Tag: side effects

How to Read a Package Insert for a Vaccine

The highlights of prescribing information of the package insert offers a nice summary of each section, with more details in the full prescribing information section that follows.
The Highlights of Prescribing Information of the package insert offers a nice summary of each section, with more details in the Full Prescribing Information section that follows.

Show me the package insert!

If you are going to ask for a package insert, you should know what’s in it and how it should be read.

Otherwise, it is easy to get misled by antivaccine propaganda, like when Mike Adams claimed he discovered “a vaccine document on the FDA’s own website that openly admits vaccines are linked to autism.”

He really just found the widely available vaccine package insert that said no such thing.

How to Read a Package Insert for a Vaccine

What goes into a package insert is dictated by the FDA, specifically the Code of Federal Regulations Title 21, and Section 314 of the NCVIA, after consultation with the Advisory Commission on Childhood Vaccines.

Much like the package inserts for other medicines, a vaccine package insert includes up to 17 major sections, including:

  1. Indications and Usage – what the vaccine is used for
  2. Dosage and Administration – the recommended dose of vaccine, when and where it should be given, and how to mix it
  3. Dosage Forms and Strengths – available dosage forms
  4. Contraindications – all situations when the vaccine should not be given
  5. Warning and Precautions – all adverse reactions and safety hazards that may occur after getting the vaccine and what you should do if they occur
  6. Adverse Reactions – this section includes clinical trials experience, postmarketing experience, and voluntary reports, and it is very important to understand that it is not always possible to establish a causal relationship to vaccination for these adverse effects. So just because something is listed here, whether it is SIDS, autism, drowning, or a car accident, doesn’t mean that it was actually caused by the vaccine.
  7. Drug Interactions – any reactions you might expect between the vaccine and other drugs
  8. Use in Specific Populations – can include recommendations for use in pregnancy, nursing mothers, pediatric use, and geriatric use
  9.  Drug abuse and dependence – usually blank
  10.  Overdosage – usually blank
  11. Description – general information about the vaccine, including how it was made and all vaccine ingredients.
  12. Clinical Pharmacology – how the vaccine works, including how long you might expect protection to last
  13. Nonclinical Toxicology – must include a section on carcinogenesis, mutagenesis, impairment of fertility, even if it is to say that the vaccine “has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.”
  14. Clinical Studies – a discussion of the clinical studies that help us understand how to use the drug safely and effectively
  15. References – when necessary, a list of references that are important to decisions about the use of the vaccine
  16. How Supplied/Storage and Handling
  17. Patient Counseling Information – information necessary for patients to use the drug safely and effectively

In addition to not having sections 9 and 10, some vaccines don’t have a section 13. It is not a conspiracy. Some older vaccines, like Varivax, do not have to have a section 13 per FDA labeling rules.

Myths About Package Inserts

Just as important as what’s listed in a vaccine package insert, is what the package insert doesn’t say.

Or what you might be led to believe it says.

“To ensure the safety of new vaccines, preclinical toxicology studies are conducted prior to the initiation of, and concurrently with, clinical studies. There are five different types of preclinical toxicology study in the evaluation of vaccine safety: single and/or repeat dose, reproductive and developmental, mutagenicity, carcinogenicity, and safety pharmacology. If any adverse effects are observed in the course of these studies, they should be fully evaluated and a final safety decision made accordingly. ”

M.D. Green on the Preclinical Toxicology of Vaccines

When reading a package insert, don’t be misled into thinking that:

  • you should be worried if a package insert states that a vaccine has not been evaluated for carcinogenic (being known or suspected of being able to cause cancer) or mutagenic (being known or suspected of causing mutations in our DNA, which can lead to cancer) potential or impairment of male fertility. Vaccines don’t cause cancer or impair male fertility, or female fertility for that matter. And as you probably know, many vaccines actually prevent cancer. Formaldehyde is the only vaccine ingredient on the list of known carcinogens, but it is the long-term exposure to high amounts of formaldehyde, usually inhaled formaldehyde, that is carcinogenic, not the residual amounts you might get in a vaccine over short amounts of time.
  • any vaccine actually causes SIDS or autism
  • pediatricians are trying to keep parents from reading package inserts. Your pediatrician is probably just confused as to why you want it, as the VIS is designed for parents, not the package insert. But if even if your pediatrician doesn’t hand you a package insert for each and every vaccine your child is going to get, they are readily available from the FDA and many other websites.

Better yet, just don’t be misled by anti-vaccine misinformation.

“Based on previous experience, carcinogenicity studies are generally not needed for adjuvants or adjuvanted vaccines.”

WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants and Adjuvanted Vaccines

Vaccines are thoroughly tested for both efficacy and safety before they are approved.

It is also important to understand that the WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants and Adjuvanted Vaccines and the European Medicines Evaluation Agency both state that mutagenicity and carcincogenicity studies are typically not required for vaccines.

Why not?

It is because vaccines have a low risk of inducing tumors.

There are also very specific guidelines and rules for when a manufacturer needs to perform fertility studies.

So, as expected, there are no surprises in vaccine package inserts. You can be sure that everything that needs to be tested to show that a vaccine is safe has been done. If it has “not been evaluated,” it is simply because it was not necessary.

Get educated about vaccines and get your family vaccinated and protected against vaccine preventable diseases.

What to Know About Reading Vaccine Package Inserts

Learn how to read vaccine package inserts so that you aren’t misled by many of the myths about what they do and don’t say, including why they are likely missing information on the vaccine’s potential to cause carcinogenicity, mutagenicity, or impairment of fertility.

More on How to Read a Package Insert for a Vaccine:

10 Reasons to Not Vaccinate Your Kids

The Pontifical Academy for Life reaffirmed the
The Pontifical Academy for Life reaffirmed the “lawfulness” of using vaccines to protect children and those around them.

Parents often have their reasons for why their kids aren’t vaccinated.

But whether they have a medical exemption, personal belief exemption, or a religious exemption to getting vaccines, they often have the same reasons for not believing in vaccines.

What are some of them?

They might be scared of toxins.

They might think that vaccines don’t work.

They might think that vaccines aren’t necessary anymore and that they can just hide in the herd.

They are just trying to fit in at a Waldorf school…

10 Reasons to Not Vaccinate Your Kids

In addition to simply being scared about things they have heard on the Internet, some of the reasons that parents don’t vaccinate their kids include that:

  1. they are vegan – many vegans vaccinate their kids
  2. they are Catholic – most Catholics vaccinate their kids – Pope Francis even led an oral polio vaccination drive recently
  3. their child is on antibiotics – having a mild illness is not usually a good reason to skip or delay getting vaccines
  4. their child had an allergic reaction to a vaccine – a severe, anaphylactic reaction to one vaccine or vaccine ingredient wouldn’t mean that your child couldn’t or shouldn’t get all or most of the others
  5. they are Jewish – most Jews vaccinate their kids
  6. a doctor wrote them a medical exemption – there are actually very few true contraindications to getting vaccinated and a permanent exemption to all vaccines would be extremely rare, which casts doubt on the ever growing rate of medical exemptions in many areas
  7. they are Muslim – most Muslims vaccinate their kids and most Islamic countries have very good immunization rates.
  8. someone at home is immunocompromised – since we stopped giving the oral polio vaccine, shedding from vaccines is not a big concern and contacts of those who are immunocompromised are usually encouraged to get vaccinated
  9. they are Buddhist – most Buddhists vaccinate their kids – the Dalai Lama even led an oral polio vaccination drive recently and Buddhist countries have very good immunization rates.
  10. someone in their family had a vaccine reaction – a family history of a vaccine reaction is not a good reason to skip or delay getting vaccinated, as it has not been shown to increase your own child’s risk of a reaction. And yes, this has even been shown for siblings of autistic children, which makes sense, since vaccines don’t cause autism.

What about other religions?

Whether you are Hindu, non-Catholic Christians, Amish, or Jehovah’s Witnesses, etc., remember that all major religions believe in vaccines. Of course, the Amish are a little more selective of when and which vaccines they will get, but as we saw in the Ohio measles outbreak, they do get vaccinated.

On the other hand, Christian Scientists don’t vaccinate, along with some small Christian churches that believe in faith healing and avoid modern medical care.

Still, most people understand why it is important to vaccinate their kids.

What to Know About These Reasons to Not Vaccinate Your Kids

What do you think about these reasons to not vaccinate your kids? Since they aren’t really absolute reasons to not get vaccinated, are you ready to get your kids vaccinated now?

More About Reasons to Not Vaccinate Your Kids

Vaccine Education for Pediatric Offices

Pediarix, Hib, Prevnar, and Rota vaccines have been prepared for an infant at her well child visit.
Pediarix, Hib, Prevnar, and RotaTeq vaccines have been prepared for an infant at her well child visit. Photo by Vincent Iannelli, MD

Why get educated about vaccines if you work in a pediatric office?

In addition to learning how to give vaccines properly, it can help you answer any questions parents might have and help them understand that vaccines are safe, vaccines work, and vaccines are necessary to protect our kids.

Who needs to get educated about vaccines?

Everyone of course. While it’s great if all of the medical assistants and nurses have done their research about vaccines, you will have missed opportunities to get kids vaccinated and protected if the folks making appointments aren’t.

Learning the Immunization Schedule

How do you know when to give a particular vaccine to an infant, child, or older teen when they come to the office, besides the fact that someone else ordered it or the school says they need it?

You can learn the rules of the immunization schedule.

There is more to it than just looking a child’s age and seeing which vaccines they are due for though.

Has the child missed any vaccines, which means you might need to use the catch-up immunization rules?

Do they have any contraindications or reasons to not get a vaccine today?

“There is no ‘alternative’ immunization schedule. Delaying vaccines only leaves a chil​d at risk of disease for a longer period of time; it does not make vaccinating safer.

Vaccines work, plain and simple. Vaccines are one of the safest, most effective and most important medical innovations of our time. Pediatricians partner with parents to provide what is best for their child, and what is best is for children to be fully vaccinated.”

Karen Remley, MD, Executive Director, American Academy of Pediatrics​

Does the child have any high risk conditions, which mean they might need an early or extra vaccine?

In addition to reviewing the latest immunization schedules, studying a summary of recommendations for child and teen immunizations can help you quickly learn when kids need vaccines.

Giving Vaccines Safely

Once you know when it’s time to give the right vaccine to the right child at the right time, you want to make sure that you are giving it to them properly.

You also want to make sure staff knows how to reduce pain associated with giving shots, keeps thorough records, and disposes of needles and syringes properly.

Storing Vaccines Safely

Vaccines must be stored properly.

For example, while some vaccines must be refrigerated, others must be frozen.

What happens if vaccines aren’t stored at the proper temperature?

If a vaccine gets too warm or too cold, it can lose some of its potency and it probably won’t work well. That can mean vaccinated kids don’t get the immunity you expect and are left unprotected to one or more vaccine-preventable diseases. Hopefully, the office discovers the problem before any kids have gotten the vaccine though and they are just left throwing out some unusable vaccines.

The California VFC Program offers
The California VFC Program offers “Do Not UnPlug” signs so that vaccines don’t get ruined.

Fortunately, there are plenty of resources to help office staff get trained about:

  • appropriate vaccine refrigerators and freezers
  • monitoring vaccine temperature with a digital data logger and certified calibrated buffered thermometer probe
  • vaccine temperature best practices
  • keeping a vaccine inventory log
  • handling vaccine deliveries
  • having a plan for refrigerator failure
  • having a plan for power failure and disasters
  • avoiding preventable errors

Does your office have a plan to keep their vaccines at a safe temperature? What about if the power goes out? Will they still be safe?

Other Vaccine Issues

Anyone who administers vaccines to kids should also know:

  • that they need to provide a copy of the latest Vaccine Information Statement from the Centers for Disease Control and Prevention (CDC) to the child’s parent or guardian before giving each vaccine
  • the answers to common questions that parents ask about vaccines
  • to explain common and more rare side effects that parents might be possible after vaccines, so that they aren’t surprised
  • how to report possible adverse reactions to VAERS
  • how to report a vaccine error to VERP
  • that children, especially teens, should be observed for 15 minutes after they are vaccinated to make sure they don’t develop syncope (fainting)
  • strategies to improve your office’s immunization rates
  • how to counter the bad advice Dr. Sears and the use of an alternative or non-standard, parent-selected, delayed protection vaccine schedule
  • the most common vaccine errors, so you can better avoid them

It is also important for all staff to know their office’s vaccine policy. Does your office have one?

What To Know About Vaccine Education for Pediatric Offices

Vaccines are safe, necessary, and still needed to protect all of our kids from vaccine-preventable diseases. Help make sure everyone in your office is educated about the latest immunization schedule and understands how to give and store vaccines safely.

More on Vaccine Education for Pediatric Offices

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Vaccines and Seizures

A newborn baby getting an EEG.
A newborn baby getting an EEG.

Can vaccines cause seizures?

Unfortunately, they sometimes can.

Vaccines and Febrile Seizures

The CDC reports that “There is a small increased risk for febrile seizures after MMR and MMRV vaccines.”

We also know that:

  • there is a small increased risk for febrile seizures when the influenza vaccine is given at the same time as either the Prevnar13 vaccine or the DTaP vaccine, although “the risk of febrile seizure with any combination of these vaccines is small and CDC’s Advisory Committee on Immunization Practices (ACIP) does not recommend getting any of these vaccines on separate days.”
  • there is a small increased risk for febrile seizures if the combined MMR and chicken pox vaccine (ProQuad) is given to infants between the ages of 12 to 23 months vs their getting the shots separately.

But remember that febrile seizures, while scary for parents and other caregivers, are rarely dangerous.

It is also important to note that while febrile seizures are common, they are not commonly triggered by vaccines. A 2016 report in Pediatrics, “Vaccines and Febrile Seizures: Quantifying the Risk,” states that “The risk is 1 febrile seizure per pediatric practice every 5 to 10 years.”

Not surprisingly though, vaccines can likely prevent many febrile seizures, as chicken pox, flu, Hib, measles, mumps, rubella, pneumococcal infections and other vaccine-preventable diseases often cause fever and can trigger febrile seizures themselves.

Also, a study recently found that children who got sick with pertussis could be at increased risk for developing epilepsy, or recurrent seizures. That’s just another good reason to get vaccinated and protected against vaccine-preventable diseases.

Vaccines and Other Types of Seizures

While vaccines can sometimes trigger febrile seizures, they do not typically cause other types of seizures.

It was once thought that seizures were a common side effect of the DPT vaccine, but many studies have found that to not be true and seizures following DPT was even removed as a table injury from the NVICP. In fact, many of these children were instead found to have Dravet syndrome, which put them at increased risk for febrile seizures.

Long-term non-febrile seizures are still listed as side effects for the DTaP and MMR vaccine, but they “are so rare it is hard to tell if they are caused by the vaccine.”

A 2010 study in Pediatrics, “Lack of Association Between Acellular Pertussis Vaccine and Seizures in Early Childhood,” did not find any “increased risk for seizures after
DTaP vaccination among children who were aged 6 weeks to 23 months.”

Do report any reaction to VAERS if you think it was caused by a vaccine though.

Seizures After Getting Vaccines

If vaccines don’t usually cause seizures, then how do you explain a healthy infant developing seizures a few days, weeks, or months after getting his vaccines?

We’re always looking for reasons why something happened. The example I use is from my wife, who is a pediatrician. She was about to vaccinate a four-month-old baby, and while she was drawing the vaccine from the syringe, the baby had a seizure — and went onto have a permanent seizure disorder. Now, my wife hadn’t given the vaccine yet. But if she had given that vaccine five minutes earlier, there would have been no amount of statistical data in the world that would have convinced that mother that the vaccine hadn’t caused the baby’s seizure. You can do studies that show no increased risk with vaccines and seizure disorders, but that mother might still say “well, that’s true for the population but it’s not true for my child.”

Temporal associations are powerful, and they’re hard to defeat with statistics or studies.

Paul Offit, MD interview for The Thinking Persons Guide to Autism

There are many seizure disorders that begin in infancy.

Some even start in the newborn period, before a baby is a month old.

They are not triggered by vaccines though.

They include:

  • Infantile Spasms (first described in 1841) – typically begin when infants are about 4 months old, just when they get their second set of vaccines, which weren’t available when Dr. West described his own son’s repeated spasms
  • Benign Familial Neonatal Seizures – often genetic, seizures may begin on a baby’s third day of life
  • Benign Neonatal Convulsions – begin on the fifth day of life – the “fifth day fits,” and the seizures stop in about a month

If your child got her first hepatitis B vaccine when she was five days old and began having seizures, would you accept a diagnosis of Benign Neonatal Convulsions or would you blame the shot?

Would you remember the saying about correlation and causation?

For More Information on Vaccines and Seizures:

Table Injuries and Vaccine Court

Vaccine injuries, while rare, are certainly real.

In fact, as most people are aware, since 1988, almost $3.5 billion dollars have been paid out by the Vaccine Court for 4,899 compensated awards under the National Vaccine Injury Compensation Program.

While most were settled and “cannot be characterized as a decision by HHS or by the Court that the vaccine caused an injury,” some of the claims were either compensated by a court decision or by concession and for which “it is more likely than not that the vaccine caused the injury or the evidence supports fulfillment of the criteria of the Vaccine Injury Table.”

History of the Vaccine Injury Table

The Vaccine Injury Table was created by the National Childhood Vaccine Injury Act of 1986 and includes “a table of vaccines, the injuries, disabilities, illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which the first symptom or manifestation of onset or of the significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine administration for purposes of receiving compensation under the Program.”

The Vaccine Injury Table:

  • “is a listing of covered vaccines and associated injuries,” although some covered vaccines, like Hib, hepatitis A, chicken pox, flu, HPV, Prevnar, and the meningococcal vaccines, are not on the table
  • “makes it easier for some people to get compensation,” since if a symptom of a table injury occurs within the time frame of getting a table vaccine, then unless another cause is found, “it is presumed that the vaccine was the cause of the injury”
  • “lists and explains injuries and/or conditions that are presumed to be caused by vaccines,” from anaphylaxis and encephalopathy to thrombocytopenic purpura
  • has been modified several times, most notably in 1995 (HHE and seizures from DTP were removed as table injuries and chronic arthritis from rubella was added), 1997 (thrombocytopenia (measles), brachial neuritis (tetanus), and anaphylaxis (hepatitis B) were added as table injuries), and 2002 (intussusception (rotavirus) added as a table injury).
  • is typically only modified if an Institute of Medicine report finds scientific evidence that a condition could be caused by a vaccine with guidance of the Advisory Commission on Childhood Vaccines

Some people, especially anti-vaccine folks who think it is too hard to get compensated under the NVICP, will be surprised that one of the main overarching guiding principles for making changes to the Vaccine Injury Table is that:

Where there is credible scientific and medical evidence both to support and to reject a proposed change (addition or deletion) to the Table, the change should, whenever possible, be made to the benefit of petitioners.

Guiding Principles for Recommending Changes to the Vaccine Injury Table

Changes to the Vaccine Injury Table were proposed last year.

Off Table Injuries

As you can imagine, since most new vaccines do not have table injuries, the VICP has shifted from Vaccine Injury Table to off-Table claims.

While that may change if last years proposed changes are adopted, off-Table claims can still be compensated, a vaccine is not just presumed as causing an injury in these cases.

For More Information on Table Injuries

 

Those Times Other Countries Impulsively Banned Vaccines

Many people know that other countries have different immunization requirements and recommendations than the United States.

In fact, it is even a popular anti-vaccine myth that we give many more vaccines than most other countries. There actually isn’t all that many differences.

What is very different is how quickly most other countries are to pull vaccines at the first sign of an issue, even when it is isn’t likely to be caused by the vaccine and when the consequences are that people are going to be put at risk of life-threatening vaccine preventable diseases.

We saw this when:

  • France suspended the routine vaccination of teens against hepatitis B because of the possible association of the vaccine with multiple sclerosis in 1998 amid “pressure from anti-vaccine groups and reports in the French media have raised concerns about a link between HBV immunisation and new cases or relapses of MS and other demyelinating diseases,” even though “scientific data available do not support a causal association between HBV immunisation and central nervous system diseases, including MS.”
  • DTP vaccination was interrupted in Sweden, Japan, UK, The Russian Federation, Ireland, Italy, the former West Germany, and Australia leading to a pertussis incidence that “was 10 to 100 times lower in countries where high vaccine coverage was maintained than in countries where immunisation programs were compromised by anti-vaccine movements.” The United States was one of the countries that did not stop using DTP at the time, at least not until we had the newer, DTaP vaccine. In Japan, where they switched from DTP to DT in 1974 and raised the ages that children be vaccinated, only 10% had been been vaccinated against pertussis by 1976. In 1979, there was a large pertussis outbreak with 41 deaths.
  • Japan switched from the combination MMR to single vaccines in 1993 because their MMR vaccine had been linked to aseptic meningitis.
  • Some reports say that Sweden and Finland suspended the use of the Pandemrix swine flu vaccine because of its association with narcolepsy, but since the vaccine was for the 2009-10 swine flu pandemic, that seems academic.
  • Japan suspended both Hib and Prevnar for a month in 2011 “because of seven deaths of children that were ultimately found to be unrelated to the vaccines.”
  • Japan also quickly began investigating the HPV vaccines shortly after they became available in Japan “because of fears of complex regional pain syndrome.”
  • Italy temporarily suspended the Fluad flu vaccine after 19 deaths in 2014, but quickly reinstated it after the vaccine was found to be safe.
  • Italy, Germany, Switzerland, Canada, and Australia temporarily suspended the Agrippal and Fluad flu vaccines in 2012 because “white particles were seen in syringes carrying the vaccines,” even though they were said to be a normal part of the manufacturing process.

What are the consequences of frequently suspending and banning vaccines? It certainly doesn’t improve people’s confidence in vaccines or help keep immunization rates up. And we know what it does to disease rates.

Of course, that is not to say that the United States will never stop or suspend the use of a vaccine. The RotaShield rotavirus vaccine is a good example. It was taken off the market just nine months after being approved because it was associated with intussusception.

And we aren’t using FluMist this flu season.

But in most other situations, vaccines were investigated and found to be safe, all without having to be suspended, leaving kids unprotected and at risk of getting a vaccine-preventable disease.

Other countries have sometimes found issues with their vaccines too. Western Australia temporarily suspended FluVax flu shots for children under age 5 years because of an increased rate of fever and febrile seizures in 2010.

Mexico suspended vaccinations after at least two kids died and 29 got sick in Chiapas in 2015 (bacterial contamination of vaccine vials). But it wasn’t all vaccines in the whole country as many reported. It was only a few lots in that part of the country, and vaccines were quickly restarted once they were found to be safe.

It should also be noted that many of these vaccines were never used in the United States, including the brand of MMR that was used in Japan and the Pandemrix swine flu vaccine.

Even FluVax was not used in the United States for young children. In 2010, Afluria, which is essentially the same vaccine, was only recommended for children who were at least 9-years-old.

For More Information:

 

References:
Akehurst C. France suspends hepatitis B immunisation for adolescents in schools. Euro Surveill. 1998;2(41):pii=1143
Gangarosa EJ. Impact of anti-vaccine movements on pertussis control: the untold story. Lancet. 1998 Jan 31;351(9099):356-61.

Jonas Salk

Dr. Jonas Salk developed the first polio vaccine in 1955, just before Albert Sabin developed his oral polio vaccine in 1961.

Approval of Salk’s vaccine followed national testing of the Polio Pioneers, one million children between the ages of six to nine years. Salk also gave his experimental vaccine to his children, his wife, and of course, to himself.

In 1955, he appeared on See It Now and told Edward R. Murrow:

Who owns the patent on this vaccine?
Well, the people, I would say. There is no patent. Could you patent the sun?

Although he could not have patented his vaccine if he had wanted to, he was right that “there is no patent.” The National Foundation for Infantile Paralysis, which he was working for, didn’t patent the vaccine either.

In 1961, Sabin’s live, attenuated polio vaccine replaced Jonas Salk’s inactivated polio vaccine that had been in use since 1955. The United States switched back to IPV in 2000 because of concerns over VAPP.

In addition to his vaccine, his Salk Institute for Biological Studies continues to do research on aging and regenerative medicine, cancer biology, immune system biology, metabolism and diabetes, neuroscience and neurological disorders and plant biology.

For More Information On Jonas Salk: