Fauci says no 'red flags' after about 20,000 pregnant women vaccinated

By Mark Kekatos, Senior Health Reporter for DailyMail.com

Published: February 10, 2021

 

Fauci says that about 20,000 pregnant women have received COVID-19 vaccines and there have been ‘no red flags' as Illinois and New York expand shot eligibility to expecting mothers

• On Wednesday, Dr Anthony Fauci said there have been no 'red flags' after 20,000 pregnant women received coronavirus vaccines 
• Fauci said clinical trials with pregnant women will begin or are underway but will not need tens of thousands, just enough volunteers to show safety and efficacy
• It comes after the WHO  recommended pregnant women not receive COVID-19 vaccines due to a lack of safety data - and then walked back its guidance
• This is despite pregnant COVID-19 patients being twice as likely to be admitted to ICUs and three times more likely to need mechanical ventilation 

Dr Anthony Fauci says there have been 'no red flags' after tens of thousands of pregnant women have received vaccines against COVID)-19.

During a White House briefing on Wednesday, the nation's top infectious disease expert said that expectant months have been given both Pfizer-BioNTech's and Moderna's shots with no unexpected side effects.

'I want to point out that since the EUA 9emergency use authorization) and under the EUA, approximately 20,000 pregnant women have been vaccinated with no red flags, as we say, and this is being monitored by the CDC and the FDA,' Fauci said.

 

While pregnant women were not included in the clinical trials for either vaccine approved in the U.S., some clinical trials including pregnant women are either about to start or already underway, he added. 

Last month, the World Health Organization (WHO) warned that COVID-19 vaccines should not be used on pregnant women - and then walked back its advice and said vaccines can be administered in expectant mothers safely. 

It also comes as states such as Illinois and New York expand their eligibility for shots to included pregnant women.

No vaccine trials to date have included pregnant women - and they are not expected to until after the first quarter of 2021 - meaning there is no safety data, the WHO says.

Researchers want to determine the vaccines are safe and effective in healthy, non-pregnant people before testing them in mothers-to-be and their future children.

'With regard to children and pregnant women, as I mentioned on a prior discussion with this group, the fact remains that we will be starting clinical trials, and some have already started. We will not need to do tens of thousands of people,' Fauci said.

'We will need just enough measured in hundreds to thousands for safety and whether or not we induce an immune response that is equivalent to the immune response that has been proven to be protective under the trials that have now shown to be 94 percent to 95 percent effective.'  

Doctors in the U.S. have opposed pregnant women being excluded from vaccine recommendations due to their high risk of severe illness from COVID-19 and say the patients should decide themselves whether or not they want the shot.

In a virtual briefing last month, the WHO's director of immunization Kate O'Brien stressed that clinical trials of the Moderna vaccine are needed on pregnant women.

'There is no reason to think there could be a problem in pregnancy, we are just acknowledging the data is not there at the moment,' she said.

However, the American College of Obstetrics and Gynecology has been staunchly against the exclusion of pregnant women from vaccination trials and guidance.

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

'Pregnant individuals are more likely to have certain manifestations of severe illness associated with COVID-19 infection such as ICU admission, mechanical ventilation, and death,' the statement reads.

'Further, upwards of half of pregnant individuals also fall into another high-priority category, including frontline workers and those with underlying conditions.

'ACOG continues to urge that for pregnant individuals, the decision to vaccinate must be left to each patient in consult with their trusted clinician.'

There is currently no data on how many women became pregnant during Moderna's coronavirus vaccine trial.

However, during the Food and Drug Administration's (FDA) advisory committee meeting on recommending whether or not approve Pfizer's vaccine - the only other shot approved in the U.S. - researchers revealed 23 pregnancies occurred during the trial as of November 14.

Of the pregnancies, 12 were among the vaccine group and 11 were among the placebo group.

In the vaccine group, four were immunized prior to their last menstrual period, four within 30 days after their last menstrual period and four more than 30 days after.

In the placebo group, two wee inoculated prior to their last menstrual period, six within 30 days after their last menstrual period and two more than 30 days after.

No outcomes are known yet aside from one woman in the placebo group who had a miscarriage at less than 20 weeks' gestation.

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

For example, expecting mothers have never been included in flu shot studies, but have been encouraged by doctors to get it after years of data showing the jab behaved normally in healthy participants.

Doctors say they are concerned about pregnant women not receiving 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 the health-care workforce are female and about 330,000 healthcare workers 'could be pregnant or recently postpartum at time of vaccine implementation.'

What's more, data from the CDC show pregnant COVID-19 patients are twice as likely to be admitted to ICUs and three times more 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 lactating women in vaccine trials. 

Dr Kristina Adams Waldorf, an obstetrician-gynecologist with the University of Washington School of Medicine, told DailyMail.com last month that she believes pregnant women need to be vaccinated  

'We are completely puzzled by this statement from the World Health Organization,' Adams Waldorf said.

'And no one quite understands where this recommendation comes from. We have excellent animal safety data, we understand biologically how this [disease] works and we know front and center the risk that pregnant patients are facing,

'One in 80 face a chance of dying. That's real.'