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Posts Tagged ‘children’

How Do We Know Vaccines are Safe?

August 15, 2018 8 comments

Vaccinate Your Family_MomGrandmaLittleGirlToo often, we hear misinformation about vaccines and their safety. Some people claim that they are not tested for safety before being licensed and recommended for use in people in the United States. Others say that vaccines are not held to the same safety standards as drugs, when in fact they are held to a higher standard. And some others wrongly proclaim that vaccines are not monitored for safety after they are licensed by the U.S. Food and Drug Administration (FDA) and recommended for the public by the Centers for Disease Control and Prevention (CDC), as they are unaware of the strong vaccine surveillance systems we have in place in the U.S.

The United States has the safest, most effective vaccine supply in its history.

Below, we offer an overview of how vaccines are tested and monitored for safety and effectiveness:

Clinical trials

Vaccines are one of the most thoroughly tested medical products available in the U.S. Before a vaccine can be considered for approval by the FDA, a vaccine manufacturer must show it is safe and effective through clinical trials. Developing a new vaccine begins with exploratory stage and pre-clinical stage before advancing to three stages of clinical trials. Together, this scientific process can take over a decade and cost millions of dollars. The FDA then examines these studies and determines whether a vaccine is safe, effective, and ready to be licensed for use. The FDA only licenses vaccines that have data that shows that the vaccines’ benefits outweigh the potential risks. If there is any question about the data, or any holes in the data, the FDA will request further studies before approving the vaccine.

Four monitoring systems 

After a vaccine is licensed for use in the U.S., there are four systems in place that work together to help scientists monitor the safety of vaccines and identify any rare side effects that may not have been found in clinical trials. Even large clinical trials may not be big enough to find very rare side effects. For example, some side effects may only happen in 1 in 100,000 or 1 in 500,000 people. Second, vaccine trials may not include certain populations like pregnant women or people with specific medical conditions who might have different types of side effects or who might have a higher risk of side effects than the volunteers who got the vaccine during clinical trials.

Vaccine Adverse Events Reporting System (VAERS)

VAERS is a passive reporting system. That means it relies on individuals to report vaccine reactions. Anyone can report a reaction or injury, including healthcare providers, patients and patients’ representatives, such as caregivers or attorneys. The system is co-managed by the FDA and the CDC. However, it is important to note that VAERS data alone can’t be used to answer the question, “Does a certain vaccine cause a certain side effect?” This is because adverse events reported to VAERS may or may not be caused by vaccines. There are reports in VAERS of common conditions that occur just by chance after vaccination. Further investigation may find no medical link between vaccination and these conditions. Instead, the purpose of VAERS is to see if unexpected or unusual patterns emerge, which may indicate a vaccine safety issue that needs to be researched further.

The Vaccine Safety Datalink (VSD)

Established in 1990, VSD is a collaboration between the CDC’s Immunization Safety Office and eight health care organizations across the country. It conducts studies based on questions or concerns raised from the medical literature and reports to VAERS. In addition, when new vaccines are recommended or if changes are made in how a vaccine is recommended, VSD will monitor the safety of these vaccines.

The Clinical Immunization Safety Assessment Project (CISA)

CISA, which was created in 2001, is a national network of vaccine safety experts from the CDC’s Immunization Safety Office, seven medical research centers and other partners. CISA addresses vaccine safety issues, conducts high quality clinical research and assesses complex clinical adverse events following vaccination. CISA also helps to connect clinicians with experts who can help consult on vaccine safety questions related to individual patients.

The Post-Licensure Rapid Immunization Safety Monitoring System (PRISM)

PRISM is a partnership between the FDA’s Center for Biologics Evaluation and Research and leading health insurance companies. It actively monitors and analyzes data from a representative subset of the general population. PRISM links data from health plans with data from state and city immunization information systems (IIS). PRISM has access to information for over 190 million people allowing it to identify and analyze rare health outcomes that would otherwise be difficult to assess.

These four post-licensure monitoring systems have been able to address several important issues related to vaccines and their safety, including:

The Department of Health and Human Services (HHS) and its agencies, health insurance companies, scientists, healthcare providers, and other public health and medical groups are all dedicated to ensuring people of all ages are protected against serious infectious diseases by a safe, effective supply of vaccines.

What Did Everyone Give Thanks For This Year?

November 30, 2009 Leave a comment

By Amy Pisani

I hope everyone had a happy and healthy Thanksgiving weekend. I wanted to give everyone an update on a very special project that the Colorado Children’s Immunization Coalition put together.  Their Healthy Kids Thank-A-Thon urged parents, grandparents and mommies-to-be to submit gratitude statements, photos, videos and blogs online explaining why they are grateful for a healthy child on the Health Kids Thank-A-Thon website.

Well, the results are in and I thought it was worth sharing with our Shot of Prevention readers, and not just because I am one of the participants! There are some really touching videos from parents and family members, and I thought that even though it’s not Thanksgiving anymore, we can still take a moment to reflect on this important topic.  Check out the YouTube videos here. Visit the Thank-A-Thon Web site here.

Pnock Out Pneumonia with the Best Shot Foundation

November 2, 2009 1 comment

By David Rubenstein, Best Shot Foundation

Today is World Pneumonia Day – a day to amplify the quiet global discussion about how best to solve a forgotten health crisis and protect millions of children from a preventable and treatable disease.

We have the medical technology to make treating and preventing pneumonia easy and affordable.  In fact, it costs only $20 to vaccinate an at-risk child from pneumonia. For children with pneumonia, treatment is even less expensive; $8 can diagnose and treat a child.

So, why does pneumonia continue to bury more children each year than any other disease? Because communities in the world’s poorest areas lack the knowledge and resources to combat pneumonia. Children across the United States are fortunate to live in healthier conditions and have access to health care that would spot and treat pneumonia. Most children in the developing world do not share such fortune.

Today, pneumonia will take 5,500 young lives. We have the potential to save thousands of those children. A safe, effective, affordable vaccine is available; we simply need leadership to make the difference. By harnessing charitable support from individuals, organizations, and the government we can ensure that the essential medical resources get to the children who need it.

I founded the Best Shot Foundation in May 2009, disheartened by the statistics and the number of children dying, but encouraged by the relatively solvable problem that pneumonia presents. One million children a year could be saved if we harness the political will and resources to tackle this problem.

We know that global health spending is skewed towards the most politically effective advocates. The Best Shot Foundation was created to raise the our voices against the world’s deadliest killer.

This winter, the Best Shot Foundation will build the fight to protect children by organizing Pnock Out Pneumonia dodgeball tournaments in 16 cities. Participants will raise both money and awareness as they compete to be dodgeball champions. They will lead the effort to spare poor families from the unspeakable heartbreak of losing a child from a preventable disease.

For more information about the Best Shot Foundation’s fight against pneumonia, go to http://www.best-shot.org. For information about the first annual World Pneumonia Day, go to http://www.worldpneumoniaday.org. 

We Are All Living Proof

October 28, 2009 1 comment

By Amy Pisani

Living Proof ProjectLast night I was glued to my computer watching the live webcast of the Gates Foundation’s Living Proof Project:  U.S. Investments in Global Health are Working.  Bill and Melinda Gates gave an awesome multimedia presentation showcasing some of the truly impressive strides we have made in global health. I was so thrilled to hear Melinda Gates call vaccines the “great miracles of our lifetime.” Thanks to vaccination, we’ve been able to bring down cases of Diphtheria 93%, Tetanus 85%, and Measles 93% since 1980.

The presentation really hit home with me when they showed villages and people in the developing world that have benefited from vaccination. I was moved by the video they showed of a village in Nicaragua called Pantasma that was able to receive shipments of the vaccine against rotavirus, which kills 500,000 children in developing countries each year.  The video showed the health clinic in Pantasma,  which saw so many cases that they had to put two kids in each bed.  One of the doctors in the clinic said that when the vaccine arrived in Pantasma, the number of cases of rotavirus dropped – and there are now no children in their rotavirus ward. Eighty percent of Nicaraguan children under the age of 5 have now been vaccinated against rotavirus, a truly impressive number that can hopefully be replicated in other nations. 

These videos are so important to watch for two reasons. First, it’s important for people in the U.S.  to see how much our investments in global health are helping those in need. And second, I think we sometimes take our own health for granted in this country. The alarming trend of parents spacing out or skipping their children’s shots does not seem like such a big deal when we don’t see the devastation of these diseases in our everyday lives. Watching presentations like this one shows us that they are only a plane ride away.

A webcast of Bill and Melinda Gates’ presentation is available online, which you can view here: http://www.gatesfoundation.org/livingproofproject/Pages/impatient-optimists-speech.aspx

At the end of the speech, Bill and Melinda asked that everyone in the audience share this with one other person whose opinion they respect. I encourage all of you to do the same.

Why I’m Getting the H1N1 and Seasonal Flu Vaccines

October 27, 2009 Leave a comment

By Danielle Romaguera

I am pregnant with my fourth child due in December.  I must say that, while I am excited for this new addition to our family, I am also nervous about the H1N1 scare and its potential impact on my baby’s health as well as my own.

As you have probably heard in the news or read online, pregnant women are a greater risk for contracting H1N1.   We are the group most threatened by the illness.   Why?   I have done some research and here is what I have found:

  • Our bodies change during pregnancy.   We have a harder time fighting off illness as our immune system is working overtime to protect the fetus.
  • As the uterus grows and pushes the diaphragm up, it is harder for us to clear our lungs.
  • Many of us are also in the younger age group most susceptible to catching the virus.

The news has been reporting on some accounts of pregnant women being affected by H1N1.  In some cases, the mother dies but they are able to save the child.  I was greatly saddened to hear about this case featured on NBC Nightly News.

It is extremely hard for me to watch these sad accounts but they should serve as a reminder to all of us to vaccinate ourselves against both H1N1 and the seasonal flu.  Talk to your doctor about getting the vaccines if you have not already.

I found the CDC’s site to be really helpful as guidance for pregnant women.  We need to protect ourselves and our babies.

Trusting a Mother’s Instincts

October 20, 2009 3 comments

By Dr. Ari Brown

A few years back, a mother that I knew well brought her four week old son into my office. She brought him in because she trusted her mommy instincts. She had three older children and she told me,   “I don’t know, but something’s wrong with this one!”He was having difficulty breathing. Some newborns have periodic breathing, where they pant for several breaths, pause, and then breath again. But this mom was describing something different. The baby would stop breathing and seemed like he couldn’t catch his breath.  And, he looked dusky when these events occurred. He was having these episodes a few times a day, and it scared even this seasoned mom.

When I examined him, he appeared perfectly normal until he started choking.  I turned to her and asked, “Are you afraid to sleep at night?” Her response—“YES!” I’ve learned over the years to always trust a mom’s judgment, so I picked up the phone.

The baby was admitted to our local children’s hospital.  During his stay, it was quite clear why his mom was so worried. He had numerous spells where he stopped breathing, and had so much trouble that he needed supplemental oxygen. He also had horrible coughing spells where he would turn red, choke, and gasp for breath. He had whooping cough.

It turns out that his mom had a hacking cough towards the end of her pregnancy that she just couldn’t shake. It continued in the weeks after she delivered, but she was too busy taking care of her newborn to worry about herself. She had whooping cough and had given it to her son.

Fortunately, this story has a happy ending. After several scary days in the hospital, receiving supplemental oxygen and constant monitoring, my little patient went home. He is a healthy, thriving kid today. But, not everyone who goes through this experience has this same rosy outcome.

Whooping cough often spreads from adults to those who are the most vulnerable—our babies, who, like my patient, are too young to be vaccinated.  Since 2005, teens and adults can receive a whooping cough booster vaccine that’s given in combination with their tetanus shot (called the TdaP vaccine).  Many hospitals now routinely give moms a TdaP booster shot right after delivery, which is a great first step. But, it’s important for all caretakers to roll up their sleeves for their precious baby. Dads, grandparents, or any other adult who spends time with a baby should get this shot. It’s called cocooning. By vaccinating those around the baby, you are protecting him from the disease.

If you can’t remember the last time you got your tetanus shot, or you got your last one when you were still seeing your pediatrician, it’s time to do it!

Ari Brown, MD, FAAP is a pediatrician in practice in Austin, TX and the author of Baby 411: Clear Answers and Smart Advice for your Baby’s First Year.

Editor’s Note: The whooping cough vaccine for children is combined with the tetanus and diphtheria vaccines (DTaP). To read more about whooping cough and how important it is for every child to receive each dose of their DTaP on time, please see The New York Times article “Risks: Pertussis Protection? Not From the Herd” at http://www.nytimes.com/2009/06/09/health/research/09risk.html?_r=2&ref=health

H1N1 and Autism: What Parents Need to Know

October 20, 2009 4 comments

By Alison Singer
President, Autism Science Foundation

There are two main questions that parents of children with autism have been asking us about H1N1 virus and H1N1 vaccine. The first is whether our children are at higher risk from complications from H1N1 and thus need to be given prioritization with regard to vaccination. Much of this concern stems from the fact that because of communication challenges, kids with a developmental disability often can’t tell us when they are sick. Thus, treatment of an H1N1 infection might be delayed.

The second question on people’s minds is whether the vaccines will contain thimerosal. According to the CDC, the 2009 novel H1N1 influenza vaccines that FDA is licensing will be manufactured in several formulations. Some will come in multi-dose vials and will contain thimerosal as a preservative. Parents can be assured that the most recent and rigorous scientific research does not support the hypothesis that thimerosal-containing vaccines are harmful.

Should kids with autism be given priority in vaccination?

The September 3, 2009 issue of CDC’s Morbidity and Mortality Weekly Report (MMWR) reported that of the 36 children with a confirmed 2009 H1N1 infection who died between April and early August 2009, twenty-four had chronic medical conditions that have been recognized to increase the risk of complications from seasonal influenza.  In particular, many children had neurodevelopmental conditions, such as cerebral palsy, epilepsy, and developmental delay. (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5834a1.htm).

One of the authors of this report, Dr. Georgina Peacock of the CDC’s National Center on Birth Defects and Developmental Disabilities, says that the majority of these children had neurodevelopmental disabilities that left them at risk for pulmonary compromise — this would include children that may have trouble clearing secretions, protecting their airway or difficulties coughing. In addition, almost all of the children had more than one neurodevelopmental problem, such as cerebral palsy and epilepsy.  Thus there is not a specific priority vaccination group for individuals with developmental delay or other neurodevelopmental conditions.

Dr. Peacock added that there has not been any prioritization for the 2009 H1N1 vaccine within the priority groups and stressed that all children and young adults should be vaccinated for 2009  H1N1 influenza  when it becomes available. In addition, children should be up to date on their pneumococcal vaccine–this would include the 7-valent vaccine (Prevnar) for children under 2 (which is part of routine vaccinations)  and  additionally  the 23-valent vaccine  (Pneumovax)  for children greater than 2 with a high-risk medical condition.  This will help to protect against some types of pneumonia, which a complication that can develop after influenza infection.

If children who are in one of the higher risk groups develop flu-like symptoms, including a fever, sore throat and/or cough, parents should contact their child’s doctor or seek medical attention.  Parents should talk to a doctor early if worried about their child’s illness.  There are anti-viral medications that can be helpful in treating influenza especially when started early. In addition, although not in a priority group, parents of children with developmental disabilities are urged to get vaccinated as soon as vaccine becomes available to the general public.

What About Thimerosal?

According to the CDC, the 2009 novel H1N1 influenza vaccines that FDA is licensing will be manufactured in several formulations. Some will come in multi-dose vials and will contain thimerosal as a preservative. Multi-dose vials of seasonal influenza vaccine also contain thimerosal to prevent potential contamination after the vial is opened.

Some vaccine manufacturers will be producing novel H1N1 influenza vaccine in single-dose units, which will not require the use of thimerosal as a preservative. In addition, the live-attenuated version of the vaccine, which is administered intranasally (through the nose), is produced in single-units and will not contain thimerosal.

Since 2001, no new vaccine licensed by FDA for use in children has contained thimerosal as a preservative, and all vaccines routinely recommended by CDC for children under six years of age have been thimerosal-free, or contain only trace amounts, except for multi-dose formulations of influenza vaccine. This was done as a precautionary step and not because there was evidence confirming that thimerosal-containing vaccines were causing health problems. The most recent and rigorous scientific research does not support the hypothesis that thimerosal-containing vaccines are harmful.

Thimerosal is an important preservative that protects vaccines against potential microbial contamination, which may occur in opened multi-dose vials of vaccine. Such contamination could cause serious illness or death. Since seasonal influenza vaccine is produced in large quantities for annual immunization campaigns, some of the vaccine is produced in multi-dose vials, and contains thimerosal to safeguard against possible contamination of the vial once it is opened.

Three leading federal agencies (CDC, FDA, and NIH) have reviewed the published research on thimerosal and found it to be a safe product to use in vaccines. Three independent organizations (The National Academy of Sciences’ Institute of Medicine (IOM), the Advisory Committee on Immunization Practices (ACIP), and the American Academy of Pediatrics (AAP)) reviewed the published research and also found thimerosal to be a safe product to use in vaccines.

Nonetheless, the presence of the preservative thimerosal in vaccines and suggestions of a relationship to autism has raised concerns. Since 2001, no new vaccine licensed by FDA for use in children has contained thimerosal as a preservative,  and all vaccines routinely recommended by CDC for children under six years of age have been thimerosal-free, or contain only trace amounts, except for some formulations of influenza vaccine, and yet, we have not seen reductions in the numbers of children diagnosed with autism, indicating that the cause of autism is not related to thimerosal.

H1N1 influenza vaccine is expected to have a similar safety profile to seasonal flu vaccines, which have a very good safety track record. Data from novel H1N1 trials among children are not available yet.

According to current federal plans, only unadjuvanted vaccines will be used in the United States during the 2009 flu season. This includes all of the 2009 H1N1 and seasonal influenza vaccines that will be available for children and adults in both the injectable and nasal spray formulations. Original plans for novel H1N1 vaccine referenced possible use of the adjuvant squalene, but this is no longer necessary given that testing showed that single dose H1N1 vaccination produced a stronger than expected immune response, thus reducing the need to “stretch” the amount of antigen available to the public by adding adjuvant to the vaccines.