“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.”
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2019–20 Influenza Season
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!
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
“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?
Breaking News: Flu season continues, as influenza activity continues to decrease in the United States, but remains elevated. (see below)
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?
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).
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..”
Everyone should get a flu vaccine each year, as long as they are at least six months old and have no true contraindications.
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.