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New Criteria for Vaccinations


Reference Document: STATE 010379, 02/10

1.  SUMMARY:  On November 13, 2009, the Department of Health and Human Services, Centers for Disease Control and Prevention (HHS/CDC) published a final notice in the Federal Register amending the criteria for vaccination requirements for U.S. immigration, eliminating the requirement to have human papillomavirus (HPV) or zoster vaccinations.  The final notice became effective December 14, 2009.  This message provides guidance to posts in handling cases affected by this change and provides questions and answers that posts can use with the public.  END SUMMARY

2.  The CDC published a final notice in the Federal Register on November 13, 2009, titled Criteria for Vaccination Requirements for U.S. Immigration Purposes that went into effect on December 14, 2009.  The final notice amended the criteria that the CDC uses to determine whether or not vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) for the general U.S. population should be required for immigrants seeking admission into the United States or aliens seeking adjustment of status.  The final notice is posted on the CDC's website (http://www.cdc.gov/ncidod/dq/laws_regs/fed_reg/vaccine/revised-vaccination-immigration.htm).

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The New Criteria
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3.  Prior to December 14, 2009, the CDC required vaccinations against vaccine-preventable diseases explicitly listed in section 212(a)(1)(A)(ii) of the Immigration and Nationality Act (INA), as well as all vaccinations recommended by the ACIP for the general U.S. population.  Under the new criteria effective December 14, the CDC continues to require vaccinations explicitly listed in section 212(a)(1)(A)(ii) of the INA, but only requires ACIP-recommended vaccines which meet the new criteria.  The new criteria for ACIP-recommended vaccinations are:

1.)  The vaccine must be age-appropriate as recommended by the ACIP for the general U.S. population; and,

2.)  At least one of the following:

a.  The vaccine must protect against a disease that has the potential to cause an outbreak; and/or,

b.  The vaccine must protect against a disease that has been eliminated or is in the process of being eliminated in the United States.

4.  Under the new criteria, vaccines against the following diseases are required:  mumps, measles, rubella, tetanus, diphtheria, meningococcal disease, pneumococcal disease, haemophilus influenza type B (Hib), rotavirus, varicella, influenza, hepatitis A, hepatitis B, pertussis, and polio.  Effective December 14, ACIP-recommended vaccines against human papillomavirus (HPV) and zoster are no longer required because they do not meet the CDC's new criteria.

5.  The CDC's 2009 Vaccination Requirements for U.S. Immigration: Technical Instructions for Panel Physicians (2009 Vaccination TIs) provide instruction to panel physicians on the administration of vaccinations and assessment of an applicant's vaccination status.  The 2009 Vaccination TIs have been updated to reflect the new criteria for vaccination requirements for U.S. immigration.  The 2009 Vaccination TIs are available on the CDC's website http://www.cdc.gov/ncidod/dq/panel.htm.

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Cases Prior to December 14
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6.  All immigrant visa (IV) applicants who applied prior to December 14 were required to provide documentation to panel physicians that they had received all vaccinations, including HPV and zoster.  Applicants who had not provided documentation of having received the HPV and zoster vaccines could not be issued visas unless they:  (1) subsequently received the vaccines, (2) were eligible for blanket waivers, or 3) received waivers of inadmissibility from the U.S. Citizenship and Immigration Services (USCIS).  Applicants who opted not to receive these two vaccines and to wait until the CDC?s final notice went into effect on December 14 should have been refused.  On or after December 14, 2009, if otherwise qualified, such applicants should be issued visas.

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FAM Update
----------

7.  9 FAM 40.11 N10.2 is being amended to remove references to the HPV and zoster vaccinations and will read as follows:

9 FAM 40.11 N10.2  Required Vaccinations

Although INA 212(a)(1)(A)(ii) (8 U.S.C. 1182(a)(1)(A)(i)) lists specific vaccine-preventable diseases, the language of INA 212(a)(1)(A)(ii) requires immigrants "to present documentation of having received vaccination against vaccine-preventable diseases" including any other vaccinations against vaccine-preventable diseases recommended by the Advisory Committee for Immunization Practices (ACIP).

On November 13, 2009, the CDC issued a final notice, which changed the criteria for requiring vaccinations based on recommendations from the ACIP.  Effective December 14, 2009, in order for a vaccination recommended by ACIP to be required for immigrants under the new criteria, the vaccine must:

a.)  be age appropriate as recommended by ACIP for the general U.S. population; and,

b.)  protect against a disease that has the potential to cause an outbreak; or,

c.)  protect against a disease that has been eliminated in the United States or is in the process of being eliminated in the United States.

Vaccinations currently required by CDC are as follows (Note - many vaccines have age-appropriate guidelines):

  1. Mumps;
  2. Measles;
  3. Rubella;
  4. Polio;
  5. Tetanus;
  6. Diphtheria;
  7. Pertussis;
  8. Haemophilus influenzae Type B;
  9. Rotavirus;
  10. Hepatitis A;
  11. Hepatitis B;
  12. Meningococcal disease;
  13. Varicella;
  14. Pneumococcal;
  15. Influenza.

Applicants are required to receive at least one dose of each age-appropriate vaccine.  If applicants had previously received a dose or doses of a required vaccine but had not completed the series, then the next required dose should be administered.  Although applicants are not required to complete the vaccine series, they are encouraged to receive as many additional doses as possible prior to travel to the United States.  The vaccinations required by the CDC include:  1) vaccinations against vaccine-preventable diseases explicitly listed in INA 212(a)(1)(A)(ii), and 2)  vaccinations recommended by the ACIP for U.S. immigration purposes.

---END TEXT of revised 9 FAM 40.11 N10.2---

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Vaccination Form Revisions
--------------------------

8.  Form DS-3025, Vaccination Documentation Worksheet, was not revised prior to December 14 to remove the HPV and zoster vaccines from the list of required vaccines. The 2009 Vaccination TIs provide instruction to panel physicians on completing the DS-3025, specifically to cross out HPV and zoster and mark them as "Not Required."  Posts may also advise their panel physicians on how to complete the Form DS-3015 in accordance with the new 2009 Vaccination TIs.

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Q's and A's
-----------

9.  Posts that receive inquiries from the public or the press concerning the CDC's new criteria for vaccinations and removal of the HPV and zoster vaccines are advised to use the following Q's and A's which will be posted on: (1) the CA web intranet Updates and Announcements and Find Visa Content sections, and (2) travel.state.gov section under the Visa News on the right rail.

Q:  What are the CDC's new criteria for required vaccinations for U.S. immigration purposes?

-- On November 13, 2009, the CDC published a final notice in the Federal Register that changed the criteria for required vaccinations for U.S. immigration, effective December 14, 2009.  In order for a vaccination recommended by the Advisory Committee on Immunization Practices (ACIP) to be required under the new criteria, the vaccine must:  a.)  be age appropriate as recommended by the ACIP for the general U.S. population; and, b.)  protect against a disease that has the potential to cause an outbreak; or, c.)  protect against a disease that has been eliminated in the United States or is in the process of being eliminated in the United States.

-- In addition to the criteria for ACIP-recommended vaccines, all vaccinations explicitly listed in section 212(a)(1)(A)(ii) of the Immigration and Nationality Act (INA) are required.

-- Based on the new criteria, HPV and zoster vaccinations are no longer required.

-- We refer you to the CDC's website for further information (http://www.cdc.gov/ncidod/dq/laws_regs/fed_reg/vaccine/revised-vaccination-immigration.htm).

Q:  Why did the CDC change the required vaccinations?

-- Since the vaccination requirements for immigrants to the United States were added to the INA in 1996, the CDC has required immigrants to receive all vaccinations recommended by the ACIP in addition to the vaccines explicitly listed in section 212(a)(1)(A)(ii) of the INA.  Vaccine development has evolved since 1996 and today a greater number of vaccines are recommended by ACIP than had been recommended in 1996.  As a result, the CDC reassessed which of the ACIP-recommended vaccines were appropriate for U.S. immigration purposes, taking into consideration both the context in which the vaccinations are given and the interests of public health.

-- We refer you to the CDC for further information.

Q:  Will any vaccines be added or removed from the list of required vaccinations for immigrants under the CDC's new criteria?

-- Effective December 14, 2009, the HPV and zoster vaccines, which are recommended by the ACIP for the general U.S. population, are no longer required for immigrant visa medical examinations and are removed from the list of required vaccinations for immigrants seeking admission to or adjustment of status in the United States.

-- The CDC is not adding any vaccines to the current list of required vaccinations for U.S. immigration at this time.  The CDC will assess on an as-needed basis whether vaccines recommended by the ACIP for the general U.S. population should be added or removed from the list of required vaccinations for U.S. immigration purposes.

Q:  How do the CDC's new vaccination criteria change the immigrant visa application process?

-- Effective December 14, 2009, immigrant visa applicants are no longer required to present documentation to panel physicians during their medical examinations showing they have received the HPV and zoster vaccines.

Q:  Are there any restrictions under the CDC's final notice?

-- Immigrant visa applicants are required to present documentation that they have received vaccinations, if age appropriate as determined by the CDC, explicitly listed in section 212(a)(1)(A)(ii).  These vaccines are: mumps, measles, rubella, polio, tetanus, diphtheria, pertussis, Haemophilus influenzae type b, and hepatitis b.

-- Under the CDC's final notice and in addition to the vaccines explicitly listed in the INA, immigrant visa applicants are also required to present documentation that they have received the following vaccinations recommended by the ACIP, if age appropriate as determined by the CDC:  rotavirus, hepatitis A, meningococcal disease, varicella, pneumococcal, and influenza.

-- We refer you to the CDC's website for further information.

Q:  Does this change affect any of the waiver options for vaccinations?

-- This change does not affect the waiver options currently in place for required vaccinations.

-- Blanket waivers for missing vaccines are available for immigrant visa applicants when a panel physician determines that administration of a required vaccine would not be age appropriate or medically appropriate given the applicant's age, medical history, or  current medical condition.  Blanket waivers are also available for vaccines that are not routinely available in a particular country or region, when there is an insufficient time interval between vaccine doses, and for the influenza vaccine when it is not fall (flu) season.

-- Immigrant visa applicants who object to receiving one or more of the required vaccinations on religious or moral grounds may seek a waiver of ineligibility under section 212(g)(2)(C) of the INA by filing Form I-601, Application for Waiver of Grounds of Inadmissibility, with the U.S. Citizenship and Immigration Services (USCIS).  USCIS consults the CDC when adjudicating Form I-601 applications filed by individuals with medical grounds of inadmissibility.

-- Children who are 10 years old or younger and adopted from countries not party to the Hague Adoption Convention may receive exemptions from receiving the required vaccinations.  The exemption can only be granted if an adoptive or prospective adoptive parent(s) executes Form DS-1981, Affidavit Concerning Exemption from Immigrant Vaccination Requirements for a Foreign Adopted Child, stating that he or she is aware of the vaccination requirements.  The adoptive or prospective adoptive parent(s) must ensure that the child receives the required vaccinations within 30 days of the child's admission to the United States, or at the earliest time that is medically appropriate.  This exemption does not exist for children adopted from Hague Adoption Convention countries though the State Department and the Department of Health and Human Services have recommended to Congress legislative changes that would exempt children from Hague Adoption Convention countries.

10.  Any procedural questions about this guidance should be directed to CA/VO/F/P [redacted].



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