After following up on the information provided by the CDC and FDA regarding the temporary suspension of the Rotarix vaccine due to contamination with a porcine type virus, it appears that there is no great concern that the virus will have any harmful effects on those who have been exposed to it.
FDA Commissioner Margaret Hamburg clarified that the FDA is not pulling Rotarix off the market, and that even asking doctors to suspend its use for the moment “was not an easy call.” After consulting with scientists at the National Institutes of Health and the Centers for Disease Control and Prevention, as well as officials at the Department of Health and Human Services, “We felt that the judicious thing to do was to make a pause and try to determine what this virus was doing in the vaccine and how it got there.”
The question now is whether the Merck vaccine product, Rotateq will be available in sufficient amounts during the temporary suspension of GlaxoSmithKline’s Rotarix vaccine.
As the U.S. suspends use of the vaccine, countries with higher burdens from this disease may decide to continue using the current vaccine. Why, because rotavirus causes nearly 500,000 deaths in children from developing nations each year! The decision to withhold vaccines in this case would most certainly result in deaths of children.
On the other side of the globe, before the vaccines were licensed here in the U.S. upwards of 50,000 children were hospitalized from rotavirus, resulting in nearly 100 deaths annually. A vaccine shortage in the U.S. is a definite possibility if the suspension extends for a lengthy period of time. We may once again be balancing a very dangerous seesaw: a shortage of vaccines resulting in exposure to deadly rotavirus on one side, countered by the possible contamination with what appears to be a benign virus on the other side. A tough decision for our country’s scientific experts indeed.
More information is available on the FDA site: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205539.htm
The Food & Drug Administration just announced a temporary suspension of Rotarix vaccine (manufactured by GlaxoSmithKline to prevent infantile diarrhea) due to the detection of contamination with what appears to be a non harmful virus strain. According to the CDC, the majority of children here in the U.S. receive an alternate vaccine made by a separate manufacturer. This vaccine is called RotaTeq. There has been no contamination detected in this vaccine. Those children who received the complete series of Rotarix do not need to be revaccinated. Those who still need more doses of Rotarix will receive the RotaTeq vaccine instead during further investigation.
Below is an excerpt from the FDA website regarding the matter:
“FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. This finding was reported to FDA by GlaxoSmithKline, based on work originally performed by an independent U.S. academic research team using a novel technique to look for viruses. GlaxoSmithKline conducted additional studies and confirmed that DNA from PCV1 is present in the finished Rotarix vaccine, as well as in the cell bank and seed from which the vaccine is derived. This confirms that the DNA from PCV1 has been present since the early stages of the vaccine’s development, including during clinical studies.
There is no evidence at this time that DNA from PCV1 in Rotarix poses a safety risk. PCV1 is not known to cause any disease in animals or humans. Rotarix has been extensively studied, before and after approval, and found to have an excellent safety record….The FDA is continuing to investigate the finding of DNA from PCV1 in Rotarix. While FDA is gathering additional information to present to its expert advisory committee in four to six weeks, the agency recommends that clinicians and public health professionals in the United States temporarily suspend the use of Rotarix.”
Please visit the FDA Web site for more information:
By Dawn Crawford, Communications Director at the Colorado Children’s Immunization Coalition.
Parents are inundated with opinions from others these days, leaving them with a myriad a questions about how to best care for their children. Is breast feeding the best or is formula okay? Give baby peanut butter or not? Co-sleeping or crib sleeping? Circumcision or au natural? Vaccinating or not?
With all these decisions, parents have to make an educated choice. They turn to experts like pediatricians, people like their parents who have been there and done that, to educational archives like websites, and to other moms and dads who are living the whole experience with them. Parents are drawing from so many resources that it’s getting hard to differentiate what is a reliable source and what is purely hearsay.
At the Colorado Children’s Immunization Coalition (CCIC), we aim to equip parents with the most up-to-date and relevant information about vaccines for their children. We know it can be a garbled world out there with lots of different talking heads and we want to cut to the facts.
We also want parents to make a fully-educated choice about vaccinating their children. Parents who fear vaccines feel that they are not being told the whole story. They feel that the government and special interest groups are hiding data and side-effects to protect the financial bottom-line.
At CCIC we guide parents to factual information about the whole picture of vaccines. We want them to know about the amazing benefits of vaccines and that they do save lives, but we also want them to know that science is not perfect. We want them to know about side-effects and ways that the government is working to keep vaccines safe and effective.
In Colorado we have a liberal vaccine exemption policy. We allow parents to opt-out of vaccines for medical, religious or philosophical reasons. When entering the 2007/2008 kindergarten school year, according to the Colorado Department of Public Health and Environment, 6% of children were exempted from vaccines.
It might be surprising for a pro-vaccine group, but we understand and appreciate our state’s exemption policy. We want parents to make an educated and purposeful choice to vaccinate their kids. We feel that if a parent has an opportunity to opt-out, that it opens a door to more conversation and greater education by vaccine providers. It also eases parents’ fears of “big brother” forcing them to do something. In the end, it gives them a choice. This lets parents make the informed choice to be part of the solution to protect our community from disease.
In the spirit of fostering a conversation about vaccines, CCIC has teamed up with a mommy blogger to talk about all the triumphs and fears of vaccines – Colorado Mom2Mom .
Colorado Mom2Mom is a blog written by moms for moms who have questions about childhood vaccines. This blog was created to support parents who vaccinate their children and to answer parents’ questions to help them make educated decisions about the health and well-being of their children. Our mommy, Melanie, discusses all aspects of childhood vaccination including the most current science, the latest research, and the emotional decisions that parents face when vaccinating their children.
The reason we partnered with Melanie as our writer is because she is a wife, mother to two beautiful fully-immunized girls, and a vaccine advocate. She is not a doctor or a nurse, but she does have a master’s degree in public health and works for a tax-funded health district in Colorado. She has extensive professional experience with vaccine education to parents and providers across Colorado. She is passionate about childhood vaccines because she believes that they are one of the most important ways you can protect your children’s health.
More than that, Melanie is a mom who had lots of questions about her babies’ vaccines. Like so many moms, she looked to the internet and health professionals to get the information she needed to make an informed decision. She wants to share her experiences and thoughts with you. She is interested in a dialogue and wants to hear what you may be thinking about, questioning or interested in knowing about childhood vaccines.
With this blog, and many other resources, CCIC connects with parents to give them the information they need to make an educated decision about vaccines. We are keeping Colorado kids healthy!
To learn more about how you can help keep your child healthy visit the Colorado Children’s Immunization Coalition at www.childrensimmunization.org.
Editor’s Note: The Colorado Immunization Coaltion site features informative videos on a variety of topics. We thought the video entitled, “Thimerosal: Something to Worry About,” was particularly interesting.
By Alison Singer
President, Autism Science Foundation
This afternoon, the U.S. Court of Federal Claims (i.e. Vaccine Court) issued its decision on whether thimerosal-containing vaccines can cause autism. The decision, handed down by three Special Masters, was a resounding “NO!”.
From King: “This case is not a close case. The overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories…based upon all the evidence that I have reviewed, I find that it is extremely unlikely that Jordan’s autism was in any way causally connected to his thimerosal-containing vaccines. In short, this is a case in which the evidence is so one-sided that any nuances in the interpretation of the causation case law would make no difference to the outcome of the case.
From Dwyer: “In an effort to render irrelevant the numerous epidemiological studies of ASD and TCVs (thimerosal containing vaccines) that show no connection between the two, they contend that their children have a form of ASD involving regression that differs from all other forms biologically and behaviorally. World-class experts in the field testified that the distinctions they drew between forms of ASD were artificial, and that they had never heard of the “clearly regressive” form of autism about which petitioners’ epidemiologist testified. Finally, the causal mechanism petitioners proposed would produce, not ASD, but neuronal death,and eventually patient death as well. The witnesses setting forth this improbable sequence of cause and effect were outclassed in every respect by the impressive assembly of true experts in their respective fields who testified on behalf of respondent.
From Dwyer: “Petitioners propose effects from mercury in [vaccines] that do not resemble mercury’s known effects in the brain, either behaviorally or at the cellular level. To prevail, they must show that the exquisitely small amounts of mercury in [vaccines] that reach the brain can produce devastating effects that far larger amounts experienced prenatally or postnatally from other sources do not.”
The special master also dismissed claims that some groups of children are unusually susceptible to the effects of mercury. “The only evidence that these children are unusually sensitive is the fact of their [autism] itself.”
This whole process began back in 2002 when the Special Masters from the Vaccine Court createdan omnibus proceeding for handling the claims that alleged that vaccines were associated with autism. Today’s ruling focuses on whether thimoerosal-containing vaccines can cause autism. Last August, the court ruled that thimerosal in combination with MMR vaccine could not cause autism.
There are two key points to keep in mind today. First, the special masters are not scientists and they did not answer a scientific question today. The science has been in for some time now in and it’s quite clear. Vaccines do not cause autism. We have multiple studies (www.autismsciencefoundation.org/autismandvaccines.html) that have been done looking at whether or not thimerosal, at the level contained in vaccines, causes autism and again, looking at hundreds of thousands of children on several different continents by several different investigators and different populations of children. Children who received thimerosal in vaccines as compared to those who received lesser quantities of thimerosal in vaccines or no thimerosal in vaccines all had the same risk of autism. And frankly, the amount of mercury one is exposed to in the environment or even breast milk as compared to what’s in vaccines would argue against vaccines being causative.
Secondly, when you look at the history of vaccine court, this court hasn’t always come down on the side of the science. The standard of evidence bar is purposely set very low in vaccine court. The court was designed to compensate victims of vaccine injury, which of course is very real. The standard of evidence is biologic plausibility, rather than scientific evidence. In other words, you don’t have to prove that thimerosal actually causes autism, only that it might. One of the goals of the legislation creating the vaccine court in 1986 was to be generous with compensation because there are people who have very real, very serious adverse reactions to vaccines and they should be compensated. And if you look at other rulings, this court tends to err on the side of overcompensating to avoid a big spillover into civil courts. Another goal of the vaccine court is too avoid massive civil litigation that could put us back where we were in the early 1980s where companies were exiting the vaccine manufacturing business over fear of litigation.
I can understand wanting to find a reason for why your child was diagnosed with autism. As a mother, it’s hard to accept the idea that your child is going to struggle and have all these challenges. It’s natural to want to blame someone or something. Believe me, I’ve been there. We love our children so much and we just want to do everything possible to help them. I can understand parents who are upset and angry and just want to know how this could have possibly happened, and I feel for the families who filed in vaccine court because they are clearly in a lot of pain. But they need to look at the data. You can’t be so focused on anger that you lose sight of what the science is saying because that’s not in the best interest of the kids. At the Autism Science Foundation we always encourage parents to look at the science and make decisions based on the science. And this is what the special masters did. They looked at the data.
And I want to stress one more point; this is really not an issue over which parents and scientists disagree. Parents have access to the studies on the internet and we know how to read. The studies are very clear. The vast majority of families have come to the same conclusions as the special masters. It’s not a scientists vs. layperson or scientist vs parents issue. Everyone is coming to the same conclusion, except a small, vocal minority of parents who just don’t want to believe what the data clearly show. And frankly it scares me to see children with autism being put at risk by therapies that have grown out of the incorrect vaccine hypothesis, like heavy metal chelation, that have no evidence of efficacy and can do real harm, especially when they divert time and energy away from therapies like Applied Behavior Analysis which have been proven to help our kids.
Hopefully after today’s ruling, we can put this issue behind us and move forward and direct our scarce autism research dollars to studies that will provide new information about what causes autism and how best to treat it.
The U.S. Court of Federal Claims today issued a decision on the Omnibus Autism Proceeding’s second theory that vaccines which contain thimerosal (a preservative) do not cause autism. The decision was based on three test cases who alleged that thimerosal-containing vaccines triggered autism in their children. After a thorough and exhaustive review of the science, the judges overwhelmingly declared that the vaccine-autism theory is “scientifically unsupportable.” One of the judges, Special Master George Hastings, wrote, “This case, however, is not a close case. The overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories…In short, this is a case in which the evidence is so one-sided that any nuances in the interpretation of the causation case law would make no difference to the outcome of the case.”
The Omnibus Autism Proceeding was created by the National Vaccine Injury Compensation Program to handle the large volume of claims that vaccines induce autism. In order to ensure that the over 4,900 cases were dealt with in a timely manner; the U.S. Court of Federal Claims divided the claims into three theories. The first theory, that MMR vaccines given in combination with thimerosal-containing vaccines could cause autism, was denied over a year ago. The second theory, that thimerosal containing vaccines cause autism, was denied today, and the third theory, that MMR vaccines alone cause autism, was not considered viable and thrown out last year.
It’s important to remember that while these legal decisions reaffirm the science, the science has already spoken for itself many times over. A series of biological and epidemiological studies have concluded that the ingredients in vaccines do not cause autism or other disorders. If you’d like to review the current body of literature on thimerosal and autism, the Children’s Hospital of Philadelphia has a wonderful resource available here, which I encourage you to share with family and friends. The Vaccinate Your Baby web site also has a handy summary of the various studies which have shown that thimerosal does not cause autism.
If you’d like to learn more about the Vaccine Court, check out our web site here.
The bottom line is that vaccines have been proven to be safe and effective, and they save lives. I think Alison Singer, President, Autism Science Foundation put it best when she said, “It’s time to move forward and look for the real causes of autism. There is not a bottomless pit of money with which to fund autism science. We have to use our scarce resources wisely. Our children deserve real answers and at this point doing more and more studies of vaccines, when the science is so clear, would be allowing politics to triumph over science.”
A new study that was released by researchers from the University of Michigan and published in the journal Pediatrics this week revealed some bittersweet news about parents’ attitudes toward vaccinating their children. While the survey of 1,552 parents found that one in four U.S. parents believes some vaccines cause autism in healthy children, the study also found that most parents continue to follow the advice of their children’s doctors, with nine out of ten saying that they parents believe that vaccination is a good way to prevent diseases for their children.
The information from this survey tells me that public education campaigns conducted by organizations such as Every Child By Two and many others (click here for a list) fill a critical role in conveying scientific information to the public. It’s only natural that parents will have questions about their children’s health, but it’s up to the public health community to answer them in a clear and comprehensive way. As lead author of the study Dr. Gary Freed says, most of parents’ fears are unfounded, so it’s essential that “physicians … take parental concerns seriously. They need to be aware of and familiar with the data on the safety of vaccines, because parents deserve to have concrete info on vaccine safety.”
Doctor-patient communication is critical, and the American Academy of Pediatrics, Centers for Disease Control and Prevention (CDC), and American Academy of Family Physicians (AAFP) partnered to develop some great resources for providers to communicate with parents about vaccine concerns. Click here to check it out.
In order to better prepare parents prior to their child’s vaccines, I’d like everyone to share with their friends and family some credible resources to which parents can turn to have some of their tough questions answered. For example, Every Child By Two posed some frequently asked questions to several experts in the fields of immunization and autism and recorded the expert answers here.
Another item that concerned me was that parents believe that newer vaccines are untested, and less safe than ones that have been around longer. I want to reiterate that all vaccines go through the same, very stringent and lengthy, regulatory review process. Because vaccines are given to healthy individuals, they undergo a more rigorous approval process than drugs which are given to cure sick people. Vaccines are also tested in combination with one another so that they are proven to be safe in the context of the CDC schedule as well. Licensing of vaccines typically takes 15 years and an average of $800 million of manufacturers’ money. For more info on this process, click here, or visit the FDA web site.
Finally, the study also pointed out that although Hispanic families have the lowest rate of vaccine refusal as compared to white or black individuals, they were more likely to believe that some vaccines cause autism. The researchers suggested that “addressing this concern explicitly before it has an impact on immunization rates should be strongly considered by both public health officials and private providers in these communities.”
I hope that you will share this information with any concerned parents out there who may not have had all of their questions answered!
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