Financial Associated Press (Shanghai, editor Ale), the American biotechnology company Modena confirmed on Monday (July 26) that the company plans to expand the clinical trial scale of its new crown vaccine in children aged 5 to 11.
The clinical trial was launched at the end of March this year, aiming to increase the possibility of discovering potentially rare side effects. The company currently refuses to disclose the number of children it hopes to recruit.
The company said in a written statement, “Expanding the scale of the trial is our intention, and we are actively discussing the proposal with the FDA. At this point, we look forward to getting a plan to be authorized in the winter of 2021 or early 2022.” Early Monday At that time, some media said that the US Food and Drug Administration (FDA) required Modena and Pfizer to enroll 3,000 children in the 5 to 11-year-old children’s trial, which is twice the size of the trial originally envisaged.
In May of this year, the FDA allowed children aged 12 to 15 to use the Pfizer-BioTech new crown vaccine. It is expected that the Modena vaccine will be approved for 12-year-old children at any time. But the FDA added a warning label to Pfizer and Modena’s new crown vaccines in June, listing cardiac inflammation reported by a small number of young people as potentially rare side effects.
Scientists say that vaccinating children is considered the key to ending this pandemic. If enough people in a particular community develop antibodies to a particular disease, but the children are not vaccinated, it is still unlikely to achieve herd immunity. Health officials also need to balance the risk of rare side effects with the risk of contracting the new crown.
Health officials said in June, “There have been more than 1,200 cases of heart inflammation, mainly in people aged 30 and under who received injections. But the benefits of the vaccine still outweigh the risks—compared to only 12.6 per million doses. Cases of heart inflammation.”
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