Tag: Vaccine Safety Datalink

Anaphylaxis After Vaccines

Anaphylaxis after vaccines is a well known side effect, but just how common is it?

Anaphylaxis After Vaccines

Since it is listed as a possible reaction to nearly all vaccines and it can be life-threatening, anaphylaxis must be fairly common, right?

“Vaccine providers should be familiar with identifying immediate-type allergic reactions, including anaphylaxis, and be competent in treating these events at the time of vaccine administration. Providers should also have a plan in place to contact emergency medical services immediately in the event of a severe acute vaccine reaction.”

Preventing and Managing Adverse Reactions

After all, pediatricians even get warned to have a plan in place and to be prepared to treat children just in case they develop anaphylaxis after getting their vaccines.

Your pediatrician will likely have an EpiPen in the office in case your child has an anaplylactic reaction after his vaccines.
Epi Is Readily Available to Treat Most Kids with Anaphylaxis After Vaccines

Still, most probably have never had to.

“Any medication can cause a severe allergic reaction. Such reactions to a vaccine are estimated at about 1 in a million doses, and would happen within a few minutes to a few hours after the vaccination.”

Possible Side-effects from Vaccines

And that’s because anaphylaxis after vaccines is very rare.

Anaphylaxis After Vaccines is Rarely Fatal

And suprisingly, it is even more rare for these cases to be fatal!

“All 30 patients with anaphylaxis survived (9 reports specified anaphylaxis, and we classified another 21 as probable cases, based on compatible clinical features, including respiratory and skin symptoms within 4 hours after vaccination). In half of 22 detailed reports, symptoms developed within 15 minutes after vaccination.”

Wise et al on Postlicensure Safety Surveillance for Varicella Vaccine

But that study just looked at the chicken pox vaccine and used VAERS, so we have to be concerned about under-reporting, right? Well, not necessarily. Under-reporting likely isn’t a big problem for serious reactions.

Anyway, that’s not the only study…

“We identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after 25,173,965 vaccine doses. The rate of anaphylaxis was 1.31 (95% CI, 0.90-1.84) per million vaccine doses.”

McNeill et al on Risk of anaphylaxis after vaccination in children and adults

The McNeill study used the Vaccine Safety Datalink, which unlike VAERS, is not a passive reporting system. So there is no concern about underreporting.

And like the Wise study, there were no deaths among these vaccine-triggered anaphylaxis cases.

“Fatalities from vaccine-induced anaphylaxis are exceedingly rare.”

Adverse reactions to vaccines practice parameter 2012 update

Similarly, a study in the UK found rare reports of anaphylaxis after vaccines in children and all those children made a full recovery.

Parents should understand that while anaphylaxis is a known side effect to getting a vaccine, it is extremely rare, and can usually be treated. This once again reinforces that vaccines are safe!

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Did the FDA Admit That the Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women?

Have you heard?

There is a new bombshell from anti-vaccine folks!

It turns out, they say, that the FDA has admitted that the government is recommending untested, unlicensed vaccines for pregnant women.

Is that true?

Did the FDA Admit That the Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women?

Of course not!

Their evidence?

A response to a Freedom of Information Act request for vaccines that don’t exist. That’s right, neither Tdap nor flu vaccines are currently FDA approved for use by pregnant women.

Of course, that doesn’t mean that Tdap and flu vaccines aren’t recommended for use by pregnant women.

Wait, why the difference?

Why are pregnant women being given a vaccine that isn’t formally FDA approved for their use?

Well, vaccine manufacturers have to seek FDA approval for their products. The FDA doesn’t just up and approve new products or give them new indications. And none have ever sought approval in pregnancy.

But that doesn’t keep health experts from making off-label recommendations, such as getting a flu vaccine when you are pregnant.

“In prelicensure evaluations, the safety of administering a booster dose of Tdap to pregnant women was not studied. Because information on use of Tdap in pregnant women was lacking, both manufacturers of Tdap established pregnancy registries to collect information and pregnancy outcomes from pregnant women vaccinated with Tdap. Data on the safety of administering Tdap to pregnant women are now available.”

Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged <12 Months — Advisory Committee on Immunization Practices (ACIP), 2011

As important as FDA approval is a recommendation from the Advisory Committee on Immunization Practices (ACIP). In fact, even after a vaccine gets approved by the FDA, it still has to get a recommendation from the ACIP before it gets on the immunization schedule and is used routinely!

“Flu shots have been given to millions of pregnant women over many years with a good safety record. There is a large body of scientific studies that supports the safety of flu vaccine in pregnant women and their babies.”

Flu Vaccine Safety and Pregnancy

Getting a flu vaccine during pregnancy is a recommendation that has been evolving since 1983. It was known to be safe then, and we are even more confident that it is safe now.

A Tdap shot has been recommended since 2011, although it was first suggested in 2008 that pregnancy was not a contraindication for receiving Tdap.

How do we know these vaccines are safe during pregnancy?

The Vaccine Safety Datalink has published more than 14 studies “related to pregnancy and vaccination during pregnancy” and has used “data to study the health of children born to women who were vaccinated during pregnancy.”

Despite what Robert F. Kennedy, Jr and his ironically named Children’s Health Defense organization might think, Tdap and flu shots in pregnancy have been well studied and have been found to be safe.

Ignoring all of the above studies, Kennedy highlights a few that he thinks found problems with flu shots in pregnancy, including one that showed “a suggestion of increased ASD risk among children whose mothers received an influenza vaccination in their first trimester,” a suggestion that was not statistically significant and which was not found in the other trimesters. And another that found an increased risk of spontaneous abortion in women who had also received a flu shot in the previous season, a safety signal that has never been seen before and which continues to be investigated.

Not surprisingly, his latest bombshell is landing with as big of a thud as his HHS lawsuit, as have most of his statements these days…

“CHD’s Chairman Robert F. Kennedy, Jr. notes that most flu shots given to pregnant women still contain a mercury-based preservative thimerosal.”

FDA Admits That Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women

Has Kennedy missed the fact that 80% of flu vaccines are now thimerosal free? It makes you wonder how he defines the word “most?”

“Thimerosal is acknowledged by Proposition 65 in California as a reproductive toxicant and exposure during pregnancy can cause learning and behavioral problems. Tdap contains aluminum, which FDA regulates as a toxin in parenteral nutrition but not in vaccines.”

FDA Admits That Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women

And what is he concerned about in thimerosal-free flu shots which also don’t contain aluminum? Are those okay in his book?

Mostly, after several flu seasons in which so many people have died, you have to wonder what his goal is here. Does Robert F. Kennedy, Jr. expect folks to skip getting a flu shot when they are pregnant and instead risk getting the flu? Should they skip their Tdap shot and risk their baby dying of whooping cough?

Or should they just stop listening to this type of anti-vaccine propaganda?

More on Did The FDA Admit That The Government Is Recommending Untested, Unlicensed Vaccines For Pregnant Women?

Why Aren’t Vaccines Regulated like Drugs?

Have you ever heard the argument that vaccines aren’t held to the same standards as drugs, food, or other products?

“Vaccines are not held to the same double blind gold standard of clinical testing as other pharmaceutical drugs because they are considered biological products under the Public Health Federal Food, Drug and Cosmetic Act. They meet the same standards as cosmetics.”

20 VACCINE “FACTS” you need to know to make an informed decision

Placebos, liability, testing – these are all arguments that anti-vaccine folks try to use to scare parents into thinking that vaccine development isn’t well regulated and vaccines aren’t held to the same standard as drugs.

Why Aren’t Vaccines Regulated like Drugs?

Would you be surprised to learn that part of their argument is true?

Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.
Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.

No, not the part that vaccine development isn’t well regulated!

“Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.”

Vaccine Product Approval Process

Federal regulations and rules ensure that our vaccines are safe.

  • Public Health Service Act (42 USC 262-63) §351
  • Food, Drug, and Cosmetic Act (21 USC 301-392)
  • Title 21 Code of Federal Regulations (CFR) 600-680 – standards for biological products
  • Title 21 CFR 314 (21 CFR 601.25[d][2], specific to biologicals – ensures adequate and well-controlled clinical trials
  • Title 21 CFR 312 – investigational new drug application (IND)
  • Title 21 CFR 210-211 – good manufacturing practices
  • Title 21 CFR 58 – good laboratory practices
  • Title 21 CFR 56 – institutional review boards
  • Title 21 CFR 50 – protection of human subjects
  • Prescription Drug User Fee Act (PDUFA) of 1992, 2002, and 2007
  • Food and Drug Agency Modernization Act (FDAMA) of 1997
  • Food and Drug Agency Amendments Act (FDAAA) of 2007

I meant the part that vaccines aren’t regulated like drugs.

While both vaccines and prescription drugs are regulated by the FDA, that work occurs within two different centers of the FDA:

  • Center for Biologics Evaluation and Research (CBER) – vaccines
  • Center for Drug Evaluation and Research (CDER) – over-the-counter and prescription drugs

Both centers work to make sure we have safe and effective vaccines and drugs to keep us healthy, even if there are some differences in how they do it.

“Vaccine clinical development follows the same general pathway as for drugs and other biologics.”

Vaccine Product Approval Process

That’s right, vaccines and drugs go through the same types of clinical trials.

After completing the three phases though, vaccine developers must then apply for a Biologics License Application (BLA), which is reviewed by a multidisciplinary FDA reviewer team. This is also when their manufacturing facility gets inspected.

“Following FDA’s review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.”

Vaccine Product Approval Process

Once approved and licensed, the FDA and CDC continue to work to make sure the vaccine is safe, including having some vaccines undergo undergo Phase 4 studies and monitoring for side effects through VAERS and the Vaccine Safety Datalink.

And then, even after approval by the FDA, new vaccines aren’t put on the immunization schedule until a review and approval by the Advisory Committee on Immunization Practices (ACIP).

“Canada, like many other countries, exercises tight regulatory oversight over vaccines because they are usually given to very large numbers of healthy individuals. Vaccines in Canada are subject to the Food and Drugs Act and the Food and Drug Regulations. Vaccines are regulated under a specific set of regulations for a subset of drugs known as biologic drugs.”

The Regulation of Vaccines for Human Use in Canada

It is also important to keep in mind that this process doesn’t just happen in the United States.

Still wondering why vaccines aren’t regulated like drugs?

“Vaccine development differs from drug development in several important ways. First, because vaccines are preventive and are given to healthy individuals – often children – they require very large clinical trials, leading to increased research and development costs. Second, vaccines are biological products that can be very complex to manufacture and are subject to stringent quality control standards, resulting in much higher capital costs. Third, unlike drugs, vaccines have no secondary markets, making it unlikely that manufacturers will generate additional profits beyond the initial target markets. Finally, unlike generic drugs, which only need to demonstrate adherence to a pre-established development process, vaccines are biologicals that require full re-development to demonstrate their equivalence. (World Health Organization, 2014). Each manufacturer is required to invest in the full regulatory approval process for their vaccine products.

Myths and Facts about Vaccine Product Price and Procurement

It’s only because vaccines are more strictly regulated than drugs and other products.

Vaccines are safe and necessary.

More on Vaccine Regulation

Can Vaccines Cause Kawasaki Disease?

Kawasaki disease is rare and there is a good chance that you have never even heard of it, even though the first case was diagnosed in 1961.

Kids with this condition are typically irritable and can develop high fever, swollen glands in their neck, red eyes, red, cracked lips, red, swollen hands and feet, and a rash.

If you have heard of it, there is a good chance it is because anti-vaccine folks are using Kawasaki disease to scare you away from vaccinating and protecting your kids. Lately, talk about Kawasaki disease and the meningococcal B vaccines have been going around.

What Causes Kawasaki Disease?

Kawasaki disease is a type of vasculitis.

Kids who develop Kawasaki disease, who are typically under age 5 years, develop inflammation of their blood vessels, which leads to many of the symptoms and complications we see.

What causes this inflammation?

“Evidence suggests that Kawasaki disease may be linked to a yet-to-be identified infectious agent, such as a virus or bacteria. However, despite intense research, no bacteria, virus, or toxin has been identified as a cause of the disease.”

AAP on Kawasaki disease

We don’t know.

Can Vaccines Cause Kawasaki Disease?

Ask about Kawasaki disease if your child has a fever for five days and other symptoms of Kawasaki disease.
Courtesy of the kdfoundation.org

Because the cause of Kawasaki disease is unknown, that leads some folks to think that it could be vaccines.

Could it?

That vaccine clinical trial data sometimes finds a higher, although not statistically significant risk for Kawasaki disease, gets some of those folks thinking about it even more, except they don’t seem to think about the fact that the risk is never statistically significant.

But aren’t there case reports of kids getting Kawasaki disease after getting a hepatitis A, yellow fever, hepatitis B, or flu vaccine?

Yes, but getting a case report published about one patient who you think got Kawasaki disease soon after getting a vaccine isn’t strong evidence that it wasn’t a coincidence.

“Childhood vaccinations’ studied did not increase the risk of Kawasaki disease; conversely, vaccination was associated with a transient decrease in Kawasaki disease incidence. Verifying and understanding this potential protective effect could yield clues to the underlying etiology of Kawasaki disease.”

Abrams et al. on Childhood vaccines and Kawasaki disease, Vaccine Safety Datalink, 1996-2006.

And not surprisingly, several studies have shown that there isn’t any extra risk for Kawasaki disease after routine vaccines.

One even showed that getting vaccinated could be protective! Another benefit of vaccines and another reason you shouldn’t skip or delay your child’s immunizations.

What to Know About Vaccines and Kawasaki Disease

While anti-vaccine folks often list Kawasaki disease among their vaccine-induced diseases, several studies have shown that vaccines are not associated with Kawasaki disease, except to maybe have a protective effective if you are fully vaccinated.

More on Vaccines and Kawasaki Disease