CDC Requirements for Immigrant Medical Examinations: COVID-19 Technical Instructions for Panel Physicians

Overview

The current pandemic of Coronavirus Disease 2019 (COVID-19) has been determined by the World Health Organization (WHO) to be a public health emergency of international concern (PHEIC) under the International Health Regulations. COVID-19 meets the definition of a quarantinable communicable disease under 42 USC 264 and Executive Order 13295, as amended by Executive Order 13375 and 13674. Specifically, COVID-19 meets the definition of severe acute respiratory syndromes as specified by Presidential Executive Order 13674 (issued July 31, 2014), thus making it a Class A Inadmissible Condition.

Applicants*, defined in these Technical Instructions as people applying for immigrant or refugee status, as well as non-immigrants (NIVs) who are required to have an overseas medical examination, are medically screened days or weeks prior to travel to the United States (US). Thus, a negative screening for COVID-19 at the time of the medical evaluation does not guarantee the applicant will not have COVID-19 at the time of immigration to the United States.

A combination of vaccination, strategic testing, and routine infection control practices will provide the best protection from COVID-19 for applicants and US communities. These instructions provide requirements for COVID-19 vaccination and testing for applicants. The Instructions in this document are to be followed for COVID-19 when assessing applicants from all countries. These Technical Instructions became effective October 1, 2021, remain in effect, and may be updated periodically.

Visit the Technical Instructions for Panel Physicians webpage for more information about the medical examination for applicants for US immigration.

*Refugees and NIVs, including K-visa applicants are not required to receive the COVID-19 vaccine as part of the immigration medical examination; however, the other components of these Technical Instructions do apply to all applicants.

COVID-19 Vaccination Requirement

The US Centers for Disease Control and Prevention and its Advisory Committee on Immunization Practices (ACIP) have recommended COVID-19 vaccination for the age-appropriate, general US population. Therefore, COVID-19 vaccination now meets the criteria for required vaccinations and is a requirement for applicants.

The COVID-19 vaccines approved for use in these Technical Instructions, hereinafter referred to as “approved COVID-19 vaccines,” are those vaccines authorized for emergency use (EUA) or approved under a Biologics License Application (BLA) by the US Food and Drug Administration (FDA) or listed for emergency use (EUL) by the World Health Organization (WHO). If an approved COVID-19 vaccine is available to the applicant in the country where the examination occurs, the applicant must complete the vaccine’s primary series and provide documentation to the panel physician in person before completion of the medical examination.

The COVID-19 vaccination requirement will differ from previous requirements in that the entire primary vaccine series (e.g., 1 or 2 doses, depending on formulation, for adults; 2 or 3 doses, depending on age and formulation, in children) must be completed in addition to the other routinely required vaccines.

Although the vaccine schedules cannot be shortened, other components of the medical examination can be scheduled at the discretion of the applicant and panel physician.COVID-19 vaccines can be given before, during, or after the first visit to the panel physician; however, the medical examination will not be considered complete until the COVID-19 vaccine requirement has been completed, a blanket waiver has been determined, a religious or moral conviction waiver has been requested from US Citizenship and Immigration Services (USCIS), or the applicant has refused vaccination and is determined to be inadmissible. The panel physician must confirm in person documentation that the applicants received all doses of COVID-19 vaccine and, if applicants want to complete the remaining components of the exam after they are fully vaccinated against COVID-19, panel physicians should accommodate them.

The applicant should be vaccinated in accordance with the specific instructions for the formulation used in the country where the examination occurs.  Although CDC does not recommend a delay between COVID-19 vaccine and other routine vaccines, if a delay is required between COVID-19 vaccination and other routine vaccinations by local regulations, panel physicians must take this into consideration when scheduling the examination so that all required vaccines can be administered.

CDC has not recommended the use of heterologous (i.e., “mix-and-match”) COVID-19 vaccine primary series. However, the use of heterologous primary series, including mixing of mRNA, adenoviral, and mRNA plus adenoviral products, is increasingly common in many countries outside of the United States. Therefore, for the purposes of these Technical Instructions, individuals 18 years of age and older can be considered to have fulfilled this requirement if they have received any single dose of an FDA-approved/authorized or WHO EUL or approved single-dose series (i.e., Janssen), or any combination of two doses of an FDA-approved/authorized or WHO EUL COVID-19 two-dose series. The recommended interval between doses of FDA-approved/authorized or WHO EUL vaccines varies by vaccine type; space the two doses according to the timing recommendations issued by the country where the examination is performed.

Panel physicians are expected to remain informed about changing recommendations, such as expansion of recommendations to include younger children by the US FDA or WHO, availability of additional COVID-19 vaccines, and any new contraindications or precautions. Panel physicians must be aware of local availability of and eligibility criteria for COVID-19 vaccines so they can determine if their applicants are eligible for a waiver. As with all vaccinations, there are specific blanket waivers that cover reasons why an applicant did not receive the required vaccination. Given the special circumstances, the blanket waivers to be used for COVID-19 vaccination are further defined below to include information specific to this vaccination.

Blanket Waivers Applicable to COVID-19 vaccination:

• Not age-appropriate
  For COVID-19 vaccines, the age at which a particular vaccine can be administered differs by formulation. If the applicant is younger than the lowest age limit set by the US FDA or WHO for the approved COVID-19 vaccine formulations in use, this blanket waiver should be documented. At this time, the WHO has only approved vaccines for people 18 years of age and older; however, the US FDA has authorized Pfizer BioNTech and Moderna COVID-19 vaccines for emergency use in children. Therefore, vaccination is required for applicant children if available to them in the country of the exam. If, in the country where the exam is performed, there is an age restriction (for example, the vaccine is only being given to people over the age of 18 and the applicant is younger than 18), this blanket waiver should be documented.
• Contraindication
  If an applicant has a contraindication or precaution to the approved COVID-19 vaccine formulation available, the “Contraindicated” reason should be documented, and the vaccine should not be administered. If the applicant has had a severe reaction to the first dose that is considered a contraindication to receiving a second dose, the first dose should be documented in addition to the blanket waiver.  Please refer to Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States or similar guidance for other vaccine formulations for information about contraindications and precautions.
• Not routinely available
  If none of the approved COVID-19 vaccines are routinely available in the country where the panel physician practices, and they are not expected to be available within 4 months following the medical exam date, the “Not routinely available” reason should be documented.  If, due to limited supply, an approved COVID-19 vaccine is not available to the applicant within the country of exam within 4 months after the exam date, then this situation would also be considered “Not routinely available.” If an applicant has already been vaccinated with a non-approved COVID-19 vaccine, and regulations or laws in the country of exam prevent the applicant from being revaccinated with an approved formulation, this would also be considered “Not routinely available.” Applicants cannot be granted this waiver due to cost or inconvenience.

 Other reasons why an applicant might not complete a COVID-19 vaccine series:

• Applicant may request a waiver based on religious or moral convictions
  If an applicant objects to vaccination based on religious or moral convictions, it must be documented that the applicant is requesting an individual waiver based on religious or moral convictions. This is not a blanket waiver. The applicant will have to submit a waiver request to USCIS. USCIS will determine if this type of waiver is granted, not the panel physician or CDC.
• Applicant refuses a COVID-19 vaccine series in part or entirety
  If an applicant refuses one or more doses of an approved COVID-19 vaccine series that is medically appropriate for and available to the applicant, it should be documented that the vaccine requirements are not complete and that the applicant refuses vaccination. This applicant is Class A and is inadmissible to the United States.
• Adoptee exemption request
  The vaccination requirements do not apply to adopted children 10 years of age or younger, provided the adoptive parent, prior to the child’s admission, signs an affidavit stating that the adoptive parent is aware of US vaccination requirements and will ensure that the child will receive all required vaccinations within 30 days of the child’s arrival in the United States. See the Department of State website for the affidavit form. The Hague Adoption Convention governs adoptions between the United States and other countries in the convention. For countries both in the convention (Hague) and not in the convention (non-Hague), the vaccination requirements do not apply to adopted children 10 years of age or younger, provided the adoptive parent, prior to the child’s admission, signs the affidavit concerning exemption from immigrant vaccination requirements for a foreign adopted child. If the adopted child has a history of vaccinations and reliable vaccination documents are available, the panel physician must complete the DS-3025 Form.

Review of Vaccination Records

• The panel physician should instruct the applicant to submit documentation of receiving a COVID-19 vaccine series. Acceptable vaccination documentation must come from a vaccination record, either a personal vaccination record or a copy of a medical chart with entries made by a physician or other appropriate medical provider. If COVID-19 vaccine is available to panel physicians, the panel physician may vaccinate applicants and document the doses.
• Panel physicians must be familiar with the COVID-19 vaccination documentation used in their country and use their judgement to evaluate the validity of these documents. Only those records of vaccine doses that include the dates of receipt (month, day, and year) are acceptable. The name or manufacturer and lot number should be included if available. The document must not appear to have been altered, and dates of vaccinations should seem reasonable. Self-reported vaccine doses without written documentation are not acceptable. 
• Panel physicians must document all valid vaccination history on the DS-3025 Form, which will become the applicant’s permanent vaccination record. All doses of the COVID-19 vaccine the applicant has received should be documented. In the eMedical USA system, panel physicians must document the COVID-19 vaccinations in the 951 Vaccinations form, in the fields designated for COVID-19 vaccines.

Laboratory confirmation of immunity

• Laboratory tests for COVID-19 immunity must not be used for the panel physician examination. The applicant is required to receive the vaccine series regardless of evidence of immunity or COVID-19 infection. The duration of immunity due to natural infection is still being investigated and might not protect the applicant throughout the immigration process. Also, COVID-19 antibody tests are not indicators of active infection.

COVID-19 Screening

Symptom Screening

COVID-19 is a respiratory illness caused by SARS-CoV-2 infection. Symptoms of COVID-19 are highly variable and include fever, chills, shortness of breath, fatigue, muscle and body aches, headache, new loss of taste or smell, sore throat, nasal congestion, runny nose, nausea, vomiting, and diarrhea.  The clinical course of the disease ranges from asymptomatic to severe illness resulting in death; studies suggest that approximately half of those who test positive are asymptomatic. Although asymptomatic infection and mild illness can occur in all age and risk groups, advanced age is a significant risk factor for severe illness and death. In addition, people with certain health conditions are at increased risk of severe COVID-19 illness.

Panel physicians and their staff should ask about symptoms and contact history when scheduling appointments, at time of check-in, and at the beginning of the visit with the physician. Doing so will allow multiple opportunities to detect symptoms or identify contacts and reschedule the exam. Panel physicians must at a minimum screen for clinical signs and symptoms of COVID-19 and contact history and postpone the exam for those with a suspected or confirmed diagnosis until the criteria to end isolation have been met, or post-exposure quarantine has been completed if recommended.

Applicants who arrive for the exam with clinical signs and symptoms of COVID-19 should receive a nucleic acid amplification test (NAAT) if possible. Antigen testing should not be used during the panel physician exam. Asymptomatic applicants who are contacts must be managed according to the Contacts section below. Applicants with symptoms of COVID-19 must complete the required isolation period before returning for the exam even if they receive a negative COVID-19 test result.  Until the applicant has met the criteria to end isolation, the applicant will be Class A, Inadmissible for COVID-19.  Panel physicians must report all applicants diagnosed with COVID-19 to local public health officials as per national guidelines and the consular section.

As vaccine coverage increases, the need for testing might decrease, and panel physicians should anticipate changes to these Technical Instructions.

Optional Laboratory Testing

In addition to symptom screening for COVID-19, panel physicians may choose to also require laboratory testing of all applicants 2 years of age and older to improve the safety of their clinics and the quality of the exam.  It is recommended that this test be performed and results be available in the 24 hours prior to the panel physician examination.  If testing is performed, the test must be performed within the 3 days prior to the examination. This will ensure the most accurate results are available for the exam, and patients who have positive test results can be rescheduled to complete their examination after recovery. Panel physicians must report all applicants diagnosed with COVID-19 and all contacts to local public health officials as per national guidelines. Negative test results do not definitively rule out infection at the time of the examination; appropriate precautions should still be taken.

Allowed Test Types

When COVID-19 testing is performed, panel sites must use a NAAT such as a reverse transcription polymerase chain reaction (RT-PCR) that has received an Emergency Use Authorization (EUA) by the US FDA or other national governing authority, and samples must be collected using nasopharyngeal (NP) swabs. Tests should be licensed for use in the country of the exam.

Other tests, such as antibody tests or antigen tests must not be used.

Panel physicians and testing laboratories should closely follow the manufacturer’s instructions in the product package insert to ensure the correct specimen is collected, stored, transported, and used by the laboratory as collection methods and specimen types may vary. Laboratories should handle all biological specimens using universal precautions and standard international biohazard practices.  Refer to the WHO Laboratory Biosafety Manual [PDF – 186 pages] for additional guidance.

COVID-19 Screening Results and Travel Clearance

Lack of COVID-19 vaccination, exposure to COVID-19 with a recommendation to quarantine, or current COVID-19 infection would make an applicant Class A, Inadmissible. The medical exam must be postponed for applicants who have symptoms of COVID-19, recent exposure to COVID-19, or a positive laboratory test for COVID-19 until recovery criteria are met as defined by CDC.  If COVID-19 testing is performed, results should be documented in the remarks section in eMedical or the DS forms. The panel physician should inform the consular section when applicant examinations are postponed because of COVID-19.

COVID-19 Treatment

Panel physicians are not expected to treat or manage COVID-19 in applicants and should follow national guidance regarding referral to local public health officials, as well as the applicant’s primary care provider. The panel physician should provide all applicants diagnosed with COVID-19 with guidance about when to seek medical attention and how to self-isolate at home. This information can be found on CDC’s web page What to Do if You Are Sick.

Exposed Contacts

Close contacts of persons with laboratory-confirmed or probable COVID-19 are Class A for COVID-19 exposure until they complete 14 days of quarantine. A close contact is defined by CDC as any individual who has been within 6 feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period. Applicants who are close contacts should be rescheduled and not complete their exam until 14 days of quarantine are complete;

• The 14 days should begin after the person’s last exposure to the person with COVID-19 or, if exposure continues, when that person has recovered.
• If possible, the contact should be tested immediately and then tested again on day 12 of the quarantine period. The same tests described above (NAAT such as RT-PCR tests) should be used.
• If the applicant develops symptoms of COVID-19 during this time or tests positive, they must meet criteria to end isolation before completing the medical examination.
• All close contacts should be reported to the consular section and local health authorities according to national guidance.

Waivers

A provision exists that allows applicants with a Class A physical disorder to petition for a Class A waiver. The Application for Waiver of Grounds of Inadmissibility Form (I-601 or I-602 for immigrants or refugees, respectively) must be completed. These waivers are submitted to USCIS on an individual basis. The CDC Division of Global Migration and Quarantine (DGMQ) also reviews the waivers and supporting medical documentation to provide an opinion regarding the case to the requesting entity (Department of State or USCIS). DGMQ’s review of the waiver and supporting medical examination documentation ensures that the applicant has been classified properly and that an appropriate US healthcare provider is identified for the applicant. USCIS has the final authority to adjudicate the waiver request.

Glossary of Abbreviations