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Institute for Vaccine Safety

Johns Hopkins Bloomberg School of Public Health

615 N. Wolfe Street

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Baltimore, MD 21205

www.vaccinesafety.edu

 
 
 

INFLUENZA VACCINE

Egg Allergy Is Not A Contraindication To Vaccination With Trivalent Influenza Vaccine.  The figure above shows recommendations regarding influenza vaccination for persons who report allergy to eggs for the 2011-12 influenza season, according to the Advisory Committee on Immunization Practices (ACIP). Persons who have experienced only hives following exposure to egg should receive influenza vaccine with the following additional measures.
Research presented at ACAAI confirms the 8-26-11 ACIP recommendations; if someone can eat cooked eggs, they can receive TIV.  Prior anaphylactic reaction to egg indicates the need to see a specialist for vaccination. 11-07-11  [link to Medscape latest news story and link to Q&A on Egg Allergy and the Flu Vaccine]

FDA and CDC recommend inactivated influenza vaccine be administered with a needle and syringe.  link to FDA's statement. 10-26-11

Influenza Vaccine 2011/12 contains the following strains:
an A/California/7/09 (H1N1)-like virus*; an A/Perth /16/2009 (H3N2)-like virus; a B/Brisbane/60/2008-like virus.         
             *A/California/7/09 (H1N1)-like virus is the pandemic (H1N1) 2009 influenza virus. 
More information is available on the FDA website.

2011-12 Flu Vaccines
Vaccine Manufactuer Approved Ages
Afluria CSL Limited 5 years and older
Agriflu Novartis 18 years and older
Fluarix GlaxoSmithKline 3 years and older
FluLaval ID Biomedical Corp 18 years and older
FluMist MedImmune 2-49 years
Fluvirin Novartis 4 years and older
Fluzone sanofi pasteur 6 months and older
Fluzone High-Dose 65 years and older
Fluzone Intradermal 18-64 years
 

 

UPDATE: European investigation into possible increased risk of  narcolepsy following H1N1 vaccine containing a novel adjuvant.  Several European countries are looking into a possible association between Pandemrix, an H1N1 vaccine that contains a novel adjuvant (ASO3), and an increase in narcolepsy in children. The preliminary data from investigations in Finland resulted in discontinuation of the use of this vaccine.   Several other European countries have noted an increase in narcolepsy but the association with the vaccine in these countries is not clear. The preliminary data from Finland revealed an approximately 9-fold increased risk associated with the vaccine (link to 2/1/11 Finland MOH statement). The data have been reviewed by the WHO GAVCS committee [link to 4/21/11 statement].   Note:  The ASO3 adjuvant has never been used  in any vaccines licensed in the United States. [6/15/11]

WHO safety committee indicates possible association between a novel adjuvanted H1N1 influenza vaccine used in Europe and onset of narcolepsy in children. The Pandemirix vaccine was not used in the United States and at present we are unaware of any associations between any other vaccines and the onset of narcolepsy in adolescents which is a rare genetic disorder.  Additional data expected later this year.  02-08-2011  link to WHO report
see also: Montastruc JL, Durrieu G, Rascol O. Pandemrix°, (H1N1)v influenza and reported cases of narcolepsy. Vaccine. 2011 Jan 11. [Epub ahead of print] PubMed link

FDA and CDC Update on Fluzone Influenza Vaccine and VAERS Reports of Febrile Seizures in Children
Possible small increased risk of febrile seizures following Fluzone influenza vaccine in young children. No change in recommendations for influenza vaccine use. 01-20-2011  link to FDA website

The CDC recommends influenza vaccine for everyone 6 months and older.  If a child 6 months - 9 years of age is receiving influenza vaccine for the first time, they will require 2 doses.  More information is available on the CDC’s flu website.

There will be only one influenza vaccine for the 2010/2011 influenza season.  The strains in this season’s vaccine are:  an A/California/7/09 (H1N1)-like virus; an A/Perth /16/2009 (H3N2)-like virus; a B/Brisbane/60/2008-like virus. More information is available on the FDA website.

 

Influenza Vaccines Approved for US
2010-11

Vaccine
click vaccine name to link to insert

Manufacturer

Ages

Afluria

CSL

9 years* and older

Agriflu

Novartis

18 yrs and older

Fluarix

GSK

3 yrs and older

FluLaval

GSK

18 yrs and older

FluMist

MedImmune

2-49 yrs

Fluvirin

Novartis

4 yrs and older

Fluzone

sanofi pastuer

6 mos and older

Fluzone High-Dose

sanofi pastuer

65 years and older

* Although licensed for 6 months and older, the ACIP has recommended that Afluria not be used in children aged 6 months through 8 years.
 
MMWR 2010;59(31):989.

All 2009 H1N1 vaccine monovalent vaccine manufactured in 2009 and distributed in the United States expired by September 15, 2010, regardless of the date on the label. link to CDC

The Advisory Committee on Immunization Practices (ACIP) Recommends Influenza Vaccine to everyone older than 6 months of age.  The ACIP recommendation, likely to be accepted by the CDC Director and HHS Secretary, will apply to the 2010/11 flu season. CDC Press Release 2-24-2010

Certain lots of Sanofi Pasteur's H1N1 in pre-filled syringes should be used by February 15, 2010. There are no safety concerns with these lots, the shelf life is just shorter than indicated on the lable. [02-02-10] More information, including lot numbers | CDC Q&A

Nasal Spray H1N1 Vaccine Recalled Due to Decreased Potency.  The 13 lots of MedImmune's vaccine are being recalled due to sub-par potency; not because of safety concerns.  Most doses are believed to have been administered while they were fully potent. [12-12-09]  More info, including lot numbers | CDC Q&A

Non-Safety-Related Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25mL, for 6-35 month olds) Vaccine in Pre-Filled Syringes.  Sanofi Pasteur has recalled this vaccine because of decreased potency - not because of safety concerns  - in these lot numbers: UT023DA, UT028DA, UT028CB, UT030CA.  [12-15-09] More info

CDC summary of adverse events following 2009 influenza vaccines reported to VAERS. Enhanced surveillance for vaccine safety is being conducted this year. No unusual adverse events have been identified as causally related to the 2009 H1N1 vaccines. MMWR 12-04-09

The US FDA approved Novatis' seasonal influenza vaccine, Agriflu. This single dose vaccine is for ages 18 and older.  FDA Press Release 11-27-09

Flu Vaccine Monitoring information provided by Uppsala Monitoring Centre (in Sweden). Lists countries using H1N1 vaccine, publishing AEFI reports, etc.  UMC Page

The US FDA approved CSL's influenza vaccines for infants and children.  Both the seasonal and the H1N1 by CSL are now approved for children as young as 6 months.   FDA Press Release 11-12-09

The US FDA approved GlaxoSmithKline's H1N1 vaccine.  With this latest approval, there are now 5 H1N1 vaccines approved  in the US.   FDA Press Release 11-16-09

GlaxoSmithKline's seasonal influenza vaccine, Fluarix, has been approved by the US FDA to include ages 3-17 years.  The prior approved use was adults 18 years and older.  Fluarix is does not protect against H1N1; it is the vaccine for the 2009/20 seasonal flu.  FDA Press Release 10-19-09

Monitoring influenza vaccine safety.  With support from the CDC, we have created an automated internet-based system that will follow-up on any self-reported adverse symptoms to influenza vaccine after vaccination. 
more information about the survey | Washington Post article on this effort

The US FDA approved four H1N1 vaccines.  Three are traditional shots; MedImmune’s is a nasal spray similar to FluMist (the other manufacturers are CSL, Novartis and sanofi Pasteur).  These vaccines are expected to be available to the public in October, some lots may be available earlier.  The people recommended to receive the vaccine first are children 6 months to 4 years, pregnant women, caregivers to infants younger than 6 months, health care/emergency workers who directly deal with patients and kids 5-18 years with chronic medical conditions. more info at WebMD.

"Prepare for a Vaccine Controversy" - on H1N1 flu/vaccine and how the government should explain the risks.  Op-Ed by Arthur Allen in August 1 2009 NYTimes
With the new H1N1 virus continuing to cause illness, hospitalizations and deaths in the US during the normally flu-free summer months and some uncertainty and about what the upcoming flu season might bring, CDC's Advisory Committee on Immunization Practices has taken an important step in preparations for a voluntary novel H1N1 vaccination effort to counter a possibly severe upcoming flu season. On July 29, 2009, ACIP met to consider who should receive novel H1N1 vaccine when it becomes available. more info from CDC

ACIP Recommendations on the Prevention and Control of Seasonal Influenza with Vaccines.  MMWR July 31, 2009. pdf |html

The US FDA approved FluMist, by MedImmune, for use in people 2-49 years of age.  This expansion now includes children 2-5 years of age.  FDA Press Release (9-19-07)

The US FDA approved Glaxo SmithKline's FluLaval influenza virus vaccine. FluLaval is for adults 18 years and older to protect against strains of influenza projected to impact the Northern Hemisphere in the 2006/07 flu season. FluLaval is manufactured by ID Biomedical Corp (a Canadian subsidiary of GlaxoSmithKline) and distributed by GSK. FDA Press Release (10-05-06)

The US FDA announces approval of Fluarix, an inactivated influenza vaccine for adults. Fluarix is manufactured in Germany by a subsidiary of GlaxoSmithKline. FDA Press Release (08-31-05)

CDC's guidelines for controlling influenza transmission in long-term care facilities (11-15-07).  PDF (150k) | HTML version

A new Influenza vaccine will be available for the 2005/6 Flu Season: The FDA has approved the license supplement of sanofi pasteur) to market a formula of their influenza vaccine produced without introducing preservatives at any step in the manufacturing process. Fluzone®, Influenza Virus Vaccine, No Preservative, Pediatric Dose is the only influenza vaccine approved for use in the U.S. in children as young as 6 months. The vaccine will be available in 0.25 mL pediatric dose and 0.50 mL for children 3 years and older. (03-09-05)

The Centers for Disease Control and Prevention has a web page devoted to the Seasonal Flu containing a wide variety of information and updates including the a US map showing flu influenza activity. 

The FDA and CDC address rumors about influenza vaccines (10-17-03). Information from a Press Release.

 

 

This page was last updated on November 17, 2011

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