Centers for Disease Control and Prevention (CDC) ALL CHET PARTNERS Update: Health Alert Notice about vacine recall

[Guest guest]

Dear Colleagues,

This is an official update from

CDC regarding a recall of specific lots of H1N1 Pre-Filled Syringes intended

for pediatric use. Please read below and distribute as you see fit within your

organization.

Bobbi

DEPARTMENT

OF HEALTH & HUMAN

SERVICES Public

Health Service

Centers

for Disease Control

And

Prevention (CDC)

This is

an official

CDC

Health Update

Distributed via Health Alert Network

December 15, 2009, 10:04 EST (10:04 AM EST)

CDCHAN-00303-09-12-15-ADV-N

Non-Safety Related

Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for

6-35 month olds) Vaccine in Pre-Filled Syringes

Summary: As part of its

quality assurance program, Sanofi Pasteur, Inc., performs additional routine,

ongoing testing of influenza vaccines after the vaccine has been distributed to

health care providers to ensure that vaccines continue to meet required

specifications.In recent testing of the amount of antigen in its influenza A

(H1N1) monovalent vaccine, Sanofi Pasteur found four distributed lots of

single-dose, pre-filled syringe pediatric (0.25 mL.) vaccine with antigen

content lower than required potency levels. The manufacturer is conducting

a non-safety related voluntary recall of these affected lots of vaccine.

Background

After

performing these tests, Sanofi Pasteur notified the Centers for Disease Control

and Prevention (CDC) and the Food and Drug Administration (FDA) that the

antigen content in one lot of pediatric syringes that had been distributed to

providers was later found to have dropped below a pre-specified limit. As a

result of this finding, Sanofi Pasteur tested additional lots and found that

three other lots that had been distributed also had an antigen content that had

fallen below pre-specified limits. This means that doses from these four

vaccine lots no longer meet the specifications for antigen content.

Recommendations

While

the antigen content of these lots is now below the specification limit for the

product, CDC and FDA are in agreement that the small decrease in antigen

content is unlikely to result in a clinically

significant reduction in immune response among persons who have received

the vaccine. For this reason, there is no need to revaccinate persons

who have received vaccine from these lots.

Providers

are being asked to return any vaccine to the manufacturer in the following lots

that remains unused to the manufacturer:

0.25 mL pre-filled syringes,

10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):

UT023DA

UT028DA

UT028CB

0.25 mL pre-filled syringes,

25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):

UT030CA

These

lots were shipped in November and are intended for children 6 months through 35

months of age. Sanofi Pasteur will send directions for returning unused vaccine

from these lots to providers.

All

vaccines are thoroughly tested prior to release and shipping to determine that

they meet all manufacturer and FDA standards for purity, potency and

safety. The affected vaccine met all specifications at the time of

release. CDC and FDA have determined that there are no safety concerns for

children who have received this vaccine. Sanofi Pasteur has discontinued

distribution of the 0.25 mL syringes of H1N1 pediatric vaccines.

The

drop in antigen content below the required specification that is described here

is specific to Sanofi Pasteur’s pediatric H1N1 monovalent vaccine in 0.25 mL

pre-filled syringes. The same vaccine packaged in other forms, such as 0.5 mL

pre-filled syringes for older children and adults and multi-dose vials,

continue to meet specifications.

The antigen content in the

affected lots of vaccine is only slightly below the specification limit. The

slightly reduced concentration of vaccine antigen found in retesting these lots

is still expected to be effective in stimulating a protective response. There

is no need to re-administer a dose to those who received vaccine from these

lots. However, as is recommended for all 2009 H1N1 vaccines, all children

less than 10 years old should get the recommended two doses of H1N1 vaccine

approximately a month apart for the optimal immune response. So, children

less than 10 years old who have only received one dose of vaccine thus far

should still receive a second dose of 2009 H1N1 vaccine.

For

children 6 months of age and older, vaccine is available in multidose

vials. The vaccine in multidose vials is safe and effective vaccine for

children. One difference between vaccine in pre-filled syringes and the

multidose vials is that the multidose vials contain a preservative (thimerosal)

to prevent potential contamination after the vial is opened. The standard dose

for this preparation for administration to infants 6-35 months old is the same

as for the pre-filled syringes, 0.25 mL. For healthy children at least 2

years of age, the nasal spray (live, attenuated influenza vaccine) is also an

option. The nasal spray vaccine is produced in single units that do not

contain thimerosal.

For

More Information:

For Questions and Answers related

to the withdrawn vaccine see http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm

Call CDC’s

toll-free information line, 800-CDC-INFO (800-232-4636) TTY: (888)

232-6348, which is available 24 hours a day, every day.

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