Delaware Division of Public Health
DECLARATION OF SHORTAGE

NOW COMES, the Division of Public Health, by and through Jaime “Gus” Rivera,
MD, FAAP Director, pursuant to 16 Del.C. §510(b), who has determined that a
shortage of mercury-free Diphtheria/Tetanus (DT) vaccine exists for children
under 8 years or pregnant women, and who sets forth this Declaration, and
herein states as follows:

RECITALS

WHEREAS, pursuant to 16 Del.C. §122(1) the Department of Health and Social
Services has “supervision of all matters relating to the preservation of the life and
health of the people of the State;” and

WHEREAS, 16 Del.C. §510 (a) restricts the administration of vaccines containing
mercury to children under 8 years or pregnant women; and

WHEREAS, 16 Del.C. §510 (b) (3) states that the prohibition against the use of
vaccines containing mercury shall not apply when “the Director of the Division of
Public Health or their designee determines that a shortage of the vaccine exists
which could threaten the health of groups of individuals within the State including
children under eight (8) years of age or pregnant women, and additional mercury-free 
vaccine cannot be made available from other medical providers,
manufacturers, distributors, agencies, jurisdictions or by any other means.”


WHEREFORE, the Director of the Division of Public Health determines that:
(1) There exists a shortage of supply of mercury-free Diphtheria/Tetanus (DT)
     vaccine that could threaten the health of children under the age of 8 and
     pregnant women in the State of Delaware;
(2) Additional mercury-free Diphtheria/Tetanus (DT)vaccine cannot be made
     available from other medical providers, manufacturers, distributors,
     agencies, jurisdictions, or by any other means; and
(3) The use of mercury containing Diphtheria/Tetanus (DT)vaccine is
     necessary to ensure these groups have access to vaccinations.
     
IN SUPPORT of this determination, the Director finds as follows;


1) 	The Diphtheria/Tetanus (DT) vaccine is administered to children less than 
	7 years of age in whom the Pertussis vaccination is not recommended.

2)	The Diphtheria/Tetanus (DT) vaccine is indicated for active immunization of
	 children up to age 7 years against diphtheria and tetanus.

3) 	Sanofi-Pasteur is the sole manufacturer of the Diphtheria/Tetanus (DT) vaccine 
	licensed for use in the USA and no formulation of the vaccine currently 
	manufactured is mercury-free.

Pursuant to 16 Del. C. §510, a provider administering a mercury containing
vaccine pursuant to this determination of shortage shall inform the client, parent
or legal guardian of the client that the vaccine contains mercury, that they believe
the vaccine to be medically necessary, and that the Director of Public Health has
made a formal determination that the vaccine may be administered due to the
existence of the shortage of mercury-free vaccines.

This determination of shortage is applicable for 12 months from the date of
signature, and may be re-issued or amended upon further determination by the
Director.  This determination will be rescinded prior to 12 months from the date of
signature if the Director determines that an FDA-approved mercury-free vaccine
is, or can be made, adequately available.




______________________________ 			_________________
Jaime “Gus” Rivera, MD, FAAP 					Date
Director, Delaware Division of Public Health