Fauci says there is no ‘red flag’ after around 20,000 pregnant women vaccinated

Dr Anthony Fauci says there has been “ no red flag ” after tens of thousands of pregnant women received COVID vaccines) -19.

In a White House briefing on Wednesday, the nation’s top infectious disease expert said future months had been injected by both Pfizer-BioNTech and Moderna without unexpected side effects.

“ I would like to point out that since the emergency use authorization of EUA 9) and within the framework of the EUA, around 20,000 pregnant women have been vaccinated without red flags, as we say, and this is monitored by the CDC and the FDA, ‘Fauci said. .

While pregnant women have not been included in clinical trials for any of the vaccines approved in the United States, some clinical trials involving pregnant women are about to start or are already underway, a he added.

Last month, the World Health Organization (WHO) warned that COVID-19 vaccines should not be used on pregnant women – then reiterated its advice and said vaccines can be safely given to women pregnant.

It also occurs when states such as Illinois and New York expand their vaccine eligibility to include pregnant women.

No vaccine trials to date have included pregnant women – and they are not expected to do so until the first trimester of 2021 – meaning there is no safety data, according to the WHO .

The researchers want to determine that the vaccines are safe and effective in healthy people who are not pregnant before testing them in expectant mothers and their unborn children.

“With regard to children and pregnant women, as I mentioned in a previous discussion with this group, the fact remains that we are going to start clinical trials, and some have already started. We won’t need to do tens of thousands of people, ”Fauci said.

“ We will need just enough measured in the hundreds to thousands for safety and whether or not we induce an immune response equivalent to the immune response which has been shown to be protective in trials which have now been shown to be 94-95% . effective.’

U.S. doctors have objected to excluding pregnant women from vaccine recommendations because of their high risk of serious illness from COVID-19 and say patients should decide for themselves whether or not they want to be vaccinated.

During a virtual briefing last month, WHO Director of Immunization Kate O’Brien stressed that clinical trials of the Moderna vaccine are needed in pregnant women.

“There is no reason to think that there could be a problem during pregnancy, we just recognize that the data is not there at the moment,” she said.

However, the American College of Obstetrics and Gynecology has strongly opposed the exclusion of pregnant women from vaccination trials and counseling.

In a statement, the organization wrote that pregnant women should choose for themselves whether or not they want to be vaccinated and be informed of any risks.

“Pregnant people are more likely to have certain manifestations of serious illnesses associated with COVID-19 infection, such as intensive care admission, mechanical ventilation and death,” the statement said.

In addition, more than half of pregnant women also fall into another high priority category, including frontline workers and those with underlying illnesses.

“ACOG continues to urge that for pregnant women, the decision to vaccinate should be left to each patient in consultation with her trusted clinician.

There is currently no data on the number of women who became pregnant during the Moderna coronavirus vaccine trial.

However, during the Food and Drug Administration (FDA) advisory committee meeting on whether or not to approve Pfizer’s vaccine – the only other vaccine approved in the United States – researchers revealed that 23 pregnancies had had held during the trial on November 14.

Of the pregnancies, 12 were in the vaccinated group and 11 were in the placebo group.

In the vaccinated group, four were immunized before their last menstrual period, four within 30 days of their last menstrual period, and four more than 30 days after.

In the placebo group, two pups were inoculated before their last menstrual period, six within 30 days of their last menstrual period and two more than 30 days after.

No results are yet known apart from a woman in the placebo group who miscarried within 20 weeks of gestation.

It is not uncommon not to include pregnant women in vaccine trials.

For example, pregnant women were never included in the flu vaccine studies, but were encouraged by doctors to get it after years of data showing the vaccine behaved normally in healthy participants. health.

Doctors say they are concerned that pregnant women are not getting the coronavirus vaccine because millions of pregnant or breastfeeding women make up the workforce.

In fact, according to the Centers for Disease Control and Prevention (CDC), 75 percent of health workers are women and about 330,000 health workers “could be pregnant or recently postpartum by the time the vaccine is implemented. “.

What’s more, CDC data shows pregnant COVID-19 patients are twice as likely to be admitted to ICUs and three times as likely to need mechanical ventilation than non-pregnant women with the disease.

Recently, the Society for Maternal-Fetal Medicine called on the federal government to include pregnant and breastfeeding women in vaccine trials.

Dr Kristina Adams Waldorf, an obstetrician-gynecologist at the University of Washington School of Medicine, told DailyMail.com last month that she believed pregnant women should be vaccinated.

“We are completely baffled by this statement from the World Health Organization,” said Adams Waldorf.

“And no one really understands where this recommendation came from. We have great animal safety data, we biologically understand how this [disease] works and we know in the foreground the risk that pregnant patients face,

“One in 80 people is at risk of dying. It’s real.’