Search results for: pregnancy

As of December 15, 2020 the CDC recommends "healthcare personnel who are pregnant" to discuss getting the COVID-19 vaccine "with a healthcare provider" as this "might help them make an informed decision". Currently there is "limited data about the safety of COVID-19 vaccines for people who are pregnant", this population was excluded from clinical trails. "While studies have not yet been done, based on how mRNA vaccines work [what about LNP], experts believe they are unlikely to pose a risk for people who are pregnant."!!! "Animal developmental and reproductive toxicity (DART) studies are ongoing and studies in people who are pregnant are planned.  CDC and the Food and Drug Administration (FDA) have safety monitoring systems in place to capture information about vaccination during pregnancy and will closely monitor reports."

On December 10, 2020 the CDC launched their new COVID-19 vaccine smartphone App called V-safe After Vaccination Health Checker.  Volunteers could download the app and then be prompted to report any "side effects" they experience following their COVID-19 vaccinations. "Depending on your answers, someone from CDC may call to check on you and get more information. And v-safe will remind you to get your second COVID-19 vaccine dose if you need one." [1]  The app prompts feedback on days 21 and 42 after each vaccine dose and at 3, 6, and 12 months after the last vaccine dose. [5] Initially, on Jan 28, 2021, the CDC planned to call anyone who reported an adverse health impact to v-safe (v-safe protocol v.2 at p.5) but by May 20, 2021 they "had to abandon that plan early on after rolling out v-safe due to the volume of people reporting impacts (v-safe protocol v.3 at pp.7-8)" [6]  They also didn't include their proposed Adverse Events of Special Interest (AESI) as check boxes. On December 29, 2020 the CDC decided to set up the V-Safe Pregnancy surveillance protocol which would look for pregnant women and ask them to join the v-safe pregnancy registry. It..> READ MORE

On Friday, April 23, 2021 at a White House virtual press briefing, CDC Director Rochelle Walensky recommended "pregnant people receive the COVID-19 vaccine", acknowledging pregnant women were excluded from clinical trials. [1] Three days earlier, April 21, 2021, CDC scientists published [original] preliminary findings from data collected from the “v-safe after vaccination health checker” surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) in order "to characterize the initial safety of mRNA COVDI-19 vaccines in pregnant persons". Between December 14, 2020, to February 28, 2021, (the first 11 weeks of the U.S.’s vaccination effort) a total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant, of which only 3,958 participants (11%) enrolled in the v-safe pregnancy registry. Of the 827 that had a completed pregnancy "115 (13.9%) were pregnancy losses and 712 (86.1%) were live births (mostly among participants vaccinated in the third trimester)".  "Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines." [2] Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Examination of the original CDC paper challenged the findings..> READ MORE