Alternative hepatitis B vaccination doses and routes

NOTICE: This is an OSHA Archive Document, and may no longer represent OSHA Policy. It is presented here as historical content, for research and review purposes only.

March 13, 1990

James R. Garb, M.D.
Director, Employee Health Service
Baystate Medical Center
[Recipient address omitted]
Dear Dr. Garb:

This is in further response to our letter of December 15, 1989, regarding the Occupational Safety and Health Administration's (OSHA) policy for alternative doses and routes of administration for the Hepatitis B vaccine and if such methods could be used as part of a randomized study using low doses given intradermally. We apologize for the delay in responding to you.

According to the Food and Drug Administration and Merck, Sharp and Dohme, Recombivax HB is only licensed for intramuscular injection; the preferred site in adults is the deltoid muscle. Recombivax HB should not be injected intravenously or intradermally. Data indicate that injections given in alternative routes result in a lower seroconversion rate and lower level of antibodies than expected.

The Centers for Disease Control's (CDC), Morbibity and Mortality Weekly Report of February 2 ("Protection Against Viral Hepatitis - Recommendations of the Immunization Practices Advisory Committee") states that "at this time, intradermal vaccination of adults using low doses of vaccine should be done only under research protocol, with appropriate informed consent and with post vaccination testing to identify persons with inadequate response who would be eligible for revaccination" (page 12). The CDC has explained that "informed consent" includes offering those affected the choice to obtain the vaccine by the normal route and in the normal amount.

In the absence of a written endorsement of your proposed research protocol by the CDC or other appropriate agency, OSHA will not consider the vaccine being given in an alternative dose or route to be standard recommended medical practice. Linda Moyer of the CDC's Hepatitis Branch has indicated the CDC's willingness to review such protocol.

Sincerely,

Gerard F. Scannell Assistant Secretary

[Earlier interim response and requester letter reproduced on OSHA page; omitted here.]