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An "official" trial with observational data typically affords several advantages, like robust and complete data and strict, standardized definitions for outcomes allowing for quality comparisons, Eckert said. Some outcome measurements in Moderna’s study include the number of participants who have infants with suspected major and minor congenital malformations and the number of participants with any pregnancy complications, but these measurements are "completely standard for any medication or vaccine given to pregnant women," Eckert stresses. specs of a51 Dr. Moncef Slaoui, chief adviser to Operation Warp Speed, speaks in the Rose Garden of the White House, Friday, Nov. 13, 2020, in Washington. (AP Photo/Evan Vucci) specs of a51 The Food and Drug Administration said in a letter to J&J that the shots remain safe and effective for at least six months when properly stored and refrigerated. It's the second time the FDA has extended the shelf life on the vaccines since June, when the agency said they could be used for up to 4 1/2 months. When first authorized in February, the FDA said the vaccines could be stored for three months at normal refrigeration levels.WHAT IS A COVID-19 VACCINE ‘BREAKTHROUGH’ CASE specs of a51 "I do think that more data is always helpful when it comes to offering reassurance to patients," Dr. Linda Eckert, professor in obstetrics and gynecology at the University of Washington, wrote in an email, later adding, "I do feel confident in the vaccines we have available but welcome more data.  I strongly believe and know that the risk of COVID infections in pregnancy are significant, and so I tell individuals who chose to be vaccinated that it seems like a wise decision for the protection of their own health and the health of their pregnancy." specs of a51

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