HHS defends decision to stop recommending Covid shots during pregnancy despite evidence supporting their safety, but still recommends continuing with the recommended dose after studies indicate that they are safe

Politico

And it claims that “a number of studies in pregnant women showed higher rates of fetal loss if vaccination was received before 20 weeks of pregnancy,” footnoting a research paper on vaccination during pregnancy.
That research was based on health-system data from Ontario, Canada, and aligned with similar population studies in the U.S., Scotland and Norway.
Similarly, HHS cited an April 2022 study in its document concerning mRNA vaccination in people undergoing in vitro fertilization, which also found no adverse effects on conception rates or on early pregnancy outcomes.
HHS deviated from past practice when it changed the Covid vaccine guidance last month, announcing the decision without the endorsement of an existing outside panel of expert advisers.
Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, told POLITICO at the time that he was disappointed by HHS’ decision and pointed to data showing that newborns can benefit from maternal antibodies from the vaccine for protection from Covid.

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In a document being circulated on Capitol Hill, the Department of Health and Human Services explains why it decided to remove the Covid-19 vaccine recommendation for expectant mothers, citing research that generally concluded the shot is safe.

Days before Secretary Robert F. Kennedy took office, HHS sent the document to lawmakers. Kennedy Jr. declared that he would dismiss the panel that advises the CDC on vaccinations, citing research indicating that pregnant women who received the vaccine experienced a higher incidence of various complications. Additionally, it cites a study on vaccination during pregnancy and states that “a number of studies in pregnant women showed higher rates of fetal loss if vaccination was received before 20 weeks of pregnancy.”.

Yet, Dr. Maria P. The lead author of one of the studies, Velez of McGill University, told POLITICO via email that “the results of our manuscript were misinterpreted.”. “”.

According to the 2023 study, women who received the Covid-19 vaccine during their pregnancies had a marginally higher rate of miscarriages. However, after controlling for “variables that can confound a crude association,” such as “age, rurality, neighbourhood income quintile, immigration status, comorbidity,” and other variables that might influence the result, Canadian researchers discovered “no association between SARS-CoV-2 vaccination and an increased risk of miscarriage,” according to Velez. “”.

According to Katelyn Jetelina, an epidemiologist who consults for the Centers for Disease Control and Prevention, raw statistics don’t take into consideration important variations between the groups being compared, such as underlying medical conditions and the time of vaccination during pregnancy. She explained that scientists, including the Canadian researchers, use statistical techniques to account for those variables, which is how they came to the conclusion that the vaccine was not linked to miscarriage.

According to the raw study data, which HHS spokesperson Andrew Nixon cited in a statement, women who received the Covid vaccine had a marginally higher rate of miscarriage in the first half of pregnancy than those who did not.

“There are valid safety concerns raised by the underlying data, which speaks for itself,” he stated. HHS will not minimize early pregnancy loss or disregard that evidence. “”.

HHS and the CDC advise people to discuss “any personal medical decision” with their providers, Nixon continued. “”.

The decision to remove the recommendation for pregnant women was met with criticism from obstetricians and vaccine researchers, and the researchers quoted in the HHS document mainly denied any link between miscarriages and the Covid vaccination.

In the study, Velez and her co-authors wrote, “The current study can inform healthcare providers, pregnant women, and those considering a pregnancy about the safety of SARS-CoV-2 vaccination in relation to miscarriage risk, given that COVID-19 infection during pregnancy is associated with serious maternal and neonatal morbidity.”. Based on Ontario, Canada’s health system data, that study was consistent with comparable population studies conducted in the United States. S. Scotland and Norway.

In its document, HHS also referenced a study conducted in April 2022 on mRNA vaccination in IVF patients, which also found no negative effects on early pregnancy outcomes or conception rates.

In the study, researchers from the Icahn School of Medicine at Mount Sinai and Mount Sinai West hospital in New York City stated that “administration of COVID-19 mRNA vaccines was not associated with an adverse effect on stimulation or early pregnancy outcomes after IVF in this study.”. Our results add to the increasing amount of data showing that the COVID-19 vaccine is safe for expectant mothers. “.”.

An incorrect link for that study is also included in the HHS document; instead, it leads to another study by Israeli researchers that found the vaccine “appears to be safe during pregnancy,” with no increase in preterm labor or low birth weight babies.

According to the February 2022 study, women who received vaccinations during the second trimester may have a higher risk of preterm births. The authors recommended further research on the effects of vaccination timing.

According to Dr. Paul Offit, a specialist who has advised the FDA and the CDC on vaccines as an outside consultant, HHS’ claim regarding serious risks to expectant mothers “contradicts the bulk of published studies.”.

Last month, HHS announced a change to the Covid vaccine guidelines without consulting an existing outside panel of expert advisers, which was a departure from previous practice.

Doctor. At the time, Steven Fleischman, president of the American College of Obstetricians and Gynecologists, expressed his disappointment with HHS’s decision to POLITICO, citing data demonstrating that the vaccine’s maternal antibodies can protect newborns from COVID-19.

With the great majority of hospitalized infants under 6 months old — those who are not yet eligible for vaccination — born to unvaccinated mothers, Fleischman stated, “in fact, growing evidence just shows how much vaccination during pregnancy protects the infant after birth.”.

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