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Posts Tagged ‘pregnancy’

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.

Vaccines, Pregnancy and my PhD

August 13, 2015 1 comment

National Immunization Awareness Month

WEEK 2: Pregnancy and Vaccines

As a PhD student, we don’t ‘settle down’ all that early. The continuing education or the ‘grind of grad school’ requires that you plan out as much of your personal life as you possibly can. This means planning where you are going to live, who is coming with you, and when and where you are going to have kids.

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As a student in the field of public health, we do more than just think about the timing of our pregnancy, we think about our health, our future lifestyle choices and the vaccines you should get during pregnancy that will protect you and your child over the entire developmental lifecycle, from pre-pregnancy to infancy.

I’m not saying my other non-academic public health friends don’t discuss these topics, it is just we discuss this topic in great detail.

For instance, emerging research is showing that the preconception period and the prenatal environment (life in the uterus) have profound effects on fetal development. Therefore planning a pregnancy doesn’t just encompass making sure you get the correct vaccines during your pregnancy, but making sure you keep up to date with you immunizations long before you decide to even have a child.

Read more…

Vaccinations “Cocoon” Infants Too Young to be Immunized

December 7, 2010 4 comments

By Christine Vara

When our first child was born, my husband and I were intent on protecting her from harm.  While we were probably like most new parents, I’ll admit my husband went to a few extremes.  He would constantly analyze the position of the car seat to ensure her airways would not be restricted. He would tip toe into her room at night to ensure she was breathing.  Once, we drove 14 hours to visit family, only for him to deny everyone the opportunity to hold her.  They all teased him for his constant hovering, but they should have been grateful.  What he really wanted to do was hand out surgical masks.   While he received a great deal of ribbing for his defensive tactics, he was just doing his best to protect her.     

The unfortunate reality is that we can’t raise our children in the proverbial “bubble” – even though that’s what we’d like to do.  But that hasn’t stopped one determined couple from trying, and I can’t say that I blame them. 

Sadly, the Van Tornhout family has suffered what must be the greatest pain imaginable. After five years and four miscarriages, Katie and Craig Van Tornhout, along with their son Cole, were overwhelmed with joy at the arrival of baby Callie into their lives.  Their happiness soon turn to devastation when Callie fell ill with pertussis at just five weeks old, and in a matter of days, quickly lost her battle with this highly contagious disease. 

Today, almost a year after losing Callie, Katie Van Tornhout is preparing to deliver another baby.  While they are certainly thrilled by this new blessing, the family is admittedly quite emotional and cautious as they prepare for the arrival of yet another miracle in their lives.  One way in which they intend to protect this precious baby is to insist that anyone who wishes to visit their newborn be up to date on their pertussis booster.  This includes family, friends and even hospital employees.  The truth is, we can take precautions like washing our hands and covering our coughs, but diseases are often transmitted through droplets in the air and immunization through vaccination has proved to be the best defense against a wide variety of diseases, including flu and pertussis. 

In the case of pertussis, full immunization isn’t typically achieved until a child has received all three doses of DTaP vaccine series which begins at 2 months of age, continues at 4 months and then concludes with the final dose at 6 months.  In the case of seasonal influenza, the vaccine is recommended annually but only for children over the age of six months.  Because of these limitations, children under six months remain most vulnerable to both pertussis and flu in those fragile early months of life.    

In response to the current pertussis outbreaks in states like California, where 10 children have already died just this year, public health officials are desperately trying to educate people regarding the importance of adult pertussis boosters, administered as TdaP shots.  Prior to the birth of a new baby, parents and family members are encouraged to be vaccinated, while pregnant women are being advised to receive their booster shot just after delivery, if they haven’t already been vaccinated before pregnancy. 

In regards to flu protection, everyone over the age of 6 months is encouraged to be vaccinated.  Additionally, pregnant women should know that vaccination during pregnancy offers triple protection.  First, changes to a woman’s immune system during pregnancy can make her more sensitive to the flu and result in serious complications if she is infected.  Secondly, pregnant woman who fall ill with the flu have a greater chance for serious problems for their unborn baby, including premature labor and delivery.  Another significant consideration in favor of flu vaccine for pregnant women is that a mother’s own immunity can be passed on to their unborn child.  In fact, the Wall Street Journal Health blog, recently reported on a study published by the Archives of Pediatric and Adolescent Medicine that found that babies born to pregnant women who were vaccinated against the flu were 41% less likely to develop the flu themselves.  This is a considerable benefit of vaccination that pregnant women may not be aware of, but is an easy way to help protect their unborn children.  

To further ensure protection of these young and vulnerable children, whose immune systems are not sufficiently developed to handle the vaccine or the illness, it becomes imperative that family members and others who come in contact with these infants get vaccinated themselves.  By surrounding a child with people who are immunized, it forms a virtual “cocoon” around them, helping to prevent them from falling ill and suffering complications, hospitalizations and the possibility of death.   

In light of the Van Tornhout’s newest arrival, and the fact that it happens to be National Influenza Vaccination Week, we hope that more people will take steps to ensure everyone in their family is up to date on their pertussis booster and vaccinated against seasonal flu.  Remember, these simple steps you take will not only protect your family,  but will also help prevent the spread of disease to others, including those like newborn Baby Van Tornhout’s, and all the other children out there that are too young to be vaccinated.