Archive

Posts Tagged ‘parenting’

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.

Protecting Myself and My Child against Vaccine-Preventable Diseases during Pregnancy

August 6, 2018 3 comments

By Erica DeWald, Director, Advocacy, Every Child By Two

Here at Every Child By Two, we practice what we preach. That’s why I got both a Tdap and influenza vaccine when pregnant with my first child (who is fully up-to-date on his childhood vaccines). Now that I’m expecting my second baby, I didn’t hesitate to get vaccinated again.

Tdap Vaccination.ERica.jpg

Why do I choose to get vaccinated?

Vaccines during my pregnancy have the ability to protect not only me, but my child as well. Infections such as flu and whooping cough, also known as pertussis, are not just a threat to me. They can also be extremely dangerous, and even deadly, to newborns.

Why get vaccinated against whooping cough?

Whooping cough is a highly contagious respiratory disease that spreads easily from person-to-person through coughing and sneezing. Symptoms can be less severe in vaccinated people and older children and adults, so adolescents or adults may unknowingly pass the infection onto vulnerable infants.

In young children, the cough can be so severe that it can cause a child to gag, turn blue, vomit or pass out. A gasp for air after a coughing fit can sometimes produces a loud “whoop” sound, though it is not uncommon to have whooping cough without producing the “whoop” sound.  This intense coughing phase can last as long as 10 weeks.

Half of all children who get whooping cough under a year of age end up in the hospital. Some will suffer lifelong complications and one of every 100 will die.

Why get vaccinated against flu?

Changes in my immune, heart, and lung functions during pregnancy make me more likely to get ill and suffer severe complications from illnesses as compared to non-pregnant women. In fact, as a pregnant woman, I am five times more likely to suffer complications or death from flu compared to non-pregnant women.  Additionally, if I fall ill during pregnancy, I have a greater chance of hospitalization, spontaneous abortion or complications that can directly impact the health of my baby such as preterm labor and delivery, and low birth weight babies.

In children, the highest incidence of hospitalization due to influenza is among infants younger than 1 year, with those younger than 6 months at highest risk. On average, about 100 children die from flu each year in the U.S. and thousands more are hospitalized.

Getting vaccinated during pregnancy also provides my child with protection during his first weeks and months.

By getting my vaccines in pregnancy when recommended by the Centers for Disease Control and Prevention (CDC), the American College of Obstetricians and Gynecologists (ACOG), and the American College of Nurse Midwives (ACNM), I can lessen my child’s chances of contracting these diseases when he is most vulnerable (and before he receives his own vaccines):

SOTI_SocialMediaGraphics_8

How do I know vaccines are safe for me and my child?

Experts carefully reviewed the safety data of the whooping cough vaccine before recommendation that women receive a Tdap vaccine during each pregnancy.  They concluded that the vaccine was safe for both pregnant women and their babies and there is a long list of published safety studies that can be reviewed here.

Additionally, science supports the safety of flu vaccination for pregnant women and their babies, and the flu shot has been safely administered to millions of pregnant women over many years.  While the scientific community will continue to gather data on this topic, various studies, such as those detailed below, already indicate that it is safe to administer the flu vaccine in pregnancy.

For now, I’m off to find a flu vaccine in order to give my child some protection against the disease before he’s born and flu season is in full swing!

Find more information on vaccines in pregnancy on these websites:

Tags: ,

Better Late Than Never

February 2, 2010 1 comment

By Amy Pisani

Tonight my small town in Eastern Connecticut will yet again host an immunization clinic at a local high school to provide H1N1 vaccine to the public. Special efforts have been made by our health district to reach out to young children who have not yet received their second dose of vaccine.   According to the Centers for Disease Control and Prevention, children nine and under need two doses in order to be fully protected against the virus.  I am somewhat mortified to admit that I have been remiss in getting my nine and a half year old that second dose.  My son’s story has been told by me on numerous occasions, he was hospitalized as an infant for complications from influenza, an experience I do not wish on my worst enemy. 

I am a consummate supporter of timely vaccination of children.  What is my excuse then?  It seems that work travel and after school activities took priority again and again as clinics were scheduled.  During a recent clinic, I traveled to D.C. to accompany Luke Duvall, Arkansas H1N1 survivor, as he spoke to the press and his Senator about his harrowing experience.  I’ve reiterated his story countless times in an effort to urge friends and neighbors to get vaccinated.  It’s nearly unconscionable that I would then allow this lapse in my own family.  My embarrassing point is that if I am remiss, how many others who do not live and breathe vaccines daily are simply blowing off the CDC’s and Health and Human Services pleas to the public?   I must assume that this number is in the millions based on the number of doses still available.  So tonight I am volunteering at the clinic and my husband and son will be vaccine recipients, come hell or high water!