Maternal and Neonatal

Immunization Field Guide for

Latin America and the
Caribbean – Annex COVID-19

Washington, D.C., 2023

[blank page]
 Maternal and neonatal
immunization field guide for
Latin America and the
Caribbean – Annex COVID-19

Washington, D.C., 2023

Maternal and Neonatal Immunization Field Guide for Latin America and the Caribbean – Annex COVID-19
PAHO/HSS/CLP/23-0012
© Pan American Health Organization, 2023
Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO license
(CC BY-NC-SA 3.0 IGO).

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Contents

Acknowledgments ...............................................................................................................................................v

Abbreviations and acronyms ............................................................................................................................. vii

Objective and background of this document ..................................................................................................... 1

Key data .............................................................................................................................................................. 1

1. Introduction .............................................................................................................................................. 3

2. COVID-19 burden among pregnant women and neonates ...................................................................... 3

2.1. Morbidity and mortality among pregnant women ......................................................................... 3

2.2. Morbidity and mortality in neonates and infants ........................................................................... 4

2.3. Vertical transmission and transmission of antibodies following maternal SARS-CoV-2 infection .. 5

3. COVID-19 vaccines in pregnancy .............................................................................................................. 5

3.1 Types of COVID-19 vaccines ............................................................................................................ 6

4. Immunogenicity and effectiveness ........................................................................................................... 7

5. Safety of COVID-19 vaccines in pregnancy ............................................................................................... 8

6. Uptake of the COVID-19 vaccines among the pregnant population ....................................................... 11

7. COVID-19 vaccine contraindications in pregnant women and birthing persons .................................... 12

8. COVID-19 vaccine recommendations during pregnancy and the postpartum period............................ 12

9. Recommendations for healthcare workers regarding COVID-19 vaccination during pregnancy ........... 16

10. End of COVID-19 public health emergency of international concern ..................................................... 18

References ........................................................................................................................................................ 20

List of tables

Table 1. COVID-19 vaccines with WHO Emergency Use Listing

Table 2. WHO Emergency Use Listing vaccines dosing and storage

Table 3. WHO COVID-19 vaccine recommendations for women and birthing persons in the postpartum
period

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Acknowledgments
We acknowledge the unrelenting efforts of the group of external experts and from the Pan American Health
Organization/World Health Organization (PAHO/WHO) Immunization and Maternal Health teams in
producing this annex on COVID-19.

Maternal immunization group of experts

Alba María Ropero – Senior Lead Immunization Agenda 2030 at World Health Organization
Flor M. Munoz – Associate Professor of Pediatrics and Infectious Diseases at Baylor College of Medicine and
Texas Children’s Hospital, United States of America
Margherita Ghiselli – Regional Advisor on Immunization at PAHO/WHO
Martha Velandia – Regional Advisor on Immunization at PAHO/WHO
Monica Chiu – International Consultant at PAHO/WHO Antimicrobial Resistance Special Program
Francisco Nogareda – International PAHO Consultant on Influenza Vaccination
Raffaela Schiavon Ermani – Independent Consultant in Sexual and Reproductive Health and member of the
Technical Advisory Group of Vaccines in Mexico
Alejandro Cravioto – Professor, Faculty of Medicine National Autonomous University of Mexico, Mexico City
Bremen De Mucio – Regional Advisor for Maternal Health at CLP/PAHO/WHO
Pablo Duran – Regional Advisor for Perinatal Health at CLP/PAHO/WHO
Rodolfo Gómez – Regional Advisor for Sexual and Reproductive Health at CLP/PAHO/WHO
Suzanne Serruya – Director of the Latin American Center of Perinatology, Women and Reproductive Health
Claudio Sosa – International Consultant in Maternal Health at CLP/PAHO/WHO
Mercedes Colomar – International Consultant in Maternal Health at CLP/PAHO/WHO

Experts who drafted the initial document

Nelson Alvis Guzmán – Universidad de Cartagena, Universidad de la Costa, ALZAK Foundation, Colombia
Fernando De la Hoz Restrepo – National University of Colombia
Jezid Miranda – University of Cartagena, Colombia
Jose Antonio Rojas Suarez – GRICIO Foundation, Colombia

Coordination of experts’ input and editing

Veronica Pingray – Independent Consultant in Maternal and Perinatal Health

v
General coordination

Bremen De Mucio – Regional Advisor for Maternal Health at CLP/PAHO/WHO

This publication was made possible through support provided by the USG COVID-19 Vaccines and Pregnancy
Project, under the terms of Grant No. 374016-0103. The opinions expressed in this publication are those of
the author(s) and do not necessarily reflect the views of the USG.

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Abbreviations and acronyms
ACOG American College of Obstetrics and Gynecology

BIBP Beijing Bio-Institute of Biological Products

CDC U.S. Centers for Disease Control and Prevention

COVID-19 coronavirus disease 2019

EUL Emergency Use Listing

ICU intensive care unit

IgG immunoglobulin G

mRNA messenger ribonucleic acid

PAHO Pan American Health Organization

VITT vaccine-induced thrombosis with thrombocytopenia

WHO World Health Organization

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Objective and background of this document

This document is an annex to the Pan American Health Organization (PAHO) Maternal Neonatal Immunization
Field Guide (1). This annex incorporates relevant information on COVID-19 vaccines to be considered by
decision-makers who plan and/or coordinate immunization programs, as well as for health professionals
working in maternal–perinatal health services at all health system levels. As in the original guide, the target
audience for this annex continues to be managers and staff of maternal and child health services,
immunization programs, healthcare providers, pregnant and lactating women and birthing persons, and the
media.

This document presents information on COVID-19, the vaccines available, and their immunogenicity,
effectiveness, safety, and contraindications for pregnant women and birthing persons. Finally, some strategies
for their implementation in Latin America and the Caribbean are included to increase immunization coverage
in this target population.

It should be noted that many cross-cutting issues (e.g., immunization information systems or social
communications) common to vaccines against COVID-19 and other vaccines are available in the original
guideline, so they will not be repeated in this annex.

This annex focuses on World Health Organization (WHO) Emergency Use Listing (EUL) vaccines against COVID-
19. These vaccines underwent a rigorous evaluation of the clinical data provided by the manufacturer. Other
vaccines are currently being evaluated. Not all vaccine manufacturers initiate or complete the WHO EUL
process, and national regulatory authorities also independently review clinical data submitted by
manufacturers and issue authorization for vaccine use within their territory.

Key facts

 Pregnant persons are at higher risk of severe COVID-19 (hospitalization, admission to intensive care
units, need for ventilatory support, and death) than nonpregnant persons.

 SARS-CoV-2 infection during pregnancy has also been associated with adverse pregnancy outcomes,
such as preterm birth, low birthweight, stillbirth, and admission to neonatal intensive care units.

 The risk of postnatal transmission of SARS-CoV-2 infection from infected mothers or other caregivers
to infants has been documented, and infants have a higher risk of hospitalization than older children.

 Current COVID-19 vaccines are safe when administered during pregnancy in all trimesters of
gestation and the postpartum period.

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 COVID-19 vaccines during pregnancy effectively protect pregnant women, birthing persons, and their
newborns against severe disease, hospitalization, and death.

 COVID-19 vaccines are strongly recommended in pregnant women and birthing persons, who are a
high priority-use group, given the potential risk of severe COVID-19 disease and complications on the
pregnant woman and birthing person, the fetus, and their infants.

 None of the current COVID-19 vaccines contain live virus; therefore, these vaccines cannot cause
COVID-19 disease in the pregnant women, birthing persons, or their infants (or anyone else).

 Monitoring immunization coverage among pregnant women and birthing persons, the safety and
effectiveness of the COVID-19 vaccine, and the burden of COVID-19 morbidity and mortality allows
health authorities to assess the impact of the immunization program on the health of pregnant
women, birthing persons, and newborns.

 Communication strategies to promote immunization against COVID-19 in pregnant women and

birthing persons should emphasize the evidence on vaccine safety and effectiveness and the
benefits for mothers and infants.

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1. Introduction

The first cases of SARS-CoV-2 infection were reported in December 2019 in Wuhan, China. On 30 January
2020, the World Health Organization declared the outbreak of the new coronavirus a public health emergency
of international concern and characterized it as a pandemic on 11 March 2020 (2).

The COVID-19 pandemic posed an unprecedented public health challenge, significantly impacting people’s
health. As of 14 June 2023, more than 767 million confirmed cases and more than 6.9 million deaths have
been officially reported worldwide (3). According to WHO, the worldwide excess mortality directly or
indirectly associated with COVID-19 is even higher. It was estimated at 4.47 million deaths (95% CI [3.91, 5.07])
in 2020 and 10.36 million deaths (95% CI [9.06, 11.97]) in 2021 (4, 5). With just over 13% of the world’s
population, the Americas contributed 30.5% and 18.0% of the excess mortality associated with COVID-19 in
2020 and 2021, respectively. In 2021, while the global excess mortality among women younger than 50 years
was 3.2%, in the Americas, it was 3.5% (5). It soon became evident that pregnancy constitutes an independent
risk factor for severe COVID-19 disease; and the pandemic resulted in a critical impact on maternal health in
several countries in the Region of the Americas (6, 7).

Pregnant women and birthing persons are a high-priority vaccine use group because of the risk of severe
COVID-19 disease and complications on the pregnant woman and birthing person, the fetus, and their infants.
During the first clinical trials for COVID-19 vaccines, pregnant women were excluded from the study
population. This initial lack of data and fear of potential vaccine safety issues in pregnant women and their
offspring contributed to this population’s low initial vaccination coverage. Despite consistent evidence
demonstrating the effectiveness and safety of maternal immunization against COVID-19, the uptake remains
lower compared to nonpregnant women of childbearing age (8–10).

2. COVID-19 burden among pregnant women and neonates

2.1. Morbidity and mortality among pregnant women

Pregnant women with COVID-19 are at increased risk of severe disease, as they have higher rates of admission
to hospitals and intensive care units (ICU), intubation, and death compared to nonpregnant women (7, 11–
14). As with the nonpregnant population, pregnant women have an increased risk of further complications if
they are 35 years or older, have a high body mass index (BMI), and have underlying comorbidities (e.g.,
diabetes or hypertension) (12, 15–17). In addition, pregnant women with COVID-19 have higher risks of
developing pregnancy complications, such as preeclampsia/eclampsia, hypertensive disorders during
pregnancy, thromboembolic disease, stillbirth, and preterm labor compared to pregnant women without
COVID-19 (13, 18, 19).

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The period dominated by the SARS-CoV-2 Delta variant notably impacted pregnant women (20, 21). During
the Delta variant period, the risk of ICU admission among pregnant women increased by 41% compared to
the pre-Delta period, while it increased by 9% for nonpregnant women. Pregnant women experienced a
substantially higher risk of invasive ventilation or extracorporeal membrane oxygenation (ECMO) during the
Delta period compared to the pre-Delta period (83% higher), while the risk increased by 34% in nonpregnant
women. Likewise, during the Delta period, the risk of death among pregnant women was 3.33 times higher
than in the pre-Delta period (22).

The risk of severe maternal disease in the period dominated by the SARS-CoV-2 Omicron variant was lower
compared to the period dominated by the Delta variant (20, 23). For example, the risk of maternal critical care
admission was substantially lower (0.3% vs. 1.8%) during the Omicron period compared to the Delta period.
Similarly, the risk of preterm birth within 28 days of infection was lower during the Omicron period (1.8% vs.
4.2%). Still, the period dominated by Omicron is particularly relevant given that this variant showed increased
transmissibility, evasion of immunity, and infant hospitalization (more details below) (24, 25).

Overall, SARS-CoV-2 infection in pregnant women carries considerable risks of morbidity and mortality
regardless of variant, particularly for pregnant women with comorbidities or unvaccinated (14, 20, 21).

2.2. Morbidity and mortality in neonates and infants

Neonates born to women with SARS-CoV-2 infection during pregnancy are at higher risk of adverse perinatal
outcomes. They are nearly three times more likely to be moderate preterm (<34 weeks) (RR 2.92, 95% CI [1.88,
4.54]) and have almost twice the risk of being born preterm (<37 weeks) (RR 1.71, 95% CI [1.28, 2.29])
compared to newborns of noninfected pregnant women (12, 13). Furthermore, they have an increased risk of
being born with low birthweight (<2500 g) (RR 1.19, 95% CI [1.02, 1.40]) and requiring admission to neonatal
intensive care units at birth (RR 1.86, 95% CI [1.12, 3.08]) (12, 13). The risk of being born with very low
birthweight (RR 1.67, 95% CI [1.07, 2.62]) was also higher in infants born to women with symptomatic COVID-
19 (RR 1.67, 95% CI [1.07, 2.62]) compared to infants born to women without COVID-19 during pregnancy (13).

Infants (0–1 year of age) can be infected through exposure to their infected mother or other caregivers. A
multi-country review found that 1% to 5% of newborns born to women infected with SARS-CoV-2 at delivery
were subsequently identified as having SARS-CoV-2 infection (16, 26–28). Overall, severe COVID-19 disease is
much less common in children compared to adults (29–31). However, studies indicate that infected
infants – compared to older children – have a higher risk of hospital admission but not to ICUs (32–34). This
increased hospitalization risk, therefore, may not necessarily reflect an increased severity of the illness. Infants
with underlying health conditions and a history of prematurity require special attention, as they particularly
face an increased risk of severe COVID-19 (35).

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Epidemiological surveillance reports have indicated a significant increase in COVID-19-associated
hospitalization rates among children during the Omicron period compared to the Delta period, with four times
higher rates (36). Since vaccination is not recommended in infants younger than 6 months old, maternal
immunization is critical to their protection (more details in section 4).

2.3. Vertical transmission and transmission of antibodies following maternal SARS-CoV-2 infection

Vertical transmission is defined as the transmission of the infectious pathogen from the mother to the fetus
during the antepartum and intrapartum periods or to the newborn during the postpartum period. A
systematic review that included 20 publications, with data from 222 newborns in whom the mother had a
suspected or confirmed SARS-CoV-2 infection, found no conclusive evidence of vertical transmission of the
disease (37). Although subsequent studies have confirmed vertical transmission, it remains a rare
phenomenon (38). Factors such as mode of birth and delayed cord clamping do not seem to impact the
likelihood of vertical transmission. Therefore, the performance of cesarean sections is not justified for this
reason (39, 40).

Vertical transmission of COVID-19 through breast milk is also very uncommon (41, 42). However, neonatal
infection from an infected mother or other caregivers is possible (43). The breast milk of infected mothers
contains antibodies against the virus and protects infants against COVID-19 and various infections (44–47).
Consequently, breastfeeding is recommended for all women, including those with suspected or confirmed
SARS-CoV-2 infection (40, 48–51). Potential aerial transmission should be minimized by wearing a mask and
practicing hand hygiene (43).

Good evidence indicates transplacental transmission of antibodies against COVID-19 following maternal
infection (52–55). Immunoglobulin G (IgG) presence was observed in umbilical cord samples, with higher
levels observed when there is a longer interval between maternal infection and birth (52, 55, 56). Moreover,
research has shown that IgG antibodies can be detected in infant blood up to six months after birth following
maternal infection during pregnancy. However, the higher levels during childbirth tend to decline over time
(52, 55, 56).

3. COVID-19 vaccines in pregnancy

Despite the absence of adverse outcomes in DART studies, pregnant women were initially excluded from
clinical trials investigating the safety and efficacy of COVID-19 vaccines. By early 2021, after several
epidemiological alerts made evident that pregnant women were at significantly higher risk of severe disease
compared with nonpregnant women (7), some professional associations, such as the American College of
Obstetrics and Gynecology (ACOG), Royal College of Midwives (RCM), and The Royal College of Obstetricians

5
and Gynaecologists (RCOG) recommended the COVID-19 vaccine to pregnant women and birthing persons
who were at very high risk of infection, such as healthcare workers. They also emphasized that pregnant
individuals who opted for vaccination should not be denied access (57–60). In July 2021, several organizations,
including WHO, PAHO, U.S. Centers for Disease Control and Prevention (CDC), ACOG, and the International
Federation of Gynecology and Obstetrics (FIGO), based on the growing benefit/risk analyses, recommended
that pregnant women and birthing persons be included among the priority groups for vaccine
administration (61–64). Since then, multiple evaluations have been carried out to assess the effectiveness and
safety of these vaccines, both in mothers and newborns. As described in more detail in the following sections,
COVID-19 vaccines have consistently been found to be safe in pregnancy and the postpartum
period (9, 14, 65–70). In addition, the efficacy of the vaccines in pregnant women is not different from that
seen in nonpregnant population, with the added benefit that infants born to vaccinated mothers have a lower
risk of severe COVID-19 and hospitalization when compared with infants born to nonvaccinated
mothers (25, 71–73).

The delays in generating evidence on the effectiveness of vaccines among pregnant women and the
development of recommendations are challenges to overcome to better position healthcare teams in the
future.

3.1 Types of COVID-19 vaccines

According to the WHO vaccine tracking report (consulted on 20 June 2023), more than 183 COVID-19 vaccines
are in the clinical development phase, and 199 are in the preclinical pipeline (74). As of May 2023, there are
currently 14 vaccines approved by WHO for emergency use among adolescents and adults, including two types
of bivalent vaccines (original variant + Omicron sublineage BA.1 or BA.4/BA.5) (75).

Messenger RNA (mRNA) vaccines. These are the vaccines for which there is a more extensive body of
evidence on safety and effectiveness when administered during pregnancy. These vaccines use genetically
modified mRNA to provide the recipient’s cells with instructions on how to produce the spike protein found
on the surface of the SARS-CoV-2 virus. After being read, the mRNA is destroyed. Immune cells then generate
a response to the spike protein, creating the antibodies that provide immunity to SARS-CoV-2. This group
includes the vaccines manufactured by Moderna (mRNA-1273/Spikevax) and Pfizer-BioNTech
(BNT162b2/COMIRNATY) and their bivalent formulations.

Protein subunit vaccines. These vaccines use subunits of the spike protein of SARS-CoV-2. Some vaccines also
contain another ingredient called an adjuvant that helps the immune system better respond to the spike
protein. It is a proven and known safe type of vaccine to give in pregnancy since most vaccines administered
during pregnancy are protein-based vaccines. Such vaccines are manufactured by Novavax (NVX-
CoV2373/Nuvaxovid) and Serum Institute of India (NVX-CoV2373/Covovax).

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Inactivated virus vaccines. In this case, vaccines include viruses that are not infective but retain the ability to
elicit antibodies that will recognize the virus in a future infection and protect against COVID-19. Inactivated
vaccines are not live and cannot replicate. These vaccines cannot cause disease, even in an immunodeficient
person. Vaccines of this type are produced by Sinovac (Coronavac), BIBP (Sinopharm), and Bharat Biotech
(Covaxin).

Viral vector vaccines. This group of vaccines uses an adenovirus vector to introduce DNA of the SARS-CoV-2
spike protein. The DNA is first copied into mRNA, and then, as is the case with mRNA vaccines, the mRNA is
used to produce copies of the spike protein, which then stimulates the immune system to create antibodies.
This group includes the COVID-19 vaccines produced by Janssen (Ad26.COV2.S/JNJ), AstraZeneca
(AZD1222/Vaxzevria), Serum Institute of India (ChAdOx1_nCoV-19/Covishield), and CanSino (Ad5-nCoV-
S/Convidecia).

Recommendations state that pregnant women and birthing persons can receive all types of COVID-19
vaccines. However, because of the rare risk of vaccine-induced immune thrombosis with thrombocytopenia
syndrome (VITT) associated with adenoviral vector vaccines when administered in younger individuals, other
types of vaccines should be the preferred choice for pregnant women and birthing persons (see section 5:
Safety of COVID-19 vaccines in pregnancy) (76, 77). If other types of vaccines are unavailable, young pregnant
women and birthing persons who receive adenoviral vector vaccines should be informed about the risk and
symptoms of thrombosis with thrombocytopenia syndrome and when to seek immediate medical care.

WHO has recently incorporated a new COVID-19 vaccine manufactured by SK Bioscience (recombinant protein
subunit/SKYCovione-GBP510). Due to the current lack of guidance regarding this vaccine’s administration to
pregnant women and birthing persons, it has not been included in the tables describing vaccines
characteristics.

4. Immunogenicity and effectiveness

COVID-19 vaccination during pregnancy elicits a strong immune response and has demonstrated high
effectiveness within 2–20 weeks after administration, comparable to that observed in nonpregnant
individuals (65, 78, 79). Studies have shown that maternal immunization against COVID-19 protects pregnant
women against severe disease, intensive care unit admission, and death, especially when complete
vaccination regimens and booster doses are administered. Increasing vaccine effectiveness through complete
schemes and boosters is particularly important during periods dominated by the Omicron variant (14, 80).
Conversely, evidence shows that the majority of pregnant women hospitalized with symptomatic COVID-19
(96%) and those requiring intensive care due to severe illness (98%) were unvaccinated (81, 82). Furthermore,

7
emerging evidence has shown that COVID-19 immunization reduces the risk of stillbirth and severe COVID-19
infections in young infants, mainly when a booster dose is administered during pregnancy (25, 71).

COVID-19 vaccines are not recommended in infants younger than 6 months old. Infants rely on antibodies
derived from their mothers through the placenta or breast milk to resist infections in early life. Maternal
immunization during pregnancy and lactation with COVID-19 vaccines confer protective immunity to
newborns through placental transfer and breast milk, with the highest antibody levels achieved through
completing the primary series and receiving a booster dose (83–85). Studies have demonstrated the presence
of SARS-CoV-2 specific IgG and secretory immunoglobulin A (IgA) in the breast milk of vaccinated mothers and
T cells specific to SARS-CoV-2. This can benefit the infant by protecting them against severe COVID-19 (86, 87).
Maternal immunization against COVID-19 has been shown to reduce the risk of infant hospitalization for
COVID-19 during the first six months of life, compared to infants born to unvaccinated mothers (25, 71).
Additionally, infants of vaccinated mothers are less likely to test positive for COVID-19 in the first four months
of life (88). Booster doses among pregnant women and birthing persons are particularly important to enhance
vaccine effectiveness to protect infants, especially against the Omicron variant, for which vaccine
effectiveness is lower than the Delta variant (25, 85).

5. Safety of COVID-19 vaccines in pregnancy

All available COVID-19 vaccines have a good safety profile during all three pregnancy trimesters, postpartum,
and lactation periods (14, 87, 89). Given the high risks associated with the infection during pregnancy, COVID-
19 immunization has been offered to all pregnant women regardless of gestational age (68, 90, 91). The basis
for this recommendation came from benefit–risk assessment and developmental and reproductive toxicology
(DART) studies showing no teratogenic concerns in animals. These studies were conducted for all the COVID-
19 vaccines with WHO interim recommendations and did not show any harmful effects of vaccination in
pregnant animals and their offspring (63). In addition, cumulative pharmacovigilance evidence after
introducing vaccines has not identified any safety concerns in adverse pregnancy-related outcomes associated
with vaccination.

Safety surveillance systems were established for real-time follow-up of safety. In several countries where large
numbers of COVID-19 vaccines are being given during pregnancy, pregnant women are being monitored and
evaluated for any safety issues. Real-world data from more than 1 500 000 pregnant women showed no safety
concerns on several COVID-19 vaccines monitored in the United States, Canada, Brazil, the United Kingdom
and India: Moderna (mRNA-1273/Spikevax), Pfizer-BioNTech (BNT162b2/COMIRNATY), Janssen
(Ad26.COV2.S/JNJ), Sinovac (Coronavac), AstraZeneca (AZD1222/Vaxzevria), and Bharat Biotech (Covaxin) (8,
63, 68, 69, 92). Based on these data, the United States CDC, PAHO/WHO, and other agencies recommended
immunizing pregnant women and birthing persons against SARS-CoV-2 with selected approved vaccines
(61, 63, 64, 93). Cumulative evidence of post-authorization research and surveillance consistently showed no

8
evidence of harmful effects when the vaccine is administered during pregnancy on embryo/fetal
development, pregnancy outcome – including miscarriage, stillbirths, congenital anomalies, preterm births,
small for gestational age, Apgar score, or neonatal intensive care unit (NICU) admission or short-term
postnatal development, regardless of the trimester women were vaccinated (9, 68, 69, 94 - 99).

Table 1 lists all COVID-19 vaccines with WHO Emergency Use Listing. Regarding the vaccine platform, mRNA
vaccines have been reported to prevent infection effectively and are considered safe for pregnant women and
their offspring, leading WHO to primarily recommend them to pregnant women and birthing persons (101,
105). These vaccines (mRNA) have accumulated substantial safety data, which is unusual for many other
vaccines except for influenza vaccines. As for the other platforms and vaccines (Janssen – Ad26.COV2.S/JNJ,
AstraZeneca – AZD1222/Vaxzevria, Serum Institute of India – ChAdOx1_nCoV-19/Covishield, CanSino – Ad5-
nCoV-S/Convidecia, Novavax – NVX-CoV2373/Nuvaxovid, Serum Institute of India – NVX-CoV2373/Covovax,
Sinovac – Coronavac, BIBP – Sinopharm, and Bharat Biotech Covaxin), given that they have lower cumulative
published evidence, WHO recommends them when mRNA vaccines are not available, whenever the benefits
of immunization outweigh their potential risks (102).

Given the safety profile of these vaccines, pregnancy testing before administering the vaccine or delaying or
interrupting pregnancy because of vaccination is not recommended (63). In addition, they can be safely
administered to postpartum and breastfeeding women and birthing persons, as to other adults, and it is not
recommended to discontinue breastfeeding because of vaccination (63).

Table 1. COVID-19 vaccines with WHO Emergency Use Listing (EUL)

WHO safety
Platform WHO EUL holder Vaccine
recommendation
COMIRNATY®
COVID-19 mRNA vaccine (nucleoside modified)
COMIRNATY® Original/Omicron BA.1 COVID-19
Pfizer BioNTech WHO recommends the use
Messenger RNA mRNA vaccine (nucleoside modified)
of these vaccines in
(mRNA)
COMIRNATY® Original/Omicron BA.4 COVID-19 pregnant women and
vaccines
mRNA vaccine (nucleoside modified) birthing persons.

SPIKEVAX
Moderna Biotech
COVID-19 mRNA vaccine (nucleoside modified)
NUVAXOVID WHO recommends using
Protein subunit
Novavax COVID-19 vaccine (SARS-CoV-2 rS [recombinant, these vaccines in pregnant
vaccines
adjuvanted]) persons when the benefits

9
 COVOVAX of vaccination to the
Serum Institute of
COVID-19 vaccine (SARS-CoV-2 rS protein pregnant woman or birthing
India
nanoparticle [recombinant]) person outweigh the
Beijing Institute potential risks. To help
of Biological Sinopharm pregnant women and
Products Co., Ltd. Inactivated COVID-19 vaccine (Vero cell) birthing persons make this
Inactivated (BIBP) assessment, they should be
virus vaccines Sinovac Life CoronaVac provided with information
Sciences Co., Ltd COVID-19 vaccine (Vero cell), inactivated about the risks of COVID-19
in pregnancy, the likely
Bharat Biotech COVAXIN COVID-19 vaccine (whole virion
benefits of vaccination in
International Ltd inactivated coronavirus vaccine)
the local epidemiological
VAXZEVRIA context, and the current
AstraZeneca AB
COVID-19 vaccine (ChAdOx1-S [recombinant]) limitations of safety data in
Serum Institute of COVISHIELD pregnant women and
Viral vector birthing persons.
India Pvt. Ltd COVID-19 vaccine (ChAdOx1-S [recombinant])
vaccines
(adenovirus)** Janssen–Cilag
COVID-19 vaccine (Ad26.COV2-S [recombinant])
International NV
CanSino Biologics CONVIDECIA
Inc. COVID-19 Vaccine (Ad5-nCoV-S [recombinant])
*Note: Only WHO Emergency Use Listing (EUL) vaccines are included in this table.

Common side effects after COVID-19 vaccination can be observed in pregnant women and birthing persons,
similar to those observed in nonpregnant individuals, with injection site pain, fatigue, headache, and myalgia
being the most common symptoms (103, 104). Common side effects are usually mild to moderate, occur
within 24–48 hours after immunization, and resolve within one to two days. Although routine prophylaxis
with paracetamol (acetaminophen) is not recommended in some countries, pregnant patients can take
paracetamol (acetaminophen) to manage the most common symptoms if they experience fever after
receiving the vaccines (105).

Adverse events after COVID-19 vaccination are rare. Below there is a summary of them:

 Severe allergic reaction following the administration of a COVID-19 vaccine. Severe allergic reactions are
infrequent with mRNA vaccines (1.1–2.5 per million doses administered) and include anaphylaxis, which
usually includes urticaria, but may also include other symptoms such as wheezing, respiratory distress, or
hypotension (anaphylactic shock) (111–113). Patients may also present with angioedema (involving the
tongue, uvula, or larynx). Finally, they may present a diffuse rash also involving the mucosa (of the type of
the Stevens–Johnson syndrome). Anaphylaxis was even less frequent after viral vector vaccines (109, 110).
A history of anaphylaxis does not preclude immunization against COVID-19; however, the
recommendation states that people should receive the vaccine in a medical setting where anaphylaxis can
be managed promptly.

 A rare syndrome of vaccine-induced thrombosis and thrombocytopenia (VITT) has been reported after
administrating adeno-vectored COVID-19 vaccines (Janssen – Ad26.COV2.S/JNJ, AstraZeneca

10
 – AZD1222/Vaxzevria, and Serum Institute of India – ChAdOx1_nCoV-19/Covishield), which is an
idiosyncratic immune reaction with considerable morbidity and mortality (111–114). It usually presents 5–
28 days after the first dose, more commonly in adults under 50 years old. Published estimates of the risk
of VITT range from 1 case per 26 500 to 127 300 first doses of ChAdOx1 nCoV-19 (115, 116) and 1 case per
263 000 doses of Ad26.COV2.S (117). The risk of VITT after the second dose of ChAdOx1 nCoV-19 is lower
and estimated at 1 case per 518 181 second doses administered (118). Available evidence does not signal
an increased association of VITT with any classic venous thromboembolism risk factors (such as pregnancy,
hormonal contraceptives, or other estrogen therapy) (111–113). The risk of developing VITT is the same
for pregnant and nonpregnant women. Comparatively, the reported incidence of thromboembolic risk in
pregnant women with SARS-CoV-2 infection is 1 case per 5000 pregnancies (similar no nonpregnant
women), with a lethality rate of 4.4 per 100 women with VTE and SARS-CoV-2 infection, without
thromboprophylaxis (119). Several countries recommend offering nonviral-vectored vaccines to
individuals under 40 years old based on this age group’s risk/benefit assessment (76, 77).

 The development of myocarditis or myopericarditis following the mRNA vaccine was reported, although it
is rare (incidence 0.01%) and lower than the risk of developing myocarditis or pericarditis following COVID-
19 infection (incidence 0.05%) (120, 121). This condition is more clearly associated with Moderna (mRNA-
1273/Spikevax) vaccine than Pfizer-BioNTech (BNT162b2/COMIRNATY) vaccine (122). Cases of myocarditis
and pericarditis have occurred most frequently in adolescent and young adult males within seven days
after receiving the second dose of an mRNA COVID-19 vaccine. However, cases have also been observed
after dose one and booster doses. The myocarditis and pericarditis following COVID-19 vaccines are
predominantly benign, self-limited disease with no long-term effects (127).

6. Uptake of the COVID-19 vaccines among the pregnant population

By the end of 2022, among the 18 countries that reported COVID-19 vaccine coverage to PAHO, the
vaccination coverage for the general population was 70.6% and 23% among the pregnant population (personal
communication with PAHO officer). A recent publication showed that nearly 100% of pregnant women know
that COVID-19 vaccines are available (123). However, a study that included multiple countries – United States,
India, Brazil, Russia, Spain, Argentina, Colombia, United Kingdom, Mexico, Peru, South Africa, Italy, Chile, and
the Philippines – showed that only 52% (n = 2747) of pregnant women intended to receive the COVID-19
vaccine if a 90% vaccine efficacy rate was achieved. Responses among pregnant women varied substantially
by country (range: 28.8–84.4%) (124).

Pregnant women report vaccine hesitancy mainly because of concern about the vaccine’s safety in pregnancy
and for their offspring (123, 125). Other reasons include not accepting other recommended vaccines in
pregnancy (e.g., influenza), concern about future fertility, including the belief that natural immunity is

11
safer (105). Conversely, a factor that seems to favor the attitude toward vaccination against COVID-19 among
pregnant women is having previously received vaccines against other viruses; for example, against
influenza (126). Hence, it is essential to support pregnant women and birthing persons across the continuum
of prenatal and perinatal care, involving maternity teams and developing activities to foster social support,
patient-centered education, with emphasis on infection prevention, increased risk perception, and the
effectiveness and safety of the recommended vaccines. This is particularly relevant now that the end of the
global public health emergency of COVID-19 has been declared (see section 10: End of COVID-19 public health
emergency of international concern). The observed decreasing trends in COVID-19 hospitalizations, ICU
admissions, and deaths may lower the risk perception of pregnant women and their health professionals,
putting at risk the already low COVID-19 vaccination levels in this high-risk population.

7. COVID-19 vaccine contraindications in pregnant women and birthing persons

There are no specific contraindications to COVID-19 vaccination in pregnant or lactating women and birthing
persons. Contraindications to COVID-19 vaccination in pregnancy are similar to those for nonpregnant
individuals. They are related to a known history of allergy to any of the components of the COVID-19 vaccine.
In this regard, some components, such as polyethylene glycol (PEG), present in both COVID-19 mRNA vaccines
and polysorbate 80, present in Novavax and Janssen COVID-19 vaccines, may trigger cross-
hypersensitivity (108).

In cases of a history of allergic reaction following COVID-19 immunization, the recommendation is to avoid
immunization with the same vaccine that generated the previous reaction. The next dose can be of any type
of anti-COVID-19 vaccine, according to the SAGE heterologous schedule recommendations (127).

When the administration of anti-D immunoglobulin is required to prevent Rh disease, immunization against
COVID-19 should be postponed for the following four weeks (61).

8. COVID-19 vaccine recommendations during pregnancy and the postpartum period

On 30 March 2023, the WHO Strategic Advisory Group of Experts (SAGE) published a roadmap on the uses of
COVID-19 vaccines in the context of the Omicron variant and substantial population immunity due to
increasing vaccine coverage and infection-induced immunity (128). These updated COVID-19 vaccine
recommendations identify pregnant women and birthing persons as a high priority-use group for COVID-19
vaccination because of the potential adverse effects of COVID-19 on the pregnant woman or birthing person,
the fetus, and the infant. If a pregnant woman or birthing person is unvaccinated, the primary series and
booster vaccination should be initiated as soon as possible. An additional booster dose should be given once
in pregnancy if the last dose was administered more than six months prior. For this additional booster dose,

12
vaccination in the mid-second trimester is preferred to optimize the protection of the pregnant woman or
birthing person, the fetus, and the infant. However, the vaccine can be safely given anytime during pregnancy
to avoid missing opportunities to vaccinate.

Box 1. COVID-19 vaccine recommendations for pregnant women and birthing persons

 Pregnant women are a high priority-use group for vaccination.

 Primary series and a booster are recommended in unvaccinated pregnant women and birthing
persons, as well as during the postpartum, and they should be initiated as soon as possible.
 An additional booster dose during pregnancy is recommended for vaccinated women and birthing
persons if the previous dose was >6 months ago, preferably in the mid-second trimester. However,
the vaccine can be safely given at any time during pregnancy to avoid missing opportunities to
vaccinate.
 Rationale for immunization during pregnancy is three-fold: to protect the pregnant woman or
birthing person, the fetus, and the infant up to the age of 6 months.

Immunization against COVID-19 is recommended regardless of the history of previous infection and without
requiring serologic testing, pregnancy testing, or medical recommendation prior to vaccination. Table 2
describes vaccines dosing and storage and provides links to more detailed information for each vaccine.

The composition of currently available COVID-19 vaccines is being updated to offer broader protection against
new variants of concern (129). Despite the potential benefit of variant-containing vaccines, current vaccines,
based on the index virus, maintain high vaccine effectiveness against severe disease in the context of the
Omicron variant and its sublineages (130). Bivalent boosters are very similar to the original monovalent
vaccine. The technology used and the basic components are the same (131). The only difference is that the
bivalent booster contains two components: in addition to the traditional booster, it adds components to
respond against BA.1 and BA.4-5 Omicron variants. Therefore, if available, bivalent booster doses can be
administered to pregnant and lactating women and birthing persons without counterindications. WHO
recommends using any of the WHO EUL COVID-19 vaccines or authorized mRNA bivalent variant-containing
vaccines for booster vaccination. When deciding which vaccine to use as a booster, each country needs to
consider access to and availability of different vaccines and their costs. Countries should not delay
implementing booster doses. Generally, there is greater benefit in ensuring that persons at high risk of
developing severe COVID-19 receive a booster than in delaying vaccination in anticipation of access to a
variant-containing vaccine (128).

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 Table 2. WHO Emergency Use Listing (EUL) vaccines dosing and storage

Link to
Storage
Platform WHO EUL holder and vaccine Recommended schedule detailed
requirements
information
Pfizer BioNTech COMIRNATY
More
COVID-19 mRNA vaccine (nucleoside Administered as a series of –75°C (–103°F)
Messenger RNA information
modified) two doses 4 to 8 weeks
(mRNA)
Moderna Biotech SPIKEVAX apart and a booster dose
vaccines More
COVID-19 mRNA vaccine (nucleoside after 4–6 months. –20°C (–4°F)
information
modified)
AstraZeneca VAXZEVRIA
COVID-19 vaccine (ChAdOx1-S Administered as a series of
[recombinant]) two doses 8 to 12 weeks More
5°C (41°F)
Serum Institute of India COVISHIELD apart and a booster dose information
COVID-19 vaccine (ChAdOx1-S after 4–6 months.
Viral vector [recombinant])
vaccines One or two doses. WHO
Janssen
(adenovirus) recommends providing two More
COVID-19 Vaccine (Ad26.COV2-S –20°C (–4°F)
doses with an interval of 2 information
[recombinant])
to 6 months.
CanSino CONVIDECIA Administered in one dose
More
COVID-19 vaccine (Ad5-nCoV-S and a booster after 4–6 5°C (41°F)
information
[Recombinant]) months.
Novavax NUVAXOVID
COVID-19 vaccine (SARS-CoV-2 rS Administered as a series of 5°C (41°F)
Protein subunit [recombinant, adjuvanted]) two doses 3–4 weeks apart More
vaccines Serum Institute of India COVOVAX and a booster dose after information
COVID-19 vaccine (SARS-CoV-2 rS 6 months. 5°C (41°F)
protein nanoparticle [recombinant])
Administered as a series of
BIBP Sinopharm
two doses 3–4 weeks apart More
Inactivated COVID-19 vaccine (Vero 5°C (41°F)
and a booster dose after 4– information
cell)
6 months.
Administered as a series of
Sinovac CoronaVac
Inactivated two doses 4 weeks apart More
COVID-19 vaccine (Vero cell), 5°C (41°F)
virus vaccines and a booster dose after 4– information
inactivated
6 months.
Administered as a series of
Bharat Biotech International COVAXIN
two doses 4 weeks apart More
COVID-19 vaccine (whole virion 5°C (41°F)
and a booster dose after 4– information
inactivated coronavirus vaccine)
6 months.

Coadministration with other vaccines

Countries should consider the coadministration of COVID-19 vaccines (including variant-containing vaccines)
with seasonal influenza vaccines whenever epidemiologically justified (128, 132, 133). Based on several
coadministration studies of COVID-19 vaccines and inferred from coadministration studies of other adult

14
vaccines, COVID-19 vaccines may be given concomitantly or at any time before or after other vaccines for
adults and adolescents, including live attenuated, inactivated, adjuvanted, or nonadjuvanted vaccines (128,
132, 133). The same applies to maternal immunization for vaccines recommended during pregnancy. When
administered concomitantly, the vaccines should be injected in separate sites, preferably in different
extremities.

Postpartum vaccination

In the context of the Omicron variant and substantial population immunity, it is recommended to offer
vaccination to women and birthing persons in the postpartum period and those who are breastfeeding,
following the same guidelines as the general nonpregnant population. WHO recommends considering healthy
younger women and birthing persons aged 18–49 in the postpartum period as a medium COVID-19 vaccine
priority-use group. This group should receive the primary vaccine series and the first booster dose, while
additional boosters are not routinely recommended. However, countries that have already implemented
policies for additional boosters should assess the evolving need based on national disease burden, cost-
effectiveness, and opportunity costs. On the other hand, younger adults with significant comorbidities such
as diabetes, chronic lung diseases, heart, liver, and kidney diseases, severe obesity, moderate to severe
immunocompromising conditions, and front-line health workers should receive an additional (second)
booster dose.

Healthy adolescents in the postpartum period under 18 years of age are considered a low priority-use group
for COVID-19 vaccination. Countries may consider providing the primary vaccine series and a first booster
dose for this group based on disease burden, cost-effectiveness, and other health and programmatic
priorities. WHO does not routinely recommend additional (second) booster doses. However, adolescents with
obesity or severe morbidity at a higher risk of severe COVID-19 should be considered a medium priority-use
group and receive the primary series and the first booster dose.

Table 3 outlines WHO’s recommendations for the optimal use of COVID-19 vaccination for primary series and
booster doses at the present time of dominant Omicron circulation and high population-level immunity. The
current recommendations and uses of COVID-19 vaccines may require reconsideration in the future, should
new variants arise that result in more severe illness or demonstrate increased immune evasion toward the
current vaccines or if the characteristics of available vaccines change substantially.

Table 3. WHO COVID-19 vaccine recommendations for women and birthing persons in the postpartum period

15
 Population (all postpartum) COVID-19 vaccine Primary series and booster Additional booster doses
priority-use
group

Adults and adolescents with High Recommended Recommended

moderate to severe
immunocompromising
conditions, significant
comorbidities, severe obesity,
and front-line health workers

Healthy adults (18–49 years old) Medium Recommended Not routinely recommended

Adolescents with severe obesity Medium Recommended Not routinely recommended

or comorbidities that put them at
higher risk of severe COVID-19

Healthy adolescents (<18 years Low Countries could consider Not routinely recommended
old) based on disease burden,
cost-effectiveness, and
other health or
programmatic priorities and
opportunity costs.
Note: “Not routinely recommended” means that such vaccines are not recommended for inclusion in routine programs
because of minimal public health impact and low cost-effectiveness in most settings. However, vaccination may be offered
in individual circumstances where added benefit is expected to be more substantial, as there are no known additional
safety issues associated with additional boosters. This recommendation acknowledges that some countries may elect to
offer such doses in the routine program based on population risks, disease epidemiology, or health priorities.

CDC, which provides guidance to the United States, recommends that all populations – including adult and
adolescent postpartum women and birthing persons – receive one dose of bivalent booster if unvaccinated
or previously vaccinated with monovalent vaccines (62).

As previously mentioned, immunization in lactating women and birthing persons is considered effective and
safe. Consequently, breastfeeding should not be postponed or interrupted when administering COVID-19
vaccines.

9. Recommendations for healthcare workers regarding COVID-19 vaccination during pregnancy

It is important for healthcare workers directly or indirectly involved in the care of pregnant women and
birthing persons to be aware of and implement the recommendations regarding vaccination against COVID-
19 during pregnancy. The following is some guidance for implementation:

1. It should be remembered that when a vaccine is introduced, the population must be provided with the
necessary information on its characteristics and benefits. This is achieved by designing and developing an
information, education, and communication (IEC) plan.

16
2. Professional bodies should be kept informed and permanently updated regarding immunization against
COVID-19 and other vaccines administered during pregnancy and the postpartum period so that they can
inform and promote the appropriate use of the vaccines.

3. Healthcare providers should know that maternal age, higher education, previous uptake of the influenza
vaccine, higher level of trust in the healthcare system, higher perceived risk of COVID-19, fertility
treatments, living in urban area, and higher socioeconomic status are factors positively associated with
vaccine uptake in pregnancy.

4. Similarly, healthcare workers should be aware that factors associated with lower odds of seeking
vaccination during pregnancy include younger maternal age, lower schooling, lower socioeconomic
status, and lack of adherence to influenza immunization recommendations.

5. The need to implement public health strategies focused on these at-risk groups is suggested due to their
previous negative experiences and distrust in the healthcare system.

6. Counseling of healthcare providers to pregnant women and birthing persons may be critical to the uptake
of COVID-19 vaccination during pregnancy (134).

7. In addition, several studies have shown that the recommendation of a healthcare provider is positively
associated with COVID-19 vaccination and is a predictor for immunization (69.4%) compared with the lack
thereof (38.5%) (p < 0.001) (135).

8. It is critical to ensure that health personnel have up-to-date information on the maternal and neonatal
safety of COVID-19 vaccines in pregnancy.

9. Equally important is for the health personnel to receive training in interpersonal communication to
appropriately respond to pregnant women’s and birthing persons’ questions, as these are necessary tools
to help guide their counseling. Therefore, it is recommended that COVID-19 vaccines be included in the
pregnancy counseling guide to remind healthcare workers to recommend them to pregnant women and
birthing persons. Likewise, special care should be taken to communicate the benefits of the vaccine to
populations with language or sociocultural barriers (e.g., Indigenous people, migrants, etc.).

10. Finally, it is important to emphasize that several essential aspects are still unknown or related evidence
is still insufficient. This raises, among others, the following questions:

 How much protection is transmitted to newborns transplacentally vs. via breast milk after maternal
vaccination?

 Does breastfeeding prolong the protection of infants beyond transplacentally acquired immunity?

 Does maternal immunization affect infant immune responses to active COVID-19 vaccination?

17
  Is vaccination in every pregnancy an option to ensure maternal and infant protection when SARS-
CoV-2 is endemic?

10. End of COVID-19 public health emergency of international concern

On 5 May 2023, WHO declared an end to the global health emergency of COVID-19 based on evidence showing
reduced risks to human health (136). This was based on the decreasing trends of COVID-19 hospitalizations,
ICU admissions, and deaths, as well as the high levels of population immunity from infection and vaccination.
However, acknowledging the remaining uncertainties posed by the potential evolution of SARS-CoV-2, WHO
advised not to reduce efforts while transitioning to long-term management of the pandemic.

To facilitate this transition, WHO issued the 2023–2025 COVID-19 Strategic Preparedness and Response Plan,
guiding countries in managing COVID-19 alongside other infectious diseases (137). Although COVID-19
remains an active threat and the global risk assessment remains high, countries are encouraged to integrate
COVID-19 surveillance and response into routine health programs. Key focus areas include integrating COVID-
19 vaccination into existing vaccination programs, ensuring the availability and supply of authorized vaccines,
diagnostics, and therapeutics, enhancing risk communication and community engagement efforts, and
supporting ongoing research to improve vaccines and understand post-COVID-19 conditions. These efforts
should include the pregnant and breastfeeding population.

It is important to note that the effort to vaccinate against COVID-19 continues beyond the end of the global
health emergency. Authorization of COVID-19 vaccines will continue, and commitment to expanding
vaccination coverage, especially for high-risk individuals – including pregnant women and birthing
persons – remains a priority, together with the administration of booster doses to enhance community
protection.

18
Box 2. Key messages: End of COVID-19 as a public health emergency

 WHO declared an end to the global health emergency of COVID-19 due to reduced risks to human health. Still,
COVID-19 remains an active threat given the remaining uncertainties regarding the potential evolution of
SARS-CoV-2.

 Transitioning to long-term management of the pandemic is advised and requires the integration of COVID-19
surveillance alongside other infectious diseases.

 Ongoing vaccination efforts, including the authorization of COVID-19 vaccines, should be maintained, along
with risk communication, community engagement, research support and expansion of vaccination coverage,
particularly among high priority-use groups – which include pregnant women and birthing persons.

Additional resources

Please visit COVID-19 Vaccination in the Americas – Toolkit for further guidance on recommendations,
planning, implementation, supplies, logistics, vaccine monitoring, training materials, vaccine-specific
resources, and integration of the COVID-19 vaccine into immunization programs.

19
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[back cover blurb]

This document is an annex to the Pan American Health Organization (PAHO) Maternal
Neonatal Immunization Field Guide. This annex incorporates relevant information on
COVID-19 vaccines to be considered by decision-makers who plan and/or coordinate
immunization programs, as well as for health professionals working in maternal-perinatal
health services at all health system levels. As in the original guide, the target audience for
this annex continues to be managers and staff of maternal and child health services,
immunization programs, health care providers, pregnant and lactating women and birthing
persons, and the media.

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