Pfizer and BioNTech Delay FDA Vaccination Request for Children Under 5

Pfizer and BioNTech revealed that a supplemental dose of their coronavirus vaccine restored complete protection
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Pfizer and BioNTech said on Friday that they are postponing their request for the FDA to approve the vaccine for children under the age of five until at least April, as they await evidence on the efficacy of a third dosage, CNBC reported.

The FDA has postponed a meeting set for Tuesday to review the children’s data.

The CDC was already building the framework for the vaccine’s distribution, advising state and local health officials that the first supplies may arrive as early as February 21.

According to a new blueprint covertly released Sunday, the CDC aims to roll out 10 million doses in three stages as soon as the Food and Drug Administration approves the lower-dose, 3-microgram Pfizer and BioNTech vaccine for children 6 months to 4 years old. According to the CDC, state and local health officials could begin preordering the first doses on Monday, and vaccination shipments would begin on Presidents Day.

Last Monday, Pfizer and BioNTech petitioned the FDA to extend the approval of their vaccination to most children under the age of five. The FDA had requested that the firms begin reporting data for the first two doses of the three-dose vaccination for children aged six months to four years.

Pfizer and BioNTech estimate that children under the age of five will require three doses to provide sufficient care against the omicron strain and future variants of the virus. Data on the third dose will be completed and submitted to the FDA in the months ahead, according to the firms.

After the first two doses failed to induce an acceptable immune response in children aged 2 to 4, Pfizer changed its clinical trial for younger children in December to include the third injection. In comparison to the 30 microgram injections permitted for adults, younger children will receive a three microgram dosage.

Children under the age of 5 are the final age group in the United States that are not vaccinated. Many parents and physicians are urging the FDA to approve the vaccination sooner rather than later, citing an increase in children hospitalized with Covid because of the omicron form.

Pfizer and BioNTech stated last week that their application for emergency authorization was in response to an “urgent public health need” for younger children due to an unprecedented epidemic of illness across the country caused by omicron.

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