UK Regulators Decide Pregnant Women Don’t Need COVID Vaccines

The JCVI decided against recommending the shots during its Oct. 2 meeting, citing the low risk of serious COVID-19 illness in pregnant women and infants and the vaccine’s cost.

by Brenda Baletti, Ph.D.

The United Kingdom’s (U.K.) vaccine advisory committee won’t recommend that pregnant women take the COVID-19 vaccine in 2025-2026, according to a rapid response letter published today in The BMJ.

The Joint Committee on Vaccination and Immunisation (JCVI) made the decision during its Oct. 2 meeting, citing the low risk of serious COVID-19 illness in pregnant women and infants and the vaccine’s cost. The committee did not address safety concerns about the vaccines for pregnant women and their infants.

The committee’s new recommendation — which must be ratified at the next meeting — followed presentations by researchers on COVID-19 epidemiology and cost-effectiveness.

The researchers presented evidence showing that COVID-19 posed a very low risk to pregnant women and their infants and that the vaccines provided minimal benefit.

They concluded that COVID-19 vaccination for pregnant women becomes cost-effective only if the cost of procuring and administering the vaccines could be kept between 10.07 and 13.19 pounds ($12.74-$16.69) per shot. They considered it “very unlikely” that this would be feasible.

The only way to increase the price at which vaccines were considered cost-effective would be if they could show the vaccine averted neonatal deaths from COVID-19 or posed a greater threat to infants. There is no existing data to support this, they said.

Doctors in the U.K. told The Defender they don’t understand why the JCVI hasn’t told them or pregnant women why the committee is waiting until next year to stop recommending the COVID-19 shots to all pregnant women.

Meanwhile, in the U.S., the Centers for Disease Control and Prevention (CDC) continues to strongly recommend the vaccines for pregnant women.

On its COVID-19 vaccine pregnancy page, the CDC warns that pregnant women are “more likely to get very sick from COVID-19” than other people. It also says they are more likely to need hospitalization, intensive care, the use of a ventilator and experience complications such as preterm birth or stillbirth.

The CDC also reminds pregnant women that “severe COVID-19 illness can lead to death.”

Major physician professional organizations including the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine and the American Society for Reproductive Medicine all continue to tell pregnant women the vaccine is “safe and effective” for pregnant and breastfeeding women.

The recommendations were made despite the lack of safety and efficacy from randomized controlled clinical trials among pregnant women and limited data on COVID-19 vaccines during pregnancy.

Pregnant women were excluded from the original safety and efficacy studies.

300,000 pregnant women need to be vaccinated to prevent one serious hospitalization

The UK Health Security Agency presented epidemiological data to the committee, showing there were no COVID-19-related ICU (intensive care unit) admissions or deaths among pregnant women in any trimester or their infants in the U.K. between October 2022 and December 2023.

In their evaluation of the “number needed to vaccinate,” a commonly used measure of vaccine effectiveness, the researchers estimated that 300,000 pregnant women would need to be vaccinated to prevent one serious hospitalization for COVID-19 during pregnancy, as such cases are rare. Similar results were observed for infants’ hospitalization.

The researchers estimated that just over 13,000 pregnant women would need to be vaccinated to prevent one serious hospital admission for an infant under age 3 months. To prevent one infant death, between 380,000 and 1.5 million pregnant women would need to be vaccinated.

They said the latter number was difficult to calculate with certainty, given the difficulty in attributing any infant deaths at all to COVID-19. They also said it was difficult to attribute any infant hospitalizations to COVID-19 — and that current data likely overestimated COVID-19 hospitalization among infants — because hospitalized infants typically had other coexisting infections.

Researchers from the University of Warwick in Coventry, England, and the Department of Health and Social Care presented modeled data on cost-effectiveness.

The U.K. will continue to use a “bespoke, non-standard cost-effectiveness assessment” through the spring 2025 COVID-19 vaccination campaign because they still have stockpiled vaccines available.

However, from fall 2025 on health officials will use JCVI’s standard cost-effectiveness model, which factors in costs for vaccine procurement, along with outcomes such as maternal or infant hospitalizations, ICU admissions and preterm birth or infant death.

Within that framework, the vaccines are not cost-effective for pregnant women and their babies, the committee concluded.

The committee agreed that starting in fall 2025 and spring 2026, only adults 75 and older, care home residents and immunosuppressed people over 6 months will be eligible for the vaccine.

They noted that COVID-19 showed no seasonality and estimated that overall the vaccine was 50% effective against hospitalization in the first four weeks following vaccination, with protection waning to zero by 28 weeks.

Cost-benefit analysis doesn’t include adverse reactions to the vaccine

The cost-benefit analysis doesn’t account for possible adverse events from the COVID-19 vaccine for pregnant mothers or their infants, despite many reports of serious side effects.

Pfizer sent the pregnancy and lactation report detailing the vaccine’s effects on women and babies from post-marketing data to the U.S. Food and Drug Administration on April 20, 2021, according to the DailyClout. The report indicated high rates of adverse events, ranging from mild to severe, including miscarriages and preterm births the company attributed to the vaccine.

Effects on lactating babies included fever, vomiting and edema, or swollen tissue, among many other issues.

Two days after Pfizer submitted its report to the FDA, then-CDC Director Rochelle Walensky gave a White House press conference, during which she told women there was no bad time to get a COVID-19 shot — before, during or after pregnancy.

Mainstream press ignores Pfizer pregnancy data

Pfizer recently published the results of its own very small randomized control trial results on pregnant women, which included only 391 mothers and 335 preterm and newborn babies globally.

The results, posted in the EU Clinical Trials Register, weren’t published in any peer-reviewed journal or discussed in the media.

Pfizer launched the study in February 2021, originally planning to enroll 4,000 women. However, the drugmaker ended enrollment early, citing the fact that so many pregnant women had already received the shot and that governments had endorsed it, according to an email sent to reporter Maryanne Demasi.

The vaccinated group received two doses of the Pfizer shot, while the other group received a placebo. The study was unblinded shortly after the babies were delivered and all women were offered two doses of the Pfizer vaccine.

In the trial results, 2 of 86 mothers who got the vaccine contracted COVID-19 compared with 2 of 89 in the placebo group. The mothers in the vaccine group had higher rates of preeclampsia and gestational hypertension, side effects that also occurred in the mRNA RSV vaccine maternal clinical trials.

Infants exposed to the vaccine in utero had a markedly lower Apgar score — a quick test performed by doctors at one and five minutes after birth to determine infant health. There were also indicators that some babies of vaccinated mothers exhibited decreased fetal movement.

Children’s Health Defense Senior Research Scientist Karl Jablonowski told The Defender that a Phase 2/3 clinical trial of 391 people, only half of whom receive the mRNA vaccine, “is way too small to produce anything clinically meaningful.”

If the product causes a severe adverse reaction in just 1 in 500 recipients, it would not be observed, he said.

He added:

“It does not make sense to perform such a small, punctuated study to ensure safety. It does make sense if the company is just looking to check a box for friendly regulators.

“It also does not make sense to vaccinate the control arm one month after birth and still evaluate the infants as if they are unexposed, as shedding through breastmilk and other routes is a known phenomenon.”