Baby 411 Blog

RECALL: H1N1 nasal spray vaccine

CDC Health Update 

Distributed via Health Alert Network

December 23, 2009, 9:20 EST (9:20 AM EST)

CDCHAN-00304-09-12-23-ADV-N

MedImmune Monovalent 2009 (H1N1) Influenza Nasal Spray Vaccine — Shortened Shelf Life of Certain Lots

 

MedImmune announces limited, voluntary, non-safety-related recall of remaining unused product

 

Summary

On December 18 and 21, MedImmune notified CDC and FDA that the potency of 13 lots of  monovalent 2009 (H1N1) nasal spray vaccine had decreased below a pre-specified limit or were at risk of falling below that limit in the next week. This slight decrease in vaccine potency is not expected to have an impact on the protective response to vaccination. There are no safety concerns with these lots of 2009 H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency and safety. However, because their potency is now or might soon be below the specified lower limit, MedImmune will send providers directions for returning any unused vaccine from these lots.

 

Recommendations

The potency of these lots is now or might soon be slightly below the specified range for the product. CDC and FDA are in agreement that the slight decrease in vaccine potency is not expected to have an impact on the protective response to vaccination. For this reason, there is no need to revaccinate persons who have received vaccine from these lots.

 

People who received vaccine from the recalled lots do not need to take any action. Children and adults aged 10 years and older who received the vaccine do not need any further doses of vaccine. As is recommended for all 2009 H1N1 vaccines, all children younger than 10 years old should get the recommended two doses of 2009 H1N1 vaccine approximately a month apart. Therefore, children younger than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine. It is best to use the same type of vaccine for the first and second doses. 

 

Background

As part of its quality assurance program, the manufacturer of the nasal spray 2009 H1N1 influenza vaccine, MedImmune, performs routine, ongoing stability testing of the vaccine after it has been shipped to providers. Stability testing means measuring the strength of a vaccine over time. 

 

The 13 lots subject to the recall include approximately 4.7 million doses. These doses were shipped to CDC’s contract distributor in October and early November. Most of the doses are believed to have already been administered while fully potent and within specifications. However, there are almost certainly some doses that have not yet been used. 

 

The potency issue described here is specific to the 13 lots of nasal spray 2009 H1N1 influenza vaccine listed below. Subsequent lots of the vaccine were produced with a slightly higher initial potency to decrease the chance that the potency would fall “below specification” before their expiration dates. Following its routine practice, the manufacturer will continue to monitor the stability of these subsequent lots. 

 

This recall does not affect 2009 H1N1 vaccine produced by other manufacturers. However, a similar recall was conducted recently, which involved lots from Sanofi Pasteur’s pediatric 2009 H1N1 vaccine in 0.25 mL pre-filled syringes. (See http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00303)

 

Before they were shipped, the lots currently being recalled passed all quality controls and met all specifications for safety, purity, and potency.

 

MedImmune will send a notification to providers who received doses from any of the 13 lots of vaccine so that they can return any unused vaccine. 

 

Lot Information

Providers are being asked to return any vaccine in the following lots that remains unused to the manufacturer:

 

•     500754P

•     500751P

•     500756P

•     500757P

•     500758P

•     500759P

•     500760P

•     500761P

•     500762P

•     500763P   

•     500764P     

•     500765P 

•     500776P     

 

For More Information:

For Questions and Answers related to the withdrawn vaccine see 

http://www.cdc.gov/h1n1flu/vaccination/sprayrecall_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. 

For manufacturer’s information about the recall, see http://www.medimmune.com/pdf/H1N1_Recall_QandA_122209.pdf 

For manufacturer’s instructions to providers on actions to be taken, see http://www.medimmune.com/pdf/H1N1_Recall_letter_122209.pdf 

H1N1 Recall, what you need to know

Breaking News: What you need to know about the recalled H1N1 vaccine!

 

Q. Which vaccine has been recalled?

The Sanofi-Pasteur brand of single-dose, pre-filled syringe, preservative free H1N1 vaccine for children 6 months to 3 years of age is the vaccine being recalled. Specifically, there are four batches (“lots”) being recalled.

 

Q. Why is this vaccine being recalled?

As part of routine testing, the manufacturer found that these four batches or lots may not be potent enough for a person to mount an adequate immune response. The vaccine is NOT being recalled for a safety issue.

 

Q. Which batches of the vaccine are the ones in question?

They are: UT023DA, UT028DA, UT028CB, and UT030CA.

 

Q. How will I know if my child received one of these batches of vaccine?

Well, for starters, your child must be between 6 months to 3 years of age to get this vaccine. And, if you know your child received the thimerosal preservative free vaccine, it is possible he got one of these batches. You can call the medical facility where your child was vaccinated as providers must document in a medical record which lot of vaccine was administered.

 

Q. Will my child need to get another dose of H1N1 vaccine if he already got one or two shots with these affected batches or lots of vaccine?

No. Your child should have adequate protection because the potency is only SLIGHTLY below acceptable concentrations known to be effective in providing an adequate response.

 

Q. If my child already got one dose of the H1N1 vaccine, does he need a second dose?

Yes, if your child is under 10 years of age. Regardless of which batch or lot of H1N1 vaccine he received, he needs two doses given at least 21-28 days apart to provide protection from H1N1 disease. And no, it’s not too late! There are other H1N1 injectable vaccine options for kids ages 6 months and up.

For more info, check out CDC.gov

RECALL: Infant Suffocation Deaths Prompt Recall of Amby Baby Motion Beds/Hammocks

 News from CPSC

U.S. Consumer Product Safety Commission

Office of Information and Public Affairs Washington, D.C. 20207

For Immediate Release Firm’s Recall Hotline: (866) 544-9721

December 8, 2009 CPSC Recall Hotline: (800) 638-2772

Release #10-FOR CLEARANCE CPSC Media Contact: (301) 504-7908

Infant Suffocation Deaths Prompt Recall of Amby Baby Motion Beds/Hammocks

WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission, in cooperation with

the firm named below, today announced a voluntary recall of the following products. Consumers

should stop using recalled products immediately unless otherwise instructed.

Name of Product: Amby Baby Motion Beds

Units: About 24,000

Manufacturer: Amby Baby USA, of Minneapolis, Minn.

Hazard: The side-to-side shifting or tilting of the hammock can cause the infant to roll and become entrapped or wedged against the hammock’s fabric and/or mattress pad, resulting in a suffocation hazard.

Incidents/Injuries: Amby Baby is aware of two infant suffocation deaths in the Amby Baby hammock. In June 2009, a 4-month-old girl in Lawrenceville, Ga died in a baby hammock and in August 2009, a 5-month-old boy from Gresham, Ore.

Description: The Amby Baby Motion Bed consists of a steel frame and a fabric hammock which are connected by a large spring and metal crossbar. There is only one model of the hammock available which can be identified by a label sewn onto the hammock stating: “Amby – Babies Love It, Naturally.”

Sold online at: Ambybaby.com and other Internet retailers from January 2003 through October 2009 for about $250.

Manufactured in: China

Remedy: Consumers should immediately stop using the Amby Baby motion beds/hammocks and contact Amby Baby USA for a free repair kit. Parents and caregivers are urged to find an alternative, safe sleeping environment for their baby.

Consumer Contact: For additional information, contact Amby Baby USA toll-free at (866) 544-9721 between 9 a.m. and 5p.m. ET Monday through Friday or visit the firm’s Web site at www.ambybaby.com.

CPSC is still interested in receiving incident or injury reports that are either directly related to this product recall or involve a different hazard with the same product. Please tell us about it by visiting https://www.cpsc.gov/cgibin/incident.aspx

Flu shot update and AAP vax website

What's going around? The U.S. has seen a steady drop in H1N1 infections in the past few weeks. In fact, I have not diagnosed a child with H1N1 in about 10 days. Yippee!!! Of course, the usual germ suspects have made their annual trek into town— viral croup, RSV bronchiolitis, and Strep throat. And oddly, kids in my community are also coming down with Hand, Foot , And Mouth (coxsackievirus) which we usually see in the spring and summer. So, there is no rest for the weary.

Is it too late to get the H1N1 vaccine? Should you bother getting your child the H1N1 vaccine at this point? Yes, we still think your child should get the H1N1 vaccine. No it isn't too late! I don't think we are done with H1N1, particularly with the holiday travel season upon us. My practice has a decent amount of both H1N1 shots and nasal spray now, so I assume other practices who have ordered the vaccine have more now too.

What about seasonal flu vaccine? More good news, the seasonal flu SHOT supply is also much better than it is was a few weeks ago. So, now kids over two years of age can get seasonal flu shot and H1N1 nasal spray or shot at the same time (there is a 4 week interval required between H1N1 and seasonal flu nasal sprays). The U.S. seen virtually no seasonal flu yet this year. Those viruses usually show up in late December/January/February. So, if you or your kids have not gotten seasonal flu vaccine yet, now would be a good time to get that done!

More vaccine info: The American Academy of Pediatrics just launched a great new website for vaccine information (not just for flu). Bookmark this page: http://www.aap.org/immunization/

I'm blogging for WebMD!

Hey everyone,

I've teamed up with WebMD to keep parents up-to-date with the latest news in child health. I've been blogging about the major crib recall and H1N1 disease this week. Take a peek: http://blogs.webmd.com/child-health-411/

I'll be posting the WebMD blog links on the Baby 411 site going forward. So, be on the lookout for new posts on the way.

Happy Thanksgiving!

H1N1 shot update for my patients

For my patients and Capital Pediatrics: Based on the extremely high demand for the H1N1 shot and the limited availability (we have many more doses of the nasal spray), we are asking (for the time being) that the shot be reserved for children ages 6 months to 2 years of age and those who are high-risk and not eligible to receive the nasal spray form of the vaccine. But, anyone who is eligible to receive the nasal spray may book a vaccine appointment.

We expect to get regular shipments of vaccine, so I promise to keep you posted on this rapidly evolving situation!

Baby 411 now available on Kindle!

Great news! Baby 411 is now available as a Kindle e-book! 

Yes, now you can download Baby 411 for your Kindle! And if have an iphone and the free Kindle for iPhone app, you can also read Baby 411 on your iPhone!

Amazon is selling the Baby 411 Kindle-book for just $9.99.

H1N1 vaccine supply—How it all works

We've received quite a few questions from blog readers about how H1N1 vaccine supply is being distributed. I'm happy to share what I know about it. In my own state, each medical practice wishing to administer H1N1 vaccine had to apply for it through the state health department. My office had to provide specific information on the ages of our patients, the number of high risk patients we cared for, and the total number of active patients in our practice. The vaccine supply we are starting to receive is based on that information and what vaccine is available. All states are handling this situation in their own way, and they are doing what they can to get vaccine to everyone as soon as possible. I know it's a frustrating situation for everyone!!!

We've also received requests from blog readers who are not patients in my practice to get H1N1 vaccine at my practice. I wish I could offer it to everyone, but unfortunately, our supply is limited (since it's based on numbers we've given to the state) and so I can only give it to existing patients. But the good news is, if my practice is starting to receive regular shipments of H1N1 vaccine now, your child's pediatric office should be starting to see it soon as well.

H1N1 Shot arrives!

Here is an update and revision from my post from yesterday. My practice just received our first shipment of the H1N1 SHOT. It is Sanofi brand and they are multi-dose vials (which means several doses of vaccine are contained in each vial). This vaccine is approved for use in children ages 6 months old and up. This version does contain a small amount of thimerosal as a preservative. Despite that, I still encourage families to get their kids vaccinated with this shot.

If you are concerned about thimerosal, here are some key stats:

Children 6 months to under 3 years old, Sanofi multidose flu vaccine: 0.0125 mg ethyl mercury (thimerosal)

Children 3 years old and up, Sanofi multidose flu vaccine: 0.025 mg ethyl mercury (thimerosal)

By comparison, 1 liter of breast milk contain 0.015 mg methylmercury and a 5 oz can of tunafish has 0.115 mg of methylmercury. Both contain more mercury!

Here are some other key points:

• The H1N1 shot can be given to anyone who is 6 months and older.
• If your child received seasonal flu shot or Flumist, there is no time interval required between that vaccine and this one. In fact, the H1N1 shot can be given at the same time as the seasonal flu shot or Flumist.
• Kids under 10 years of age need 2 doses given 28 days apart for best protection.
• It takes about 2 weeks to mount an immune response to the vaccine.

Who cannot get this vaccine?

• People who have a severe allergy to chicken eggs.
• People who have had a severe reaction to an influenza vaccination.
• People who developed Guillain Barre Syndrome within 6 weeks of getting an influenza vaccine previously. 
• Children younger than 6 months of age
• People who have a moderate-to-severe illness with a fever (they should wait until they recover to get vaccinated.)

I just got the H1N1 shot and I'm feeling pretty good! For patients at Capital Pediatrics: We have 320 doses of the H1N1 shot and just received another 500 doses of the H1N1 Nasal spray. Anyone who wants to get the vaccine can set up an appointment.

H1N1 vaccine news for Capital Pediatrics

Hey CPG patients,

Effective Wednesday, October 28, our practice will be offering the H1N1 Nasal Spray vaccine to anyone who wants it and is eligible to receive it (see prior blog posts on those restrictions). Please check it out to avoid frustration by showing up for an appointment and then being told your child is not eligible. We expect to receive another 750 doses of the nasal spray in the coming days so we should have enough to get rolling!! Please call the office to schedule a nurse visit appointment for each child who will get the vaccine.

We are still waiting to receive the H1N1 Shot (injectable form). We are told that we will receive 500 doses of the Sanofi brand--which is approved for children ages 6 months of age and older, and is thimerosal-preservative free. As soon as it arrives in the office, I will let you all know. In short: We do NOT have the shots yet.