Clinical Considerations for Special Populations

People who are moderately or severely immunocompromised

Risk

People with immunocompromising conditions and people who take immunosuppressive medications or therapies are at increased risk for severe outcomes from COVID-19 ^{[1, 2]}including:

• Hospitalization
• Intensive care unit admission
• Mechanical ventilation
• Death

Studies show that people with hematologic or solid organ cancer, with hematopoietic stem cell or solid organ transplant, and who are taking immunosuppressive medications can experience lower vaccine effectiveness than those who are immunocompetent.^{[3, 4, 5]} However, studies suggest administering a third vaccine dose as part of the initial series and more than one dose of an updated COVID-19 vaccine, can increase immune response and protection against severe illness. ^{[6, 7, 8]}

Additional Protection

Pre-exposure prophylaxis (prevention) medication is available for some people who are moderately or severely immunocompromised. Pre-exposure prophylaxis helps prevent COVID-19 but does not take the place of vaccination in people who are eligible to receive an updated COVID-19 vaccine. Everyone ages 6 months and older should stay up-to-date with their COVID-19 vaccines. For more information, please see the FDA Fact Sheet for Providers.

Pemivibart (Pemgarda™) is a monoclonal antibody for COVID-19 pre-exposure prophylaxis for people who:

• Are moderately or severely immunocompromised,
• Unlikely to mount an adequate immune response to COVID-19 vaccination, and
• Meet the FDA-authorized conditions for use

Pemivibart may provide another layer of protection against COVID-19 in addition to the protection provided through vaccination. It can be given at least 2 weeks after receiving a COVID-19 vaccine.

Pemivibart is administered as a single intravenous infusion, over 60 minutes at a doctor's office or healthcare facility. If continued protection is needed, additional doses should be administered every 3 months. Pemivibart is still being studied and there is limited information about the safety and effectiveness of pemivibart in preventing COVID-19.

Treatment

There are several therapeutics available, including:

• The oral antiviral medication ritonavir-boosted nirmatrelvir (Paxlovid)
• The intravenous antiviral remdesivir
• The oral antiviral molnupiravir (Lagevrio)

These therapeutics are beneficial in this population for early treatment of COVID-19. Treatment is best initiated as soon as possible after diagnosis and within 5 to 7 days after illness onset.

The FDA has issued an emergency use authorization (EUA) for COVID-19 convalescent plasma (CP) with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19. CP is recommended for patients with immunosuppressive disease or patients receiving immunosuppressive treatment. CP may be administered in an outpatient or inpatient setting. For more information, please see the FDA Fact Sheet for Providers.

Management

Recommendations on who should be considered for CP and clinical information on treating patients with CP who have immunocompromising conditions, can be found in the Infectious Diseases Society of America (IDSA) Guidelines on the Treatment and Management of Patients with COVID-19. There are additional guidelines about COVID-19 vaccines, and prioritization for therapies specific to this population.

Pregnancy and recent pregnancy

Risk

Pregnant and recently pregnant people (at least 6 weeks following the end of pregnancy) are at increased risk of severe illness from COVID-19, ¹²including:

• Hospital admission
• Intensive care unit admission
• Receipt of invasive mechanical ventilation
• Extracorporeal membrane oxygenation

Race and ethnicity, 234older maternal age, working in a healthcare setting, and number and type of underlying conditions are associated with severe COVID-19 illness among pregnant people. ²⁵⁶

Data from meta-analyses 78910and observational studies 61112suggest that, compared to pregnant people without COVID-19, pregnant people with COVID-19 are at increased risk of preterm birth and stillbirth and might be at increased risk of pregnancy complications, including pre-eclampsia.

In addition, compared to recently pregnant people without COVID-19, those with COVID-19 are at increased risk for postpartum complications, including hospital readmission. ¹³¹⁴ However, methods for defining the period of recent pregnancy vary from study to study. While some include people with COVID-19 immediately after delivery, others include people with COVID-19 up to at least 6 weeks after a live birth or pregnancy loss.

Treatment

It is not recommended to withhold COVID-19 treatment from pregnant or lactating individuals because of theoretical safety concerns. For more information on treating COVID-19 in pregnant people, see the IDSA guidelines on initiating remdesivir and nirmatrelvir/ritonavir (Paxlovid).

Management

In general, the therapeutic management of pregnant people with COVID-19 is the same as management of people who are not pregnant.

Multisystem Inflammatory Syndrome

Pediatric populations

Risk

The initial clinical presentation of COVID-19 in children can include:

• Fever
• Cough
• Other respiratory symptoms

Many children also experience gastrointestinal symptoms 1516including:

• Nausea
• Vomiting
• Diarrhea

Viral tests are recommended for diagnosing COVID-19 in children. Children who develop severe illness can develop abnormal vital signs and markers of severe inflammation once hospitalized. 17A study of over 10,000 hospitalized children found that lower blood pressure, higher heart and respiratory rates, and abnormal markers of inflammation, including D-dimers and ferritin, were associated with severe illness in children. 17

Studies suggest that most children experience asymptomatic, mild, or moderate COVID-19 illness, but some children can experience severe illness requiring admission to the hospital or ICU, or use of invasive mechanical ventilation, and some die. 1819Like adults, children with one or more underlying medical conditions, including obesity, diabetes, and cardiac, lung, and neurologic disorders, have increased risk of severe COVID-19. 1718202122

While increasing age is the strongest risk factor for severe COVID-19 illness in adults, being <12 months of age is the strongest risk factor in children. 2324In addition to individual risk factors, the COVID-19 variant circulating at the time of infection may also impact disease severity. Compared to prior periods, studies of COVID-19 in the pediatric population during the Delta predominant period found increased rates of hospitalization. 2526Increases in overall number of pediatric hospitalizations were observed during the Omicron predominant period, particularly for children under the age of 5 years. However, pediatric patients experienced less severe disease during the Omicron period than in previous waves. 242728

Treatment and Management

Some of the medications authorized for the treatment of COVID-19 in adults have been authorized for use in children. For information on medications that are authorized for use in children in ambulatory and hospital settings, see IDSA Guidelines on the Treatment and Management of Patients with COVID-19.

For information on recommendations for clinical management, see the American Academy of Pediatrics Management Strategies in Children and Adolescents with Mild to Moderate COVID-19.

Resources

Immunocompromising Condition

• COVID-19 Risk Factors

MIS

• IDSA Multisystem Inflammatory Syndrome in Adults

Pregnancy (for general audience)

• COVID-19 Vaccines While Pregnant or Breastfeeding
• COVID-19 and Breastfeeding