraternal Society of St. Peter, www.baroniuspress.com)

Feast days of the week 15-21 April, A.D. 2007 (1962 liturgical calendar).

SECOND PART OF THE LITURGICAL YEAR: THE EASTER CYCLE (MYSTERY OF THE REDEMPTION).[1]
II. EASTERTIDE

Sunday, 15 April, 2007
Low Sunday (I)
"This Sunday is called from the first words of the Introit, the Sunday of Quasimodo, or Sunday in Albis (deponendis) because the neophytes on that day put aside their white garments. In English the term Low Sunday is in contrast with Easter or High Sunday. Another Latin name Pascha clausum is preserved in the French: Paques closes and in the Dutch or Flemish: Beloken Pasen; close of Easter, this Sunday ending the Octave. Let us proclaim our faith in the risen Lord, and in His divine Presence in the Holy Eucharist."
Epistle: I John 5:4-10.
Gospel: John 20:19-31.

Monday, 16 April, 2007
Ferial (IV)
Epistle: I John 5:4-10.
Gospel: John 20:19-31.

Tuesday, 17 April, 2007
Ferial (IV)
Epistle: I John 5:4-10.
Gospel: John 20:19-31.

St. Anicetus, Pope, Martyr. (Comm.)
"This Pope governed the Church under Marcus Aurelius from 155 to 166. He suffered so much for the faith that, although he did not shed his blood he was given the title of martyr."
Epistle: I Peter 5:1-4, 10-11.
Gospel: Matt 16:13-19.

Wednesday, 18 April, 2007
Ferial (IV)
Epistle: I John 5:4-10.
Gospel: John 20:19-31.

Thursday, 19 April, 2007
Ferial (IV)
Epistle: I John 5:4-10.
Gospel: John 20:19-31.

Friday, 20 April, 2007
Ferial (IV)
Epistle: I John 5:4-10.
Gospel: John 20:19-31.

Saturday, 21 April 2007
St. Anselm, Bishop, Confessor, and Doctor of the Church (III)
"St. Anselm, the famous Archbishop of Canterbury, was a Benedictine monk, who fought intrepidly for the faith and liberty of the Church. He is one of the greatest philosophers and mystics of the eleventh century. He died A.D. 1109."
Epistle: II Timothy 4:1-8.
Gospel: Matt 5:13-19.

[1] Remarks are abstracted from The Daily Missal and Liturgical Manual, from Editio Typica of the Roman Missal and Breviary, 1962
(Baronius Press Limited, London, 2004, in conjunction with the Fraternal Society of St. Peter, www.baroniuspress.com)

Notes from the Roman Missal (1962): Eastertide (The Easter Cycle)

SECOND PART OF THE LITURGICAL YEAR: THE EASTER CYCLE (MYSTERY OF THE REDEMPTION).

II. EASTERTIDE

"Eastertide begins with the Mass of the Easter Vigil and ends on the Saturday after Pentecost. It is a time of uninterrupted joy and Feasts, during which we celebrate the Mysteries of the Resurrection, the Ascension, and the Descent of the Holy Ghost on the Apostles and His Church. The date of Easter, from which the date of all movable feasts is determined, is fixed according to the Jewish method and may vary between March 22 and April 25.

In the Liturgy of Eastertide, we commemorate the various appearances of Our Lord, during which He instructed His Apostles and prepared them for the Descent of the Holy Ghost and His own Ascension.

The triumph and joy of Eastertide is reflected in the decoration of the sanctuary and the priest's use of white vestments, symbolizing joy and purity. The 'Asperges me' is supplanted by the 'Vidi aquam,' which refers to the waters of Baptism. Every year at Easter the Church rejoices for a double reason: Christ is risen, and many of her children are redeemed.

Until Ascension Day, the paschal candle shines in the sanctuary as a symbol of the visible presence of Our Lord upon earth, and white vestments are used. The joyful repetition of 'Alleluia, alleluia, alleluia,' which was omitted since Septuagesima, follows every Introit, Antiphon, Verse, and Response as a sign of joy and peace."

Easter Sunday.

"In many modern languages the name given to this Feast comes from a Hebraic word Pasch or Passover, which means Passage through the Red Sea: Pascha in Latin, Paques in French, Pasg in Welsh, Pasen in Dutch or Flemish. The English word Easter is derived from Eostre, the name of a pagan Saxon goddess, and a spring festival in her honour was Christianized so that the word became the English equivalent of the Pasch. The Mass is full of allusions to the Resurrection of our Lord and to Baptism, which is a spiritual resurrection. The Sequence or Prose is a survival of a rich literature. It is one of the most beautiful of all and contains in a few simple lines all the elements of the Mystery: it gives the details of Jesus' immolation; Jesus triumphs on the cross and He comes forth triumphant from the sepulchre. Alleluia!

'This is the day which the Lord had made; let us celebrate it with transports of joy.' (Office of the Church)

Jesus confounded all His enemies by clothing in glory and splendour that body which had been the Victim of the cruelty of man. Christ's triumph over Death is the most conclusive proof of His Divinity and the foundation of our faith, 'If Christ be not risen again your faith is in vain.' (1 Cor 15)

And 'God hath given us the victory through our Lord Jesus Christ. He hath raised us up together with Christ and hath made us sit together in the heavenly places.' (St. Paul)."

Feast days of the week 8-14 April, A.D. 2007 (1962 liturgical calendar).

SECOND PART OF THE LITURGICAL YEAR: THE EASTER CYCLE (MYSTERY OF THE REDEMPTION).[1]
II. EASTERTIDE

"Eastertide begins with the Mass of the Easter Vigil and ends on the Saturday after Pentecost. It is a time of uninterrupted joy and Feasts, during which we celebrate the Mysteries of the Resurrection, the Ascension, and the Descent of the Holy Ghost on the Apostles and His Church. The date of Easter, from which the date of all movable feasts is determined, is fixed according to the Jewish method and may vary between March 22 and April 25.

In the Liturgy of Eastertide, we commemorate the various appearances of Our Lord, during which He instructed His Apostles and prepared them for the Descent of the Holy Ghost and His own Ascension.

The triumph and joy of Eastertide is reflected in the decoration of the sanctuary and the priest's use of white vestments, symbolizing joy and purity. The 'Asperges me' is supplanted by the 'Vidi aquam,' which refers to the waters of Baptism. Every year at Easter the Church rejoices for a double reason: Christ is risen, and many of her children are redeemed.

Until Ascension Day, the paschal candle shines in the sanctuary as a symbol of the visible presence of Our Lord upon earth, and white vestments are used. The joyful repetition of 'Alleluia, alleluia, alleluia,' which was omitted since Septuagesima, follows every Introit, Antiphon, Verse, and Response as a sign of joy and peace."

Sunday, 8 April, 2007
Easter Sunday (I)
"In many modern languages the name given to this Feast comes from a Hebraic word Pasch or Passover, which means Passage through the Red Sea: Pascha in Latin, Paques in French, Pasg in Welsh, Pasen in Dutch or Flemish. The English word Easter is derived from Eostre, the name of a pagan Saxon goddess, and a spring festival in her honour was Christianized so that the word became the English equivalent of the Pasch. The Mass is full of allusions to the Resurrection of our Lord and to Baptism, which is a spiritual resurrection. The Sequence or Prose is a survival of a rich literature. It is one of the most beautiful of all and contains in a few simple lines all the elements of the Mystery: it gives the details of Jesus' immolation; Jesus triumphs on the cross and He comes forth triumphant from the sepulchre. Alleluia!

'This is the day which the Lord had made; let us celebrate it with transports of joy.' (Office of the Church)

Jesus confounded all His enemies by clothing in glory and splendour that body which had been the Victim of the cruelty of man. Christ's triumph over Death is the most conclusive proof of His Divinity and the foundation of our faith, 'If Christ be not risen again your faith is in vain.' (1 Cor 15)

And 'God hath given us the victory through our Lord Jesus Christ. He hath raised us up together with Christ and hath made us sit together in the heavenly places.' (St. Paul)."
Epistle: I Cor 5:7-8.
Gospel: Mark 16:1-7.

Monday, 9 April, 2007
Easter Monday (I)
"This Octave is entirely consecrated to the neophytes. The week was for them a continual feast; and they kept their white baptismal garments, which were not laid aside until the following Sunday (in albis deponendis). The Masses of this Octave allude, like that of Pentecost, sometimes to the Resurrection, sometimes to Baptism. Let us follow the example of the neophytes, let us all be one in mind and heart, in proclaiming together our faith in the risen Christ Jesus our Lord."
Lesson: Acts 10:37-43.
Gospel: Luke 24:13-35.

Tuesday, 10 April, 2007
Easter Tuesday (I)
Lesson: Acts 13:16,26-33.
Gospel: Luke 24:36-47.

Wednesday, 11 April, 2007
Easter Wednesday (I)
Lesson: Acts 3:13-15, 17-19.
Gospel: John 21:1-14.

St. Leo I, Pope, Confessor, and Doctor of the Church (III)
"St. Leo the Great saved Rome from the invasion of Attila. He defended the rights of the Holy See, condemned Nestorianism at the Council of Ephesus, and the Monophysites at the Council of Chalcedon. He died A.D. 461."
Epistle: I Peter 5:1-4, 10-11.
Gospel: Matt 16:13-19.

Thursday, 12 April, 2007
Easter Thursday (I)
Lesson: Acts 8:26-40.
Gospel: John 20:11-18.

Friday, 13 April, 2007
Easter Friday (I)
Epistle: I Peter 3:18-22.
Gospel: Matt 28:16-20.

St. Hermenegild, Martyr (III)
"Son of the King of the Visigoths in Spain, he was put to death by the Arians out of hatred for his faith in the consubstantiality of the Word of God with the Eternal Father. A.D. 586."
Lesson: Wisdom 5:1-5.
Gospel: Luke 14:26-33.

Saturday, 14 April 2007
Easter Saturday (I)
Epistle: I Peter 2:1-10.
Gospel: John 20:1-9.

St. Justin, Martyr (III)
"St. Justin was converted from pagan philosophy to Christianity. He became the most illustrious opponent of pagan philosophers. He addressed two Apologies to the persecuting emperors. He died A.D. 165."
Epistle: I Cor 1:18-25, 30.
Gospel: Luke 12:2-8.

[1] Remarks are abstracted from The Daily Missal and Liturgical Manual, from Editio Typica of the Roman Missal and Breviary, 1962
(Baronius Press Limited, London, 2004, in conjunction with the Fraternal Society of St. Peter, www.baroniuspress.com)

Human Technology Manufacturing Platforms Part III: Human Technology Manufacturing Platforms.

In addition to the vaccines already discussed, several other vaccines dependent on human diploid cell cultures are on the horizon. The polio vaccine currently used in the United States, IPOL (Aventis-Pasteur)[1] is comprised of three strains of polio grown in monkey kidney cultures. However, the same manufacturer has another polio vaccine, Poliovax, which is cultured in the MRC-5 human diploid cell line. Although not yet widely distributed in the United States, this vaccine has been licensed by the FDA.[2]

Smallpox was declared eradicated from the planet in 1980, with the last reported natural case occurring in Somalia in 1977. Routine smallpox vaccination was discontinued in the United States in 1971, though it continued in the U.S. military until 1990.[3] However, subsequent to 9/11 it was reintroduced in selected groups of the military, usually those who were in, or scheduled to go to, the Middle East. The current smallpox vaccine, DRYVAX (Weyth)[4] was prepared from the traditional New York Board of Health vaccinia strain prepared in calf lymph, and stored as a freeze dried product. Although this freeze dried strain presents no moral problem, it is no longer manufactured in the United States[5] and aggressive development of a 2nd generation smallpox vaccine is underway using the MRC-5 cell line.[6] It's worth looking at this situation a little more closely. In October, 2001, the Washington Post reported that the British company Acambis, PLC, had been awarded a contract from the Department of Health and Human Services (DHHS) to develop 54 million doses of smallpox vaccine using the MRC-5 line. This information was picked up by the organization Children of God for Life, as well as the online news daily, WorldNetDaily, and these outfits conducted a poll of over 3,300 persons. Their findings were that 56% of those polled would refuse a smallpox vaccine manufactured using lines derived from aborted fetuses. In addition, a letter writing campaign to the DHHS was organized, and the result was that in December, 2001 DHHS modified the contract such that doses subsequent to the initial 54 million would be manufactured using the Vero monkey kidney line.[7] Currently, both MRC-5 and Vero are being used to develop the vaccine.[8]

At least two more human cell lines have been developed. The 293 cell line was developed from fetal kidney, and the PER.C6 line was developed in 1995 from embryonic retinal cultures obtained in 1985.[9] The reasons for the abortion of the baby which resulted in the 293 cell line were not clear, but that cell line was intended only for basic research.[10] However, many medical details regarding the 1985 abortion are thoroughly documented. This is because, from the beginning, the intent was to develop this line as a base for vaccine and pharmaceutical manufacturing, and since the researchers knew that the line would sooner or later be submitted for FDA licensure, they needed scrupulous documentation. The abortion was done in France on an 18 week unborn child, and the abortion was performed solely because "the woman wanted to get rid of the fetus."[11] There were no medical problems with the parents or with the unborn child. Indeed, the researchers wanted a healthy fetus; an unborn child with medical problems, or from parents with medical problems or with a family history of medical problems, would not be acceptable as a source of material for cell lines which were to be submitted for regulatory approval.. The abortion was performed, the cells were procured from the retina, frozen, and ten years later thawed for the development of the PER.C6 line, a cell line developed “just for pharmaceutical manufacturing..."[12] The researcher responsible for developing the PER.C6 cell line made this observation regarding the development of the line: "(a)nd then (there is) the pharmaceutical industry standard. I realize that this sounds a bit commercial, but PER.C6 were (sic) made for that particular purpose. Also, as far as I know, more than fifty different companies have taken license for PER.C6."[13] The company which developed and licensed the line is the Dutch biotechnology company, Crucell N.V.

Crucell originated in 1993 as company called IntroGene, which was formed with the intent of using stem cell technology to develop gene therapies.[14] However, the company recognized that existing technologies were primarily for research, and would not meet pharmaceutical industry standards, so, in 1995, IntroGene entered into formal collaboration with Leiden University to develop the PER.C6 line, "initially intended for the production of virus-based products."[15] The PER.C6 cell line ("PER.C6" is a registered trademark of Crucell) was introduced in 1997 for the commercial production of gene therapies, and in 1999 the line's use was expanded. In 2000, IntroGene and a company called U-Bisys merged, forming Crucell, N.V. By 2001 the PER.C6 line was being reported in the literature as a "new manufacturing system for the production of influenza vaccines."[16] In 2002 the PER.C6 line was further expanded onto a commercial scale as one of the company’s two "broadly applicable human technology platforms"[17] for developing pharmaceuticals. PER.C6, according to Crucell, will be used as a manufacturing system "on which a wide range of biopharmaceuticals can be developed and manufactured, such as vaccines, antibodies, therapeutic proteins and gene therapy products."[18] In addition to licensing the PER.C6 line to other vaccine manufacturers, Crucell purchased the Swiss vaccine company Berna Biotech AG in February, 2006, making Crucell "the world's leading independent vaccine company."[19] In August, 2005, the company had a market capitalization of EURO 735 million (this is prior to the Berna acquisition) and listed over 40 licensees of the PER.C6 line.[20] We will look briefly at some of the companies and products using this human technology manufacturing platform, but first, next week we need to say a few words about the flu.

Next week: The flu and Crucell.

Endnotes
[1] Package insert, IPOL, Aventis-Pasteur, 1999. Institute for Vaccine Safety.
[2] "Vaccines Licensed for Immunization and Distribution in the US." U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, updated 9/2005. www.fda.gov/cber/vaccine/licvacc.htm
[3] Infectious Diseases, 3rd Ed. Gorbach, S. et al, Lippincott, Williams & Wilkins, 2004. Pg. 376.
[4] Package insert, DRYVAX, Wyeth Pharmaceuticals, 2004. Institute for Vaccine Safety.
[5] "Regulatory Requirements for the Historical and New Smallpox Vaccines: Review of U.S. Regulations." K. Midthun, M.D., Center for Biologics Evaluation and Research, U.S. FDA, G7+ Workshop, Langen, Germany, 5-6 September, 2002. www.fda.gov/cber/smlpx/smlpxreg090502km.pdf
[6] ibid.
[7] "Update 12-03-01: Acambis/Baxter announces second contract for 155 million doses of the new smallpox vaccine will use Vero cell lines - not MRC-5." Children of God for Life, www.cogforlife.org/vaxalert.html
[8] "Smallpox vaccination and adverse events training module." CDC Emergency Preparedness & Response, Smallpox, About the Vaccine. www.bt.cdc.gov/training/smallpoxvaccine/reaction/about_vaccine.html
[9] Transcriptions of the U.S. FDA Center for Biologics Evaluation and Research, Vaccines and Related Biological Products Advisory Committee Meeting, Wednesday, 16 May, 2001. pg. 77ff. www.fda.gov/ohrms/dockets/ac/01/transcripts/3750t1_01.pdf
[10] ibid, pg 94.
[11] ibid, pg.91.
[12] ibid, pg 94, my emphasis.
[13] ibid, pg. 95. My emphasis. The researcher narrating this portion of the transcript is Dr. Alex van der Eb of the University of Leiden, The Netherlands. Dr. van der Eb also disclosed at the "Disclosure" section of the transcript that he has received consulting fees from Crucell (the company sponsoring the development of the PER C6 line) for "scientific advice" on human cell lines.
[14] This synopsis is developed from the "Corporate History" section of Crucell's website, www.crucell.com.
[15] ibid. Please note that "PER.C6" is a registered trademark of Crucell, N.V.
[16] Pau, M.G. et al, "The human cell line PER.C6 provides a new manufacturing system for the production of influenza vaccines." Vaccine 21 Mar 2001, 19 (17-19):2716-2721.
[17] "Crucell's PER.C6 Cell-Line Used in Merck's HIV-1 Vaccines Research Program." United Business Media PR Newswire, 3 April 2001, www.prnewswire.com My emphasis.
[18] "About Crucell.," corporate website, ibid. My emphasis.
[19] ibid.
[20] Crucell website, "Factsheet"