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Ensuring the safety and supply of donor human milk in the COVID-19 pandemic: a global response and call to action

Authors: 1,2Natalie Shenker BM BCh, PhD, 3Marta Staff MSc, 4Amy Vickers IBCLC, 5Joao Aprigio MD, 6

Satish Tiwari MD, 7Sushma Nangia MD, 8Ruchika Chugh Sachdeva, 9Vanessa Clifford MD, 10Anna Coutsoudis PhD, 11Penny Reimers PhD, 12Kiersten Israel-Ballard DrPh, 12Kimberly Mansen MSPH, MSc (Nutr), 13Radmila Mileusnic-Milenovic MD, 14Aleksandra Wesolowska PhD, 15J B van Goudoever MD, 16Mohammadbagher Hosseini MD, 17Anne Hagen Grøvslien IBCLC, 2Gillian Weaver RD, *Virtual Collaborative Network of Milk Banks and Associations.

Author Affiliations:1 Department of Surgery and Cancer, Imperial College London, London W12 0HS, UK 2 Human Milk Foundation, Rothamsted Institute, Hertfordshire, AL5 2JQ UK

3 The Centre for Simulation, Analytics and Modelling (CSAM), University of Exeter Business School, Exeter EX4 4PU, UK4 Executive Director, Mothers’ Milk Bank of North Texas; President, Board of Directors, Human Milk Bank Association of North America5 Coordinator, Professor; Ibero-American Human Milk Bank Program; National Milk Bank Service of Brazil; Fernandes Figueira Institute, Oswaldo Cruz Foundation - FIOCRUZ, Ministry of Health - Brazil6 President, National Human Milk Bank; Director, Professor & Head, Department of Neonatology, Dr Punjabrao Deshmukh Memorial Medical College, Amravati, Maharashtra, 4446037 Convener, National Human Milk Bank; Director, Professor & Head, Department of Neonatology, Lady Hardinge Medical College & Kalawati Saran Children's Hospital, New Delhi 1100018 Maternal Newborn Child Health and Nutrition, PATH India, Gopaldas Bhawan Building, Connaught Place, New Delhi 110001, India9 Australian Red Cross Lifeblood, Level 3, 417 St Kilda Road, Melbourne, Victoria, Australia10 HMBASA (Human Milk Banking Association of South Africa); Professor Emeritus, School of Clinical Medicine, University of KwaZulu-Natal, Durban, South Africa11 HMBASA; Advisor, iThembu Lethu Community Milk Bank, P.O. Box 41138, Rossburgh, 4072, KwaZulu Natal12 Maternal, Newborn, Child Health and Nutrition, PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA13 First Serbian Human Milk Bank, Institute of Neonatology, Belgrade, Serbia14 Human Milk Bank Foundation, Holy Hospital, Medical University of Warsaw, Warsaw, Poland15 Professor of Pediatrics, Division of Neonatology, Department of Pediatrics, Erasmus MC and Sophia Children's Hospital, Rotterdam, The Netherlands16 Clinical Director, Dept. Neonatology, Tabriz University of Medical Sciences, Neonatal and Perinatal Department, Alzahra Teaching Hospital, Artesh Ave. Tabriz, Iran17 Milk Bank Manager, Norwegian Accredited Breastfeeding Consultant, Multi-cultural Healthcare Consultant, Department of Pediatrics, Oslo University Hospital, Oslo, Norway*Virtual Collaborative Network of Milk Banks and Associations: please see the attached table of contributors.

Corresponding author: Dr Natalie Shenker, BM BCh, PhD; Dept. Surgery and Cancer, Imperial College London, W12 0HS, United Kingdom; Tel: +44 1582 314132; natalie.shenker09@imperial.ac.uk

Main text word count: 5502

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* Virtual Collaborative Network of Milk Banks and Associations contributors:

Country Name Qualifications Role, where known Address

AustraliaChristine Sulfaro RN Milk Bank Manager

Australian Red Cross Lifeblood, Level 3, 417 St Kilda Road, Melbourne, Victoria, Australia

Australia Gillian Opie MDNeonatal Paediatrician, Head of Unit

Mercy Health Breastmilk Bank, Melbourne Australia

Australia Laura Klein PhD Research FellowAustralian Red Cross Lifeblood, Level 3, 417 St Kilda Road, Melbourne, Victoria, Australia

CanadaFrances Jones

RN, MSN, IBCLC

Executive Director, Past President, HMBANA

British Columbia Women's Mothers' Milk Bank, Vancouver, Canada

CanadaJanette Festival RN, INCLC Executive Director

Northern Star Mothers Milk Bank, Calgary, Alberta, Canada

China Xihong Liu MDDirector of Clinical Nutrition

Guangzhou Women and Children Medical Center

Croatia

Branka Golubić-Ćepulić MD

Head of Dept of Transfusion Medicine

Department of Transfusion Medicine and Transplant Biology, Clinical Hospital Centre, Zagreb

DenmarkAnne Bille Olin RD Lead Clinical Dietician

Children’s Department, Women’s Milk Center, Hvidovre Hospital, Kvindemælkcentralen afs. 529, Kettegård Allé 30, 2650 Hvidovre

Estonia Annika Tiit MD Clinical DirectorHuman Milk Bank, East Tallinn Central Hospital

FranceClaude Billeaud

MD, MSc, Dr of Science and Nutrition

President AEEP, Asst Clin Director of Paediatrics, Scientific Manager

Marmande Human Milk Bank Association Européenne pour l'Enseignement en Pédiatrie, University of Bordeaux

FranceJean-Charles Picaud MD

Professor, Head of Dept of Neonatal Intensive Care

Croix Rousse Hospital, 103 Grand Rue de la Croix Rousse, 69004 Lyon

France Rachel BuffinMD, Neonatologist

Neonatologist in Charge of the Lactarium/Human Milk Bank

13 Auvergne Rhone Alpes regional Human Milk Bank, Lyon, France; Médecin du Lactarium Régional Rhône Alpes, Hôpital de la Croix Rousse, 103, grande rue de la Crois Rousse, 69317, Lyon Cedex 04

Germany Daniel Klotz MD Head of Neonatology

Center for Pediatrics, Division of Neonatology and Pediatric Intensive Care Medicine, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg

IndiaAdhisivam Bethou MD

Ass Prof and Head of Dept

Dept. of Neonatology JIPMER, Pondicherry 605006

IndiaHimabindu Singh MD Clinical Director Human Milk Bank, Osmania Medical College

India Jai Singh MD PresidentMonitoring and Mentoring Committee, Human Milk Banks, Rajasthan

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IndiaJayendra Kasar MD Clinical Director

Centre for Health Research and Innovation (CHRI)

India Kajal Jain MD Clinical Director Human Milk Bank Lead, AIIMS, Delhi

IndiaKetan Bharadva MD President Elect

Human Milk Banking Association (India); Human Milk Donation Camps of Surat Pediatric Association, India.

IndiaPoonam Singh MD Clinical Director Neonatologist, Surat Milk Bank, Gujarat

India Pratibha Kale MD Clinical Director Human Milk Bank, Amrivati

IndiaRoopa Bellard MD Clinical Director NJ Medical College, Karnataka, India

India Sila Deb MDDeputy Commissioner, Child Health Ministry of Health and Family Welfare

IndiaSuksham Jain MD Neonatologist

Government Medical College Hospital, Chandigarh

IndiaSuchandra Mukherjee MD Clinical Director Human Milk Bank Lead, Kolkota

India Jayaraman MD Professor, State Advisor Saveetha Hospital, Tamil Nadu

IranMohammad Heidarzadeh MD Ministry of Health

Iran Sabouthe MD Clinical DirectorHuman Milk Bank of Shahid Akbarabadi Hospital of Tehran

IrelandTanya Cassidy PhD, MA

School of Nursing, Psychotherapy, and Community Health, Dublin City University, Ireland

ItalyEnrico Bertino MD

President, EMBA; Professor of Neonatology

Università degli Studi di Torino | UNITO · Dipartimento di Scienze della Sanità Pubblica e Pediatriche

Italy Guido Moro MD

Professor of Neonatology (ret), President AIBLUD

Italian Association of Donated Human Milk Banks (AIBLUD); Biomedia, Via Libero Temolo No 4,. 20126, Milan, Italy

KenyaAngela Kithua MSc (Nut)

Nutrition Program Associate

PATH, supporting the Pumwani Maternity Hospital, Kenya

Kenya Faith Njeru RN Paediatric Nurse

Pumwani Maternity Hospital Lactation Support Center and Human Milk Bank, Nairobi, Kenya

KenyaMary Waiyego MD Clinical Director

Pumwani Maternity Hospital Lactation Support Center and Human Milk Bank, Nairobi, Kenya

MyanmarNant San San Aye MD

Professor of Neonatology Central Women’s Hospital, Yangon

MyanmarSan San Myint MD

Former Prof Neonatology, Milk Bank Founder Central Women’s Hospital, Yangon

MyanmarZaw Win Moe MD Clinical Director Yankin Children’s Hospital, Yangon

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New Zealand

Anthea Franks RN Milk Bank Manager

Human Milk Bank, Neonatal Unit, Christchurch Women’s Hospital, New Zealand

Norway Anne Bærug PhD ConsultantNorwegian National Advisory Unit on Breastfeeding, Oslo, Norway

PhilippinesEstrella J. Olonan-Jusi MD, MPM

Human Milk Bank Director; President

Human Milk Bank Association of the Philippines; Dr. Jose Fabella Memorial Hospital, Philippines

SerbiaRadmila Milenovic MD Neonatologist

First Serbian Human Milk Bank, Institute of Neonatology, Belgrade, Serbia

SloveniaAndreja Domjan MD

Consultant Paediatrician, Director

Human Milk Bank, Ljubljana Maternity Hospital, Ljubljana

South Africa Jenny Wright RN CEO

Milk Matters, Human Milk Bank, Cape Town, South Africa; Board of HMBASA (Human Milk Banking Association of South Africa)

Spain Antoni Gaya MD, PhD Director, Tissue Bank

Fundació Banc de Sang i Teixits de les Illes Balears, Institut d’Investigacions Sanitaries Illes Balears (IDISBA), Palma, Spain

SpainNadia Garcia-Lara MD Neonatologist

12 Octubre Hospital Regional Milk Bank, Madrid, Spain

SwedenJosefin Lundstrom MD Neonatologist Sachsska Children's and Youth Hospital

Taiwan

Florence Leefang Fanglee MD

Medical Director, Human Milk Bank, Head of Neonatal Unit Taipei City Hospital Milk Bank, Taipei

TaiwanYungchieh Lin (Apple) MD

Medical Director Human Milk Bank, Neonatologist Southern Milk Bank

ThailandSopapan Ngerncham MD

Associate Professor in Pediatrics

Division of Neonatology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok

TurkeySertac Arslanoglu MD, PhD

Professor Neonatology, Vice-President EMBA

Director, Dr Behcet Uz Children’s Hospital, Izmir

UKJackie Hughes RN

Chair, UK Association for Milk Banking Northwest Human Milk Bank, Chester

UK (Scotland)

Debbie Barnett RN Manager Scottish National Milk Bank Service, Glasgow

USAErin H Spence MD

Neonatologist, Co-Medical Director

Mother's Milk Bank of North Texas, 7617 Benbrook Parkway, Fort Worth, Texas 76126

USANaomi Bar Yam PhD Director

Mother's Milk Bank Northeast, 377 Elliot St, Newton Upper Falls, MA 02464

USA

Laraine Lockhart Borman IBCLC

Director of Outreach, Milk Bank

Director, Mothers' Milk Bank, Rocky Mountain Hospital for Children, 1719 E, 19th Ave, Denver CO 80218 USA

USA Lindsay Groff MBA Executive Director

Human Milk Banking Association of North America (HMBANA), 455 Camp Bowie Blvd. Suite 114-88, Fort Worth, TX76107

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USAPauline Sakamoto MS, RN, PHN Past HMBANA President

Operations and Regulatory Consultant, San Jose Mothers’ Milk Bank, HMBANA

USASybil Sanchez MIA, CLC Associate Director

Human Milk Banking Association of North America (HMBANA), 455 Camp Bowie Blvd. Suite 114-88, Fort Worth, TX76107

VietnamTran Thi Hoang MD, PhD Vice-Director

Human Milk Bank, Da Nang Hospital for Women and Children, Da Nang

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SUMMARY

If mother’s milk is not available, the World Health Organisation recommends that the first

alternative should be pasteurised donor human milk (DHM). Human milk banks (HMBs) screen and

recruit milk donors, and screened DHM principally feeds very-low-birth weight babies, protecting

them from a range of complications. Underlying these crucial roles is the more important task of

protecting, promoting, and supporting breastfeeding. While precise data are lacking, we estimate

>800,000 infants annually receive DHM worldwide each year. The COVID-19 pandemic is presenting

several challenges to HMBs worldwide, and highlights a range of vulnerabilities in service provision.

For the first time, the global HMB community has come together to collaborate, share learnings, and

plan. Here, we describe COVID-19-specific challenges, with the potential for impacts on DHM access

and neonatal health, and mitigation strategies to ensure DHM safety achieved by group consensus.

Also, we explore the most appropriate responses worldwide and in local HMB service settings to

emergency-preparedness, while optimising data collection and sharing. Furthermore, we call on

policymakers to minimise the impact of future challenges through greater investment in milk bank

infrastructure, research, and innovation to protect this essential service.

Keywords

Infant feeding; breastfeeding; prematurity; nutrition; donor human milk; milk bank.

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INTRODUCTION

If mother’s own milk (MOM) is not available for low-birthweight or otherwise vulnerable infants,

donor human milk (DHM) from a human milk bank (HMB) is recommended by the World Health

Organisation (WHO),(1, 2) United Nations Children's Fund (UNICEF),(3) American Academy of Pediatrics,

(4) European Society for Paediatric Gastroenterology Hepatology and Nutrition, (5) and Japan Pediatric

Society(6) as the next best option for achieving exclusive human milk diets and ensuring optimal

nutrition.

In February 2020, the WHO issued specific advice for breastfeeding during the severe acute

respiratory syndrome coronavirus 2 (COVID-19) outbreak. They stated that women who become too

unwell to breastfeed or express “should explore the possibility of relactation (restarting

breastfeeding), wet nursing (another woman breastfeeding), or using donor human milk”. (7)

In this article, we seek to outline the challenges facing provision of donor human milk, describe how

HMBs worldwide are working rapidly together to mitigate them, and call on policymakers and

technical leaders to support exclusive human-milk diets for vulnerable neonates during the COVID-

19 pandemic and beyond.

GLOBAL SCOPE OF HMBs

HMB capacity worldwide has increased in recent years as clinical evidence has mounted regarding

the implications of early exposure to infant formula, particularly for very-low-birthweight babies. (8-11)

Currently, HMBs operate in ≥66 countries, but accurate data regarding the true need for DHM is

lacking. HMB expansion, however, has been challenged due to a lack of global guidelines on safety

and operations.(12) Data is still needed to document the number of babies who lack an adequate

supply of MOM and the reasons why, the number of infants who received DHM, the length of time it

is required, and the volumes used.(13) Not all preterm babies and low-birthweight babies need DHM,

but nutritional supplementation is required for a proportion of infants, and this varies between 7

countries (and even individual hospital neonatal units (HNUs) within countries). The possible need

for DHM has been estimated using per-country birth rates and preterm birth rates per region from

published data;(14) however, importantly this must account for systems-level challenges that simply

prevent MOM reaching her infant. Nonetheless, it is estimated that approximately 1.3 million babies

born before 32 weeks of gestational age (GA) may require DHM for countries with active HMBs, and

2.5 million worldwide.(14)

As of 13th April 2020, out of the 66 countries with known operational HMBs, information has been

obtained from 32 countries. From the 446 HMBs for which data were made available, projections

were made for the remaining 310 out of all known 756 HMBs, showing that ~806,000 babies receive

DHM annually in the hospital setting worldwide (Table 1). It would be tempting to conclude from the

estimates that >50% of babies born before 32 weeks GA would have access to DHM in countries with

HMBs (806,000 vs. 1.3 million). In different settings, the feeding policies and lactation support differ

from the optimal. Nevertheless, a significant overall shortfall of DHM worldwide is likely. (14)

The recipient population, average duration and volume of DHM provision varies by setting; this is

made clear in the estimated figures provided by or projected for each region (Table 1). The

estimated average volume of DHM per recipient worldwide is 0.71 litres. However, DHM provisions

are non-uniform, even within a single county, and the range will be extremely wide. For example,

the estimated average volume of DHM per recipient in India is ~230 mL, but detailed data from a

single HMB in India estimated the average volume of DHM per recipient is <100 mL per infant, with

this volume serving as a bridge to full maternal milk provision. This contrasts with availability and

provision of donor milk found in countries within high income countries. In Norway, where

breastfeeding initiation rates are 97% and 71% of babies are breastfed at 6 months, (15) the average

volume per recipient is over 3 litres of DHM, reflecting the much wider criteria for use (i.e., term,

sick infants in hospital), as well as high numbers of donations. The figures provided for the

represented countries in the Latin America region show that current provisions for DHM exceeds

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that required for infants born below 32 weeks GA (Table 1), suggesting that older infants are also

receiving DHM, but that this would not be true for the estimated provision throughout all other

regions. The average duration and volume of the provision of DHM varies by setting, as does the

recipient population; this is made clear in the estimated figures provided by or projected for each

region (Table 1).

COVID-19 RESPONSE AND DONOR HUMAN MILK

The COVID-19 pandemic declared in March 2020 brings additional considerations and challenges for

the mother–infant dyad, newborn nutrition, and HMB operation. Increased separation of mothers

and infants limiting access to maternal milk (as is happening in many settings due to suspected

infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) despite WHO

guidance),(7) together with reduced availability of DHM could lead to an increase in morbidity and

mortality related to prematurity and other health conditions (e.g., congenital cardiac conditions,

neurological disease, gastroschisis, bowel atresia).(16-18) Where used as part of optimal lactation

support, DHM accessibility can also support mothers to establish their own milk supply. (19-22)

As the COVID-19 pandemic has developed, individual countries have published their own guidance

for the care of mothers and their babies in the perinatal period. Also, in the absence of global safety

standards, HMB associations and individual HMB programs have published their own specific

guidance relating to DHM in the context of COVID-19 for regional areas. (23, 24)

On 17th March 2020, two of the authors (GW, NS) started a virtual collaborative network (VCN) of

HMB leaders worldwide, which has rapidly facilitated the sharing of information, discussion of

evidence, and development of consensus views of best practice related to local circumstances. The

group now includes over 70 members from 32 countries. The VCN endorses the WHO’s

recommendations not to separate the mother and infant and to support breastfeeding, thereby

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decreasing the demand for DHM and improving outcomes for the mother and her infant. However,

in the context of separation of a symptomatic mother and infant, DHM use may be a critical ‘bridge’

for the infant, assuming that systems will simultaneously provide critical lactation support to ensure

the mother can initiate and maintain lactation during separation. Reduced access to mother’s milk

through reduced availability of face-to-face breastfeeding support and, in some areas, problems with

the supply of infant formula, has led to increased demand for DHM from hospitals as well as from

families in the community where quarantine-related mother-infant separation is impacting direct

breastfeeding or lactation initiation is taking time to become established. This increased demand is

placing further pressure on DHM supply and current HMB infrastructure.

LACK OF EVIDENCE OF SARS-CoV-2 TRANSMISSION THROUGH HUMAN MILK

Viral transmission through breast milk has been described for a range of viruses, including the

human immunodeficiency virus (HIV) and cytomegalovirus (CMV).(25, 26) Coronaviruses (CoVs) are

enveloped, single-stranded RNA viruses that are primarily spread via droplet and contact

transmission. CoVs have not been detected in breast milk, and transmission of CoVs via breast milk

has not been reported, although it is likely that mothers could infect infants via the respiratory route

whilst breastfeeding.(27) Seven CoVs are known to infect humans. Four seasonal CoVs generally cause

mild upper respiratory tract symptoms, but three CoVs are more likely to cause severe respiratory

complications, including pneumonia, acute respiratory distress syndrome, multiple-organ failure and

death. (27) These include Middle East Respiratory Syndrome coronavirus (MERS-CoV) and Severe

Acute Respiratory Syndrome coronavirus (SARS-CoV), with reported case fatality rates of 35-40% and

10%, respectively.(28, 29)

In December 2019 in Wuhan (Hubei Province, China), a seventh CoV was identified, named “SARS-

CoV-2” on 11th February 2020 by the WHO, with the resultant disease termed COVID-19. COVID-19

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was declared a global pandemic by the WHO on 11th March 2020. As of 14th April 2020, almost 2

million confirmed infections have been reported, with almost 120,000 deaths. The actual number of

infections is likely to be many fold higher because of insufficient testing.

SARS-CoV-2 has been isolated from nasopharyngeal swabs, sputum, serum and faeces. (30) No studies

have yet found SARS-CoV-2 to be present in milk samples from COVID-19-positive mothers. It is

highly unusual for a CoV or other respiratory virus to cross into breast milk. (31) Severe disease in the

mother can lead to preterm birth, and vertical transmission in utero has been reported as a rare

mode of transmission,(32-34) but conclusive studies are yet to be published. Neither direct

breastfeeding nor feeding of expressed human milk has been shown to be a route to vertical

transmission. For the limited data available, where breast milk has been analysed from mothers

infected in the third trimester of pregnancy, evidence of viral particles in samples of expressed milk

is lacking (though little information has been given regarding sample collection). (35)

Vertical transmission has to date been reported in utero in two infants, with IgM and IgG antibodies

present 2 h after birth,(36) and in one single infant at 3 months of age exposed to their COVID-19-

positive grandmother.(37) Typically, serum antibodies appear 5 days after symptom development,

with specific IgM antibodies appearing at 10 days and IgG antibodies developing by 14 days. (38)

Profiling of human milk for immunoglobulin (Ig)G or IgM antibodies against SARS-CoV-2 has not yet

been reported. Serological screening of donor mothers may be useful as part of research into

whether infants exposed to or infected with SARS-CoV-2 may benefit from DHM from mothers who

have recovered from COVID-19. This strategy, if shown to work, would enable antibody-positive

human milk to be targeted to HNUs to feed infants of symptomatic mothers unable to express their

own milk: this should be a research priority.

The persistence of antibodies after SARS-CoV-2 infection is not known. However, a case report from

the SARS outbreak in 2003 showed that a pregnant woman infected at 7 days of gestation was

antibody-positive at 28 days and 64 days post-illness, and at birth at 36 weeks, but milk samples

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were negative for SARS-CoV antibodies. Another woman, who developed symptoms at 19 weeks of

gestation and delivered at 36 weeks, had SARS-CoV antibodies detected in serum, umbilical-cord

blood, and breast milk by enzyme immunoassays and indirect immunofluorescence assays 130 days

after infection.(39-41) Research is needed urgently to understand true viral presence in breastmilk

across gestation and lactation during COVID-19 infection in order inform guidelines for infant feeding

worldwide for the general population, as well as HNUs and paediatrics units.

Additional practices that are common to HMB services are likely to mitigate the risk of SARS-CoV-2

transmission. HMB services operate according to guidelines set by national bodies or local

organisations. Donors are screened using interviews and questionnaires based on health and

lifestyle. This strategy aims to reduce the risk of microbial or other contamination of donated milk

and is usually employed in addition to serological screening for common blood-borne infections.

Human milk is collected and, with a few exceptions (e.g., Norway), pasteurised which, in most HMBs

is via Holder pasteurisation (milk heated to 62.5°C for 30 min). Most importantly, studies have

documented complete heat inactivation of genetically similar viruses such as SARS and MERS by

treatment at 60°C for 15–30 min.(42-44) Recent work has shown that SARS-CoV-2 is inactivated by

heating in a dose-dependent manner, with viral inactivation at 10–30 min at 56°C, or 5 min at 70°C,

(45) although no specific studies have yet investigated viral inactivation in human milk under Holder

pasteurisation conditions or flash heat treatment.

DHM PROVISION

Worldwide, DHM is used primarily for premature babies being cared for in in HNUs, as well as those

who are low birthweight, critically ill, orphaned or abandoned. With regard to DHM provision,

countries have experienced an increase in demand (related to the increase in mothers who are ill

and unable to express milk for preterm babies as well as separation of symptomatic mothers from

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their neonates) and decrease in demand (whereby fewer babies have been born preterm and

clinicians in some countries are risk-averse to using DHM). Guidelines have been published for the

care of symptomatic infants and mothers in neonatal care (e.g., Italy(46)), but most national bodies

and regional policy leaders (e.g., CDC, RCPCh) have not released specific advice regarding DHM use.

The WHO is advocating for culturally specific use of re-lactation support, wet nursing, or DHM if

breastfeeding is challenging, in line with IYCF emergency settings guidance.(7, 47) Research will be

needed that ‘layers’ the relationship between attitudes towards DHM and lactation support in HNUs

and the community with national cultural perceptions of breastfeeding and human milk.

Many HMBs also supply DHM to families who meet specific criteria in the community if surplus DHM

is available, and breastfeeding is not possible as a result of maternal ill-health (e.g., cancer,

psychosis) or maternal absence (e.g., death, fostering, adoption). DHM can also be efficacious as a

bridge if mothers need time and support to establish a full supply of milk. Increased demand from

hospital HNUs raises questions as to which clinical situations should be prioritised, and the capacity

of HMB infrastructures to respond.

Here, the global VCN aims to share information with clinicians, parents and other carers regarding

DHM safety. We identified key challenges, alongside potential solutions to mitigate their impacts,

which HMBs have either adopted or will consider should their local situation worsen. It can be

particularly difficult for individual services, those with few staff, and those without a cohesive

national framework to respond to new and urgent challenges such as the COVID-19 pandemic

rapidly and appropriately. The purpose of this contribution is not only to disseminate best practice

and highlight areas that necessitate further research, but also to act as a call to HMB leaders

worldwide to continue collaboration in the months and years to come.

CHALLENGES AND MITIGATIONS TO ENSURE DHM SAFETY

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DHM availability

Challenge: The Chinese Expert Consensus Group on COVID-19 Response for Perinatal and Neonatal

Services reported that infants who were symptomatic or positive for COVID-19 should be cared for in

a quarantine room and fed DHM for 14 days.(48) Such recommendations have influence beyond China

and, as a result, will place pressure on HMB services working to meet the challenge worldwide. Even

the largest national network, which is in Brazil (where a national HMB service was established in

1998 and >200 HMBs are active), has encountered low supplies of DHM as a result of decreased

donations and increased demand.

Worldwide, there are notable differences in the mechanisms by which mothers donate surplus

breastmilk to HMBs. They may be mothers who: (i) just gave birth in hospital and have low-

birthweight or sick infants; (ii) are donating a one-off store of milk expressed while their infant is in

the NICU; (iii) are at home and are recruited to prospectively collect milk for donation; (iv) become

bereaved. The range of donated milk varies from as little as 50 ml as a single donation to >100 litres

of milk over several weeks or months. Different scenarios elicit different challenges during COVID-19

restrictions, each impacting a donor’s ability to donate her surplus milk to an HMB.

Mitigation: If direct breastfeeding is not possible, the first option should be to consider use of

expressed mother’s milk.(49) If this is unavailable, DHM should be the next feeding option. This

approach may need HMBs to scale-up their activities and recruit more donors. The National Milk

Bank Service of Brazil has launched a media appeal across social, print, television and radio to

encourage milk donors to donate, and ensure donors are aware of the safest ways to express and

store their surplus milk, including additional screening for COVID-19 symptoms (personal

communication, J Aprigio). If the largest HMB service in the world is needing to recruit donors

actively, this puts into context the situation affecting less well supported services.

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There has been an overwhelmingly positive response from mothers in many communities offering

their milk, as noted in the USA, UK, India, France and the Netherlands. However, some countries

(e.g., China, Poland) have noted a reduction in the number of milk donors coming forward, possibly

as a result of fear about leaving the house to be screened or to donate milk.

HMBs have an ethical duty to ensure that donors are not coerced to give milk that may be needed

for their own baby. The emotional drive to donate altruistically (which many donors express openly)

should not override their own safety or that of their infants. HMBs should, therefore, if appropriate,

encourage mothers to reserve a stock of expressed milk to feed their babies in case their own supply

drops, or they become ill themselves.

Cultural attitudes to human milk and perceptions of breastfeeding appear to map onto DHM use

and, therefore, service provision. In some areas, demand for donor milk from hospital HNUs has

decreased. This is probably related to lack of dissemination of evidence about SARS-CoV-2

inactivation during DHM pasteurisation and fears of transmission. In the USA, India and Iran, there is

some evidence that HNUs are stricter in rationing donor milk to only the most vulnerable, preterm,

and very-low-birthweight babies;(50) and personal communications for example, in Iran only babies with

birthweights less than 1.2 kg are now receiving DHM rather than the usual policy of infants <1.5 kg.

Pre-screening for COVID-19 exposure in milk donors

Challenge: In order to identify donors at risk of COVID-19 infection, HMB staff must understand

which epidemiological risk factors increase the likelihood of SARS-CoV-2 infection, and which

symptoms are suggestive of SARS-CoV-2 infection, communicate this knowledge adequately to milk

donors, and apply this rigorously to their recruitment processes.(51) For example, current guidance

for screening in the UK is to stop accepting milk donations for 8 days after symptoms develop in a

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(fully recovered) donor (in accordance with guidance for healthcare workers) or for 14 days after

exposure to a confirmed case or symptomatic contact.(52)

Mitigation: The process for selection and screening of donors has been developed to exclude at-risk

donors, in accordance with screening procedures implemented in parallel by local blood-transfusion

services.(27) In response to the currently known features of COVID-19 presentation and SARS-CoV-2

transmission, additional questions should be incorporated during screening and into national

guidelines to identify donors currently or recently exhibiting symptoms of COVID-19, or who have

tested positive for SARS-CoV-2. The exclusion also applies if the donor is a known contact of

someone with these symptoms, or a COVID-19 diagnosis 14 days after contact. Donors should delay

donation or expressing and storing milk for donation until asymptomatic, or may be deferred

permanently. Additional measures should be taken by milk bank staff who are in contact with donors

by wearing situation appropriate personal protection equipment (PPE), particularly given

asymptomatic transmission is likely.

Serological screening for potential milk donors

Challenge: Usually, potential milk donors are required to undergo routine serological screening

testing. These vary according to type of test, infections screened for, and the timing of the tests. In

the UK, Clinical Guideline #93 Donor Milk Banks: service operation (which is used widely in Europe

and beyond) from the National Institute for Health and Clinical Excellence recommends screening at

the time of recruitment.(53) If donor recruitment takes place over large geographical areas, blood may

need to be posted to the HMB laboratory. As a result of COVID-19 restrictions, potential milk donors

are finding it increasingly difficult to access phlebotomy services because they are closed or have

been redirected.

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Mitigation: HMBs encountering difficulties recruiting donors are learning actively from countries

with different screening systems (particularly ‘contactless’ screening) to navigate local ‘roadblocks’

while maintaining safety standards. Screening advisors have also discussed using antenatal screening

tests rather than the current mandatory postnatal tests upon recruitment. However, this option

would be the minimum standard and would be considered only if stocks become critically low and

should be approved by local governance structures. Milk banks are also focussing on recruiting

donors whose babies are in the HNU, where blood tests could be performed onsite by HNU teams.

Screening difficulties can lead to novel opportunities and innovative partnerships. For example, the

National Health Service Blood Transfusion Service in the UK, which has never previously worked

formally in this way with a HMB service in the UK, has allowed potential milk donors to the Hearts

Milk Bank to access phlebotomy services at two of their donor centres in the southeast. This strategy

may open future opportunities for the two services to operate more closely beyond the pandemic.

Communication by HMBs

Challenge: Communication regarding regular updates is vital, albeit time intensive and rapidly

evolving, to reassure parents (particularly in the immediate perinatal period), the community, and

healthcare providers as new evidence emerges around safe handling and processing of human milk

in the context of COVID-19. Donors have reported increased levels of anxiety in wanting to reduce

risk of SARS-CoV-2 transmission through their actions, warranting improved mechanisms to alleviate

fact from misinformation.

Mitigation: Databases that enable rapid (but secure) communication with milk donors should be

maintained by individual HMBs to ensure the security of personal information. Anecdotal evidence

from HMB leaders suggests that an increased awareness of pump-and-hand hygiene is reducing the

volume of milk that fails microbiological checks. HMBs should also communicate regularly with their

17

local network of HMBs and HNUs: (i) to determine levels of demand and changes to infant-feeding

policies that could affect DHM use; and (ii) to inform units about any potential interruption of DHM

supply. Social media has proved to be a useful tool to disseminate updates and guidance for milk

donors. Additionally, systems to improve communications and networking between HMBs are

needed to ensure rapid mechanisms to share learnings, protocols and experiences, related to

COVID-19 safety.

DHM collection and transportation

Challenge: The COVID-19 pandemic has led some governments to impose social-distancing (SD)

measures that impact on the collection and delivery of DHM, preventing donor mothers from

reaching ‘milk drop’ sites or couriers from reaching residences. Furthermore, basic transport

infrastructure has been closed in some areas, such as the ferry network in British Columbia, or air

freight services where milk banks serve a large geographical area.

Mitigation: Non-contact collection-and-delivery processes have been implemented and HMBs are

working rapidly to adapt to these new measures while adhering to all aspects of screening and

quality control. Donors should be screened before face-to-face contact with the HMB team

according to the additional screening questions suggested above. Even in countries where self-

isolation and SD is not imposed by the government, SD and facemask-wearing should be considered

and observed where appropriate by donors, staff, volunteers and couriers engaged on behalf of

HMBs.

DHM handling

Challenge: SARS-CoV-2 can maintain infectivity while on plasticware, stainless steel, and cardboard

for several hours/days under experimental settings,(45, 54) although this has not been shown to be a 18

major route of transmission. This phenomenon poses a potential risk to individuals involved in the

handling and transport of containers of donated milk at HMBs. There is, therefore, a small risk of

accidental transmission from handling of containers/bags touched by an asymptomatic

donor/courier in cases where standard protocols for DHM handling are breached.

Mitigation: Typically, hygiene and handwashing are highly stringent in HMBs. Optimal handling of

containers and human milk-storage bags during the COVID-19 pandemic has been postulated, but

without an evidence base to support some of its suggestions.(55) Furthermore, following these

suggestions may introduce a secondary risk of feed contamination with bleach or other viricides. (56)

HMB staff must: (i) practice regular handwashing; (ii) wear gloves whenever handling

containers/bags containing donated milk; (iii) avoid touching their faces/spectacles; (iv) protect their

skin from repeated exposure to soap, alcohol gel and water; (v) be encouraged to re-moisturise their

hands at the end of work;(57) (vi) allow only limited access to their premises (including laboratory

spaces and offices; (vii) practice SD between staff members; (viii) self-isolate if in contact with a

symptomatic individuals for 14 days. Solitary working procedures should also be considered if

feasible.

Some HMBs are instituting ‘milk quarantine’ principles whereby pre-pasteurised milk is kept

separate from other stocks until 14 days after the date of last expression. Before milk is removed

from the freezer, donors are contacted to ensure they have been symptom-free for the previous 14

days. However, this is guidance only, and in no way should compromise stocks of donor milk if

sufficient supplies are not in stock. The risks for formula feeding have been assessed in some

countries (e.g., South Africa) as being higher than the risk for babies receiving pasteurised DHM from

mothers who have been screened via questioning regarding COVID-19 symptoms/exposure. An

interruption of supply would have serious implications because the lack of HMB capacity would

mean many more vulnerable babies would receive formula milk despite optimal support for

breastfeeding.

19

Contingency planning

Challenge: Traditionally, HMBs have been under-resourced and staffed minimally, and so may

operate without a DHM surplus. A recent UK survey suggested that most HMBs operate with 1–2

staff and carry only 2–3 weeks’ supply of DHM. Other HMBs may close as a result of staff losses and

self-isolation. To face a pandemic whereby restrictions on SD and transport could last for weeks will

lead to potential shortcomings in DHM supply to hospitals. Specific issues affect HMBs located within

hospitals (e.g., infection control, SD) and those located in external institutions (e.g., sample

transportation for microbiological screening).

Mitigation: Each HMB should be actively considering contingency plans for which HMBs (if more

than one is operating within a reasonable geographical range) could cooperate to safeguard

supplies. There is no way to document the impact of HMBs closing, and there is a need for a multi-

country assessment of the impact of HMB loss or being able to overcome logistical challenges.

Innovation is needed to rectify the lack of a global communication platforms linking HMBs

worldwide, which has limited the rapid sharing of information, data or protocols for a pandemic or

other disaster response. As one beneficial effect of the VCN, the Indian and UK milk bank services

have already started to streamline their data collection and communication networks, and work is

now starting that aims to simplify data collection strategies within and between countries. The

importance of HMBs must be highlighted by neonatologists and other healthcare professionals to

avoid a collapse in services as a consequence of access to DHM being regarded as ‘non-essential’.

DISCUSSION

Based on best available evidence, there is a high probability that SARS-CoV-2 is not transmitted

through human milk. However, during this critical COVID-19 response period facing healthcare

systems around the world, HMBs are facing challenges in terms of maintaining adequate staffing,

20

donor recruitment, safe handling/transportation of DHM, and increased demand as a result of

mothers and infants being separated. It is imperative that systems to provide DHM to vulnerable

infants not be inadvertently impacted by efforts to contain COVID-19. With appropriate use in the

context of optimal support for lactation, a short period of DHM provision can support mothers to

establish their milk supply without the need for supplementation with infant formula milk. The

critical impact of an exclusive human-milk diet has been widely documented and highlights the

importance of short periods of DHM availability. In their 2017 call to action to ensure DHM is

available as the preferred alternative for low-birthweight infants where MOM is unavailable, the

WHO stated: “...interventions to improve feeding of LBW infants are likely to improve the immediate

and long-term health and well-being of the individual infant, and have a significant impact on

neonatal and infant mortality levels in the population.”(49)

On the 9th April, the CDC altered its original advice around need for separation of symptomatic

mothers from new babies, bringing it into line with the consensus view to keep mother and infants

together in spite of COVID-19 infection from the WHO, Royal College of Obstetrics and Gynaecology

and Academy of Breastfeeding Medicine.(7, 58, 59) The Italian Society for Neonatology (based in Italy,

suffering from one of the most intense outbreaks of COVID-19) goes further, emphasising that

mothers should stay with their newborns and that MOM should not be heat-treated so as not to

affect its immunological and bactericidal properties.(46) They emphasise that, to date, there is no

evidence that SARS-CoV-2 is transmitted in breast milk, and that the benefits of breastfeeding and

from human milk far outweigh impacts from the low risk of transmission.

The global nature of this VCN reflects advice from the WHO with regards to health systems in both

developed and developing nations. HMB leaders who have lived and worked through the earliest

years of the HIV pandemic bring insights into the mistakes that occurred in the 1980s, with fear of

breastfeeding discouraging mothers and costing the lives of many babies who received infant

formula in unsafe conditions.(25) Unlike HIV where transmission via breastfeeding was a source of

infection, there is currently no evidence around SARS-CoV-2 transmission from breastfeeding or

21

human milk. Therefore, to avoid further impacting an already strained health system during the

COVID-19 pandemic, the best chance to keep infants healthy is to promote breastfeeding and

exclusive human milk diets. If DHM provision can play a part, HMB services should be supported. The

consensus from this VCN is that a comprehensive approach should be implemented to maintain

contact between mothers and babies, with skin-to-skin and breastfeeding support. If DHM is

provided during any separation during COVID-19, this should be for as short a time as possible as a

bridge to receiving mother’s own milk. By limiting mother-infant separation and supporting use of

mother’s own milk, the over-demand for DHM would diminish. This, in turn would mean that the

global supply of DHM can continue to be used for those most vulnerable, when maternal

breastfeeding is not possible. This approach increases the chances that these infants will leave the

NICU breastfeeding exclusively: this is critical for the longer-term health of mother and baby.

The worldwide incidence of neonatal deaths in 2018 was 18/1,000 live births, representing an

estimated 2.5 million newborns, of which ~0.85 million died due to the complications of preterm

birth.(60) The United Nations Sustainable Development goals (61) call for neonatal mortality to fall to 12

deaths/1,000 by 2030, with particular impacts for regions that require specific resourcing (e.g., south

Asia, Africa). Reduction in preterm-associated mortality via more widespread provision of DHM, as

one of the strategies to protect, promote and support breastfeeding, could be a key contributor to

meeting this goal.

CONCLUSIONS

The COVID-19 response to prevent infection and reduce global spread must also ensure that

inadvertent harm is not done to other critical aspects of care and prevention. Ensuring safety

between mother and infant during suspected or confirmed COVID-19 infection is complex and has

resulted in mixed messages and confusion. Currently, global policy leaders now agree that mothers

and infants should remain together and safe breastfeeding and access to human milk should be

22

supported. Human milk banks around the world are facing unprecedented challenges to maintain

safe DHM supplies in volatile health system infrastructures that limit routine operations.

The primary role of HMBs is to protect, promote, and support breastfeeding. If donor milk is used as

a short-term intervention, this must align with the provision of ongoing support to enable mothers

to establish their supply and take over the provision of breast milk for their infants. This emphasis on

the importance of breast milk for these vulnerable infants within HNUs creates an environment in

which breast milk is seen as the valuable lifesaving medication/resource that it is. Mothers are more

likely to breastfeed if DHM is available and used appropriately with optimal support for lactation.

Many human milk bank systems around the world have struggled to respond to the COVID-19

pandemic, with issues deepened by the lack of globally agreed safety guidelines on HMB, no global

mechanism for rapid communications among HMBs, and limited data and infrastructure to ensure

responsiveness during a crisis. Strengthening of the HMB system is required to ensure that provision

of safe DHM remains an essential component of early and essential newborn care – during routine

care, as well as emergency scenarios, such as natural disasters and pandemics.

We, therefore, call on global policy-leaders and funding agencies to recognize and prioritize the need

for logistics, research, and innovation to address five high-impact areas: 1) neonatal nutrition,

significantly associated with reduced morbidity and mortality, should be considered an essential

focus and not be neglected during emergencies such as the COVID-19 pandemic; 2 ) basic research

and implementation science research are needed to optimize HMB systems related to safety in

response to new infectious threats; 3) innovation across all aspects of HMB processing is needed to

improve responsivity, access and quality of DHM provision; 4) learnings and innovations by the

global HMB community during COVID-19 be integrated within newborn, nutrition and emergency

response planning for future emergency scenarios; 5) a global network of HMBs to enable enhanced

communication and sharing of data and best practice.

23

COVID-19 has presented challenges and opportunities for health systems; the HMB sector seeks to

build upon the learnings from this period to inform and improve response in the future. This VCN is

now focussed on building upon this cooperation through creating a Global Alliance of Milk Banks and

Associations.

ACKNOWLEDGMENTS

We give our thanks to Aunchalee E.L. Palmquist, Department of Maternal and Child Health, Carolina

Global Breastfeeding Institute, Gillings School of Global Public Health, University of North Carolina-

Chapel Hill (USA), who read and made invaluable suggestions to the final manuscript.

FUNDING

No funding was received in the writing of this manuscript or collation of data. NS is a UKRI Future

Leaders Fellow at Imperial College London, UK, which supported the writing.

CONFLICTS OF INTEREST

All authors are in some way connected to milk banking services in their countries, and some are

remunerated as part of their work. KIB and KM are employed by PATH, an international health NGO

working to improve health outcomes for people in low-resource settings by creating and advancing

quality health solutions. NS receives a UKRI Future Leaders Fellowship which includes her salary.

AUTHOR CONTRIBUTIONS

NS, MS, AC, PR, KIB, KM, JBvG, MBH and GW drafted the manuscript from virtual discussions with

the other authors. MS, KIB, KM, RCS and GW coordinated the data collection regarding the number

and scale of milk bank services. RMM, VC and AW provided expert input regarding virology and

screening. AV, JA, ST and SN coordinated and collated the collection of regional experiences. All

authors and VCN contributors read and approved the final manuscript.

24

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TABLES

Table 1: Number of projected current recipients in hospital settings (unspecified GA), and number of

predicted premature births of <32 weeks GA, per region per year for countries with HMBs.

Region* Estimated current recipients (no. of known HMBs)**

Average number of recipients per HMB

Number of preterm births

<32 weeks GA***

Northern Africa and Western Asia

None known n/a 21,698

Latin America and the Caribbean

261,334 (306) 854 139,623

Developed 381,008 (289) 1,318 171,070

Central and Eastern Asia 5,433 (28) 194 211,566

South-Eastern Asia and Oceania

4,659 (25) 186 123,946

Sub-Saharan Africa 35,944 (24) 1,498 88,528

Southern Asia 117,147 (84) 1,395 575,208

TOTAL 805,524 (756) 1,331,639

*As defined in Blencowe et al.(14)

**Three approaches were employed for estimation where data was missing. (A) For countries where only the volume of DHM is reported, then the number of recipients is estimated using the volume per recipient, averaged over those responses (which included the volume and number of recipients). (B) For countries reporting data for only a subset of known HMBs, data were extrapolated to the full set of known HMBs within that country. (C) For countries for which only the number of HMBs was known, the number of recipients was estimated based on the average of the calculated number of recipients per HMB where data allows.

*** Based on statistics of population and birth rates per country with operational and planned milk banks, and proportion of preterm births per region for GA<32 weeks per Blencowe et al. (14)

29