Contraindications to COVID-19 vaccination include: Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine. Known diagnosed allergy to a component of the COVID-19 vaccine (see Appendix C for a list of vaccine components).
Categories of noncitizen, nonimmigrants that meet the criteria for an exception under the proclamation and CDC’s order include: Persons on diplomatic or official foreign government travel Children under 18 years of age Persons with documented medical contraindications to receiving a COVID-19 vaccine Participants in certain COVID-19 vaccine trials Persons issued a humanitarian or emergency exception Persons with valid visas [excluding B-1 (business) or B-2 (tourism) visas] who are citizens of a foreign country with limited COVID-19 vaccine availability. Members of the U.S. Armed Forces or their spouses or children (under 18 years of age). Sea crew members traveling pursuant to a C-1 and D nonimmigrant visa Persons whose entry would be in the national interest, as determined by the Secretary of State, Secretary of Transportation, or Secretary of Homeland Security (or their designees)
The FDA can issue EUA during a public health emergency—like a pandemic—to allow the use of unapproved medical products to diagnose, treat or prevent serious or life-threatening diseases. Prior to issuing EUA, safety and efficacy must be demonstrated and certain FDA criteria must be met; there also must be evidence that strongly suggests that patients have benefited from a treatment or test, and there are no adequate, approved or available alternatives.
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg)
On October 29, 2021, the Pfizer-BioNTech pediatric COVID-19 vaccine received Emergency Use Authorization for children aged 5–11 years in the United States.
The Centers for Disease Control and Prevention, along with a number of professional societies, endorse SARS-CoV-2 vaccination for the immunocompromised population. Current Centers for Disease Control and Prevention guidelines also recommend a third dose of an mRNA vaccine for severely immunocompromised patients.
Patients with chronic liver disease can receive the COVID-19 vaccine as soon as it is available to them. Although the immunogenicity of vaccines has not been fully described in this population, vaccination has been associated with lower risk of COVID-19 in patients with cirrhosis.