COVID-19 VACCINATION IN BREASTFEEDING

A brief discussion on COVID-19 vaccination in breast feeding females.

1. COVID-19 Vaccination for POSTPARTUM LACTATING Women

2. Professor and Unit Chief, L.T.M.M.C & L.T.M.G.H, Sion Hospital Joint Treasurer, FOGSI (2021-2024) Vice President, MOGS (2021-2022) Member Oncology Committee, SAFOG (2020-2022) (2021-2023) Dean AGOG & Chief Content Director, HIGHGRAD & FEMAS Courses Editor-in-Chief, FEMAS & JGOG Journal 54 publications in International and National Journals with 58 citations National Coordinator, FOGSI Medical Disorders in Pregnancy Committee (2019-2021) Chair & Convener, FOGSI Cell Violence Against Doctors (2015-16) Member, Oncology Committee AOFOG (2013-2015) Coordinator of 11 batches of MUHS recognized Certificate Course of B.I.M.I.E at L.T.M.G.H (2010-16) Member, Managing Committee IAGE (2013-17), (2018-20) Editorial Board, European Journal of Gynaec. Oncology (Italy) Course Coordinator of 3 batches of Advanced Minimal Access Gynaec Surgery (AMAS) at LTMGH (2018-19) DR. NIRANJAN CHAVAN MD, FCPS, DGO, MICOG, DICOG, FICOG, DFP, DIPLOMA IN ENDOSCOPY (USA)

3. introduction COVID-19 was declared as a global public health emergency by the World Health Organization on 30 January 2020. Incidentally, the first case of COVID-19 was diagnosed and declared in India on the same day . Later, on 11 March 2020, WHO declared it as a pandemic. In India, the pandemic, especially in its second wave, has put enormous burden on the health infrastructure.

4. In  India , from  3 rd January 2020  to 1 st Octo ber 2021 , there have been  33,766,707 (3Cr 37 Lacs) confirmed cases  of COVID-19 with  448,339 deaths , reported to WHO. As of  27 September 2021 , a total of  870,708,636 vaccine doses (87 Crores 7 Lacs))  have been administered. Source: World Health Organization Dashboard

5. There is no precise data for COVID-19 infections in pregnancy and puerperium at a global or national level. FOGSI has initiated the National Registry on COVID -19 Infection in Pregnancy for this purpose. Pregnant women are not at increased risk of getting infected as compared to the general population. Compared to non-pregnant women and pregnant women who are not infected with COVID-19, pregnant women who are infected with COVID are more likely to need hospitalization. COVID vaccine is thought to be the definitive tool to slow down or halt the pandemic

6. The rationales of vaccine in COVID-19 To reduce the risk of infection as it is a public health problem To reduce the risk of severe acute morbidity and mortality from the infection To prevent long term effects of infection To prevent transmission to other individuals

7. Considerations • Level of activity of the virus in the local community • Potential efficacy of the vaccine • Lack of safety data specific to its use in pregnancy • Risk and potential severity of maternal disease, including the possible effects of the disease on the fetus (preterm birth) and newborn • Timing of vaccination during pregnancy

8. vaccines AVAILABLE in India COVISHIELD – produced by Serum Institute of India (SII) in collaboration with Astra-Zeneca COVAXIN – produced by Bharat Biotech Ltd. This is an indigenous vaccine and is an inactivated (killed) whole virus vaccine. ZYCOV-D- produced by Zydus Cadila Healthcare. It is a DNA plasmid based COVID-19 vaccine. SPUTNIK-V- produced by Gamaleya Research Institute. It is an adenovirus vector based vaccine. The vaccines are approved for emergency use for individuals over 18 years of age by the Central Drugs Standard Control Organization (CDSCO) of India.

9. FIGO statement on COVID 19 vaccination and breastfeeding 2 nd March 2021

10. 25 th April 2021

11. Recommended vaccine timing according due to rcog guidelines

12. American Journal of Obstetrics and Gynaecology, volume 225, Issue 3, September 1, 2021. A study 131 women ( 84 pregnant, 31 lactating and 16 non pregnant) were enrolled in a prospective study at two tertiary care centers between Dec 2020 to February 2021. Vaccine induced antibody titres were recorded, baseline and after second dose of vaccine. They concluded that coronavirus disease 2019 messenger RNA vaccines generated robust humoral immunity in pregnant and lactating women, with immunogenicity and reactogenicity similar to that observed in nonpregnant women. Vaccine-induced immune responses were statistically significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

13. Vaccines, Volume 9, Issue 6, 17 th June 2021 The study included 32 breastfeeding women with the aim to evaluate the immune response to COVID-19 vaccinations in breastfeeding women. The immune response to the vaccination against SARS-CoV-2 is strongest 7 ± 3 days after the second dose. The levels of IgA and IgG antibodies specific to the SARS-CoV-2 spike antigen in breast milk and serum samples from mothers after a COVID-19 vaccine were positively correlated.

14. In the United Nations, from December 14, 2020, to February 28, 2021, data from the “v-safe after vaccination health checker” surveillance system was used to characterize the initial safety of mRNA Covid-19 vaccines in pregnant women. Among 3958 participants enrolled in the study, 827 had a completed pregnancy , of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester).Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines.

15. FOGSI STATEMENT

16. Besides these direct medical benefits Immunization will ease the enormous burden that healthcare infrastructure is facing It will allow healthcare to be utilized for non COVID-19 medical issues as routine. There are also other non-medical benefits of vaccination including the safe resumption of economic activity, social events and life in general as we knew it before COVID-19 arrived. Studies have shown that various vaccines have a 70 to 90% protection rate. There is nothing to separate the various vaccines in terms of efficacy at present. Individuals should take the COVID vaccine that is available to them at the earliest opportunity

17. References https://www.mohfw.gov.in/pdf/OperationalGuidanceforCOVID19vaccinationofPregnantWoman.pdf Wei SQ, Bilodeau-Bertrand M, Liu S, Auger N. The impact of COVID-19 on pregnancy outcomes: a systematic review and meta-analysis. CMAJ. 2021 Apr 19;193(16):E540-E548. doi : 10.1503/cmaj.202604. Epub 2021 Mar 19. PMID: 33741725; PMCID: PMC8084555 Outcomes of Neonates Born to Mothers with Coronavirus Disease 2019 (COVID-19) – National Neonatology Forum (NNF) India COVID-19 Registry; early online version, Indian pediatrics https:// www.heart.org / en /coronavirus/coronavirus-questions/questions-about-covid-19- vaccination SAGE guidance for the development of evidence-based vaccination-related recommendations. Geneva: World Health Organization; 2017 (https:// www.who.int /immunization/sage/ Guidelines_development_recommendations.pdf , accessed 19 April 2021). Interim Clinical Considerations for Use of COVID -19 Vaccines Currently Authorized in the United States; Centers for Disease Control and Prevention; https:// www.cdc.gov /vaccines/ Covid -19/info-by-product/ clinical-considerations.html#pregnant ; accessed on 16 May 2021. Royal College of Obstetricians and Gynecologists (RCOG). COVID -19 vaccines, pregnancy and breastfeeding. [Online] 16 April 2021. https:// www.rcog.org.uk / en /guidelines-research- services/coronavirus- Covid -19-pregnancy-and-womens-health/ Covid -19-vaccines-and- pregnancy/ Covid -19-vaccines-pregnancy-and-breastfeeding/; Accessed: 16 May April 2021 Gray KJ, Bordt EA, Atyeo C, et al. Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study. Am J Obstet Gynecol. Published online March 25, 2021. DOI:https :// doi.org /10.1016/j.ajog.2021.03.023 Goldshtein I, Nevo D, Steinberg DM, et al. Association Between BNT162b2 Vaccination and Incidence of SARS-CoV-2 Infection in Pregnant Women. JAMA. Published online July 12, 2021. doi:10.1001/jama.2021.11035 Perl SH, Uzan-Yulzari A, Klainer H, et al. SARS-CoV-2–Specific Antibodies in Breast Milk After COVID-19 Vaccination of Breastfeeding Women. 2021;325(19):2013–2014. doi:10.1001/jama.2021.5782 Shimabukuro TT, Kim SY, Myers TR, et al. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. N Engl J Med 2021; 384:2273-2282. DOI: 10.1056/NEJMoa2104983 Jakuszko , K., Kościelska-Kasprzak , K., Żabińska , M., Bartoszek , D., Poznański , P., Rukasz , D., Kłak , R., Królak-Olejnik , B., & Krajewska , M. (2021). Immune Response to Vaccination against COVID-19 in Breastfeeding Health Workers. Vaccines, 9(6), 663. https://doi.org/10.3390/vaccines9060663 s : 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.

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