Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use COMIRNATY safely and effectively. See full prescribing information for COMIRNATY.

USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to COMIRNATY during pregnancy. Women who are vaccinated with COMIRNATY during pregnancy are encouraged to enroll in the registry by visiting https://mothertobaby.org/ongoing-study/covid19-vaccines/.

Risk Summary

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. A developmental toxicity study has been performed in female rats administered the equivalent of a single human dose of COMIRNATY on 4 occasions; twice prior to mating and twice during gestation. These studies revealed no evidence of harm to the fetus due to the vaccine (see Animal Data).

8.2 Lactation

Risk Summary It is not known whether COMIRNATY is excreted in human milk. Data are not available to assess the effects of COMIRNATY on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for COMIRNATY and any potential adverse effects on the breastfed child from COMIRNATY or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

https://www.fda.gov/media/151707/download

>>14442195

"certain uses" of COMIRNATY that are not approved in the BLA are authorized under the existing EUA.

https://www.youtube.com/watch?v=aHAGnDz9F_w

COMIRNATY sounds like COMORBIDITY

>>14442195

>>14442460

it looks like they are attempting to get the most coverage by retaining both EAU and BLA

[could use some forestry management. kek]

Maddalena, the co-captain of the UAF rifle team, is considered one of the best shooters in the U.S. She will return for finals, graduate and then compete in Munich before relocating to the Olympic Training Center in Colorado Springs. She would like to compete in the 2020 Olympics.

Maddalena got her first shooting experience with a 4-H club. She thought she might try it out but after the first meeting, she said, “I was hooked.”

Maddalena, who is from central California, chose to study at UAF because she wanted a school that had a good rifle team and a natural resources management degree.

She found both in Kentucky and UAF and figured Alaska would have more opportunities to study forestry, which is her prime interest.

She became interested in forestry after working for a timber and brush management company following high school. Also, a large fire in 2013, known as the Rim Fire, burned to within a few miles of her family home, which is near Yosemite National Park. The forest was particularly vulnerable to fire and western bark beetle infestation because of drought conditions.

“It was at that point I realized the importance of forest management,” she said.

https://afes-news.blogspot.com/2018/04/