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In a significant step forward, Pfizer has announced that it has submitted preliminary data to the FDA regarding its COVID-19 vaccine trial for children aged 5 to 11. This eagerly anticipated news, shared on September 28, brings us closer to potential vaccine authorization for this younger demographic. Many parents have been awaiting this development, and information about a possible timeline has circulated for months, making this announcement particularly exciting.
It’s essential to clarify that this submission does not constitute a request for emergency authorization just yet. Pfizer indicated that such a request will follow “in the coming weeks.” This aligns with recent statements from former FDA Commissioner Scott Gottlieb, who suggested that if all goes well, the vaccine could receive authorization for kids aged 5 to 11 by the end of October.
The announcement follows promising results from Pfizer’s trials, which reported a “favorable safety profile and robust neutralizing antibody responses” for this age group. The doses administered in the trial were one-third the size of those given to adults.
On September 10, FDA officials, including Janet Woodcock and Peter Marks, expressed their eagerness to see children vaccinated. They emphasized the importance of allowing scientific data to guide the process and reassured the public that they are working diligently to expedite vaccine availability for children without compromising safety. They noted that while they cannot provide a specific timeline for when the review will be completed, they are committed to addressing this critical public health need.
Once the complete application for emergency use authorization is submitted, the FDA will conduct a thorough and independent examination of the data, aiming for a swift review process. The speed of this review will depend significantly on the quality and timeliness of the submissions from manufacturers.
Pfizer also stated that it expects to have trial results for children under 5 as early as the fourth quarter of this year.
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In summary, Pfizer’s recent submission of data to the FDA for its COVID-19 vaccine for children aged 5 to 11 is a promising development that could lead to authorization soon. The company reported positive trial results, and regulatory officials are working to ensure safety and efficacy in the approval process.
Keyphrase: COVID vaccine for children
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