As cases of COVID-19 continue to rise, the promise of upcoming vaccines is front and center in the media. Yet, with so much information from varied sources available it can be confusing to sort through the vaccines in development, their safety, efficacy and their ethics. In the US there are 5 vaccines in Phase 3 clinical trials at this time[i] and one company has applied to the FDA for emergency use authorization already. As we near the possibility of distribution of these vaccines, we hope the following information may be helpful to you.
First of all, it may be helpful to know what it means to be in a Phase 3 clinical trial.
Phase 3 clinical trials are the last stage of required testing before a vaccine can be approved for distribution. When a vaccine has reached the point of a phase 3 trial, the final dose and schedule has been determined from previous testing and now the vaccine is put to the test with the population it is targeted for to determine how effective it is and whether there are any further side effects or safety issues that did not come up in phase 1 or 2 trials. The participants usually receive either the true vaccine or a placebo vaccine. If a phase 3 clinical trial demonstrates both efficacy and safety, a vaccine company can submit an application to the national regulatory authority to license and market the vaccine[ii].
COVID-19 Vaccines and Emergency Use Authorizations (EUAs)
In the case of vaccines for COVID-19, companies marketing vaccines are applying for “emergency use authorization” while Phase 3 trials are still ongoing if the preliminary data shows safety and efficacy. The FDA would then be able to approve distribution of the vaccine if it is determined that the benefits outweigh the risks of not having the final data from the trial. The hope is that this will help the vaccines become approved and available for the general population sooner.
Helpful COVID-19 Vaccine Resources
An additional concern that weighs on the minds of many Catholics is whether available vaccines were produced in an ethical manner. It is important to have a clear understanding of the Church’s teaching on vaccine development and remote connection with abortion in order to make an informed and free choice as COVID-19 vaccines are approved by the FDA. Following are some resources that may be helpful:
- “Moral Considerations Regarding the New COVID 19 Vaccine.” Statement of Chairmen of the Committee on Doctrine and the Committee on Pro-Life Activities United States Conference of Catholic Bishops. United States Conference of Catholic Bishops promulgated December 11, 2020. https://www.usccb.org/moral-considerations-covid-vaccines.
- This 2018 article from The Linacre Quarterly discusses the “licitness, quasi-benefits, and consequences of using aborted fetal tissue in vaccines and medical research”. It was published during the outbreak of the Zika virus: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6027112/[iii]
- This article published December 7, 2020 by The National Catholic Bioethics Center provides an excellent summary on the Catholic Church’s teaching regarding the use of vaccines remotely connected to abortion and some specifics about the COVID-19 vaccines: https://static1.squarespace.com/static/5e3ada1a6a2e8d6a131d1dcd/t/5fd11df4fb49ea12ba12a59b/1607540212284/NCBC+Vaccine+Statement.pdf[iv]
- The John Paul II Medical Research Institute is a group dedicated to ethical medical research in accord with the Catholic Church’s teachings on the dignity of all human life. They have a FAQ section on COVID-19 vaccines that discusses how vaccines are developed and which are connected to aborted fetal cell lines: https://www.jp2mri.org/faq-regarding-covid19-vaccines[v]
- The Charlotte Lozier Institute has a comprehensive list of COVID-19 vaccines in all stages of development and which are connected with abortion-derived cell lines: https://s27589.pcdn.co/wp-content/uploads/2020/12/COVID-19-Vaccine-Candidates-and-Abortion-Derived-Cell-Lines.pdf[vi]
Let us continue to pray for one another, for the safety of all healthcare workers, for all who work in medical research, and for an end to the coronavirus pandemic.
Pope Francis’ Prayer for Protection during the Coronavirus Pandemic:
O Mary,
You shine continuously on our journey
as a sign of salvation and hope.
We entrust ourselves to you, Health of the Sick,
who, at the foot of the cross,
were united with Jesus’ suffering,
and persevered in your faith.
“Protectress of the Roman people”,
you know our needs,
and we know that you will provide,
so that, as at Cana in Galilee,
joy and celebration may return
after this time of trial.
Help us, Mother of Divine Love,
to conform ourselves to the will of the Father
and to do what Jesus tells us.
For he took upon himself our suffering,
and burdened himself with our sorrows
to bring us, through the cross,
to the joy of the Resurrection.
Amen.
We fly to your protection,
O Holy Mother of God;
Do not despise our petitions
in our necessities,
but deliver us always
from every danger,
O Glorious and Blessed Virgin.[vii]
[i] Different COVID-19 Vaccines. (n.d.). Retrieved December 10, 2020, from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html
[ii] Singh, K., & Mehta, S. (2016). The clinical development process for a novel preventive vaccine: An overview. Journal of postgraduate medicine, 62(1), 4–11. https://doi.org/10.4103/0022-3859.173187
[iii] McKenna, K. C., PhD. (2018). Use of Aborted Fetal Tissue in Vaccines and Medical Research Obscures the Value of All Human Life. The Linacre Quarterly, 85(1), 13-17. doi:10.1177/0024363918761715
[iv] Ethicists of the National Catholic Bioethics Center. (2020, December 7). Points to Consider on the Use of COVID-19 Vaccines. Retrieved December 10, 2020, from https://static1.squarespace.com/static/5e3ada1a6a2e8d6a131d1dcd/t/5fd11df4fb49ea12ba12a59b/1607540212284/NCBC Vaccine Statement.pdf
[v] Moy, A., MD. (n.d.). John Paul II Medical Research Institute – FAQ Regarding COVID-19 Vaccines. Retrieved December 10, 2020, from https://www.jp2mri.org/faq-regarding-covid19-vaccines
[vi] Charlotte Lozier Institute. Update: COVID-19 Vaccine Candidates and Abortion-Derived Cell Lines. (n.d.). Retrieved December 10, 2020, from https://s27589.pcdn.co/wp-content/uploads/2020/12/COVID-19-Vaccine-Candidates-and-Abortion-Derived-Cell-Lines.pdf
[vii] Covid-19: Pope offers prayer to Virgin Mary for protection. (2020, March 11). Retrieved December 10, 2020, from https://www.vaticannews.va/en/pope/news/2020-03/pope-francis-prayer-our-lady-protection-coronavirus.html
Posted December 16, 2020