Tag: recommendations

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?

The 2018-19 Flu Season Update

Breaking News: Flu season continues, as influenza activity continues to decrease in the United States, but remains elevated. (see below)

We are nearing the end of flu season - a long flu season.
We are nearing the end of flu season – a long flu season.

While flu season typically peaks in February, it is very important to understand that there are few things that are typical about the flu.

Since 1982, while we have been twice as likely to see a flu activity peak in February than other winter months, we have been just as likely to get that peak in December, January, or March. That makes it important to get your flu vaccine as soon as you can.

You really never know if it is going to be an early, average, or late flu season. That’s why it is best to not try and time your flu vaccine and to just get it as soon as you can.

Flu Season Facts

There will likely be some surprises this flu season – there always are – but there are some things that you can unfortunately count on.

Among these flu facts include that:

  • there have been over 1,660 pediatric flu deaths since the 2003-04 flu season, including 185 flu deaths last year
  • of the average 118 kids that die of the flu each year – most of them unvaccinated
  • antiviral flu medicines, such as Tamiflu, while recommended to treat high-risk people, including kids under 2 to 5 years of age, have very modest benefits at best (they don’t do all that much, are expensive, don’t taste good, and can have side effects, etc.)
  • a flu vaccine is the best way to decrease your child’s chances of getting the flu
  • FluMist, the nasal spray flu vaccine, is once again available for healthy kids who are at least 2-years-old

You can also count on the fact that even in a mild flu season, a lot of kids get sick with the flu.

What about reports that the flu shot won’t be effective?

Don’t believe them. The flu vaccine works and besides, it has many benefits beyond keeping you from getting the flu

This Year’s Flu Season

As of mid-April, the CDC reports that flu “influenza activity continues to decrease in the United States, but remains elevated.”

The CDC has also recently reported that:

  • 11 states, Arizona, California, Connecticut, Delaware, Maine, Massachusetts, New Hampshire, New York, Ohio, Rhode Island and Virginia, are still reporting widespread flu activity
  • 20 states, Alabama, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Missouri, Montana, Nevada, New Jersey, New Mexico, North Dakota, Pennsylvania, South Carolina, Tennessee, Utah, Washington and Wisconsin, are still reporting regional flu activity
  • 17 states, Alaska, Arkansas, Colorado, Hawaii, Idaho, Iowa, Kansas, Minnesota, Mississippi, Nebraska, North Carolina, Oklahoma, Oregon, South Dakota, Vermont, West Virginia and Wyoming, are now reporting local flu activity
  • 2 states, Indiana and Texas, are now reporting sporadic flu activity
  • no states are reporting no flu activity yet
  • the proportion of people seeing their health care provider for influenza-like illness (ILI) was down 2.4%, which is still above the national baseline of 2.2%, but far below the 7.5% we saw last year
  • The overall hospitalization rate was 62.3 per 100,000. The highest rate of hospitalization was among adults aged ≥65 (206.5 per 100,000 population), followed by adults aged 50-64 (77.8 per 100,000 population) and children aged 0-4 (71.0 per 100,000 population).
  • there have already been 91 pediatric flu deaths this year, including 5 new deaths this past week

While influenza A(H1N1)pdm09 viruses predominated from October to mid-February, influenza A(H3N2) viruses have been more commonly identified since late February.

Some good news?

The “majority of influenza viruses characterized antigenically and genetically are similar to the cell-grown reference viruses representing the 2018–2019 Northern Hemisphere influenza vaccine viruses..”

And the interim estimates of flu season effectiveness are fairly good, with an overall vaccine effectiveness of 61% in children and teens.

Are you going to get your kids a flu vaccine this year?

“CDC recommends that everyone 6 months and older get a  flu vaccine as soon as possible.”

CDC Influenza Situation Update

Although flu season has started, it is definitely not too late to get a flu vaccine.

For More Information on the 2018-19 Flu Season

Updated February 25, 2019

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Are Your Kids at High Risk for Flu Complications?

Everyone should get a flu vaccine each year, as long as they are at least six months old and have no true contraindications.

Everyone needs a flu shot. When will you get yours?
Everyone needs a flu shot. When will you get yours? Photo by Gabriel Saldana (CC BY-SA 2.0)

That has been the recommendation since at least the 2010-11 flu season.

And while most kids get vaccinated, not all do.

Are Your Kids at High Risk for Flu Complications?

There are some kids, those at high risk for flu complications, who definitely shouldn’t skip or delay their flu vaccine.

  • all children aged 6 through 59 months (younger than age 5 years);
  • children who have chronic medical conditions, including pulmonary (such as asthma and cystic fibrosis), cardiovascular (excluding isolated hypertension), genetic (Down syndrome), renal, hepatic, neurologic (cerebral palsy, epilepsy, stroke, muscular dystrophy, and spina bifida, etc.), hematologic (sickle cell disease), or metabolic disorders (including diabetes mellitus and mitochondrial disorders);
  • children who are immunocompromised due to any cause (including immunosuppression caused by medications or by HIV infection);
  • teens who are or will be pregnant during the influenza season;
  • children and adolescents (aged 6 months through 18 years) who are receiving aspirin- or salicylate-containing medications (like for Kawasaki disease) and who might be at risk for experiencing Reye syndrome after influenza virus infection;
  • residents of nursing homes and other long-term care facilities;
  • American Indians/Alaska Natives;
  • children who are extremely obese (body mass index ≥40).

You also shouldn’t skip or delay getting a flu vaccine if your:

  • kids are household contacts of children aged ≤59 months (i.e., aged <5 years) and adults aged ≥50 years, particularly contacts of children aged <6 months;
  • kids are household contacts of someone with a medical condition that puts them at higher risk for severe complications from influenza.

Again, since everyone should get a flu vaccine, these higher risk classes shouldn’t determine whether or not you vaccinate your kids, but they might influence the timing.

Again, don’t skip your child’s flu vaccine because they aren’t in a flu high risk group.

In most flu seasons, about 80% of children with the flu who die are not vaccinated. And many of them will be otherwise healthy, without an underlying high risk medical condition.

Get your child vaccinated against the flu. And if they are in a high risk group, make sure you do it well before flu season starts and maybe as soon as flu vaccine becomes available in your area.

More on Being at High Risk for Flu Complications

When Should I Get My Flu Shot?

For most the folks, the real question isn’t if they should get a flu shot, but when.

When Should I Get My Flu Shot?

The original flu shot recommendations  were based on the fact that flu vaccine became available for distribution in September, but was not completed until December or January. And that high-risk folks should get vaccinated “to avoid missed opportunities for vaccination” if flu vaccine was available in September and they were already at a doctor’s appointment or in the hospital.

Everyone needs a flu shot. When will you get yours?
Everyone needs a flu shot. When will you get yours? Photo by Gabriel Saldana (CC BY-SA 2.0)

But for most people, the original recommendation was really that “the optimal time for vaccination efforts is usually during October–November.”

“Persons and institutions planning substantial organized vaccination campaigns (e.g., health departments, occupational health clinics, and community vaccinators) should consider scheduling these events after at least mid-October because the availability of vaccine in any location cannot be ensured consistently in early fall. Scheduling campaigns after mid- October will minimize the need for cancellations because vaccine is unavailable.”

Prevention and Control of Influenza Recommendations of the Advisory Committee on Immunization Practices (2006)

What was the problem with this strategy?

Early flu seasons.

And trying to vaccinate over 100 million people in such a short time.

While it might work fine if flu season doesn’t hit until January or February, waiting until mid-October could leave a lot of folks unvaccinated if you had an early flu season that was peaking in November or December.

Fortunately, we don’t have to rush to get people vaccinated so quickly anymore. For one thing, manufacturers have gotten much better at distributing flu vaccine and are able to get a lot of the doses out at the very beginning of flu season. And with more manufacturers, we are seeing fewer delays and shortages of flu vaccine than we used to.

That’s why the recommendation on the timing of flu vaccination has changed over the years.

“In general, health-care providers should begin offering vaccination soon after vaccine becomes available and if possible by October. To avoid missed opportunities for vaccination, providers should offer vaccination during routine health-care visits or during hospitalizations whenever vaccine is available.”

Prevention and Control of Influenza Recommendations of the Advisory Committee on Immunization Practices (2010)

That nice, simple message has changed yet again though.

To balance the concerns that getting a flu shot too early might leave you unprotected at the end of a late flu season, but getting a flu shot too late might leave you unprotected at the beginning of an early flu season, the latest recommendations from the CDC on the timing of flu vaccination aren’t so clear cut:

  • Balancing considerations regarding the unpredictability of timing of onset of the influenza season and concerns that vaccine-induced immunity might wane over the course of a season, it is recommended that vaccination should be offered by the end of October.
  • Community vaccination programs should balance maximizing likelihood of persistence of vaccine-induced protection through the season with avoiding missed opportunities to vaccinate or vaccinating after onset of influenza circulation occurs.
  • Revaccination later in the season of persons who have already been fully vaccinated is not recommended.
  • Vaccination should continue to be offered as long as influenza viruses are circulating and unexpired vaccine is available.
  • To avoid missed opportunities for vaccination, providers should offer vaccination during routine health care visits and hospitalizations.
  • Optimally, vaccination should occur before onset of influenza activity in the community.
  • Although vaccination by the end of October is recommended, vaccine administered in December or later, even if influenza activity has already begun, is likely to be beneficial in the majority of influenza seasons.

What’s the problem with these recommendations?

If everyone waits until the end of October to get vaccinated, then you might have a hard time getting a flu vaccine. And you might get stuck if you try and time your flu shot with the onset of flu activity. Unless you have a crystal ball, you don’t know when flu season is going to start.

Still, it is important to note that the CDC doesn’t actually say to wait until the end of October. They say to get vaccinated by the end of October. Getting your kids vaccinated as soon as you can is the best way to make sure that happens.

Could getting a flu shot early leave your kids unprotected at the very end of flu season?

Maybe, but that’s typically when flu activity is low. And we have that same type of low flu activity in early October, well before flu season peaks.

So just remember that your child could end up unvaccinated and unprotected if you mistime their flu vaccine.

What to Know About the Best Time to Get a Flu Vaccine

Experts say to get vaccinated by the end of October. Getting your kids vaccinated as soon as you can is the best way to make sure that happens.

More on the Best Time To Get a Flu Vaccine