The United States’s emergency authorization of Pfizer and Moderna’s COVID vaccines in the Funny it’s not Halloween until the Maltipoo shows up shirt but in fact I love this U.S.—shown to be 95% effective in large-scale clinical trials—feels, for many, like a turning point in the pandemic. But while questions still loom large about the availability of and accessibility to said vaccines, there are also broader concerns for some about the vaccine’s safety, specifically among people who are pregnant or trying to conceive, and for parents of younger children, all of whom have been, so far at least, excluded from clinical trials. On December 11, the FDA announced it would allow pregnant and lactating women to access the vaccine, even if it hasn’t been tested on them, but it remains unavailable for anyone under 16. Then, in January, the World Health Organization (WHO) declared that pregnant women shouldn’t get the Moderna or Pfizer vaccines unless they were at increased risk of exposure, but, after a public outcry, withdrew that advice on January 26, recommending instead that it should be offered to them. And Johnson & Johnson—at 66%, their vaccine is less effective than the Pfizer and Moderna options, but the advantage is it is a single, versus double dose—will be petitioning the FDA for emergency use authorization this month. While Shayk has been putting more time into her beauty routine, she’s also been elevating her street style look. Before the pandemic, Shayk wouldn’t necessarily dress up to go outside. “In my normal life, I never got dressed up, because for me it was all about comfort,” she says. Though it was during lockdown that she yearned to have more fun with her clothes, even during routine moments, like when she dropped her daughter off at school. “Before, we used to go to big events and parties with makeup and get dressed up,” she says. “Now, I think I miss those fun moments, so I decided that I can have fun with a street style.” It’s equally fun to watch her street style looks, which can be downright smoldering: She’s worn a gray velour sweatsuit with matching heeled boots (accessorized with a zebra mask and matching baguette bag) as well as a biker chic look with a black moto jacket and leather pants, sweetened up by her daughter’s lunch bag that she was carrying at the moment. To remix her look, Shayk has been taking time to explore her closet and experiment with brighter color palettes. “I had so many different pieces sitting in my closet from years ago,” she says. “When I didn’t know what to wear, I’d wear something simple and black. Now, I figured it is time to use a splash of color in my wardrobe. When you put on some color, it just brings your mood to a different level.” While we love her lime green silk set she wore back in October, you can’t beat a touch of 24-karat gold on the lips. Shayk is golden every time she steps out. Because we are still early on in the vaccine timeline, the answers for many questions remain to be seen. To walk us through what we know and what we don’t know about the vaccine as it relates to maternal health, we asked two experts whose specialties lie in treating and studying women and children—Heidi K. Leftwich, D.O., an assistant professor of obstetrics and gynecology in UMass’s Division of Maternal and Fetal Medicine, and Kelly Fradin, M.D., a New York–based pediatrician and author of the recent (and very timely) book Parenting in a Pandemic.
Funny it’s not Halloween until the Maltipoo shows up shirt, hoodie, tank top, sweater and long sleeve t-shirt
Historically, pregnant and lactating women have been excluded from clinical and vaccine trials because of safety concerns for the Funny it’s not Halloween until the Maltipoo shows up shirt but in fact I love this mother and child. But that exclusion can pose its own risks, a point that’s been repeatedly raised by the Society of Maternal-Fetal Medicine and various medical professionals. “It’s common, and it’s a cause for concern,” says Fradin. “When the consequences of toxic medications DES and Thalidomide were noted in the 1940s and 1960s, in 1977 the FDA barred pregnant and lactating women from phase 1 and phase 2 studies. This was intended to increase the safety of pregnant women, embryos, and infants. However, functionally this leads to barriers including women of reproductive age in medical research, which leads to less knowledge, advancement, and innovation in women’s health.” It’s a problem that many national societies are working tirelessly to rectify in the future. “Many are advocating to ethically include pregnant and lactating women in future clinical trials, but until this is more commonplace, physicians and other healthcare practitioners will need to continue to monitor updates in the data to best inform their patients regarding the COVID-19 vaccines,” adds Leftwich. As of January, Pfizer announced plans to begin testing the vaccine in pregnant women in the coming months though none have been enrolled yet, and Moderna was beginning to monitor the potential side effects in women who were immunized via a registry. On February 3rd, Anthony Fauci announced that he had seen “no red flags” in the 10,000 pregnant women who had received the vaccine in the U.S. In short, yes, simply because pregnancy itself is designated high risk for the development of severe disease, hospitalization, and even death, says Leftwich. “The MMWR [Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention] estimated that pregnant women are at three times higher risk for requiring admission to an ICU or requiring a ventilator [because of COVID-19] and that their risk of death is about 70% higher than their nonpregnant peers,” adds Fradin. That risk is compounded for pregnant women of color. The maternal death rate for black mothers is already double the rate of white mothers, and nationally Black and Latina women are disproportionately affected by COVID-19 during pregnancy. So grave are the concerns around COVID-19 and maternal mortality that legislation to address the issue was introduced this year by Massachusetts senator Elizabeth Warren and Representative Lauren Underwood of Illinois. In January, JAMA Internal Medicine published a study that found a significantly higher rate of complications (like preterm birth, preeclampsia, and blood clotting) among women who had COVID-19 and gave birth in hospitals between April and November of last year. But JAMA also published a study recently that found that the majority of women who tested positive for COVID-19 during delivery passed antibodies along to their newborns.