Tag: flu shots

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?

Is H1N1 Flu Back This Year?

You remember H1N1 flu, right?

Is it back this year?

Is H1N1 Flu Back This Year?

While H1N1 seems to be the most frequently identified influenza virus type this year, in reality, since causing the “swine flu” pandemic in 2009, this strain of flu virus never really went away.

It instead became a seasonal flu virus strains.

So it is back again this year, but just like it was back during the 2013-14 and 2015-16 flu seasons.

Is that good news or bad news?

In general, it’s good news, as “flu vaccines provide better protection against influenza B or influenza A (H1N1) viruses than against influenza A (H3N2) viruses.”

“The 2009 H1N1 influenza virus (referred to as “swine flu” early on) was first detected in people in the United States in April 2009. This virus was originally referred to as “swine flu” because laboratory testing showed that its gene segments were similar to influenza viruses that were most recently identified in and known to circulate among pigs. CDC believes that this virus resulted from reassortment, a process through which two or more influenza viruses can swap genetic information by infecting a single human or animal host. When reassortment does occur, the virus that emerges will have some gene segments from each of the infecting parent viruses and may have different characteristics than either of the parental viruses, just as children may exhibit unique characteristics that are like both of their parents. In this case, the reassortment appears most likely to have occurred between influenza viruses circulating in North American pig herds and among Eurasian pig herds. Reassortment of influenza viruses can result in abrupt, major changes in influenza viruses, also known as “antigenic shift.” When shift happens, most people have little or no protection against the new influenza virus that results.”
Origin of 2009 H1N1 Flu (Swine Flu): Questions and Answers

The only reason we were so concerned about this strain of H1N1 in 2009 was because it was new.

Still, even in a good year, it is important to remember that a lot of people die with the flu, including a lot of kids. And most of them are unvaccinated.

So while it might be interesting to talk about which flu virus strain is going around, just remember that your best protection against that strain is a yearly flu vaccine.

Can I Get a Second Flu Shot for Extra Protection?

If one flu shot is good, wouldn’t two be better?

Can I Get a Second Flu Shot for Extra Protection?

Some people do get a second flu shot.

In fact, all kids eight years and younger, if it is their first time getting a flu vaccine, get two doses of flu vaccine.

How many doses of flu vaccine will your kids need this year?

The first dose is a priming dose and the second, at least 28 days later, is a booster dose.

Why do we do it that way?

Because studies have shown that is the best way to do it.

We don’t need to use this same priming/booster strategy in older children and adults though.

But with recent talk that protection against the flu after a flu vaccine might wane before the end of a flu season, some folks are likely wondering if they should just get another flu shot later in the season.

“Revaccination later in the season of persons who have already been fully vaccinated is not recommended.”
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season

And the official answer is no, except for younger children getting vaccinated for the first time, you should just get one dose per season.

Why not?

Mostly because a lot of studies haven’t been done to see what effect that second dose will have. And since some studies have even suggested that regular annual flu vaccines could actually lower vaccine effectiveness, you would want to know if getting an extra flu vaccine was safe and effective before we started to do it.

Not surprisingly, someone has looked into this already. One small study, Influenza revaccination of elderly travelers: antibody response to single influenza vaccination and revaccination at 12 weeks, actually showed that a second dose in the same season “did not enhance the immune response.”

So just one flu vaccine per season.

“Prior-season vaccination history was not associated with reduced vaccine effectiveness in children, supporting current recommendations for annual influenza vaccination of children.”
McLean et al on Association of Prior Vaccination With Influenza Vaccine Effectiveness in Children Receiving Live Attenuated or Inactivated Vaccine

But do get a flu vaccine every season.

Again, while there were some reports that an annual flu vaccine could lower vaccine effectiveness, other studies have disproven this.

Understanding Flu Season

Flu season starts.

A lot of folks get sick as flu season peaks.

Flu season eventually ends.

What’s to understand?

Understanding Flu Season

While we see flu activity at epidemic levels every year, some years are clearly much worse than others.

What kind of flu season will we have this year?

And while the severity of a flu season is easy to see after it is over, many of us could use a little help making sense of things when we are still in the middle of it.

Geographic Spread of Influenza Viruses – when you hear that there is widespread flu activity in a lot of states, this is what they are talking about. The only problem is that this doesn’t really tell you anything about the severity of a flu season. We get widespread flu activity in all states, or almost all states, each and every year as flu season peaks.
ILI Activity Indicator Map – like the maps showing the geographic spread of the flu, the ILI activity indicator map can help you tell where flu is spreading, but since it doesn’t necessarily represent the whole state, it can be misleading.
Influenza-like Illness Surveillance – the proportion of outpatient visits for influenza-like illness (ILI), or basically, how many people are going to the doctor with flu symptoms. Once we get above the national baseline of 2.2%, we know that flu season is starting in an area. How high can ILI get? Recently, it has peaked between 3.6% (2015-2016) and 7.5% (2017-2018). But that’s nationally. Because of wide variability in regional level data, you might see much higher ILI numbers in your state. For example, the regional baseline in Texas is 4%, while it is just 1.1% in Idaho. Still, widespread flu activity with a high ILI likely means a bad flu season.
Flu-Associated Hospitalizations – laboratory-confirmed influenza-associated hospitalizations. Overall, as flu season peaks, this can range from 4 to 5 per 100,000 population in a typical flu season, to 9 or 10 in a more severe flu season. This is also reported by age group. During a bad flu season, flu-associated hospitalizations will be high.
Mortality Surveillance – the proportion of deaths attributed to pneumonia and influenza. At some point in flu season, we get above an epidemic threshold and more people die with the flu, especially during a bad flu season.
Pediatric Deaths – pediatric influenza-associated deaths have been a nationally notifiable condition since the 2004 flu season and since then, on average, about 118 kids die with the flu each year. Last season was especially bad, with 185 pediatric flu deaths.

So how do you really know if it is a bad flu season?

Look for a high ILI%, high flu-associated hospitalizations, which will almost certainly be followed by a high mortality surveillance.

You also want to check viral surveillance data. Are the majority of influenza viruses being tested antigenically and genetically similar to the cell-grown reference viruses representing the 2018–2019 Northern Hemisphere influenza vaccine viruses? If not, that could mean a vaccine strain mismatch and a worse flu season.

And don’t be surprised by reports of widespread flu activity or rising ILI. That’s just flu season.

Were More Than Half of the Kids with Severe or Fatal Influenza in California Last Year Vaccinated?

We know that the flu is deadly and that most kids who die with the flu aren’t vaccinated.

Would it be news to anyone if Bob Sears was pushing misinformation about pediatric flu deaths in California?

That’s likely why some folks might have been surprised when Dr. Bob Sears said that “half of the patients admitted to ICUs for severe or (eventually) fatal cases of influenza last year were vaccinated.”

He seemed to be citing a news report from the California Department of Public Health.

Were More Than Half of the Kids with Severe or Fatal Influenza in California Last Year Vaccinated?

So what did the report from CDPH actually say?

“Influenza vaccination information was available for 455 (47.8%) of the 952 adult cases reported with severe or fatal influenza; 211 (46.4%) received the 2017–2018 influenza vaccine. One hundred twenty (64.2%) of the 187 reported pediatric cases >6 months of age had influenza vaccination information available; 61 (50.8%) received the 2017–2018 influenza vaccine.”
Influenza Surveillance Report 2017–2018 Season

When you do the math, you quickly see that only 61 of 187 kids, or 33% of the pediatric patients were known to be vaccinated.

The numbers are even lower for adults with severe or fatal flu – only 211 of 952 adults, or 22% were known to be vaccinated.

Melissa Floyd does not seem to understand basic epidemiology.

So the majority of kids and adults were either unvaccinated or their vaccination status was unknown. While an unknown vaccinated status doesn’t mean that they weren’t actually vaccinated, it certainly doesn’t mean that they were.

What about the idea that these vaccinated patients would “eventually” turn into fatal cases, as Dr. Bob posted?

Although there were 18 fatal pediatric flu cases in California during the 2017-18 flu season, and that is more than any of us want to see, it should be clear, with 194 non-fatal ICU cases, that most severe cases weren’t eventually fatal.

Hopefully it isn’t a newsflash to anyone that most kids who die with the flu aren’t vaccinated.

What Are the Side Effects of the Flu Vaccine?

Like other vaccines, flu vaccines can have side effects.

Fortunately, most of those side effects are mild.

What Are the Side Effects of the Flu Vaccine?

Not surprisingly, a lot of things that get blamed as being caused by flu vaccines are not actually side effects.

Did you actually get the flu in the days or weeks after your flu vaccine?

That’s not a side effect of your flu vaccine. Neither the inactivated flu shot, nor the attenuated FluMist can actually cause a flu infection.

Did you get a little sore at the site where you got your flu shot?

That’s a common side effect to getting a flu shot.

So is having some redness and swelling at the site, all of which begin soon after getting the shot and go away in a few days. You can also get a headache, fever, nausea, and muscle aches or signs and symptoms of an allergic reaction.

Do you have a runny nose or a cough? Side effects of the nasal spray flu vaccine can include a few days of runny nose, wheezing, headache, vomiting, muscle aches, fever, sore throat and cough.

Again, a bad cough and cold after a flu shot isn’t a side effect of the vaccine though.

Remember, correlation does not imply causation.

If you found out you were pregnant shortly after getting a flu shot, you wouldn’t think they were associated, would you?

What about narcolepsy?

“An increased risk of narcolepsy was found following vaccination with Pandemrix, a monovalent 2009 H1N1 influenza vaccine that was used in several European countries during the H1N1 influenza pandemic.”
Narcolepsy Following Pandemrix Influenza Vaccination in Europe

Although the focus has been on the Pandemrix flu vaccine as a trigger for narcolepsy in some countries (the vaccine wasn’t used in the United States), interestingly, several countries that weren’t using the vaccine also saw a spike in narcolepsy cases as the 2009 H1N1 pandemic hit.

Doctors and pharmacies rarely give away flu shots for free. They might not charge a copay sometimes because they are getting paid by your insurance company!

What about all of the reports of severe reactions and deaths after getting a flu shot that you might hear about? In addition to vaccine injury stories, those reports are to VAERS and typically are not causally related to getting a vaccine.

Why are there so many reports to VAERS and the NVICP about flu vaccines? Since 2006, over 1.6 trillion doses of flu vaccine have been distributed in the United States, which equals about the total of all other vaccines we use.

What Are the Side Effects of This Year’s Flu Shot

Even when folks understand that flu vaccines don’t typically cause serious side effects, the question always comes up whether or not this year’s flu shot is causing more side effects than usual.

That’s actually not unreasonable, even when you consider that the biggest change in most flu vaccines from year to year is the strain of flu viruses they include, and not any of the other ingredients.

In addition to the Pandemrix flu vaccine, in 2010, the use of one brand of flu vaccines in Australia was suspended because they were causing more side effects (fever and febrile seizures) in young children than expected.

“The studies flesh out preliminary findings from CSL in June 2012, which said that the manufacturing process retained more virus component than that of other manufacturers and that the 2010 virus components triggered an excessive immune response in some young kids.”
CSL studies shed light on 2010 flu vaccine seizures

So are there any more side effects this year?

No, there is no evidence of increased side effects from this year’s flu vaccines

Did a Healthy NY Senator Die After Getting a Flu Shot?

Update: the medical examiner has ruled that Senator José Peralta, of Queens, passed away from natural causes, complications of acute promyelocytic leukemia.

Anti-vaccine folks are heavily pushing the idea that José Peralta, a New York State Senator, died as the result of getting a flu shot.

All of the same things? Exactly? Senator Peralta did not die of a severe allergic reaction. He died of sepsis.

While Senator Peralta did die several days after getting a flu shot, it appears that he had already been sick for several weeks. And no, that doesn’t mean that the flu shot made him even sicker.

“The senator would be disappointed to find that conspiracy theorists are using his death to forward their agenda by misrepresenting the facts.”
Chris Sosa on No Evidence New York Legislator Died from Flu Shot

New York State Sen. José Peralta had reportedly just gotten his flu shot at a public event, where he was encouraging others in his community to get protected with free flu shots.

Senator Jose Peralta partnered with a local hospital to help get members of his community free flu shots.

And while he did die about four days later, there is absolutely no reason to think that his getting a flu shot was connected to his death.

Anti-vaccine folks have no shame, as they not only don’t respect the privacy of Senator Peralta’s wife, children, family and friends, but also are using him to attack his legacy.

Of course, this is the method of operation of the modern anti-vaccine movement. They make folks think that anything and everything is a vaccine injury and they actually go out of their way to exploit people who have died.

Learn the Risk of falling for anti-vaccine propaganda.

There is no evidence that New York State Senator Jose Peralta died from getting a flu shot.

In fact, the medical examiner has ruled that he had acute promyelocytic leukemia when he died.

Don’t let anti-vaccine folks dishonor his legacy by pushing false stories about flu shots – scaring people away from getting vaccinated and protected.

Vaccines are safe, effective, and necessary.

More on Flu Shot Propaganda

Updated January 16, 2019

VAXOPEDIA

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

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

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