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Pfizer has announced a delay in its request to the FDA for emergency authorization of its COVID-19 vaccine for children aged 6 months to 5 years, meaning parents will have to wait longer than anticipated. Initially, there was excitement about the possibility of vaccinating the youngest members of families after reports surfaced on January 31 that Pfizer was preparing to submit its application. However, this plan has now been paused.
As reported by NBC News, Pfizer is putting its rolling application on hold, which would have allowed children in this age group to receive the first two doses of the vaccine. While many parents are understandably disappointed, Pfizer stated that the pause is necessary to gather more data. The company is seeking additional information on the efficacy of a three-dose regimen, which may offer greater protection for this age group. They anticipate that the relevant data won’t be available until early April.
Originally, Pfizer aimed to expand the authorization of its two-dose vaccine for younger children, even though initial trial results indicated that the two doses did not elicit a strong enough immune response in kids aged 2-4. The plan was to allow children to start receiving the first two doses while later submitting data on the third dose. Now, with the request on hold, Pfizer will have more time to ensure that the third dose provides adequate protection.
Just days before the announcement, Pfizer’s CEO, Alex Jordan, expressed confidence that the FDA would approve the request for the first two doses. However, the company has now decided to prioritize the additional data from the three-dose study, especially given the ongoing high rates of infection among young children.
Dr. Sarah Collins, who oversees the FDA’s vaccine safety department, emphasized that this pause should reassure parents that the regulatory process follows strict standards based on scientific evidence. While this delay is a setback for many families, the hope is that it ultimately leads to a safer and more effective vaccine for children.
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