Baby 411 & Toddler 411 Blog

Shots for tots

 It's National Infant Immunization Week....an annual reminder that to protect our youngest and most vulnerable from vaccine-preventable diseases. The current childhood vaccination schedule protects against 14 different nasty diseases, that I guarantee you wouldn't wish on your worst enemy!

This year, I've teamed up with the American Academy of Pediatrics to let parents know that as a pediatrician and a mom, I vaccinated my own children to protect them, and I wouldn't advise anything differently for your kids. Really.

Learn about vaccines. Learn about vaccine-preventable diseases. Talk to your pediatrician. But let's protect all our kids. This requires a group effort, people!

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 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!

Clarification on HIB booster post

We need to post a clarification regarding the HIB booster for toddlers. Kids who are 12-15 months will be getting their HIB booster at their upcoming well child visits, which is the regular vaccination schedule prior to the shortage.

Any child between 15-60 months old who has not received his final booster shot, can get it now. We commented that kids under age 3 need to be caught up on this HIB booster dose because that is the primary group of kids who had to wait to get that vaccine until the shortage was over. But, any child under age 5 who is not up to date for HIB vaccine should get it.

Sorry for any confusion!

Sound advice on vaccines

Yes, swine flu is on everyone's mind today, but it also happens to be National Infant Immunization Week. In light of that, the American Academy of Pediatrics has put together a great new resource for parents on vaccines. You can listen to the entire podcast, or just specific segments here:

http://www.cispimmunize.org/fam/soundadvice.html

Stay tuned for HIB vax booster to return

As many of you know, there is an ongoing shortage of an important vaccine that protects against one form of bacterial meningitis, HIB—Haemophilus Influenzae B. Infants are receiving their primary protective vaccines for it. But toddlers have to wait on their booster shots until the shortage resolves.

There is no official word yet when the vaccine shortage will be over, but it may be this summer. Please stay tuned to our website, enews, blog, and now on our twitter account (follow us at twitter.com/baby411) and we will be sure to let you know when the shortage is over. Ask your child’s doctor if your toddler will need to get the booster
shot(s) of HIB.

MMR vaccine has its day in court

Vaccines and Autism. For too long now, those two words have been put together in one sentence—despite the overwhelming evidence that speaks against a connection. And, understandably, it's made new parents a little hesitant about signing off on their baby's shots. But today, a U.S. Federal Court came to the same conclusion that doctors around the world already know: the theory that the combination MMR vaccine causes autism is ...bunk.

After reviewing petitioners' medical records and listening to numerous hours of testimony, the special masters who conducted the proceedings released a 183 page document today. It explained, in great depth, their decision to deny government funded financial compensation to families who felt their child developed autism after receiving the MMR vaccine.

If you want to read the entire document, here is the link to the Federal Court of Appeals' special vaccine injury compensation program. But, I think the passage below says it all:

"After studying the extensive evidence in this case for many months, I am convinced
that the reports and advice given to the Cedillos by Dr. Krigsman and some other physicians,
advising the Cedillos that there is a causal connection between Michelle’s MMR vaccination and her chronic conditions, have been very wrong. Unfortunately, the Cedillos have been misled by
physicians who are guilty, in my view, of gross medical misjudgment."

And here is the Cliff's Notes version of the verdict:

"Considering all of the evidence, I found that the petitioners have failed to demonstrate
that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR
vaccine can contribute to causing either autism or gastrointestinal dysfunction. I further conclude
that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the
petitioners have also failed to demonstrate that her vaccinations played any role at all in causing
those problems."

So, while the drama will likely continue as appeals and civil courts hear these cases, and bloggers continue to blog, I think it's time to separate these two words in our minds and maybe put a few new ones together.

Vaccines: Safe and Effective...which translates into better immunization rates and protection for all our kids

Autism: Support and Hope....which translates into insurance coverage for treatment, access to services, and research dollars for promising causes and treatments

By closing this chapter and starting a new one, all kids will benefit.

America's kids get an A for getting their shots

The National Immunization Survey released their annual report card on how well the nation's kids are vaccinated. We get an A this year. That may be surprising to you, given how much media attention has been given to parents who choose to opt out or delay vaccinations.

But, the truth is, 99% of America's kids are getting vaccinated, and most are completely up to date on their shots by two years of age. Yes, Virginia there is a Santa Claus, and most parents actually choose to follow the recommended schedule of vaccinations. A mere 1% are completely unvaccinated—the parents of these kids are just loud.

MMR studied again! No link to autism found.

Yes, we've heard this one before, but it's worth mentioning yet again for those who doubted all the studies that came before this one. Three separate research teams across the world set out to try to replicate the findings of a 10 year old discredited study on the combo MMR vaccine and concerns for it causing gut abnormalities found in some kids with autism.

Guess what? None of the research labs could find any evidence of that the vaccine triggered autism, and in fact, found that the children with autism they studied had intestinal problems BEFORE even getting vaccinated with the MMR shot.

This is really no surprise, given the fact that 10 of the 13 researchers who collaborated on the original study in 1998 refuted their original claims.

We think the time has come (since its been a decade now) to move on to more likely suspects and hotter leads as to the cause of autism. We're sick of talking about it, and we are even sicker about seeing children suffering from measles based on parents' vaccine fears.

(Stop if you've heard this before . . .) Do Vaccines cause Autism?

Like the bad guy in a horror movie that keeps coming back to life, the controversy over vaccines and autism was back in the news last week—again!

The big news involved a decision by the Vaccine Court. What’s that? Here’s an Q&A to help understand the latest events:

What is the Vaccine Court?

    The United States Court of Federal Claims created a National Vaccine Injury Compensation Program in 1988 to give no-fault compensation to people who were injured or died due to vaccination. Over the years, families have never been awarded compensation for children who have autism due to vaccination.
    In June 2007, the federal court began processing about 4800 claims by families who believe their child’s autism was caused by vaccination. This is being called the Omnibus Autism Proceeding. To expedite this process, certain individual claims will be  “Test Cases” first to get a court opinion on the arguments. The 4800 claims are divided into three main arguments or “theories of causation” from the plaintiffs:

1) Did thimerosal (mercury) preservative in vaccines cause the child’s autism?

2) Did the combination MMR vaccine cause the child’s autism?

3) Did the thimerosal preservative and the MMR vaccine cause autism?

    Cases have already been heard, but no formal conclusions will be available until the entire legal process (including appeals) are completed.

What happened in the case that we’ve been hearing about on the news?

    Hannah Poling is a 9 year old girl whose case was reviewed by the vaccine court as a possible test case. After the court reviewed the child’s medical history, it was determined that her situation was NOT appropriate to be a test case by which to judge one of the theories of causation for vaccines causing autism.
    She was born with an underlying mitochondrial disorder, which predisposed her to neurological deterioration. This case is not a typical of other children with autism. The court (not a scientific study) determined that her neurological deterioration may have been aggravated by being vaccinated and settled her case.

What are mitochondria?

    Mitochondria are the powerhouses of our cells, in charge of energy production.

What is a mitochondrial disorder (MD)?

    MD’s are actually a group of several disorders. Many children do not show any symptoms until the body is stressed and requiring extra energy. Some children will have low muscle tone. They may have several episodes of deterioration and recovery. Some disorders affect only body organ, some affect several. Because of that, kids with MD’s can have different symptoms.
    Hannah Poling had an abnormality in the DNA (genetic makeup) of her mitochondria. This type of MD is something you are born with, not something that you develop later in life.

Did the court decide that vaccines triggered a child to have autism?

    No, what the federal vaccine court said was that the vaccinations may have stressed a child who had an underlying disease—this disease predisposed her to have deterioration of her brain and nervous system. Bottom line: Being born with a genetic mitochondrial disorder like Hannah Poling’s is like being born with an aneurysm. It’s a time bomb, waiting to be set off.

Did the court think the vaccines caused the mitochondrial disorder?

    No. The mitochondrial disorder Hannah Poling has is present at birth and it may not manifest any symptoms until the body is stressed. A stomach virus with dehydration, a high fever…any stress that requires body energy may be the tipping point that causes the deterioration.

If a child has a mitochondrial disorder, should he be vaccinated?

    Yes. Neurologists recommend vaccinating even kids with known MD’s because the stress of having the vaccine preventable disease—chickenpox or flu could be far more devastating, and likely more of a problem than the stress of getting vaccinated.

Could mitochondrial disorders explain the rise in children diagnosed with Autism Spectrum Disorders?

    No. Mitochondrial disorders are rare. There is not any significant data to show that the rate of mitochondrial disorders is any higher in children with autism than in the general population.

Can parents request to do a screening test for Mitochondrial Disorders at birth?
   
    We know what the next natural question is… why not just test every child for mitochondrial disorders before vaccinating them?
    Some tests on the state newborn metabolic screens do test for a few mitochondrial disorders (MCAD, LCHAD, VLCAD disorders).
    But, the gold standard tests for diagnosing many of the MD’s are invasive, and require muscle biopsies and spinal fluid. You can’t just do a simple screening blood test for MD before vaccinating all kids.
    And, remember, even if a child has a mitochondrial disorder, the recommendation is still to vaccinate.

Will this case change the vaccine recommendations?

    No, in fact, Dr Julie Gerberding, who heads the Centers for Disease Control, commented that Hannah’s case was a very special situation and that nothing from this case could be generalized to all children.

Why do we give a number of vaccines at the same time?

    There is a method to our madness. Giving several shots at one time is not just a matter of convenience. While doing them all at one office visit will save parents time and co-payments (most insurance companies charge a co-payment for each visit, even if it is just for a nurse to administer a shot), there are three good reasons why:

1. Vulnerability. The children most vulnerable to serious consequences from vaccine-preventable diseases are the youngest. For instance, a two month old with whooping cough, is much more likely to be hospitalized or die from it than a two year old. So, we try to give as many vaccines as we can, as early as we can, as safely as we can, to protect the youngest. We want kids to be protected as soon as possible. Otherwise, it’s just rolling the dice.

2. Insurance issues. While it is fine to give one vaccine or two vaccines at a time and return next week for a couple more, some families don’t have that luxury. They may have health insurance this week and not again for six months. Having a very staggered schedule leaves more risk of kids missing much needed shots.

3. Separation requirements for live vaccines. While some vaccines can be given one week apart, others cannot. Live vaccines must be separated by at least four weeks. Those are measles, mumps, rubella, varicella, flumist, rotavirus. If you decide to separate those out, you have to space them by at least four weeks each time—thus delaying protection until the series can be completed.

Whew! We know this is a bit much to digest—but the important message here is that vaccines do NOT cause autism. And vaccines save lives.