Standard Interpretations - Table of Contents Standard Interpretations - (Archived) Table of Contents
• Status: Archived

Archive Notice - OSHA Archive

NOTICE: This is an OSHA Archive Document, and may no longer represent OSHA Policy. It is presented here as historical content, for research and review purposes only.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 Springfield, Massachusetts 01199

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

James R. Garb, M.D. Director, Employee Health Service Baystate Medical Center Springfield, Massachusetts 01199

Dear Dr. Garb:

This is an interim response to your letter of October 13, concerning the Occupational Safety and Health Administration's (OSHA) policy for alternative doses and routes of administration for the Hepatitis B vaccine and if such method would be accepted by OSHA as standard recommended medical practices.

In order to fully address your concerns we are in the process of gathering information. As soon as we receive this information, you will be promptly notified.

Thank you for your patience.

Sincerely,

G. F. Scannell Assistant Secretary

October 13, 1989

Alan C. McMillan Acting Assistant Secretary of Labor for Occupational Safety and Health U S Department of Labor 200 Constitution Avenue N W Washington, D.C. 20210

Dear Mr. McMillan:

I am writing to you with a question regarding the proposed rule on blood born pathogens that was promulgated by OSHA in the Federal Register on May 30, 1989. Specifically, the question is whether alternative doses and routes of administration of the Hepatitis B vaccine would be considered by OSHA to be "according to standard recommendations for medical practice".

There are several small studies reported in the literature using low doses of Hepatitis B vaccine given intradermally instead of the standard dose given intramuscularly. There are also some reports using low doses given intramuscularly. These reports suggest that the vaccine is effective when given in this manner.

The Immune Practices Committee (ACIP) of the Centers for Disease Control discussed this topic last month. What I have been told verbally is that they endorsed the use of low dose intradermal administration of the Hepatitis B Vaccine for research protocols.

Our institution, which has over 4,000 employees, is about to embark on a broadened program of offering the Hepatitis B vaccine to employees. I would like to propose doing a randomized study comparing the effectiveness of a low dose intradermal and/or a low dose intramuscular vaccination schedule with the traditional dosing schedule. Although the details are not finalized at this time, the protocol would involve initial antibody testing prior to vaccination and antibody testing on a regular basis, probably every 6 months, for approximately 3 years following completion of vaccination for all groups.

I spoke with Linda Moyer at the CDC and she indicated that they would be interested in the results of such studies. In fact, she offered to investigate the possibility of the CDC doing the antibody titers for us.

Before proceeding with a formal study proposal, I want assurance that OSHA would not fault us for failing to follow the "standard recommendations for medical practice". Your prompt reply would be most appreciated. If you have any questions, you may reach me at 413-784-3726.

Sincerely yours,

James R. Garb, M.D. Director, Employee Health Service

JRG/gak

cc: Richard H. Brody, M.D.


Archive Notice - OSHA Archive

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.


Standard Interpretations - Table of Contents Standard Interpretations - (Archived) Table of Contents