Establishes Children's Vaccine Adverse Event Reporting System.

A1559

ASSEMBLY, No. 1559

STATE OF NEW JERSEY

222nd LEGISLATURE

�

PRE-FILED FOR INTRODUCTION IN THE 2026 SESSION

Sponsored by:

Assemblyman SEAN T. KEAN

District 30 (Monmouth and Ocean)

Co-Sponsored by:

Assemblywoman Fantasia

SYNOPSIS

���� Establishes Children's Vaccine Adverse Event
Reporting System.

CURRENT VERSION OF TEXT

���� Introduced Pending Technical Review by Legislative
Counsel.

��

An Act
establishing a vaccine adverse event reporting system
and supplementing Title 26 of the Revised Statutes.

����
Be It
Enacted
by the Senate and General Assembly of
the State of New Jersey:

���� 1.��� This act shall be known
and may be cited as the �Children�s Vaccine Adverse Event Reporting Act.�

���� 2.��� The Legislature finds
and declares that:

���� a.���� The use of vaccines has
greatly reduced the incidence of many infectious diseases, disability, and
death, has resulted in the eradication of smallpox, and has dramatically
decreased the transmission of certain types of polio globally.

���� b.��� Routine immunization of
children in the United States targets numerous vaccine-preventable diseases,
and children receive multiple doses of some vaccines between birth and age six,
with certain boosters required through the pre-teen and teenage years to ensure
efficacy.

���� c.���� Generally, vaccines
have an excellent safety record, and pharmaceutical research has spurred the
development of less reactogenic vaccines, however vaccines can, like most
medical procedures and medications, have side effects.

���� d.��� Newly approved vaccines,
such as that for human papilloma virus, have resulted in an increase in the
number of vaccines that are recommended during childhood and adolescence.

���� e.���� In order to contribute
to the scientific knowledge and pharmacovigilance of vaccines in children, it
is appropriate that the State provide a means by which health care
professionals report suspected adverse reactions to vaccines in children.

���� 3.��� As used in this act:

���� �Adverse Event� means any
unfavorable or unintended medical occurrence, including any sign, laboratory
finding, symptom, or disease that the child experiences within eight weeks
following the administration of a vaccine.

���� �Child� means an individual
who is under 19 years of age.

���� �Commissioner� means the
Commissioner of Health.

���� �Department� means the
Department of Health.

���� �Health care provider� means a
physician, physician assistant, advanced practice nurse, registered nurse,
pharmacist, or other professional licensed pursuant to Title 45 of the Revised
Statutes and authorized to administer vaccines.

���� �System� means the Children�s
Vaccine Adverse Event Reporting System established pursuant to this act.

���� 4.��� a.�� The commissioner
shall establish and maintain a Children�s Vaccine Adverse Event Reporting
System in the Department to receive and maintain all adverse event information
that is reported pursuant to this act, and any other information that the
commissioner deems relevant and appropriate to effectuate the purposes of this
act. The commissioner shall also ensure that an adverse event report received
pursuant to this act that is not subject to mandatory reporting pursuant to the
�National Childhood Vaccine Injury Act of 1986� (42 U.S.C. ss.300aa-1 et seq.)
is reported to the Vaccine Adverse Event Reporting System (VAERS) operated by
the federal Centers for Disease Control and Prevention and the United States
Food and Drug Administration.

���� b.��� A health care provider
shall report to the system an adverse event experienced by a child in the
provider�s care or to whom the health care provider administered a vaccine, and
occurring within eight weeks following the administration of a vaccine to the
child, regardless of whether the vaccine is deemed, in the professional opinion
of the health care provider, to be the cause of the adverse event. A health
care provider who treats a child in the emergency department of a hospital or
an urgent care center in the State shall be subject to the reporting
requirements of this act.

���� c.���� The report shall be in
a form and manner to be determined by the commissioner and shall include the
name and address of the health care provider submitting the report, the name,
age, and address of the child, the adverse event or events experienced by the
child, the date of administration of the child�s most recent vaccine, the
vaccine or vaccines that were administered, any product inserts that were
packaged with the vaccine, and any other pertinent information as may be
required by the commissioner.

���� d.��� A health care provider
that provides information to the department pursuant to this act shall not be
deemed to be, or held liable for, divulging confidential information.

���� e.���� The commissioner may
share the information in the system solely: (1) with recognized public health
entities that analyze data on vaccines and adverse events, except that the
identity of any child or health care provider shall not be disclosed or made
public; and, (2) as required pursuant to subsection a. of this section.

���� f. Nothing in this act shall
be deemed to supercede or abrogate the provisions of P.L.1986, c.134 (C.26:2N-1
et seq.) concerning the reporting of adverse reactions to pertussis vaccines.

���� 5.��� This act shall take
effect on the first day of the sixth month next following the date of enactment
but the commissioner may take such anticipatory administrative action in
advance as is necessary for the implementation of this act.

STATEMENT

���� This bill requires the
establishment of a Children�s Vaccine Adverse Event Reporting System in the
Department of Health to receive and maintain reports of adverse events
experienced by a child under 19 years of age, in the eight weeks following the
administration of a vaccine. The bill requires that health care providers
report any adverse event experienced by a child in the provider�s care or to
whom the health care provider administered a vaccine(s), regardless of whether
the vaccine(s) is deemed, in the professional opinion of the health care
provider, to be the cause of the adverse event.� The reporting requirements
would apply to a physician, physician assistant, advanced practice nurse,
registered nurse, pharmacist, or other professional licensed pursuant to Title
45 of the Revised Statutes and authorized to administer vaccines, including
those who provide care to a child in the emergency department of a hospital or
an urgent care center in the State.

���� The bill provides that the
Commissioner of Health is to determine the form and manner of reports made to
the system and that such reports include the name and address of the health
care provider submitting the report, the name, age, and address of the child,
the adverse event or events experienced by the child, the date of
administration of the child�s most recent vaccine, the vaccine or vaccines that
were administered, any product inserts that were packaged with the vaccine, and
any other pertinent information as may be required by the commissioner.

���� The bill authorizes the
commissioner to share the adverse event reports only with: (1) recognized
public health entities that analyze data on vaccines and adverse events, except
that the identity of any child or health care provider shall not be disclosed
or made public; and, (2) with the Vaccine Adverse Event Reporting System
(VAERS) operated by the federal Centers for Disease Control and Prevention and
the United States Food and Drug Administration, in the event that the
healthcare provider was not required to report the particular adverse event to
VAERS under the provisions of federal law.

���� The bill would take effect on
the first day of the sixth month next following enactment.