Primary sources

Primary scientific reports of clinical data on the safety and effectiveness of SARS-CoV-2 vaccines in pregnancy, and in women of childbearing age. In reverse order. Regularly updated. Click here for ripe-tomato.org’s Covid-19 navigation page. Thank you Susan Bewley and Keelin O’Donoghue for getting this started. Click here for “Vaccine in pregnancy news reports“.  We are not providing running totals by vaccine or control group but Viki Male @VikiLovesFACS is doing so here. .

Update 14 June – sources 43 and 44 added

Source 44 – 38 vaccinated pregnant health-care workers

Twenty got Pfizer-BioNTech, and 18 Moderna (click here or source). Pregnancy-related events (gestational hypertension (1), threatened labor (1), miscarriage (1), premature delivery (1) from the Pfizer-BioNTech group and none from the Moderna group. Self-reported via SurveyMonkey. Citation: Kalyan Kadali RA, Janagama R, Peruru SR, Racherla S, Tirumala R, Madathala RR, Gajula V, Adverse effects of COVID-19 mRNA vaccines among pregnant women: A cross-sectional study on healthcare workers with detailed self-reported symptoms, American Journal of Obstetrics and Gynecology (2021), doi: https://doi.org/10.1016/j.ajog.2021.06.007.

Source 43 – Case report from Italy

A 42-year-old pregnant healthcare worker received the Comirnaty (Pfizer/BioNTech) mRNA vaccination at 31 and 34 weeks (click here or source). Cord blood antibodies were present. The hospital is not named but the authors came from Firenze, Italy. Citation: Riviello C, Pontello V. Maternal and neonatal SARS-CoV-2 antibodies assessment after mRNA maternal vaccination in the third trimester of pregnancy. Int J Gynaecol Obstet. 2021 Jun 11. doi: 10.1002/ijgo.13783. Epub ahead of print. PMID: 34115887.

Update 8 June – sources 40 to 42 added

Source 42 – 14 lactating women from Portugal

All vaccinated with Pfizer BNT162b2 mRNA (click here or source). From Centro Hospitalar Universitário Lisboa Central. Citation: Juliana Gonçalves, A. Margarida Juliano, Nádia Charepe, Marta Alenquer, Diogo Athayde, Filipe Ferreira, Margarida Archer, Maria João Amorim, Fátima Serrano, Helena Soares. Non-neutralizing secretory IgA and T cells targeting SARS-CoV-2 spike protein are transferred to the breastmilk upon BNT162b2 vaccination. medRxiv 2021.05.03.21256416; doi: https://doi.org/10.1101/2021.05.03.21256416

Source 41 – 6 lactating women from USA

Five vaccinated with BNT162b2 (Pfizer) and one with mRNA-1273 (Moderna) (click here or source). From University of California, San Francisco. Citation: Yarden Golan, Mary Prahl, Arianna Cassidy, Christine Y. Lin, Nadav Ahituv, Valerie J. Flaherman, Stephanie L. Gaw. COVID-19 mRNA vaccine is not detected in human milk. medRxiv 2021.03.05.21252998; doi: https://doi.org/10.1101/2021.03.05.21252998

Source 40 – 122 vaccinated women from USA

Eighty five had Pfizer-BioNTech, & 37 Moderna (click here or source). From Weill Cornell Medicine, New York. Citation: Malavika Prabhu, Elisabeth A. Murphy, Ashley C. Sukhu, Jim Yee, Sunidhi Singh, Dorothy Eng, Zhen Zhao, Laura E. Riley, Yawei J. Yang. Antibody response to SARS-CoV-2 mRNA vaccines in pregnant women and their neonates. bioRxiv 2021.04.05.438524; doi: https://doi.org/10.1101/2021.04.05.438524

Update 7 June – source 39 added

Source 39 – 86 vaccinated pregnant women from Israel

From eight Israeli hospitals (click here or source). Compared with 65 pregnant women who had had Covid – see study 714. Citation: Beharier O, Plitman Mayo R, Raz T, Nahum Sacks K, Schreiber L, Suissa-Cohen Y, Chen R, Gomez-Tolub R, Hadar E, Gabbay-Benziv R, Jaffe Moshkovich Y, Biron-Shental T, Shechter-Maor G, Farladansky-Gershnabel S, Yitzhak Sela H, Benyamini-Raischer H, Sela ND, Goldman-Wohl D, Shulman Z, Many A, Barr H, Yagel S, Neeman M, Kovo M. Efficient maternal to neonatal transfer of antibodies against SARS-CoV-2 and BNT162b2 mRNA COVID-19 vaccine. J Clin Invest. 2021 May 20:150319. doi: 10.1172/JCI150319. Epub ahead of print. PMID: 34014840.

Update 6 June – source 38 added

Source 38 – 47 vaccinated women undergoing IVF in Israel

Forty seven women underwent IVF and ICSI, both before and after BNT162b2 COVID-19 vaccination (click here or source). There were no major differences between the pre- and post-vaccination cycles. They were cared for at the Hadassah Hebrew-University Medical Center in Jerusalem. Citation: Myriam Safrai, Amihai Rottenstreich, Shmuel Herzberg, Tal Imbar, Benjamin Reubinoff, Assaf Ben-Meir. Stopping the misinformation: BNT162b2 COVID-19 vaccine has no negative effect on women’s fertility. medRxiv 2021.05.30.21258079; doi: https://doi.org/10.1101/2021.05.30.21258079

Update 3 June – sources 36 and 37 added

Source 37 – four pregnant & four breast-feeding women vaccinated

These authors report a convenience sample (overweight on health workers) of women who responded to an online survey in January 2021 (click here or source). 87/656 (13%) of non-pregnant, 4/216 (1.9%) of pregnant, and 4/122 (3.3%) of breast-feeding respondents had been vaccinated. Citation: Desmond Sutton, Mary D’Alton, Yijia Zhang, Ka Kahe, Ana Cepin, Dena Goffman, Anna Staniczenko, Hope Yates, Anna Burgansky, Jaclyn Coletta, Zev Williams, Cynthia Gyamfi-Bannerman, COVID-19 Vaccine Acceptance Among Pregnant, Breastfeeding and Non-pregnant Reproductive Aged Women, American Journal of Obstetrics & Gynecology MFM (2021), doi: https://doi.org/10.1016/j.ajogmf.2021.100403

Source 36 – interim report of S African Ad26.COV2.S vaccine study

This interim report (click here or source) of adverse thromboembolic events in the ongoing Sisonke study of the Ad26.COV2.S (Janssen) vaccine (NCT04838795) includes a a 38-year-old woman who had given birth to twins nine months before vaccination and presented with features of transient ischemic attack 8 days post vaccination. Citation: Simbarashe Takuva,Azwidhwi Takalani, Nigel Garrett, Ameena Goga, Jonny Peter, Vernon Louw, Jessica Opie, Barry Jacobson, Ian Sanne, Linda Gail‑Bekker, Glenda Gray. Thromboembolic Events in the South African Ad26.COV2.S Vaccine Study. NEJM. June 2, 2021 DOI: 10.1056/NEJMc2107920

Update 29 May – source 35 added

Source 35 – two pregnant and five breast-feeding women

The authors for this MedRxiv preprint report 15 women (two pregnant, five breast feeding) who received at least one dose of the BNT162B2 vaccine (click here or source). None of them showed any cross reactivity to human syncytin-1. Nor was any mRNA detected in breast milk. Citation: Citra NZ Mattar, Winston Koh, Yiqi Seow, Shawn Hoon, Aparna Venkatesh, Pradip Dashraath, Li Min Lim, Judith Ong, Rachel Lee, Nuryanti Johana, Julie SL Yeo, David Chong, Lay-Kok Tan, Jerry Chan, Mahesh Choolani, Paul Anantharajah Tambyah. Addressing anti-syncytin antibody levels, and fertility and breastfeeding concerns, following BNT162B2 COVID-19 mRNA vaccination. medRxiv 2021.05.23.21257686; doi: https://doi.org/10.1101/2021.05.23.21257686

Update 27 May – source 34 added

Source 34 – Ten pregnant women in Chinese vaccine (WIV04 and HB02) trial

In this interim analysis of a randomised trial (40,382 participants), conducted in six centres in the Middle East, of two SARS-Cov-2 vaccines (WIV04 and HB02) 5 pregnant women received the first dose of the WIV04 vaccine, 2 the HBO2 vaccine, and 3 placebo (click here or source). No pregnancy outcomes are reported. The vaccines were developed by the Wuhan Institute of Biological Products Co, Ltd, and the Beijing Institute of Biological Products Co, Ltd, both of which belong to the China National Biotec Group Company Limited. The trial centres were Sheikh Khalifa Medical City in Abu Dhabi and the Al Qarain Health Center in Sharjah, both in the United Arab Emirates (UAE); the Salmanyia Medical Complex in Bahrain; Vacsera Medical Center and Katameya Medical Center in Egypt; and Prince Hamza Hospital in Jordan. Citation: Al Kaabi N, Zhang Y, Xia S, et al. Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial. JAMA. Published online May 26, 2021. doi:10.1001/jama.2021.8565

Update 26 May – source 33 added

Source 33 – no pregnancies among three cases of Astra Zeneca VITT

There were no pregnant women among three cases (two women of childbearing age) of ischemic stroke associated with vaccine-induced immune thrombotic thrombocytopaenia (VITT) after the Astra Zeneca ChAdOx1 nCoV-19 vaccine (click here or source). See also Source 27. These case are probably not included in Source 27. Citation: Al-Mayhani T, Saber S, Stubbs MJ, et alIschaemic stroke as a presenting feature of ChAdOx1 nCoV-19 vaccine-induced immune thrombotic thrombocytopaeniaJournal of Neurology, Neurosurgery & Psychiatry Published Online First: 25 May 2021. doi: 10.1136/jnnp-2021-326984

Update 24 May – source 32 added

Source 32 – Birth outcomes for 140 women vaccinated in pregnancy

MedRxiv preprint. Cases collected by the Mayo clinic (click here or source). Citation: Regan N. Theiler, Myra Wick, Ramila Mehta, Amy Weaver, Abinash Virk, Melanie Swift. Pregnancy and birth outcomes after SARS-CoV-2 vaccination in pregnancy. medRxiv 2021.05.17.21257337; doi: https://doi.org/10.1101/2021.05.17.21257337

Update 15 May – sources 30 and 31 added

Source 31 – USA. 84 vaccinated pregnant women and controls

From author affiliations identified through Feinberg School of Medicine, and the Ann and Robert H. Lurie Children’s Hospital of Chicago, Illinois (click here or source). Citation: Shanes ED, Otero S, Mithal LB, Mupanomunda CA, Miller ES, Goldstein JA. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination in Pregnancy: Measures of Immunity and Placental Histopathology. Obstet Gynecol. 2021 May 11. doi: 10.1097/AOG.0000000000004457. Epub ahead of print. PMID: 33975329.

Source 30 – USA. 30 pregnant and 16 lactating vaccinated women

Identified through the Beth Israel Deaconess Medical Center, Boston, Massachusetts (click here or source). Citation: Collier AY, McMahan K, Yu J, Tostanoski LH, Aguayo R, Ansel J, Chandrashekar A, Patel S, Apraku Bondzie E, Sellers D, Barrett J, Sanborn O, Wan H, Chang A, Anioke T, Nkolola J, Bradshaw C, Jacob-Dolan C, Feldman J, Gebre M, Borducchi EN, Liu J, Schmidt AG, Suscovich T, Linde C, Alter G, Hacker MR, Barouch DH. Immunogenicity of COVID-19 mRNA Vaccines in Pregnant and Lactating Women. JAMA. 2021 May 13. doi: 10.1001/jama.2021.7563. Epub ahead of print. PMID: 33983379.

Update 6 May – source 29 added

Source 29 – five pregnancies in Novavax vaccine trial in South Africa

Two women became pregnant after their first dose in the vaccine arm and three in the control, in this trial of the Novavax NVX-CoV2373 vaccine (click here or source). Citation: Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, Lalloo U, Masilela MSL, Moodley D, Hanley S, Fouche L, Louw C, Tameris M, Singh N, Goga A, Dheda K, Grobbelaar C, Kruger G, Carrim-Ganey N, Baillie V, de Oliveira T, Lombard Koen A, Lombaard JJ, Mngqibisa R, Bhorat AE, Benadé G, Lalloo N, Pitsi A, Vollgraaff PL, Luabeya A, Esmail A, Petrick FG, Oommen-Jose A, Foulkes S, Ahmed K, Thombrayil A, Fries L, Cloney-Clark S, Zhu M, Bennett C, Albert G, Faust E, Plested JS, Robertson A, Neal S, Cho I, Glenn GM, Dubovsky F, Madhi SA; 2019nCoV-501 Study Group. Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant. N Engl J Med. 2021 May 5. doi: 10.1056/NEJMoa2103055. Epub ahead of print. PMID: 33951374.

Update 5 May – source 28 added

Source 28 – 10 vaccinated & lactating women from Singapore

This MedRxiv preprint reports ten women who had received the Biontech BNT162b2 vaccine while lactating (click here or source). Citation: Jia Ming Low, Yue Gu, Melissa Shu Feng Ng, Zubair Amin, Le Ye Lee, Yvonne Peng Mei Ng, Bhuvaneshwari D/O Shunmuganathan, Yuxi Niu, Rashi Gupta, Paul Anantharajah Tambyah, Paul A MacAry, Liang Wei Wang, Youjia Zhong BNT162b2 vaccination induces SARS-CoV-2 specific antibody secretion into human milk with minimal transfer of vaccine mRNA medRxiv 2021.04.27.21256151; doi: https://doi.org/10.1101/2021.04.27.21256151

Update 2 May – source 27 added

Source 27 – no pregnancies among 21 women with thrombotic thrombocytopenia after Oxford/AZ or Janssen/J&J vaccines

Of 11 cases (including nine women age 22-49) of thrombotic thrombocytopenia after the Oxford/Astra Zeneca ChAdOx1 nCov-19 vaccine, none were currently or recently pregnant (click here or source). Citation: Greinacher A, Thiele T, Warkentin TE, Weisser K, Kyrle PA, Eichinger S. Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination. N Engl J Med. 2021 Apr 9. doi: 10.1056/NEJMoa2104840. Epub ahead of print. PMID: 33835769. Of 12 cases (all women under age 60) following the Janssen/Johnson & Johnson Ad26.COV2.S vaccine, none were currently or recently pregnant (click here or source). Citation: See I, Su JR, Lale A, et al. US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021. JAMA. Published online April 30, 2021. doi:10.1001/jama.2021.7517

Update 22 April – source 26 added

Source 26 – 35,691 vaccinated pregnant people from USA

The first peer reviewed publication with pregnancy outcome data from the v-safe and VAERS vaccine surveillance systems (click here or source). Citation: Tom T. Shimabukuro, Shin Y. Kim, Tanya R. Myers, Pedro L. Moro, Titilope Oduyebo, Lakshmi Panagiotakopoulos, Paige L. Marquez, Christine K. Olson, Ruiling Liu, Karen T. Chang, Sascha R. Ellington, Veronica K. Burkel, Ashley N. Smoots, Caitlin J. Green, Charles Licata, Bicheng C. Zhang, Meghna limchandani, Adamma Mba-Jonas, Stacey W. Martin, Julianne M. Gee, Dana M. Meaney-Delman, for the CDC v-safe COVID-19 Pregnancy Registry Team. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. New Engl J Med April 21, 2021 DOI: 10.1056/NEJMoa2104983

Update 18 April – source 25 added

Source 25 – 131 reproductive-age vaccine recipients from USA

Further immunological studies from the same 84 pregnant, 31 lactating, and 16 non-pregnant women who received either the Pfizer/BioNTech or Moderna mRNA vaccines reported in source 15 (click here or source). Citation: Atyeo C, DeRiso EA, Davis C, Bordt EA, DeGuzman RM, Shook LL, Yonker LM, Fasano A, Akinwunmi B, Lauffenburger DA, Elovitz MA, Gray KJ, Edlow AG, Alter G. COVID-19 mRNA vaccines drive differential Fc-functional profiles in pregnant, lactating, and non-pregnant women. bioRxiv [Preprint]. 2021 Apr 5:2021.04.04.438404. doi: 10.1101/2021.04.04.438404. PMID: 33851165; PMCID: PMC8043455.

Update 16 April – source 24 added

Source 24 – 1,508 vaccinated pregnant women from Israel

There were 1,508 vaccinated pregnant women in this real world study of 596,618 people who received the BNT162b2 mRNA vaccine between December 20, 2020, and to February 1, 2021, and an equal number of matched unvaccinated controls (click here or study). Data from Clalit Health Services, insurer of about half the Israeli population. Citation: Dagan N, Barda N, Kepten E, Miron O, Perchik S, Katz MA, Hernán MA, Lipsitch M, Reis B, Balicer RD. BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting. N Engl J Med. 2021 Apr 15;384(15):1412-1423. doi: 10.1056/NEJMoa2101765. Epub 2021 Feb 24. PMID: 33626250; PMCID: PMC7944975.

Update 15 April – sources 22 and 23 added

Source 23 – Follicular function in nine vaccinated women from Israel

The authors of this MedRxiv preprint report follicular function in nine women vaccinated with the BNT162b2 mRNA vaccine (click here or source). They were cared for at Hadassah-Hebrew University Medical Center, in Jerusalem. Citation: Yaakov Bentov, Ofer Beharier, Arbel Moav-Zafrir, Maor Kabessa, Miri Godin, Caryn S. Greenfield, Mali Ketzinel-Gilad, Efrat Esh Broder, Hananel E. G. Holzer, Dana Wolf, Esther Oiknine-Djian, Iyad Barghouti, Debra Goldman-Wohl, Simcha Yagel, Asnat Walfisch, Anat Hersko Klement Ovarian follicular function is not altered by SARS-Cov-2 infection or BNT162b2 mRNA Covid-19 vaccination. medRxiv 2021.04.09.21255195; doi: https://doi.org/10.1101/2021.04.09.21255195

Source 22 – Twenty two vaccinated & breast-feeding women from USA

The authors of this MedRxiv preprint report SARS-CoV-2 IgA and IgG levels in the milk of 22 lactating women who had received the SARS-CoV-2 mRNA vaccine (Pfizer/BioNtech or Moderna) (click here or source). They were cared for at Shands Hospital, in Florida. Citation: Vivian Valcarce, Lauren S. Stafford, Josef Neu, Nicole Cacho, Leslie Parker, Martina Mueller, David J Burchfield, Nan Li, Joseph Larkin III Detection of SARS-CoV-2 specific IgA in the human milk of COVID-19 vaccinated, lactating health care workers medRxiv 2021.04.02.21254642; doi: https://doi.org/10.1101/2021.04.02.21254642

Update 14 April – source 15 updated

Update 13 April – source 22 added

Source 22 – 84 vaccinated breast feeding women from Israel

Women who had received 2 doses of the Pfizer-BioNTech vaccine and were breastfeeding (click here or source). There were no serious adverse events, and antibodies were detected in breast milk. Citation: Perl SH, Uzan-Yulzari A, Klainer H, et al. SARS-CoV-2–Specific Antibodies in Breast Milk After COVID-19 Vaccination of Breastfeeding Women. JAMA. Published online April 12, 2021. doi:10.1001/jama.2021.5782

Update 7 April – source 7 update.

Update 6 April– source 21 added

Source 21 – 69,337 women in v-safe were pregnant. 3,953 in v-safe vaccine register

As of March 29th, 69,337 v-safe participants indicated they were pregnant at the time they received COVID-19 vaccination. 3,953 women have also been enrolled in the v-safe COVID-19 Vaccine Pregnancy Registry. Click here for details. The data up to February 16 (published 1 March) (click here or source) includes 30,494 pregnancies (16,039 Pfizer/Biontech and 14,455 Moderna). Adverse events include 29 miscarriages and one stillbirth.

Update 2 April source 20 added

Source 20 – 27 vaccinated women from USA

Twenty seven vaccinated women who delivered at Prentice Women’s Hospital in Chicago, (January-March 2021) (click here or source). 25/28 (one set of twins) infants had positive cord IgG. The exact vaccine is not reported but the authors note that at the time Pfizer/BioNTech and Moderna/NIH were available. Citation: MITHAL LB, OTERO S, SHANES ED, GOLDSTEIN JA, MILLER ES, Cord Blood Antibodies following Maternal COVID-19 Vaccination During Pregnancy, American Journal of Obstetrics and Gynecology (2021), doi: https://doi.org/10.1016/j.ajog.2021.03.035.

Update 17 March – source 19 added

Source 19 – 20 vaccinated women from Israel

This MedRxiv preprint reports 20 pregnant women who received two doses of the Pfizer/BioNTech vaccine in late pregnancy in February 2021 (click here or 2021.03.11.21253352v1.full). All women efficiently transferred antibodies to the fetus. They were cared for at Hadassah Medical Center in Jerusalem. Citation: Amihai Rottenstreich, Gila Zarbiv, Esther Oiknine-Djian, Roy Zigron, Dana G. Wolf, Shay Porat. Efficient maternofetal transplacental transfer of anti- SARS-CoV-2 spike antibodies after antenatal SARS-CoV-2 BNT162b2 mRNA vaccination medRxiv 2021.03.11.21253352; doi: https://doi.org/10.1101/2021.03.11.21253352

Update 10 March – sources 15 to 18 added

Source 18 – 6 postnatal vaccinated women in USA

The MedRxiv preprint describes six lactating women who received both doses of the Pfizer-BioNTech or Moderna vaccine between December 2020 and January 2021 (click here or 2021.02.23.21252328v1.full). They all developed IgA and IgG antibodies in breast milk within seven says. They were cared for at Providence Portland Medical Center, Oregon. Citation: Jill K. Baird, Shawn M. Jensen, Walter J. Urba, Bernard A. Fox, Jason R. Baird SARS-CoV-2 antibodies detected in human breast milk post-vaccination. medRxiv 2021.02.23.21252328; doi: https://doi.org/10.1101/2021.02.23.21252328

Source 17 – case report of 3rd trimester vaccination from USA

A 34-year-old woman received the Pfizer-BioNTech, mRNA vaccine at 32 weeks (click here or 13224_2021_Article_1436). The birth was uncomplicated and the baby had cord blood antibodies. The hospital is unnamed, but the authors were from University of Minnesota, Minneapolis. This is the first peer reviewed report of vaccination in pregnancy. Citation: Gill L, Jones CW. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antibodies in Neonatal Cord Blood After Vaccination in Pregnancy. Obstet Gynecol. 2021 Mar 8. doi: 10.1097/AOG.0000000000004367. Epub ahead of print. PMID: 33684922.

Source 16 – 10 nursing mothers vaccinated in Israel

This MedRxiv preprint describes ten nursing mothers who received the Pfizer-BioNTech mRNA vaccine (click here or 2021.03.06.21252603v1.full). Clinical details and exact vaccine timings in supplementary table 1 (click here or media-1) From author affiliations the women were probably cared for at Lis Maternity & Women’s Hospital, Tel Aviv. Citation: Michal Rosenberg Friedman, Aya Kigel, Yael Bahar, Yariv Yogev, Yael Dror, Ronit lubetzky, Ariel Many, Yariv Wine BNT162b2 COVID-19 mRNA vaccine elicits a rapid and synchronized antibody response in blood and milk of breastfeeding women medRxiv 2021.03.06.21252603; doi: https://doi.org/10.1101/2021.03.06.21252603

Source 15 – 131 reproductive-age vaccine recipients from USA

This MedRxiv preprint includes 84 pregnant, 31 lactating, and 16 non-pregnant women who received either the Pfizer/BioNTech or Moderna mRNA vaccines (click here or 2021.03.07.21253094v1.full). From author affiliations the hospitals were probably Massachusetts General Hospital, and Brigham and Women’s Hospital, both in Boston, Massachussetts. Citation: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Lydia L Shook, Dana Cvrk, Kaitlyn James, Rose De Guzman, Sara Brigida, Khady Diouf, Ilona Goldfarb, Lisa M Bebell, Lael M Yonker, Alessio Fasano, Sayed A Rabi, Michal A Elovitz, Galit Alter, Andrea G Edlow COVID-19 vaccine response in pregnant and lactating women: a cohort study medRxiv 2021.03.07.21253094; doi: https://doi.org/10.1101/2021.03.07.21253094 Update 14 March. For peer reviewed publication (click here or source). Citation: Gray KJ, Bordt EA, Atyeo C, Deriso E, Akinwunmi B, Young N, Medina Baez A, Shook LL, Cvrk D, James K, De Guzman R, Brigida S, Diouf K, Goldfarb I, Bebell LM, Yonker LM, Fasano A, Rabi SA, Elovitz MA, Alter G, Edlow AG, COVID-19 vaccine response in pregnant and lactating women: a cohort study, American Journal of Obstetrics and Gynecology (2021), doi: https://doi.org/10.1016/j.ajog.2021.03.023.

Update 6 March – sources 13 and 14 added. (We do not plan to update these unless the links change).

Source 14 – UK Yellow card reports for COVID-19 vaccine AstraZeneca

Available here. The latest (25 Feb) report (click here or COVID-19_AstraZeneca_Vaccine_Analysis_Print) included 1 vaccine exposure before pregnancy, 30 during pregnancy and 9 postnatal (p 23). The adverse events included 4 spontaneous abortions, 1 or 2 preterm births, and ten cases of morning sickness (p 41). This was out of 42,917 reports, of 157,637 reactions, of which 244 were fatal. Readers should note that “Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the Print alone” and “The overall safety experience with both vaccines is so far as expected from the clinical trials.”  https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/966183/COVID-19_AstraZeneca_Vaccine_Analysis_Print.pdf Accessed 6 March (Not updated unless links change)

Source 13 – UK Yellow Card reports for COVID-19 mRNA Pfizer- BioNTech vaccine

Available here. The latest (4th March) report (click here or COVID-19_mRNA_Pfizer-_BioNTech_Vaccine_Analysis_Print__2_) included 1 vaccine exposure before pregnancy, 37 during pregnancy and 9 postnatal (p 24). The adverse events included 16 spontaneous abortions, 2 or 3 preterm births, and four cases of morning sickness (p 42). This was out of 29,715 reports, of 85,179 reactions, of which 212 were fatal. Readers should note that “Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the Print alone” and “The overall safety experience with both vaccines is so far as expected from the clinical trials.” https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/966631/COVID-19_mRNA_Pfizer-_BioNTech_Vaccine_Analysis_Print__2_.pdf Accessed 6 March. (Not updated unless links change)

Update 28 Feb – sources 11 and 12 added

Source 12 – Janssen register trial of Ad26.COV2.S in pregnancy

Janssen have registered an RCT of the vaccine Ad26.COV2.S in pregnant women (click here). Planned sample size 824. Anticipated primary completion date January 16, 2023

Source 11 – Pfizer/BioNTech register trial of BNT162b2 in pregnancy

Pfizer/BioNTech have registered an RCT of the vaccine BNT162b2 in pregnant women (click here). Planned sample size 4,000. Estimated primary completion date January 8, 2023

Update 24 Feb – source 10 added

Source 10 – Janssen Ad26.COV2.S Vaccine FDA briefing document

See p 52 for pregnancy data (click here or VRBPAC-02.26.21-Meeting-Briefing-Document-FDA). “Eight pregnancies were reported through January 22, 2021 (4 vaccine, 4 placebo). In 7 participants (3 vaccine, 4 placebo) vaccination was within 30 days after LMP, and in 1 vaccine recipient vaccination was prior to LMP. Unsolicited AEs related to pregnancy include spontaneous abortion (1 vaccine, 0 placebo), incomplete abortion (0 vaccine, 1 placebo), elective abortion (0 vaccine, 2 placebo) and ectopic pregnancy (1 vaccine, 0 placebo). Among participants in the vaccine group, two pregnancies are ongoing with outcomes unknown at this time.” Note: Janssen is a subsidiary of Johnson & Johnson, and the Ad26.COV2.S vaccine is usually referred to in the press as the “Johnson & Johnson vaccine”. Citation: Vaccines and Related Biological Products Advisory Committee Meeting. February 26, 2021. FDA Briefing Document. Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Accessed 24 Feb 2021 https://www.fda.gov/media/146217/download

Update 21 Feb – Source 9 added – special HT Keelin O’Donogue. One out of 31,000 vaccinations!

Source 9 – one pregnant woman tested positive following vaccination

This preprint reports 31,069 people who received at least one dose of a COVID-19 vaccine via the Mayo Clinic health system, in Arizona, Florida, Minnesota, or Wisconsin, between December 1^st 2020 and February 8^th 2021. Of the 263 who subsequently received a positive PCR test, one (0.4%) was pregnant (table 3) (click here or Pawlowski pre print). In a propensity matched cohort of 2,630 unvaccinated individuals who also tested positive, seven (0.3%) were pregnant. Citation: Colin Pawlowski, Patrick Lenehan, Arjun Puranik, Vineet Agarwal, AJ Venkatakrishnan, Michiel J.M. Niesen, John C. O’Horo, Andrew D. Badley, John Halamka, Venky Soundararajan. FDA-authorized COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system. medRxiv 2021.02.15.21251623; doi: https://doi.org/10.1101/2021.02.15.21251623 

Update 20 Feb – Source 8 added

Source 8 – 15,131 post vaccine pregnancies reported to V-safe

Up to 20 January 8,633 pregnancies related to, or following, the Pfizer-BioNTech vaccine and 6,498 after the Moderna vaccine had been self-reported to the CDC using the V-safe vaccine tracker (click here or 06-COVID-Shimabukuro). Over the same period nearly 22m people had received at least one vaccine dose, and 2M had registered with the V-safe vaccine tracker.  As of January 22nd, 227 pregnancies had also been enrolled in the V-safe pregnancy registry. Citation: Advisory Committee on Immunization Practices (ACIP): COVID-19 vaccine Safety update—January 2021 (slide deck)

Update 6 Feb – source 7 added

Source 7 – IgG in cord blood post SARS-CoV-2 vaccine

This Medxiv preprint reports detection of anti-SARS-CoV-2 IgG in a baby whose mother had received the Moderna mRNA COVID-19 vaccine three weeks prior to birth (click here or 2021.02.03.21250579v1.full). The baby was healthy, with normal newborn nursery course and subsequent well-infant evaluation. The hospital is unnamed but the authors were affiliated with Charles E. Schmidt College of Medicine, Boca Raton, Florida. Citation: Paul D Gilbert, Chad A Rudnick. Newborn antibodies to SARS-CoV-2 detected in cord blood after maternal vaccination. medRxiv 2021.02.03.21250579; doi: https://doi.org/10.1101/2021.02.03.21250579 Update 7 April. Peer reviewed paper published in BMC Pediatrics (click here or source). Citation: Paul G, Chad R. Newborn antibodies to SARS-CoV-2 detected in cord blood after maternal vaccination – a case report. BMC Pediatr. 2021 Mar 22;21(1):138. doi: 10.1186/s12887-021-02618-y. PMID: 33752624; PMCID: PMC7982334.

Update 25 Jan – source 6 added

Source 6 – Astra Zeneca/Oxford. Safety & Efficacy report, Lancet

The supplementary appendix of the interim safety and efficacy report of four trials of the Astra Zeneca/Oxford (ChAdOx1 nCoV-19) vaccine reports one spontaneous abortion in the intervention group and one in the control group. For main paper (click here or PIIS0140673620326611) appendix (here or mmc1). These cases are presumably included in Source 3. Citation: Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O’Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Török ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Erratum in: Lancet. 2021 Jan 9;397(10269):98. PMID: 33306989; PMCID: PMC7723445.

Update 18 Jan – source 5 added

Source 5 – BioNTech/Pfizer. Safety and Efficacy report, NEJM

The Safety and Efficacy report of the phase 2/3 placebo controlled trial of the BioNTech/Pfizer (BNT162b2 mRNA) Covid-19 Vaccine (click here or nejmoa2034577) includes four pregnancies in the vaccine group and five in controls. These will overlap with those in studies 1 and 4.  Citation; Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10. PMID: 33301246; PMCID: PMC7745181.

Update 15 Jan – source 4 added

Source 4 – Comirnarty. EMA asessment report

See p 109 for pregnancy data (click here or comirnaty-epar-public-assessment-report_en). Comirnarty is the EU name for the BioNTech/Pfizer vaccine. The data therefore likely overlap with Source 1. Citation: European Medicines Agency. 21 December 2020. EMA/707383/2020. Committee for Medicinal Products for Human Use (CHMP). Assessment report. Comirnaty. Common name: COVID-19 mRNA vaccine (nucleoside-modified) Procedure No. EMEA/H/C/005735/0000. Accessed 14 January 2021. https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf 

Update 14 Jan – Sources 1-3 added

Source 3 – Astra Zeneca/Oxford. MHRA public assessment report

See p 48 onward for pregnancy data (click here or UKPAR_COVID_19_Vaccine_AstraZeneca_05.01.2021). Citation: Medicines and Healthcare products Regulatory Agency. Public Assessment Report. Authorisation for Temporary Supply. COVID-19 Vaccine AstraZeneca, solution for injection in multidose container COVID-19 Vaccine (ChAdOx1-S [recombinant]). Department of Health and Social Care (DHSC) AstraZeneca AB. Accessed January 14 2021. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/949772/UKPAR_COVID_19_Vaccine_AstraZeneca_05.01.2021.pdf 

Source 2 – Moderna. FDA briefing document

See p 44 onward for pregnancy data (click here or VRBPAC-12.17.20-Meeting-Briefing-Document-FDA_0). Citation: U.S. Food and Drug Administration. Vaccines and Related
Biological Products Advisory Committee meeting—December 17, 2020—FDA briefing document—Moderna COVID-19 vaccine. Accessed January 14, 2021. https://www.fda.gov/media/144434/download

Source 1 – BioNTech/Pfizer. FDA briefing document

See p 42 onwards for pregnancy data (click here or VRBPAC-12.10.20-Meeting-Briefing-Document-FDA). Citation: U.S. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee Meeting, December 10, 2020. FDA Briefing Document. Pfizer-BioNTech COVID-19 Vaccine. Accessed January 14 2021. https://www.fda.gov/media/144245/download 

Jim Thornton