Pfizer delays its application to the FDA to expand its Covid vaccine to kids under 5
Brayden, 3 years old, plays with Maggie Kail, CCLS, child life specialist while being treated by coronavirus (COVID-19), at the Children’s Hospital of Georgia. This was January 14, 20,22.
Hannah Beier | Reuters
Pfizer and BioNTech announced Friday they would delay their request that the Food and Drug Administration approve the vaccine for kids under 5 because they are waiting for data regarding the effectiveness of a third dose.
Pfizer released a statement saying that cases continue to accrue according to their study protocol. More data is being collected because infection rates and illnesses remain high in this age group, particularly due to Omicron surge.
FDA announced that it was postponing Tuesday’s meeting, which had been scheduled to examine the data of children.
Already, the Centers for Disease Control and Prevention had laid the foundation for the distribution of the shots. They informed state and local officials that they would receive the first shipment by February 21.
The CDC intends to distribute 10,000,000 doses of the 3-microgram lower-dosedrug regimen in 3 phases once the Food and Drug Administration approves it. Pfizer and BioNTech shot for children 6 months to 4 years old, according to a new planning document quietly issued Sunday. State local health officials could start preordering the first doses Monday and will start receiving vaccine shipments on Presidents Day, according to the CDC.
Pfizer BioNTech asked the FDA last week to expand the authorization for their vaccine to most kids under 5. FDA requested that the vaccine be approved for two doses in the initial three-dose vaccination for infants aged 6 months to 4 years.
Pfizer, BioNTech and others expect that children under five will need to be given three doses in order to provide the best protection against future strains and the omicron Covid variant. In the next few months, the companies will submit data about the third dose to FDA.
Pfizer changed its clinical trial to test a third shot in December for the study of younger children after two previous doses failed to create an immune response in kids aged 2 to 4. The three-microgram dose will be smaller than the 30-microgram adult shots.
The last group of children under 5 years old in America that’s not eligible for vaccines is the child below 5. Many parents have been pressing the FDA to approve the vaccine faster than the omicron version. This has led to an increase of Covid-infected children.
BioNTech and Pfizer said that they applied for an emergency approval last week in an effort to address an “urgent health need” for children younger than five years old, as the outbreak of omicrons has created an unimaginable wave of infections across the nation.