The FDA has delayed the authorization to vaccinate children under 5 years old, saying a third dose of data is still needed

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On the 11th local time, the US Food and Drug Administration (FDA) announced that after reviewing the latest clinical trial data, it decided to suspend the approval of the emergency use authorization for the Pfizer-BioNTech new crown vaccine for children under 5 years old.

According to the Associated Press reported on the 11th, the FDA said on the same day that after Pfizer and BioNTech proposed an emergency use authorization application for vaccination for children under five years old, the agency has reviewed the latest clinical trial data and decided to suspend the approval of use, believing that more data is needed to make a decision.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said the decision was based on the results of a scientific review, and after Pfizer submitted its application, the agency decided to make a decision after obtaining data on a third dose that was still being tested.

Since then, Pfizer has said that these data are expected to be released in early April. But the report also notes that it will take weeks for the FDA and other agencies to review and make the data public after it completes its submission.

According to previous reports, at least 1,000 children have died from COVID-19 infections since the start of the 2020 pandemic, and the latest data shows that more than 94,000 children infected with COVID-19 have been admitted to U.S. hospitals. According to the American Academy of Pediatrics, Omiqueron has infected more than 11.4 million children, accounting for 18.6 percent of all cases in the United States since the pandemic began.

Considering the surge in infections, including children, caused by the Omilon strain, the US Food and Drug Administration has urged Pfizer to expedite the submission of applications for ultra-low doses of COVID-19 vaccines for children under five years old, but it has not yet been clear whether this age group needs two or three doses of vaccine. It is reported that the FDA was scheduled to publicly discuss the feasibility of vaccinating children under five years of age with two doses of the vaccine next week.