Immunization Program Memorandum

TO: All Vaccines for Children (VFC) Providers

FROM: Victor M. Negron, Program Manager - Immunization Program

DATE: March 17, 2003

SUBJECT: Changes to School/Day Care Immunization Requirements

On January 15, 2003, the Immunization Program issued a memorandum highlighting changes in the school/day care immunization requirements. In response to some of the questions and comments we have received, this memorandum provides additional highlights of significant changes and clarifies some of the highlights included in the January 15th memorandum.

What is the effective date of the new requirements? The amended administrative regulation became effective on December 18, 2002. However, the requirements are not retroactive, thus, children who received school physicals and immunizations prior to the effective date of the regulation do not have to be recalled to comply with the new requirements.

Were additional requirements added for Hepatitis B? Yes

A dose of Hep B is now required for children who are at least three (3) and less than (5) months of age.

Two (2) doses of Hep B are now required for children who are at least five (5) months and less than twelve (12) months of age.

Three (3) doses of Hep B are now required for all children who are at least twelve (12) months (See exception below).

Was a new requirement added for adolescents to receive additional doses of HEP B? No, the regulation was only amended to allow adolescents 11-15 years of age the option of receiving an alternative two (2) dose series. The alternative two (2) dose hepatitis B series is only approved for children 11-15 years of age (two 10 mcg doses separated by 4-6 months completed by age sixteen). The only vaccine currently licensed for the alternative two dose series for adolescents is RecombivaxHB manufactured by Merck Vaccine Division. Please note that RecombivaxHB is not currently available through the Vaccines for Children Program.

Was an additional requirement added for DTP/DTaP and OPV/IPV for children who are at least five (5) months of age and less than seven years of age? Yes. By the time a child is seven years of age, he or she should have received five (5) doses of DTP or DTaP or a combination of the two vaccines and four (4) doses of OPV or IV or combinations of the two vaccines. If the fourth dose of DTP/DTaP was given on or after the child’s fourth birthday, the fifth dose is not required. If the third dose of OPV/IPV was given on or after the child’s fourth birthday, the fourth dose is not required.

Please clarify the Tetanus/Diphtheria (Td) Booster requirement for children 11-12 years of age. If a child is 11-12 years of age and he or she has completed the initial series, and if it has been at least five (5) years since the child received the last dose of DTaP, DTP, or DT, then a booster dose of Td should be administered. However, in the event a child received this booster dose of Td at less than 11-12 years of age, but at least five (5) years had elapsed since the last dose of DTaP, DTP, or DT, the dose is considered valid and will not have to be repeated at 11-12 years of age. Subsequent booster doses of Td should be administered every ten (10) years thereafter.

Does a "written sworn statement" for a religious exemption to the immunization requirements have to be notarized? The statute on which this requirement is based states that a parent who is opposed to immunizations may "object by a written sworn statement." A written sworn statement may be notarized, but for the purposes of this regulation, it is not required.

When should a provisional immunization certificate expire? Provisional immunization certificates should expire 14 days after the date the next dose is required, and should not be issued for longer that one (1) year.

If a child presents with a certificate for a past immunization that does not include the full date (day, month, year) the vaccine was given, does it have to be repeated? Not, necessarily. This would be an instance where common sense would have to prevail. For example, if a child born on 1/7/03 received his or her 1st dose of DTaP on 3/9/03, the 2nd dose of DTaP on 5/03, and the 3rd dose of DTaP on 6/13/03, the second dose would be valid because more than four (4)

weeks certainly had elapsed since the first dose. But, one could not be certain that four (4) weeks had elapsed between the 2nd dose and the 3rd dose. Therefore, the third dose would have to be repeated.

Does an immunization certificate have to be signed by a physician, ARNP, PA, local health department administrator? Yes, except that a physician or a local health department administrator may designate any staff member to sign the immunization certificates.

Do the different types of immunization certificates have to be on different color paper? No. Most computer-generated certificates are on white paper. For the last several years, the official certificates provided by the state immunization program have been color coded for the convenience of provider. However, in order to decrease our printing costs, all certificates printed at the state office will now be on white paper.

Is it true that a dose may be given up to four (4) days early? Yes. According to the MMWR 2/8/02/Vol.51/No.RR-2, page 4, "ACIP recommends that vaccine doses administered < 4 days before the minimum interval or age be counted as valid." However, since this should be the exception and not the rule, Kentucky chose not to specifically identify a 4-day leeway in the school/day care regulation. Instead, the Kentucky school/day care requirements specify that in order for a vaccine dose to be valid, it must be administered no sooner than at the minimum age and at the minimum interval between doses, as recommended by the ACIP. This may, in some instances, include a dose that was administered 4 days early. The January 15, 2003 memorandum stated that a dose must be administered no later than at the minimum age and at the minimum interval between doses, as recommended by the ACIP. The sentence should have read, no sooner than at the minimum age and at the minimum interval between doses, as recommended by the ACIP. An exception to this rule occurs when administering two (2) live vaccines not given on the same clinic day. For example, MMR and varicella not given on the same clinic day must be separated by at least 28 days; the four day grace period does not apply.

Attached for your reference is a chart showing the ages at which doses should be administered. However, when in doubt, always refer back to the regulation. If you have any questions regarding these changes, please contact the Immunization Program at (502) 564-4478.