CDC Recommends Hep B Vax During Pregnancy, Removes Safety Warning

Written by Brenda Baletti PhD on December 21, 2024. Posted in Current News

Changes to the CDC’s updated 2025 immunization schedule for children, adults and pregnant women published last month consisted largely of timing revisions, newly approved brands of existing vaccines — including a new Hep B vaccine for pregnant women — or additional shots recommended for immunocompromised people

The CDC didn’t add new types of vaccines to the schedule — last year the agency added COVID-19 vaccines and RSV shots for children, RSV for older adults and mpox for high-risk adults.

The CDC now recommends more than 200 shots over an individual’s lifetime. In 1983, the CDC recommended just 11 doses of seven vaccines for children.

There were no vaccine recommendations for adults, including pregnant women, before 1986, when the National Childhood Vaccine Injury Act of 1986 granted vaccine manufacturers protection from liability for vaccine injuries.

x.com/AaronSiriSG

Pregnant women until 2012 were advised against getting most vaccines based on concerns the vaccines could harm the fetus.

Now the CDC recommends five or more routine shots (seven or more vaccines) during pregnancy, including flu, COVID-19, Tdap (tetanus, diphtheria, pertussis), RSV or respiratory syncytial virus, Hepatitis B or Hep B, Hep A (if at risk for infection) and possibly a flu booster.

The CDC says getting vaccinated while pregnant is essential because it helps mothers avoid disease and also creates antibodies that will protect their babies during the first few months of life before they can be vaccinated themselves.

However, experts who spoke with The Defender said the rising number of recommended shots for pregnant women is concerning, particularly because of the lack of randomized controlled trials large enough to identify safety issues and because long-term safety data are lacking.

“Vaccine safety data are scarce,” said Children’s Health Defense Senior Research Scientist Karl Jablonowski. “In pregnancy, it’s even more scarce. And it’s almost non-existent in situations where multiple vaccines are administered during pregnancy — which is the clinical reality.”

Where data do exist, the sample sizes are often so small the study is practically unusable, Jablonowski said.

CDC adds new Hep B brand despite lack of safety data in pregnant women

This year, the CDC added a new brand of Hepatitis B vaccine, Heplisav-B, to the list of vaccines that can be administered to pregnant women — after removing language that said Heplisav-B was not recommended in pregnancy “due to lack of safety data in pregnant persons.”

In the October meeting of the CDC’s Advisory Committee on Immunization Practices, the CDC said its division of viral hepatitis was working to update the guidance for the use of the Hep B vaccine during pregnancy based on changes made to the U.S. Food and Drug Administration (FDA) package insert, but the proposed deletion hadn’t been discussed with the working group.

The Heplisav-B label indicates that “there are no adequate and well-controlled studies of HEPLISAV-B in pregnant individuals.” Instead, the claims of safety for pregnant women are based on a toxicity study in rats and a post-licensure study of 81 women who were exposed to the vaccine during the 28 days before pregnancy or during pregnancy.

Providers who spoke with The Defender were surprised to learn that the Hep B shot was one of the recommended vaccines for pregnant women, and concerned about the changes to that shot added this year.

The vaccine first appeared on the schedule for pregnant women In 2022, when the agency recommended the Hep B vaccine to all adults ages 19-59, including pregnant women who hadn’t previously been vaccinated.

Information about whether pregnant women should get the Hep B shot is contradictory on the CDC website. One CDC pregnancy webpage updated in June recommends that high-risk women get the Hep B vaccine — a recommendation in line with most other countries.

However, the main CDC pregnancy and vaccine webpage, updated in July and listing all routine and non-routine vaccines for pregnant women indicates that the Hep B vaccine is recommended as a routine vaccination for pregnant women who are not already vaccinated.

The American College of Obstetricians and Gynecologists (ACOG), which represents over 60,000 OB-GYN members and is one of the key organizations setting the norms for that industry, also recommends the Hep B vaccine for all unvaccinated pregnant women.

ACOG changed its guidelines and began recommending Hep B in 2022, after the CDC added the shot to the adult immunization schedule for all adults, including pregnant women, ages 19-59.

Hepatitis B is a liver infection that can become chronic, transmitted through bodily fluids, typically through high-risk adult behaviors like unprotected sex or IV drug use.

In 1991, the Hep B vaccine was added to the childhood vaccine schedule with limited safety investigation, even though only those infants whose mothers have the disease are at risk. Also, recent research shows that 10 – 35 percent of vaccinated babies born to infected mothers still contract the disease.

Adding the vaccine to the childhood schedule is expected to grow the market from $8.38 billion in 2023 to $8.85 billion in 2024 and $13.31 billion by 2032, Fortune Business Insights reported.

Vaccines considered unsafe for pregnant women until 2009

Maternal vaccination is a recent phenomenon. Vaccines typically weren’t given during pregnancy out of concern the weakened virus in the vaccine might hurt the developing fetus, according to the Children’s Hospital of Philadelphia (CHOP).

But according to CHOP, that risk is only “theoretical.” The hospital’s website states that public health agencies developed their justifications for vaccinating pregnant women following the recent series of pandemics.

Marion Gruber, Ph.D., vaccine developer and former director of the FDA’s Office of Vaccines Research & Review, told CHOP that during the 2009 H1N1 influenza pandemic “it became important” to try to prevent pregnant women from being infected because they were at higher risk for severe flu.

Gruber also said the “2014-2016 Ebola outbreak” further strengthened public health officials’ resolve that pregnant women needed vaccines — although it appears she meant to refer to the Zika outbreak. She said that because of those concerns, the thinking on vaccinating pregnant women has changed.

Tdap added to schedule in 2012

In 2012, the CDC’s advisory committee voted to recommend that pregnant women receive a dose of Tdap between 27 and 36 weeks of gestation to protect babies from whooping cough, which can be serious.

However, the bacteria that causes whooping cough (pertussis) contained in the Tdap likely no longer provides protection, as it’s outdated. The CDC has been tracking changes in the prevalence of bacteria causing whooping cough for years. The most recent CDC data suggests that Bordetella parapertussis whooping cough has significantly overtaken B. pertussis, the type treated by the vaccines.

Research published in Vaccines in March shows the existing vaccines “scarcely provide protection” against this strain.

Tdap shots also contain vaccines for tetanus and diphtheria, exposing both mother and baby to more drugs.

Obstetrician Dr. James Thorp told The Defender the Tdap recommendation for pregnant women is concerning. “I’ve been practicing for over 45 years and I’ve never seen a case of tetanus or diphtheria. Why are we giving this shot?”

Flu vaccine has low efficacy rates and concerning safety data

The CDC has recommended the flu vaccine for pregnant women since at least 2013, although there is evidence the recommendation may have begun earlier. The CDC says flu shots have been given to pregnant women for over 50 years.

Even proponents of the flu vaccine say it is only 22%-56% percent effective in any given year — the 2014-2015 influenza vaccine was only 13%-23% effective. Research shows the shot has no major effect on hospitalization, mortality, infections in small children or the risk of contracting the flu for pregnant women and their babies.

There are also serious concerns with the vaccine, particularly for pregnant women and children, because the shots often contain thimerosal, a mercury-based preservative. According to the CDC, flu vaccines in multi-dose vials contain the chemical.

The CDC cites several studies of its Vaccine Safety Datalink data that show no increased risk of miscarriage or other adverse health events among women who received the vaccine. However, the cited studies were effectiveness studies.

An analysis of the Vaccine Safety Datalink data published in the journal Vaccine in 2017 found that women who received the flu vaccine had twice the odds, or higher, of spontaneous abortion as women who didn’t. The CDC says on its website that this study had “several limitations,” and points to other studies showing there is no risk.

COVID shot recommended for pregnant women in U.S., but not other countries

In April 2021, the CDC issued an urgent recommendation that pregnant women and new mothers get the COVID-19 vaccine, even though pregnant women were excluded from the original safety and efficacy studies and no randomized controlled trial had yet been conducted.

Then-CDC Director Rochelle Walensky issued the recommendation just two days after Pfizer submitted its pregnancy and lactation report detailing the vaccine’s effects on women and babies from post-marketing data to the FDA.

The report indicated high rates of adverse events, ranging from mild to severe, including miscarriages and preterm births the company attributed to the vaccine.

The very small randomized control trial results on pregnant women that Pfizer eventually ran, beginning in 2021, included only 391 mothers and 335 preterm and newborn babies globally.

The trial results showed mothers in the vaccine group had higher rates of preeclampsia and gestational hypertension and infants exposed to the vaccine in utero had a markedly lower Apgar score, higher rates of congenital malformations, and other issues.

In a recent reanalysis of the Vaccine Adverse Event Reporting System (VAERS), researchers found safety signals for 37 adverse events after the COVID-19 shot in pregnant women.

The United Kingdom and other countries stopped recommending the shots for pregnant women for 2025, citing the low risk of serious COVID-19 illness in pregnant women and infants based on real-world epidemiological data.

However, the CDC continues to tell pregnant women they are more likely to get sick, need hospitalization and have a preterm or stillborn baby if they get COVID-19, so they should get vaccinated.

RSV shots had elevated rate of preterm birth in clinical trials

Once the initial panic over COVID-19 began to wane by late 2022, the media began warning of a possible “tripledemic” as COVID-19, seasonal influenza and RSV were all circulating.

Months later, RSV vaccines targeting pregnant women and seniors, and new monoclonal antibody shots for newborns were unveiled and submitted for approval to the regulatory agencies.

Initially, both Pfizer and GSK were developing nearly identical RSV vaccines aimed at pregnant women.

GSK stopped trials of its maternal RSV vaccine when it found a safety signal for preterm births among vaccinated women. In that study, for every 54 infants born to women who received the vaccine, one additional preterm birth occurred.

Pfizer’s own clinical trial data for its RSV vaccine Abrysvo also showed elevated rates of preterm birth among vaccinated women, but Pfizer said the higher rates were not “statistically significant.”

Pfizer also observed more hypertensive disorders of pregnancy among vaccine recipients compared with placebo recipients in its Abrysvo trials. The drugmaker determined the rate of disorders was not statistically significant.

Still, the FDA limited approval of the vaccine for women in weeks 32-36 of their pregnancy to reduce risk and mandated post-market follow-up studies for both preterm birth and eclampsia.

The agency also labeled preterm birth a potential risk associated with the vaccine.

Some members of the FDA’s vaccine advisory committee said they had serious safety concerns based on the clinical trial data, and four members voted against approving the drug.

See more here childrenshealthdefense.org

Header image: Stoke Travel Clinic

Please Donate Below To Support Our Ongoing Work To Defend The Scientific Method

PRINCIPIA SCIENTIFIC INTERNATIONAL, legally registered in the UK as a company incorporated for charitable purposes. Head Office: 27 Old Gloucester Street, London WC1N 3AX. 

Trackback from your site.