FREQUENTLY ASKED QUESTIONS: COVID-19 vaccines and breastfeeding based on WHO interim recommendations (12 August 2021) 1 Fr eq ue nt ly A sk ed Q ue st io ns :B re as tfe ed in g an d C O V ID -1 9. Fo rh ea lth ca re w or ke rs |w w w .w ho .in t/n ew s- ro om /q -a -d et ai l/q -a -o n- co vi d- 19 -a nd -b re as tfe ed in g Preface This FAQ complements the WHO interim guidance: Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected (13 March 2020 - www.who.int/publications-detail/clinical-management-of-severe-acute- respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected ) and provides responses to questions that have arisen about the recommendations. The interim guidance and FAQ reflect: i. the available evidence regarding transmission risks of COVID-19 through breastmilk; ii. the protective effects of breastfeeding and skin-to-skin contact, and, iii. the harmful effects of inappropriate use of infant formula milk. The FAQ also draws on other WHO recommendations on Infant and Young Child Feeding and the Interagency Working Group Operational Guidance on Infant and Young Child Feeding in Emergencies. A decision tree shows how these recommendations may be implemented by health workers in maternity services and community settings, as part of daily work with mothers and families. www.who.int/news-room/q-a-detail/q-a-on-covid-19-and-breastfeeding 1. Can COVID-19 be passed through breastfeeding? Active COVID-19 (virus that can cause infection) has not, to date, been detected in the breastmilk of any mother with confirmed/suspected COVID-19. It appears unlikely, therefore, that COVID-19 would be transmitted through breastfeeding or by giving breastmilk that has been expressed by a mother who is confirmed/suspected to have COVID-19. Researchers continue to test breastmilk from mothers with confirmed/suspected COVID-19. 2. In communities where COVID-19 is prevalent, should mothers breastfeed? Yes. In all socio-economic settings, breastfeeding improves survival and provides lifelong health and development advantages to newborns and infants. Breastfeeding also improves the health of mothers. In contrast, transmission of COVID-19 through breastmilk and breastfeeding has not been detected. There is no reason to avoid or stop breastfeeding. 3. Following delivery, should a baby still be immediately placed skin-to-skin and breastfed if the mother is confirmed/suspected to have COVID-19? Yes. Immediate and continued skin-to-skin care, including kangaroo mother care, improves thermal regulation of newborns and several other physiological outcomes, and is associated with reduced neonatal mortality. Placing the newborn close to the mother also enables early initiation of breastfeeding which also reduces neonatal mortality. The numerous benefits of skin-to-skin contact and breastfeeding substantially outweigh the potential risks of transmission and illness associated with COVID-19. 4. If a mother is confirmed/suspected to have COVID-19, should she continue breastfeeding? Yes. High quality evidence shows that breastfeeding reduces neonatal, infant and child mortality including in high resource settings and improves lifelong health and development in all geographies and economic settings. The transmission of COVID-19 through breastmilk and breastfeeding has not been detected. Among the few cases of confirmed COVID-19 infection in children from other sources, most have experienced only mild or asymptomatic illness. While breastfeeding, a mother should still implement appropriate hygiene measures, including wearing a medical mask if available, to reduce the possibility of droplets with COVID-19 being spread to her infant. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected: Interim guidance V 1.2. -1- This is the second edition (version 1.2) of this document for the novel coronavirus SARS-CoV-2, causing COVID-19 disease. It was originally adapted from the publication Clinical management of severe acute respiratory infection when MERS-CoV infection is suspected (WHO, 2019). This document is intended for clinicians involved in the care of adult, pregnant and paediatric patients with or at risk for severe acute respiratory infection (SARI) when a SARS-CoV-2 infection is suspected. Considerations for paediatric patients and pregnant women are highlighted throughout the text. It is not meant to replace clinical judgment or specialist consultation but rather to strengthen clinical management of these patients and to provide up-to-date guidance. Best practices for infection prevention and control (IPC), triage and optimized supportive care are included. This document is organized into the following sections: 1. Background 2. Screening and triage: early recognition of patients with SARI associated with COVID-19 3. Immediate implementation of appropriate infection prevention and control (IPC) measures 4. Collection of specimens for laboratory diagnosis 5. Management of mild COVID-19: symptomatic treatment and monitoring 6. Management of severe COVID-19: oxygen therapy and monitoring 7. Management of severe COVID-19: treatment of co-infections 8. Management of critical COVID-19: acute respiratory distress syndrome (ARDS) 9. Management of critical illness and COVID-19: prevention of complications 10. Management of critical illness and COVID-19: septic shock 11. Adjunctive therapies for COVID-19: corticosteroids 12. Caring for pregnant women with COVID-19 13. Caring for infants and mothers with COVID-19: IPC and breastfeeding 14. Care for older persons with COVID-19 15. Clinical research and specific anti-COVID-19 treatments Appendix: resources for supporting management of severe acute respiratory infections in children These symbols are used to flag interventions: Do: the intervention is beneficial (strong recommendation) OR the intervention is a best practice statement. Don’t: the intervention is known to be harmful. Consider: the intervention may be beneficial in selected patients (conditional recommendation) OR be careful when considering this intervention. This document aims to provide clinicians with updated interim guidance on timely, effective and safe supportive management of patients with suspected and confirmed COVID-19. It is organized by the patient journey. The definitions for mild and severe illness are in Table 2, while those with critical illness are defined as patients with acute respiratory distress syndrome (ARDS) or sepsis with acute organ dysfunction. The recommendations in this document are derived from WHO publications. Where WHO guidance is not available, we refer to evidence-based guidelines. Members of a WHO global network of clinicians, and clinicians who have treated SARS, MERS or severe influenza patients, have reviewed the recommendations (see Acknowledgements). For queries, please email: outbreak@who.int with “COVID-19 clinical question” in the subject line. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. Interim guidance 13 March 2020 Fr eq ue nt ly A sk ed Q ue st io ns : C O VI D -19 v ac ci ne s an d br ea st fe ed in g ba se d on W H O in te rim re co m m en da tio ns | 1 2 Au gu st 2 02 1 These Frequently Asked Qu stions (FAQs) have been developed jointly by he IFE Core Group, UNICEF, the World Health Organization (WHO) and the COVID-19 Infant F eding Working Group based on the most recent recommend t ns f m the WHO Strategic Advisory Group of Experts (SAGE) on Immunization: • Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency U Lis i g • Interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19 • Interim ecommendatio s for us of the AZD1222 (ChAdOx1-S [recombinant]) vaccine against COVID-19 developed by Oxford University and AstraZeneca • Interim recommendations for the use of the Janssen Ad26.COV2.S (COVID-19) vaccine • Interim recommendations for use of the inactivated COVID-19 vaccine BIBP developed by China National Biotec Group (CNBG), Sinopharm – Interim guidance • Interim recommendations for use of the inactivated COVID-19 vaccine, CoronaVac, developed by Sinovac The FAQs are intended to provide answers to health care providers and the public, including mothers who are breastfeeding or expressing milk, on breastfeeding and the following COVID-19 vaccines: • Pfizer-BioNTech BNT162b2 • Moderna mRNA-1273 • Oxford University – AstraZeneca AZD1222 • Janssen Ad26.COV2.S • Sinopharm – BIBP vaccine • Sinovac – CoronaVac COVID-19 and breastfeeding Breastfeeding is safe for infants and young children even when mothers are suspected or known to have COVID-19. The numerous benefits of breastfeeding substantially outweigh the potential risks of illness associated with the virus. Breastfed children have not been shown to be at risk of transmission of SARS-CoV-2 through breastmilk. Consequently, WHO and other organizations such as the United States Centers for Disease Control and Prevention (CDC), UNICEF and the Royal College of Obstetricians and Gynaecologists recommend that mothers continue to breastfeed their infants if suspected or known to have COVID-19. Refer to FREQUENTLY ASKED QUESTIONS: Breastfeeding and COVID-19 for health care workers 1 Fr eq ue nt ly A sk ed Q ue st io ns : B re as tfe e d in g a nd C O V ID -1 9. F o r he al th c ar e w o rk e rs | w w w .w ho .in t/n e w s- ro o m /q -a -d e ta il/ q- a- o n- co vi d -1 9 -a nd -b re as tfe e d in g FREQUENTLY ASKED QUESTIONS: Breastfeeding and COVID-19 For health care workers (12 May 2020) Preface This FAQ complements the WHO interim guidance: Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected (13 March 2020 - www.who.int/publications-detail/clinical-management-of-severe-acute- respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected ) and provides responses to questions that have arisen about the recommendations. The interim guidance and FAQ reflect: i. the available evidence regarding transmission risks of COVID-19 through breastmilk; ii. the protective effects of breastfeeding and skin-to-skin contact, and, iii. the harmful effects of inappropriate use of infant formula milk. The FAQ also draws on other WHO recommendations on Infant and Young Child Feeding and the Interagency Working Group Operati nal Guidance on Infant and Young Child Feeding in Emergencies. A decision tree shows how these recommendations may be implemented by health workers in maternity services and community settings, as part of daily work with mothers and families. www.who.int/news-room/q-a-detail/q-a-on-covid-19-and-breastfeeding 1. Can COVID-19 be passed through breastfeeding? Active COVID-19 (virus that can cause infection) has not, to date, been detected in the breastmilk of any mother with confirmed/suspected COVID-19. It appears unlikely, therefore, that COVID-19 would be transmitted through breastfeeding or by giving breastmilk that has been expressed by a mother who is confirmed/suspected to have COVID-19. Researchers continue to test breastmilk from mothers with confirmed/suspected COVID-19. 2. In communities where COVID-19 is prevalent, should mothers breastfeed? Yes. In all socio-economic settings, breastfeeding improves survival and provides lifelong health and development advantages to newborns and infants. Breastfeeding also improves the health of mothers. In contrast, transmission of COVID-19 through breastmilk and breastfeeding has not been detected. There is no reason to avoid or stop breastfeeding. 3. Following delivery, should a baby still be immediately placed skin-to-skin and breastfed if the mother is confirmed/suspected to have COVID-19? Yes. Immediate and continued skin-to-skin care, including kangaroo mother care, improves thermal regulation of newborns and several other physiological outcomes, and is associated with reduced neonatal mortality. Placing the newborn close to the mother also enables early initiation of breastfeeding which also reduces neonatal mortality. The numerous benefits of skin-to-skin contact and breastfeeding substantially outweigh the potential risks of transmission and illness associated with COVID-19. 4. If a mother is confirmed/suspected to have COVID-19, should she continue breastfeeding? Yes. High quality evidence shows that breastfeeding reduces neonatal, infant and child mortality including in high resource settings and improves lifelong health and development in all geographies and economic settings. The transmission of COVID-19 through breastmilk and breastfeeding has not been detected. Among the few cases of confirmed COVID-19 infection in children from other sources, most have experienced only mild or asymptomatic illness. While breastfeeding, a mother should still implement appropriate hygiene measures, including wearing a medical mask if available, to reduce the possibility of droplets with COVID-19 being spread to her infant. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected: Interim guidance V 1.2. -1- This is the second edition (version 1.2) of this document for the novel coronavirus SARS-CoV-2, causing COVID-19 disease. It was originally adapted from the publication Clinical management of severe acute respiratory infection when MERS-CoV infection is suspected (WHO, 2019). This document is intended for clinicians involved in the care of adult, pregnant and paediatric patients with or at risk for severe acute respiratory infection (SARI) when a SARS-CoV-2 infection is suspected. Considerations for paediatric patients and pregnant women are highlighted throughout the text. It is not meant to replace clinical judgment or specialist consultation but rather to strengthen clinical management of these patients and to provide up-to-date guidance. Best practices for infection prevention and control (IPC), triage and optimized supportive care are included. This document is organized into the following sections: 1. Background 2. Screening and triage: early recognition of patients with SARI associated with COVID-19 3. Immediate implementation of appropriate infection prevention and control (IPC) measures 4. Collection of specimens for laboratory diagnosis 5. Management of mild COVID-19: symptomatic treatment and monitoring 6. Management of severe COVID-19: oxygen therapy and monitoring 7. Management of severe COVID-19: treatment of co-infections 8. Management of critical COVID-19: acute respiratory distress syndrome (ARDS) 9. Management of critical illness and COVID-19: prevention of complications 10. Management of critical illness and COVID-19: septic shock 11. Adjunctive therapies for COVID-19: corticosteroids 12. Caring for pregnant women with COVID-19 13. Caring for infants and mothers with COVID-19: IPC and breastfeeding 14. Care for older persons with COVID-19 15. Clinical research and specific anti-COVID-19 treatments Appendix: resources for supporting management of severe acute respiratory infections in children These symbols are used to flag interventions: Do: the intervention is beneficial (strong recommendation) OR the intervention is a best practice statement. Don’t: the intervention is known to be harmful. Consider: the intervention may be beneficial in selected patients (conditional recommendation) OR be careful when considering this intervention. This document aims to provide clinicians with updated interim guidance on timely, effective and safe supportive management of patients with suspected and confirmed COVID-19. It is organized by the patient journey. The definitions for mild and severe illness are in Table 2, while those with critical illness are defined as patients with acute respiratory distress syndrome (ARDS) or sepsis with acute organ dysfunction. The recommendations in this document are derived from WHO publications. Where WHO guidance is not available, we refer to evidence-based guidelines. Members of a WHO global network of clinicians, and clinicians who have treated SARS, MERS or severe influenza patients, have reviewed the recommendations (see Acknowledgements). For queries, please email: outbreak@who.int with “COVID-19 clinical question” in the subject line. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. Interim guidance 13 March 2020 WHO SAGE Interim recommendations Pfizer– BioNTech BNT162b2 vaccine Moderna AstraZeneca AZD1222 Janssen Ad26. COV2.S Sinopharm BIBP vaccine Sinovac- CoronaVac Ok for breastfeeding mothers? ✓ ✓ ✓ ✓ ✓ ✓ 1. Should women currently breastfeeding or providing expressed milk receive the vaccines? Yes. WHO recommends the use of COVID-19 vaccines in lactating women as in other adults. Therefore, healthy individuals currently breastfeeding or expressing milk CAN receive the vaccines. Breastfeeding is vital to the health of infants and their moth rs. Re earch on COVID-19 vaccine did not include breastfeeding women or consider the effects of mRNA or non-replicating vaccines on them or on the breastfed child. However, the absence of data does not mean that the vaccine is not safe for lactating women or their 2children. WHO recommends that mothers who are vaccinated continue breastfeeding after vaccination. For countries facing insufficient vaccine supplies, the WHO Prioritization Roadmap1 and the WHO Values Framework2 are recommended to guide the prioritization of target groups. 2. What advice should women currently breastfeeding or expressing milk receive regarding the vaccine? Lactating women considering receiving the COVID-19 vaccine should have access to information about the safety and efficacy of the vaccine including that: • Breastfeeding is vital to the health of infants and their mothers; and • Vaccine efficacy in lactating women is expected to be similar to efficacy in non-lactating women. Although data are lacking on the potential benefits and risks of COVID-19 vaccines to breastfed children, they are biologically and clinically unlikely to pose a risk: • Pfizer–BioNTech BNT162b2 and Moderna mRNA-1273 are not live virus vaccines and the mRNA does not enter the nucleus of the cell and is degraded quickly; • AZD1222 vaccine and the Janssen Ad26.COV2.S are not live virus vaccines; and • Sinopharm BIBP and Sinovac-CoronaVac use an inactivated vaccine with an adjuvant that is routinely used in many other vaccines with a documented good safety profile, including in pregnant women. Two recent small studies support these expectations, finding comparable antibody and T-cell response against SARS-CoV-2 after COVID-19 mRNA vaccination.3,4 It is important to continue to provide the necessary counselling and support for breastfeeding women to build confidence in the safety and adequacy of breastfeeding and risks of not breastfeeding in the context of COVID-19. Refer to FREQUENTLY ASKED QUESTIONS: Breastfeeding and COVID-19 for health care workers. 3. Is it safe for mothers to breastfeed after they are vaccinated? Yes. For Pfizer-BioNTech, Moderna mRNA-1273, Sinopharm BIBP and Sinovac-CoronaVac, WHO clarifies that: “As the vaccine is not a live virus vaccine , it is biologically and clinically unlikely there is a risk to the breastfeeding child,” and for AZD1222 and Janssen Ad26. COV2.S “as the vaccine is a non-replicating vaccine, it is unlikely to pose a risk to the breastfeeding child”. Mothers who are vaccinated should be encouraged to continue breastfeeding to protect their infants. 4. Does the ability to continue breastfeeding or provide expressed milk change after a mother is vaccinated? (i.e. Can/will the vaccine decrease milk supply?) It is highly unlikely that vaccination will have any impact on women’s ability to make milk. WHO does NOT recommend stopping breastfeeding after vaccination. Women currently breastfeeding or expressing milk should continue to do so after receiving the vaccine and can be confident that vaccination will not affect their milk supply. Taking the vaccine should not be an impediment to begin breastfeeding or a cause for its interruption. 5. Should there be research undertaken on vaccination of breastfeeding women? WHO acknowledges the lack of data on COVID-19 vaccination of lactating women. Given the importance of breastfeeding, researchers are encouraged to prioritize this topic and provide data on the safety of these vaccines for breastfeeding mothers and their infants. In accordance with the International Labour Standards5, governments and employers must continue to respect and uphold the right of women to breastfeed. Workers who are currently breastfeeding should not be forced to leave employment if not vaccinated. They should be supported to remain employed and incentivized to continue breastfeeding whether they receive the vaccine or not. Fr eq ue nt ly A sk ed Q ue st io ns : C O VI D -19 v ac ci ne s an d br ea st fe ed in g ba se d on W H O in te rim re co m m en da tio ns | 1 2 Au gu st 2 02 1 Feedback This guidance will be periodically updated as new evidence on these vaccines emerges, additional vaccines are approved and new questions arise. You can pose questions to the moderated online forum https://www.en-net. org/forum/31.aspx and send feedback on the FAQs to the IFE Core Group, ife@ennonline.net Suggested citation: IFE-Core Group, UNICEF, WHO, COVID-19 Infant Feeding Working Group. Frequently asked questions: COVID-19 vaccines and breastfeeding based on WHO interim recommendations (12 August 2021). Geneva: World Health Organization; 2021 (WHO/2019-nCoV/FAQ/Breast_feeding/Vaccines/2021.1). © World Health Organization 2021. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO licence. WHO reference number: WHO/2019-nCoV/FAQ/Breast_feeding/Vaccines/2021.1 1 WHO SAGE roadmap for prioritzing uses of COVID-19 vaccines in the context of limited supply. Geneva: World Health Organization 2021 (https://www.who.int/ publications/i/item/who-sage-roadmap-for-prioritizing-uses-of-covid-19-vaccines- in-the-context-of-limited-supply, accessed July 2021) 2 WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination. Geneva: World Health Organization; 2020 (https://apps.who.int/iris/handle/10665/334299, accessed 04 June 2021). 3 Gray, K. J., Bordt, E. A., Atyeo, C., Deriso, E., Akinwunmi, B., Young, N., ... & Edlow, A. G. (2021). Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study. American Journal of Obstetrics and Gynecology. 4 Collier, Ai-ris Y., Katherine McMahan, Jingyou Yu, Lisa H. Tostanoski, Ricardo Aguayo, Jessica Ansel, Abishek Chandrashekar et al. "Immunogenicity of COVID-19 mRNA Vaccines in Pregnant and Lactating Women." Jama (2021) 5 International Labour Organization; 2020. ILO Standards and COVID-19 (coronavirus) FAQ. https://www.ilo.org/wcmsp5/groups/public/---ed_norm/--- normes/documents/genericdocument/wcms_739937.pdf
FREQUENTLY ASKED QUESTIONS: COVID-19 vaccines and breastfeeding based on WHO interim recommendations (12 August 2021) 1 Fr eq ue nt ly A sk ed Q ue st io ns :B re as tfe ed in g an d C O V ID -1 9. Fo rh ea lth ca re w or ke rs |w w w .w ho .in t/n ew s- ro om /q -a -d et ai l/q -a -o n- co vi d- 19 -a nd -b re as tfe ed in g Preface This FAQ complements the WHO interim guidance: Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected (13 March 2020 - www.who.int/publications-detail/clinical-management-of-severe-acute- respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected ) and provides responses to questions that have arisen about the recommendations. The interim guidance and FAQ reflect: i. the available evidence regarding transmission risks of COVID-19 through breastmilk; ii. the protective effects of breastfeeding and skin-to-skin contact, and, iii. the harmful effects of inappropriate use of infant formula milk. The FAQ also draws on other WHO recommendations on Infant and Young Child Feeding and the Interagency Working Group Operational Guidance on Infant and Young Child Feeding in Emergencies. A decision tree shows how these recommendations may be implemented by health workers in maternity services and community settings, as part of daily work with mothers and families. www.who.int/news-room/q-a-detail/q-a-on-covid-19-and-breastfeeding 1. Can COVID-19 be passed through breastfeeding? Active COVID-19 (virus that can cause infection) has not, to date, been detected in the breastmilk of any mother with confirmed/suspected COVID-19. It appears unlikely, therefore, that COVID-19 would be transmitted through breastfeeding or by giving breastmilk that has been expressed by a mother who is confirmed/suspected to have COVID-19. Researchers continue to test breastmilk from mothers with confirmed/suspected COVID-19. 2. In communities where COVID-19 is prevalent, should mothers breastfeed? Yes. In all socio-economic settings, breastfeeding improves survival and provides lifelong health and development advantages to newborns and infants. Breastfeeding also improves the health of mothers. In contrast, transmission of COVID-19 through breastmilk and breastfeeding has not been detected. There is no reason to avoid or stop breastfeeding. 3. Following delivery, should a baby still be immediately placed skin-to-skin and breastfed if the mother is confirmed/suspected to have COVID-19? Yes. Immediate and continued skin-to-skin care, including kangaroo mother care, improves thermal regulation of newborns and several other physiological outcomes, and is associated with reduced neonatal mortality. Placing the newborn close to the mother also enables early initiation of breastfeeding which also reduces neonatal mortality. The numerous benefits of skin-to-skin contact and breastfeeding substantially outweigh the potential risks of transmission and illness associated with COVID-19. 4. If a mother is confirmed/suspected to have COVID-19, should she continue breastfeeding? Yes. High quality evidence shows that breastfeeding reduces neonatal, infant and child mortality including in high resource settings and improves lifelong health and development in all geographies and economic settings. The transmission of COVID-19 through breastmilk and breastfeeding has not been detected. Among the few cases of confirmed COVID-19 infection in children from other sources, most have experienced only mild or asymptomatic illness. While breastfeeding, a mother should still implement appropriate hygiene measures, including wearing a medical mask if available, to reduce the possibility of droplets with COVID-19 being spread to her infant. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected: Interim guidance V 1.2. -1- This is the second edition (version 1.2) of this document for the novel coronavirus SARS-CoV-2, causing COVID-19 disease. It was originally adapted from the publication Clinical management of severe acute respiratory infection when MERS-CoV infection is suspected (WHO, 2019). This document is intended for clinicians involved in the care of adult, pregnant and paediatric patients with or at risk for severe acute respiratory infection (SARI) when a SARS-CoV-2 infection is suspected. Considerations for paediatric patients and pregnant women are highlighted throughout the text. It is not meant to replace clinical judgment or specialist consultation but rather to strengthen clinical management of these patients and to provide up-to-date guidance. Best practices for infection prevention and control (IPC), triage and optimized supportive care are included. This document is organized into the following sections: 1. Background 2. Screening and triage: early recognition of patients with SARI associated with COVID-19 3. Immediate implementation of appropriate infection prevention and control (IPC) measures 4. Collection of specimens for laboratory diagnosis 5. Management of mild COVID-19: symptomatic treatment and monitoring 6. Management of severe COVID-19: oxygen therapy and monitoring 7. Management of severe COVID-19: treatment of co-infections 8. Management of critical COVID-19: acute respiratory distress syndrome (ARDS) 9. Management of critical illness and COVID-19: prevention of complications 10. Management of critical illness and COVID-19: septic shock 11. Adjunctive therapies for COVID-19: corticosteroids 12. Caring for pregnant women with COVID-19 13. Caring for infants and mothers with COVID-19: IPC and breastfeeding 14. Care for older persons with COVID-19 15. Clinical research and specific anti-COVID-19 treatments Appendix: resources for supporting management of severe acute respiratory infections in children These symbols are used to flag interventions: Do: the intervention is beneficial (strong recommendation) OR the intervention is a best practice statement. Don’t: the intervention is known to be harmful. Consider: the intervention may be beneficial in selected patients (conditional recommendation) OR be careful when considering this intervention. This document aims to provide clinicians with updated interim guidance on timely, effective and safe supportive management of patients with suspected and confirmed COVID-19. It is organized by the patient journey. The definitions for mild and severe illness are in Table 2, while those with critical illness are defined as patients with acute respiratory distress syndrome (ARDS) or sepsis with acute organ dysfunction. The recommendations in this document are derived from WHO publications. Where WHO guidance is not available, we refer to evidence-based guidelines. Members of a WHO global network of clinicians, and clinicians who have treated SARS, MERS or severe influenza patients, have reviewed the recommendations (see Acknowledgements). For queries, please email: outbreak@who.int with “COVID-19 clinical question” in the subject line. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. Interim guidance 13 March 2020 Fr eq ue nt ly A sk ed Q ue st io ns : C O VI D -19 v ac ci ne s an d br ea st fe ed in g ba se d on W H O in te rim re co m m en da tio ns | 1 2 Au gu st 2 02 1 These Frequently Asked Qu stions (FAQs) have been developed jointly by he IFE Core Group, UNICEF, the World Health Organization (WHO) and the COVID-19 Infant F eding Working Group based on the most recent recommend t ns f m the WHO Strategic Advisory Group of Experts (SAGE) on Immunization: • Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency U Lis i g • Interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19 • Interim ecommendatio s for us of the AZD1222 (ChAdOx1-S [recombinant]) vaccine against COVID-19 developed by Oxford University and AstraZeneca • Interim recommendations for the use of the Janssen Ad26.COV2.S (COVID-19) vaccine • Interim recommendations for use of the inactivated COVID-19 vaccine BIBP developed by China National Biotec Group (CNBG), Sinopharm – Interim guidance • Interim recommendations for use of the inactivated COVID-19 vaccine, CoronaVac, developed by Sinovac The FAQs are intended to provide answers to health care providers and the public, including mothers who are breastfeeding or expressing milk, on breastfeeding and the following COVID-19 vaccines: • Pfizer-BioNTech BNT162b2 • Moderna mRNA-1273 • Oxford University – AstraZeneca AZD1222 • Janssen Ad26.COV2.S • Sinopharm – BIBP vaccine • Sinovac – CoronaVac COVID-19 and breastfeeding Breastfeeding is safe for infants and young children even when mothers are suspected or known to have COVID-19. The numerous benefits of breastfeeding substantially outweigh the potential risks of illness associated with the virus. Breastfed children have not been shown to be at risk of transmission of SARS-CoV-2 through breastmilk. Consequently, WHO and other organizations such as the United States Centers for Disease Control and Prevention (CDC), UNICEF and the Royal College of Obstetricians and Gynaecologists recommend that mothers continue to breastfeed their infants if suspected or known to have COVID-19. Refer to FREQUENTLY ASKED QUESTIONS: Breastfeeding and COVID-19 for health care workers 1 Fr eq ue nt ly A sk ed Q ue st io ns : B re as tfe e d in g a nd C O V ID -1 9. F o r he al th c ar e w o rk e rs | w w w .w ho .in t/n e w s- ro o m /q -a -d e ta il/ q- a- o n- co vi d -1 9 -a nd -b re as tfe e d in g FREQUENTLY ASKED QUESTIONS: Breastfeeding and COVID-19 For health care workers (12 May 2020) Preface This FAQ complements the WHO interim guidance: Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected (13 March 2020 - www.who.int/publications-detail/clinical-management-of-severe-acute- respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected ) and provides responses to questions that have arisen about the recommendations. The interim guidance and FAQ reflect: i. the available evidence regarding transmission risks of COVID-19 through breastmilk; ii. the protective effects of breastfeeding and skin-to-skin contact, and, iii. the harmful effects of inappropriate use of infant formula milk. The FAQ also draws on other WHO recommendations on Infant and Young Child Feeding and the Interagency Working Group Operati nal Guidance on Infant and Young Child Feeding in Emergencies. A decision tree shows how these recommendations may be implemented by health workers in maternity services and community settings, as part of daily work with mothers and families. www.who.int/news-room/q-a-detail/q-a-on-covid-19-and-breastfeeding 1. Can COVID-19 be passed through breastfeeding? Active COVID-19 (virus that can cause infection) has not, to date, been detected in the breastmilk of any mother with confirmed/suspected COVID-19. It appears unlikely, therefore, that COVID-19 would be transmitted through breastfeeding or by giving breastmilk that has been expressed by a mother who is confirmed/suspected to have COVID-19. Researchers continue to test breastmilk from mothers with confirmed/suspected COVID-19. 2. In communities where COVID-19 is prevalent, should mothers breastfeed? Yes. In all socio-economic settings, breastfeeding improves survival and provides lifelong health and development advantages to newborns and infants. Breastfeeding also improves the health of mothers. In contrast, transmission of COVID-19 through breastmilk and breastfeeding has not been detected. There is no reason to avoid or stop breastfeeding. 3. Following delivery, should a baby still be immediately placed skin-to-skin and breastfed if the mother is confirmed/suspected to have COVID-19? Yes. Immediate and continued skin-to-skin care, including kangaroo mother care, improves thermal regulation of newborns and several other physiological outcomes, and is associated with reduced neonatal mortality. Placing the newborn close to the mother also enables early initiation of breastfeeding which also reduces neonatal mortality. The numerous benefits of skin-to-skin contact and breastfeeding substantially outweigh the potential risks of transmission and illness associated with COVID-19. 4. If a mother is confirmed/suspected to have COVID-19, should she continue breastfeeding? Yes. High quality evidence shows that breastfeeding reduces neonatal, infant and child mortality including in high resource settings and improves lifelong health and development in all geographies and economic settings. The transmission of COVID-19 through breastmilk and breastfeeding has not been detected. Among the few cases of confirmed COVID-19 infection in children from other sources, most have experienced only mild or asymptomatic illness. While breastfeeding, a mother should still implement appropriate hygiene measures, including wearing a medical mask if available, to reduce the possibility of droplets with COVID-19 being spread to her infant. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected: Interim guidance V 1.2. -1- This is the second edition (version 1.2) of this document for the novel coronavirus SARS-CoV-2, causing COVID-19 disease. It was originally adapted from the publication Clinical management of severe acute respiratory infection when MERS-CoV infection is suspected (WHO, 2019). This document is intended for clinicians involved in the care of adult, pregnant and paediatric patients with or at risk for severe acute respiratory infection (SARI) when a SARS-CoV-2 infection is suspected. Considerations for paediatric patients and pregnant women are highlighted throughout the text. It is not meant to replace clinical judgment or specialist consultation but rather to strengthen clinical management of these patients and to provide up-to-date guidance. Best practices for infection prevention and control (IPC), triage and optimized supportive care are included. This document is organized into the following sections: 1. Background 2. Screening and triage: early recognition of patients with SARI associated with COVID-19 3. Immediate implementation of appropriate infection prevention and control (IPC) measures 4. Collection of specimens for laboratory diagnosis 5. Management of mild COVID-19: symptomatic treatment and monitoring 6. Management of severe COVID-19: oxygen therapy and monitoring 7. Management of severe COVID-19: treatment of co-infections 8. Management of critical COVID-19: acute respiratory distress syndrome (ARDS) 9. Management of critical illness and COVID-19: prevention of complications 10. Management of critical illness and COVID-19: septic shock 11. Adjunctive therapies for COVID-19: corticosteroids 12. Caring for pregnant women with COVID-19 13. Caring for infants and mothers with COVID-19: IPC and breastfeeding 14. Care for older persons with COVID-19 15. Clinical research and specific anti-COVID-19 treatments Appendix: resources for supporting management of severe acute respiratory infections in children These symbols are used to flag interventions: Do: the intervention is beneficial (strong recommendation) OR the intervention is a best practice statement. Don’t: the intervention is known to be harmful. Consider: the intervention may be beneficial in selected patients (conditional recommendation) OR be careful when considering this intervention. This document aims to provide clinicians with updated interim guidance on timely, effective and safe supportive management of patients with suspected and confirmed COVID-19. It is organized by the patient journey. The definitions for mild and severe illness are in Table 2, while those with critical illness are defined as patients with acute respiratory distress syndrome (ARDS) or sepsis with acute organ dysfunction. The recommendations in this document are derived from WHO publications. Where WHO guidance is not available, we refer to evidence-based guidelines. Members of a WHO global network of clinicians, and clinicians who have treated SARS, MERS or severe influenza patients, have reviewed the recommendations (see Acknowledgements). For queries, please email: outbreak@who.int with “COVID-19 clinical question” in the subject line. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. Interim guidance 13 March 2020 WHO SAGE Interim recommendations Pfizer– BioNTech BNT162b2 vaccine Moderna AstraZeneca AZD1222 Janssen Ad26. COV2.S Sinopharm BIBP vaccine Sinovac- CoronaVac Ok for breastfeeding mothers? ✓ ✓ ✓ ✓ ✓ ✓ 1. Should women currently breastfeeding or providing expressed milk receive the vaccines? Yes. WHO recommends the use of COVID-19 vaccines in lactating women as in other adults. Therefore, healthy individuals currently breastfeeding or expressing milk CAN receive the vaccines. Breastfeeding is vital to the health of infants and their moth rs. Re earch on COVID-19 vaccine did not include breastfeeding women or consider the effects of mRNA or non-replicating vaccines on them or on the breastfed child. However, the absence of data does not mean that the vaccine is not safe for lactating women or their 2children. WHO recommends that mothers who are vaccinated continue breastfeeding after vaccination. For countries facing insufficient vaccine supplies, the WHO Prioritization Roadmap1 and the WHO Values Framework2 are recommended to guide the prioritization of target groups. 2. What advice should women currently breastfeeding or expressing milk receive regarding the vaccine? Lactating women considering receiving the COVID-19 vaccine should have access to information about the safety and efficacy of the vaccine including that: • Breastfeeding is vital to the health of infants and their mothers; and • Vaccine efficacy in lactating women is expected to be similar to efficacy in non-lactating women. Although data are lacking on the potential benefits and risks of COVID-19 vaccines to breastfed children, they are biologically and clinically unlikely to pose a risk: • Pfizer–BioNTech BNT162b2 and Moderna mRNA-1273 are not live virus vaccines and the mRNA does not enter the nucleus of the cell and is degraded quickly; • AZD1222 vaccine and the Janssen Ad26.COV2.S are not live virus vaccines; and • Sinopharm BIBP and Sinovac-CoronaVac use an inactivated vaccine with an adjuvant that is routinely used in many other vaccines with a documented good safety profile, including in pregnant women. Two recent small studies support these expectations, finding comparable antibody and T-cell response against SARS-CoV-2 after COVID-19 mRNA vaccination.3,4 It is important to continue to provide the necessary counselling and support for breastfeeding women to build confidence in the safety and adequacy of breastfeeding and risks of not breastfeeding in the context of COVID-19. Refer to FREQUENTLY ASKED QUESTIONS: Breastfeeding and COVID-19 for health care workers. 3. Is it safe for mothers to breastfeed after they are vaccinated? Yes. For Pfizer-BioNTech, Moderna mRNA-1273, Sinopharm BIBP and Sinovac-CoronaVac, WHO clarifies that: “As the vaccine is not a live virus vaccine , it is biologically and clinically unlikely there is a risk to the breastfeeding child,” and for AZD1222 and Janssen Ad26. COV2.S “as the vaccine is a non-replicating vaccine, it is unlikely to pose a risk to the breastfeeding child”. Mothers who are vaccinated should be encouraged to continue breastfeeding to protect their infants. 4. Does the ability to continue breastfeeding or provide expressed milk change after a mother is vaccinated? (i.e. Can/will the vaccine decrease milk supply?) It is highly unlikely that vaccination will have any impact on women’s ability to make milk. WHO does NOT recommend stopping breastfeeding after vaccination. Women currently breastfeeding or expressing milk should continue to do so after receiving the vaccine and can be confident that vaccination will not affect their milk supply. Taking the vaccine should not be an impediment to begin breastfeeding or a cause for its interruption. 5. Should there be research undertaken on vaccination of breastfeeding women? WHO acknowledges the lack of data on COVID-19 vaccination of lactating women. Given the importance of breastfeeding, researchers are encouraged to prioritize this topic and provide data on the safety of these vaccines for breastfeeding mothers and their infants. In accordance with the International Labour Standards5, governments and employers must continue to respect and uphold the right of women to breastfeed. Workers who are currently breastfeeding should not be forced to leave employment if not vaccinated. They should be supported to remain employed and incentivized to continue breastfeeding whether they receive the vaccine or not. Fr eq ue nt ly A sk ed Q ue st io ns : C O VI D -19 v ac ci ne s an d br ea st fe ed in g ba se d on W H O in te rim re co m m en da tio ns | 1 2 Au gu st 2 02 1 Feedback This guidance will be periodically updated as new evidence on these vaccines emerges, additional vaccines are approved and new questions arise. You can pose questions to the moderated online forum https://www.en-net. org/forum/31.aspx and send feedback on the FAQs to the IFE Core Group, ife@ennonline.net Suggested citation: IFE-Core Group, UNICEF, WHO, COVID-19 Infant Feeding Working Group. Frequently asked questions: COVID-19 vaccines and breastfeeding based on WHO interim recommendations (12 August 2021). Geneva: World Health Organization; 2021 (WHO/2019-nCoV/FAQ/Breast_feeding/Vaccines/2021.1). © World Health Organization 2021. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO licence. WHO reference number: WHO/2019-nCoV/FAQ/Breast_feeding/Vaccines/2021.1 1 WHO SAGE roadmap for prioritzing uses of COVID-19 vaccines in the context of limited supply. Geneva: World Health Organization 2021 (https://www.who.int/ publications/i/item/who-sage-roadmap-for-prioritizing-uses-of-covid-19-vaccines- in-the-context-of-limited-supply, accessed July 2021) 2 WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination. Geneva: World Health Organization; 2020 (https://apps.who.int/iris/handle/10665/334299, accessed 04 June 2021). 3 Gray, K. J., Bordt, E. A., Atyeo, C., Deriso, E., Akinwunmi, B., Young, N., ... & Edlow, A. G. (2021). Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study. American Journal of Obstetrics and Gynecology. 4 Collier, Ai-ris Y., Katherine McMahan, Jingyou Yu, Lisa H. Tostanoski, Ricardo Aguayo, Jessica Ansel, Abishek Chandrashekar et al. "Immunogenicity of COVID-19 mRNA Vaccines in Pregnant and Lactating Women." Jama (2021) 5 International Labour Organization; 2020. ILO Standards and COVID-19 (coronavirus) FAQ. https://www.ilo.org/wcmsp5/groups/public/---ed_norm/--- normes/documents/genericdocument/wcms_739937.pdf