Today, FDA amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals. go.usa.gov/xFVdR pic.twitter.com/cqwF5j8pYp
Hats off to the @US_FDA for approving a third booster shot for at risk folks with weakened immune systems. Unlike politically motivated mask mandates, this booster shot will go a long way in saving lives. www.marshall.senate.gov/press-releases/sen-marshall-statement-on-fda-approval-of-covid-19-vaccine-booster-shot-for-immunocompromised-patients/
🚨BREAKING: @US_FDA authorizes extra #CovidVaccine doses for immunocompromised patients to bolster protection against #COVID19. Details about how shots will be administered—and who are eligible—will be discussed Friday at a meeting of @CDCgov advisers. www.washingtonpost.com/health/2021/08/12/booster-shot-coronavirus/
BREAKING: U.S. regulators have “transplant recipients and others with weakened immune systems can get an extra dose of the COVID-19 vaccine to better protect them as the delta variant continues to surge,” the @AP reports. apnews.com/article/bc9c6451c1b31a59a8c752abc3a1b839
13 August, 2021 - 11:20am
Max Cuevas, 12, holds his mother's hand as he receives the Pfizer COVID-19 vaccine from nurse practitioner Nicole Noche at Families Together of Orange County in Tustin, Calif., Thursday, May 13, 2021. The state began vaccinating children ages 12 to 15 Thursday. Jae C. Hong/AP Photo
UW Health will be participating in a clinical trial of the Moderna vaccine for the remaining group of children not yet eligible to get a shot. On Friday, enrollment will begin for children 6 months to 11 years old. The 14-month study will evaluate the safety and effectiveness of the Moderna COVID-19 vaccine.
Eighty children will be enrolled at American Family Children’s Hospital in Madison. The University of Wisconsin-Madison School of Medicine and Public Health is part of a larger Moderna study taking place at more than 75 locations in the United States and Canada, which aims to have as many as 12,000 children taking part.
Children will get two doses of the COVID-19 vaccine, four weeks apart. Older children ages 6 to 11 will be studied first, then those ages 2 to 6 years old, and finally the youngest group of children age 6 months to 2 years old.
The first group to be studied — kids ages 6 to 11 — will get half the dose adults get said Dr. William Hartman, a UW Health anesthesiologist and co-leader of the study.
Study sites around the country will be administering different levels of vaccine to see what is the minimum amount that is most effective to protect against the disease, he said. Not everyone will get the Moderna vaccine; 1 in 3 participants will get a placebo.
Children in the study will be monitored closely for adverse effects. Some adolescents and young adults have experienced heart swelling, or myocarditis, after getting the Pfizer and Moderna vaccines. The condition is rare and the Centers for Disease Control and Prevention is monitoring these reports.
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"The vaccines themselves induce an inflammatory state. That’s what you want them to do is make antibodies that go after the virus," said Hartman. "Sometimes this will put the body into a hyperimmune state where the body has a big inflammatory response which is likely leading to myocarditis."
Currently, only the Pfizer vaccine is available for children 12 and older. Moderna has also applied to the U.S. Food and Drug Administration for approval of its vaccine for the same age group.
In the meantime, Dane County Public Health Director Janel Heinrich says parents can protect their unvaccinated kids by choosing where they go and whether they mask up.
"Someone who has a child under 12 in their household who is not eligible to receive the vaccine might make more cautious decisions than someone whose entire household is vaccinated," she said during a Thursday media briefing.
Federal health officials have recommended everyone wear masks indoors — regardless of vaccination status — in COVID-19 hotspots.
Those interested in signing up their child for the COVID-19 clinical trail can go to www.kidcovestudy.com or call 608-262-8300.
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12 August, 2021 - 01:17pm