Guidance on COVID-19 Vaccine Including Pregnancy
SUMMARY:
The CDC does not currently recommend COVID-19 vaccination during pregnancy and the lactation period in the absence of other risk factors. However, ACOG and SMFM continues to recommend vaccination during pregnancy and lactation to mitigate the significant risks associated with COVID.
Pregnancy Counseling Points
- Counseling should include the following elements
- Available data on vaccine safety
- Potential side effects (e.g., site pain, headache, fatigue, fever and rarely allergic reactions including anaphylaxis)
- Risk of side effects not increased in pregnancy
- Pregnant patients have higher risk of moderate to severe disease
- Level of COVID-19 community transmission
Maternal and Obstetric Risk
- With symptomatic COVID-19, pregnancy is an independent risk factor compared to symptomatic non-pregnant patients for
- ICU admission: 3-fold increase
- Mechanical ventilation
- ECMO: 2 to 4 fold increase
- Death: 1.7 fold increase
- May increase preterm birth and stillbirth
- Other risk factors for severe COVID-19 disease include
- Cancer | Chronic kidney disease | COPD | Heart conditions | Immunocompromised state | Sickle cell disease | Smoking
- Hispanic or Latinx and Black patients are disproportionally affected by higher prevalence of COVID-19
- More severe maternal morbidity | Higher risk of death
Considerations for Administration During Pregnancy
- Pregnancy test prior to vaccination is not recommended
- No need to delay pregnancy following vaccine administration
- No trimester-specific indications at this time
Fetal Considerations
- mRNA vaccines
- Available data suggests low risk
- Rapid degradation (approximately 10 to 20 days)
- Does not enter the cell’s nucleus or become integrated into the DNA; therefore, “no risk of genetic modification to people receiving the vaccine”
- Maternal antibodies cross the placenta | May provide neonatal protection
CDC Adverse Event Data
- Healthcare providers are required to report certain adverse events following COVID-19 vaccination to the Vaccine Adverse Event Reporting System (VAERS)
- “Anyone can submit a report to VAERS – healthcare professionals, vaccine manufacturers, and the general public. VAERS welcomes all reports, regardless of seriousness, and regardless of how likely the vaccine may have been to have caused the adverse event.”
Breastfeeding
- Vaccination is recommended during lactation
- Counseling should provide balance with respect to lack of data vs the patients’ individual risk for infection and severe disease
- Although there is a lack of data “the theoretical risks regarding the safety of vaccinating lactating people do not outweigh the potential benefits of the vaccine”
Antibody Titers in Pregnancy
- Studies have demonstrated vaccine-induced antibody titers to be similar in pregnant women compared to nonpregnant women
- Transfer of antibodies to newborns following maternal vaccination may confer neonatal protection
- Vaccine-induced IgG is transferred to the neonate
- Higher umbilical cord blood titers are associated with longer time intervals from vaccination
- Second vaccine dose increases cord blood IgG levels
KEY POINTS:
- The COVID-19 vaccine should be recommended to all pregnant and lactating patients
- There is no preference for any particular approved vaccine
- Providers should discuss individual risks and benefits of the vaccine during pregnancy
- Safety profile from the CDC Adverse Event Monitoring site shows no increased risk of worse pregnancy outcomes post-vaccination
- COVID-19 vaccines and other vaccines may be administered together (e.g., flu or Tdap)
Learn More – Primary Resources
SMFM: Provider Considerations for Engaging in COVID-19 Vaccine Counseling With Pregnant and Lactating Patients
SMFM: COVID_Vaccine
SMFM Reaffirms COVID-19 Vaccination Recommendations During Pregnancy
CDC: COVID-19 Vaccines
ACOG Practice Advisory: COVID-19 Vaccination Considerations for Obstetric–Gynecologic Care
CDC: Vaccine Adverse Event Reporting System (VAERS)
Respiratory Support of Pregnant Women with COVID-19 Including Fetal Assessment Recommendations
SUMMARY:
Although overall respiratory management is similar for pregnant women with COVID-19 compared to the general population, there are certain issues that are unique to this group. In addition, fetal wellbeing needs to be taken into consideration. This expert review by Pacheco et al. (Green Journal, 2020) provides key management points for treating patients with COVID-19 related respiratory compromise during pregnancy.
Management Algorithm
Pregnant Patient with Confirmed or Suspected COVID-19 and SpO2 <94%
- Initial management
- Conventional O2 therapy*: Target range 94% to 96%
- Consider self-awake prone position
- Limit fluids
- Ensure airway expert is aware of patient
- If patient not improving using conventional oxygen delivery methods
- Start high-flow nasal cannula**: 60 L/min | FiO2 1.0 (100% O2)
- Monitor closely for 30 to 60 minutes
- If patient improves using high-flow nasal cannula
- Wean FiO2 first prior to flow
- Reduce flow 5 to 10 L/min every 4 to 6 hours when an FiO2 of 0.4 to 0.5 is reached
- Target SpO2 level >94%
- If patient still does not improve
- Consider intubation and invasive mechanical ventilation
*Conventional Oxygen Delivery Methods
- Conventional Nasal Cannula
- O2 flow: 1 to 6 L/min
- O2 concentration: 24% to 40%
- Conventional face mask
- O2 flow: Set between 5 and 10 L/min
- O2 concentration: Typically 40%
- Venturi mask
- Same as conventional face mask, but operator has more control over FiO2
- Partial rebreather mask
- O2 concentration: 60% to 70%
- Nonrebreather mask
**Requirements for high-flow nasal cannula
- Ensure patient is
- Hemodynamically stable with normal mental status
- Can protect her own airway: Clear own secretions and good cough reflex
KEY POINTS:
Fetal Assessment for Patients with COVID-19 Respiratory Failure
- <23 to 24 weeks
- Fetal monitoring is not recommended
- Stable and on conventional oxygen delivery system or high-flow nasal cannula
- Mechanical ventilatory support
- 24 to 28 weeks: Individualize based on multiple clinical factors including EFW, NICU support, maternal body habitus and availability of PPE
- >28 weeks: Continuous monitoring
- If patient’s respiratory status is deteriorating
- Especially >28 weeks, the authors recommend:
…proceeding with a controlled delivery (likely cesarean) instead of awaiting fetal distress from refractory hypoxemia and needing an emergent delivery in the intensive care unit
Note: Authors caution that it is still important to weigh risks and benefits of fetal monitoring due to the significant risks associated with emergency cesarean delivery in patients with impaired respiratory function | Delivery “does not improve respiratory status of patients with acute respiratory failure” although authors acknowledge that this statement is based on limited evidence
Learn More – Primary Sources:
Early Acute Respiratory Support for Pregnant Patients With Coronavirus Disease 2019 (COVID-19) Infection
ACOG COVID-19 FAQs for Obstetrical Care
NOTE: Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date. This entry has been updated with additional information on counseling patients working in a non-healthcare setting.
SUMMARY:
ACOG has released FAQs that address common questions faced by obstetrical care professionals. The recommendations in this document reinforce CDC guidance and clarify some issues specific to obstetrics. Below are highlighted FAQs from the document (please see ‘Learn More – Primary Sources’ below for link to complete document)
Masks
For Pregnant Women
- Not fully vaccinated
- Wear a mask or cloth face covering in public and when around people outside of the household
- ACOG recommends the above particularly when social distancing may not be doable
- Fully vaccinated
- Follow CDC guidance | However, some pregnant women may wish to continue using masks and should be supported
- Healthcare settings, schools, public transport
- Regardless of vaccine status, precautions including mask or cloth face covering should be used
- CDC specifies cloth vs surgical masks or respirators, which should be reserved for healthcare personnel
Health Care Professionals (CDC Guidance)
- Source control options (prevent spread of respiratory secretions when breathing, talking, sneezing or coughing) for HCP include
- NIOSH-approved N95 or equivalent or higher-level respirator or
- A respirator approved under standards used in other countries that are similar to NIOSH-approved N95 filtering facepiece respirators (note: these should not be used instead of a NIOSH-approved respirator when respiratory protection is indicated) or
- A well-fitting facemask
- When used solely for source control, any of the options listed above could be used for an entire shift unless they become soiled, damaged, or hard to breathe through
- If masks used for protective equipment (PPE) (e.g., NIOSH-approved N95 or equivalent or higher-level respirator during the care of a patient with SARS-CoV-2 infection, facemask during a surgical procedure or during care of a patient on Droplet Precautions) then discard after the patient care encounter
- Healthcare providers should use PPE, including respirators or face masks, goggles, gowns and gloves | N95 respirators should be used for aerosol-generating procedures
- ACOG states that “COVID-19 infection is highly contagious, and this must be taken into consideration when planning intrapartum care”
KEY POINTS:
Clinical Guidelines that Remain Unchanged
Continue to Manage According to Current Clinical Guidance
- Timing of delivery
- COVID-19 should generally not impact timing of delivery
- Exception: If a woman is infected in the third trimester and there are no medical indications to the contrary, “it is reasonable” to try and postpone delivery until there is a negative test result or quarantine lifted
- Induction of labor
- Operative delivery
- Mode of delivery
- Delayed cord clamping
- Antenatal fetal testing
- Antenatal fetal surveillance
- Detailed mid-trimester anatomy scan “may be considered” after pre-pregnancy or first-trimester maternal infection
- Interval growth assessments “could be considered depending on the timing and severity of infection”
- Timing and frequency of ultrasound should take in to account clinical setting and additional maternal risk factors
Antenatal Fetal Surveillance: Additional Considerations
- Antenatal fetal surveillance
- Detailed mid-trimester anatomy scan “may be considered” after pre-pregnancy or first-trimester maternal infection
- Interval growth assessments “could be considered depending on the timing and severity of infection”
- Timing and frequency of ultrasound should take in to account clinical setting and additional maternal risk factors
Anti-SARS-CoV-2 Monoclonal Antibodies
Monoclonal antibodies are recommended by the NIH for use in the following clinical scenarios (see ‘Related ObG Topics’ below for NIH COVID Treatment Guidelines)
- For patients with mild to moderate COVID-19 who are at high risk of clinical progression
- Start treatment as soon as possible after positive SARS-CoV-2 antigen or NAAT report becomes available and within 10 days of symptom onset
- Post-exposure prophylaxis (PEP) should be considered for inadequately vaccinated individuals who have been exposed to SARS-CoV-2
- These individuals include those who have had a recent exposure to an individual with SARS-CoV-2 for a cumulative total of ≥15 minutes over a 24-hour period or
- There is a recent occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting AND are 1) not fully vaccinated or 2) fully vaccinated but may not mount an adequate immune response
- The NIH specifically addresses use of PEP in pregnancy and states
PEP should not be withheld from pregnant or lactating individuals who have been exposed to SARS-CoV-2, especially those with additional conditions that increase their risk of progressing to severe disease
Pregnant or lactating patients and their providers should determine whether the potential benefits of the drugs outweigh the potential risks
- ACOG supports the use of monoclonal antibodies in both clinical scenarios (risk for progression or PEP) and states the following
Pregnancy is included among the conditions that put individuals at high risk for clinical progression
This makes patients with pregnancy as their only risk factor eligible to receive outpatient monoclonal antibodies, according to the EUA (NIH)
Obstetric care clinicians may consider the use of monoclonal antibodies for the treatment of non-hospitalized COVID-19 positive pregnant individuals with mild to moderate symptoms, particularly if one or more additional risk factors are present (eg BMI >25, chronic kidney disease, diabetes mellitus, cardiovascular disease)
Lactation is not a contraindication for the use of monoclonal antibodies
Note: Some monoclonal antibodies that were effective against previous variants have limited effectiveness against Omicron variant and therefore ACOG recommends “physicians should consult their facilities as to which monoclonal antibody therapies against SARS-CoV-2 infection are available for treatment options”
SARS-CoV-2 Protease Inhibitors in Pregnancy
PAXLOVID
- Oral medication
- Includes nirmatrelvir (SARS-CoV-2 main protease inhibitor) and ritonavir (HIV-1 protease inhibitor and CYP3A inhibitor)
- Available only under emergency use authorization (EUA)
- Recommended for the treatment of outpatients with mild to moderate COVID-19 infection who
- Have a positive SARS-CoV-2 viral test
- Are at higher risk of clinical progression
- Pregnancy
- Pregnancy is a risk factor for clinical progression and therefore meets criteria for use of medication use, particularly if other high risk factors are pregnant (e.g., diabetes)
- Lactation
- Breastfeeding is not a contraindication to use and can be used as indicated in this population
- Dosage
- Start as soon as possible following diagnosis and within 5 days of symptoms
- The dose for patients with normal renal function is nirmatrelvir 300 mg (two 150 mg tablets) plus ritonavir 100 mg (one 100 mg tablet) orally twice daily for 5 days
Note: There is risk for drug interactions including mediations used in pregnancy (e.g., nifedipine) | ACOG recommends that “Prescribing clinicians should consult the full prescribing information prior to and during treatment for potential drug interactions”
Fetal Risks
- Nirmatrelvir
- Human study data
- None available but observational data has not demonstrated increased risk for birth defects
- Animal studies
- Reduced fetal body weights noted among pregnant rabbits at doses 10 times higher than comparable typical human exposure
- Ritonavir
- Used commonly for management of HIV during pregnancy, suggesting acceptable safety profile
Note: ACOG states that “short-term exposure to these medications must be balanced against the maternal and fetal risks associated with untreated COVID-19 in pregnancy”
PPH: Use of TXA and Hemabate
TXA
- COVID-19 appears to be a hypercoagulable state
- TXA can be considered for the treatment of PPH in keeping with guidance for non-COVID-19 patients
- However, the document states
Because of the possible additive effect of the increased risk of thrombosis from COVID-19 infection and the hypercoagulative state of pregnancy, it may be prudent to consider this increased likelihood of clotting before adminisitering TXA for postpartum hemorrhage
Hemabate
- While Hemabate is not used in asthma due to risk for bronchospasm, patients with COVID-19 have respiratory symptoms consistent with viral pneumonia
- While there is no data specific to COVID-19 and this medication, “Hemabate is not generally withheld” in patients with viral pneumonia
Visitation Policies During COVID-19
- Visitation policy decisions are ultimately guided by
- Local facilities and capabilities (e.g., physical space, equipment)
- Community spread and prevalence
- Governmental regulations and recommendations at multiple levels
- ACOG recommends that for both inpatient and outpatient
- Reduce number of visitors to minimum necessary
- Limit to those individuals “essential for the pregnant individual’s well-being (emotional support persons)”
- Screen all visitors for symptoms of respiratory illness
- Patient should be attended to by an asymptomatic visitor
- A visitor with fever or respiratory symptoms should not accompany the patient
- Additional support persons
- Encourage the use of alternative forms of interaction (e.g., video-call apps)
- Counseling patients and families regarding restrictive visitation policies
- Acknowledge value of support persons
- Explain the temporary nature of the policies and that they are in place to protect everyone’s safety, including the patient, baby and community at large
- Special considerations for underserved communities
- Support systems including support persons are especially important throughout the delivery journey, including postpartum care
- ACOG states that
…institutions should be mindful of how restrictions might differentially and negatively affect these communities, which in many areas are also disproportionately affected by COVID-19
Learn More – Primary Sources:
COVID-19 FAQs for Obstetrician-Gynecologists, Obstetrics
Infection Control: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) | CDC
