mRNA based drugs are also not "Chocolates" -- battle between medical ethics and legislation for pregnant women in clinical trials
Dear Editor
A number of controversial reports regarding safety profile of mRNA based drugs/vaccines have been floating in the clinical trial world. On one side, non inclusion of pregnant women provides safety against non-pecuniary damage (psychic damage suffered by parents having to face a new, unforeseen situation of malformation or disease in their child) and pecuniary damage consisting of additional expenses incurred in order to properly care for and meet the needs of the malformed child. However on the other side, it also promotes inequity towards right of pregnant women towards any medical benefit during pregnancy. It has been observed that keeping in view the regulations in medical ethics as well legislative bindings of different countries, mRNA vaccines can’t be distributed as Chocolates to each and every pregnant woman.
Even the largest case series on the safety profile of mRNA vaccines in more than 35,000 women have not shown clear safety signals among pregnant persons who received mRNA COVID-19 vaccines. (1)
Researchers in the US have compared the rate of stillbirth, fetal abnormalities, cesarean section, small for gestational age newborns, admission to maternal intensive care unit or neonatal intensive care unit and prematurity in 131 vaccinated and 393 unvaccinated pregnant women (2), and a study in the UK, including more than 200,000 vaccinations during pregnancy, no adverse effects greater than those in the non-pregnant population were reported (3).
In the event of vaccine complications, Italian legislation provides for the protection of the injured party in two possible ways: indemnity regulated by law no. 210 of 1992 [28] that do not require the existence of profiles of guilt and compensation for damages. However, the provisions of paragraph 1 bis of art. 1 of law no. 210/1992, introduced with Legislative Decree no. 4 of 27 January 2022 (4) “indemnity is also due to those who have suffered injury or disability resulting in a permanent impairment of psycho-physical integrity, due to the anti SARS-CoV-2 vaccination recommended by the Italian health authority”.
Hence in both of the conditions, all of the stake holders like pharmaceutical companies, patients, regulatory authorities may face good or bad outcomes. It is hoped that this overview in Italy on COVID-19 vaccination in pregnant and lactating women may help systematize processes that could be implemented to protect the health of this population worldwide. These outcomes may also be helpful in other endemic or pandemic situations that might occur in the future and the experience of the COVID-19 pandemic signals the need for any regulations based on scientific evidences on vaccines and risk–benefit ratio in the particular case of their administration in pregnancy.
1. Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu R, Chang KT, Ellington SR. Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons. New England Journal of Medicine. 2021,21.
2. Blakeway H, Prasad S, Kalafat E, Heath PT, Ladhani SN, Le Doare K, Magee LA, O’brien P, Rezvani A, von Dadelszen P, Khalil A. COVID-19 vaccination during pregnancy: coverage and safety. American journal of obstetrics and gynecology. 2022; 1;226(2):236-e1
3. Public Health England. Health Chiefs Encourage More Pregnant Women to Get Their COVID-19 Vaccine. Available online: https://www.gov.uk/government/news/health-chiefs-encourage-more-pregnant...
4. Scendoni R, Fedeli P, Cingolani M. The State of Play on COVID-19 Vaccination in Pregnant and Breastfeeding Women: Recommendations, Legal Protection, Ethical Issues and Controversies in Italy. In Healthcare 2023 ;11(3),328. MDPI.
Competing interests:
No competing interests
07 February 2023
Parveen Bansal
Joint Director
Dr. Cherry Bansal, MBBS,MHA (MD); Dr. Renu Bansal, Ph.D.; Dr. Vikas Gupta, M.Pharm. Ph.D.
University Center of Excellence in Research, Academic Block, Baba Farid University of Health Sciences, Faridkot, Punjab, India.
Rapid Response:
mRNA based drugs are also not "Chocolates" -- battle between medical ethics and legislation for pregnant women in clinical trials
Dear Editor
A number of controversial reports regarding safety profile of mRNA based drugs/vaccines have been floating in the clinical trial world. On one side, non inclusion of pregnant women provides safety against non-pecuniary damage (psychic damage suffered by parents having to face a new, unforeseen situation of malformation or disease in their child) and pecuniary damage consisting of additional expenses incurred in order to properly care for and meet the needs of the malformed child. However on the other side, it also promotes inequity towards right of pregnant women towards any medical benefit during pregnancy. It has been observed that keeping in view the regulations in medical ethics as well legislative bindings of different countries, mRNA vaccines can’t be distributed as Chocolates to each and every pregnant woman.
Even the largest case series on the safety profile of mRNA vaccines in more than 35,000 women have not shown clear safety signals among pregnant persons who received mRNA COVID-19 vaccines. (1)
Researchers in the US have compared the rate of stillbirth, fetal abnormalities, cesarean section, small for gestational age newborns, admission to maternal intensive care unit or neonatal intensive care unit and prematurity in 131 vaccinated and 393 unvaccinated pregnant women (2), and a study in the UK, including more than 200,000 vaccinations during pregnancy, no adverse effects greater than those in the non-pregnant population were reported (3).
In the event of vaccine complications, Italian legislation provides for the protection of the injured party in two possible ways: indemnity regulated by law no. 210 of 1992 [28] that do not require the existence of profiles of guilt and compensation for damages. However, the provisions of paragraph 1 bis of art. 1 of law no. 210/1992, introduced with Legislative Decree no. 4 of 27 January 2022 (4) “indemnity is also due to those who have suffered injury or disability resulting in a permanent impairment of psycho-physical integrity, due to the anti SARS-CoV-2 vaccination recommended by the Italian health authority”.
Hence in both of the conditions, all of the stake holders like pharmaceutical companies, patients, regulatory authorities may face good or bad outcomes. It is hoped that this overview in Italy on COVID-19 vaccination in pregnant and lactating women may help systematize processes that could be implemented to protect the health of this population worldwide. These outcomes may also be helpful in other endemic or pandemic situations that might occur in the future and the experience of the COVID-19 pandemic signals the need for any regulations based on scientific evidences on vaccines and risk–benefit ratio in the particular case of their administration in pregnancy.
1. Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu R, Chang KT, Ellington SR. Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons. New England Journal of Medicine. 2021,21.
2. Blakeway H, Prasad S, Kalafat E, Heath PT, Ladhani SN, Le Doare K, Magee LA, O’brien P, Rezvani A, von Dadelszen P, Khalil A. COVID-19 vaccination during pregnancy: coverage and safety. American journal of obstetrics and gynecology. 2022; 1;226(2):236-e1
3. Public Health England. Health Chiefs Encourage More Pregnant Women to Get Their COVID-19 Vaccine. Available online: https://www.gov.uk/government/news/health-chiefs-encourage-more-pregnant...
4. Scendoni R, Fedeli P, Cingolani M. The State of Play on COVID-19 Vaccination in Pregnant and Breastfeeding Women: Recommendations, Legal Protection, Ethical Issues and Controversies in Italy. In Healthcare 2023 ;11(3),328. MDPI.
Competing interests: No competing interests