Drug manufacturers and U.S. regulators are planning to launch clinical trials in January to test the safety of the Govit-19 vaccine on pregnant women and young children, said Dr. Anthony Fucci, director of the National Institute of Allergy and Infectious Diseases. Both groups have been excluded from clinical trials of the Covid-19 vaccine until researchers determine whether the vaccine is relatively safe for healthy adults before being tested in the most vulnerable population. Fassi noted Thursday in a discussion hosted by Columbia University that pregnant women have not yet been included in any Govt vaccine clinical trials. It is unclear whether pregnant women can avoid receiving the approved vaccine until additional safety information is collected. Studies on pregnant women will come in later tests, he said. “It’s not necessary to look at performance, but we’ll look at safety and immunity to control the performance of non – adult pregnant people,” he said at Columbia University’s Grand Rounds 2020 event. “This also applies to child populations. Those studies will begin in mid-January to late January.” Doctors have identified an increased risk of complications for pregnant women with Covit-19, said Aaron Hall, head of Covit Response. CDC He told the FDA’s Vaccines and Related Biological Products Advisory Council on Thursday that while covit-19 appears to be less likely to cause death in infants, researchers have found that children have a higher risk of developing multisystem inflammatory syndrome, also known as MIS-C, in the heart and lungs. And inflammatory bowel disease, which affects many organ systems throughout the body, including the brain. The FDA’s Deputy Director of Vaccines and Related Products, Doreen Fink, said on Thursday that there was “very little data on use in pregnancy.” ரினார். “We recognize that among the first groups to prioritize vaccine use under an EU are the ability to have children, including women who are pregnant, knowingly or unknowingly,” she told the crowd Thursday afternoon. At this time there is no data demanding a contraindication for use in pregnancy. “Under emergency use authorization, pregnant women and women will be free to make their own decisions.” Previously, they said they would conduct DART studies or growth and reproductive toxicity studies. Pfizer spokeswoman Jerica Pitts told CNBC News that the vaccine “does not seriously prevent pregnancy.” DART studies are conducted in animals to assess the risks associated with the vaccine for the developing fetus. “Pfizer recognizes that developing a potential SARS-CoV-2 vaccine for widespread use is important to help prevent infection. Pregnant women,” Pitts said in a statement. “Pfizer plans to submit DART surveys and available data to the agency.” Pfizer admitted at the FDA’s vaccination meeting on Thursday that it did not find any information about vaccine exposure in pregnant women, according to a slide presentation. Representatives of the company told the advisory board that they expect initial results from its DART studies in mid-December. It also found no information on the effects of the vaccine on children under the age of 16 and teenagers. The FDA is expected to come soon after the FDA’s advisory panel vote on its unbounded recommendation Thursday – CNBC’s Amanda Magias contributed to the report. .
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