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Animal Ethics Biosafety Human Research Ethics Research Integrity

Pfizer begins coronavirus vaccine trial in pregnant women – The Hill (Celine Castronuovo | February 2021)

Posted by Dr Gary Allen in Human Research Ethics on February 25, 2021
Keywords: Beneficence, Clinical trial, Human research ethics, Medical research, Protection for participants, Respect for persons

The Linked Original Item was Posted On February 18, 2021

A pregnant woman holding biological tube with positive result on COVID-19.

Pfizer and BioNTech on Thursday announced a new trial aiming to test the safety and efficacy of its coronavirus vaccine among pregnant women.

It is great to see this long overdue trial happening. It is an ethically troubling reality in which brave pregnant women who gambled on the safety of the vaccine, pave the way for a clinical trial to be conducted exploring the safety of the vaccine for pregnant women.

The companies, which together produced one of the two COVID-19 vaccines the Food and Drug Administration approved for emergency use in the U.S., said in a press release that it had given doses to its first group of participants in the new study, which aims to provide clear data on any impacts the inoculation may have for expectant mothers and their newborn children.

William Gruber, senior vice president of Vaccine Clinical Research and Development at Pfizer, said in a statement along with the press release, “We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations.”

Read the rest of this news story

Related Reading

Fauci: 10K Pregnant Women Have Had Covid Vaccine, With ‘No Red Flags’ – KHN (February 2021)

(US) The pandemic is rewriting the rules of science. But at what cost? – The Washington Post (Frances Stead Sellers | October 2020)

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