Pfizer DELAYS FDA Application for COVID-19 Vaccine for Children Ages Six Months to Four Years

Pfizer DELAYS FDA Application for COVID-19 Vaccine for Children Ages Six Months to Four Years

TIME: Pfizer DELAYS FDA Application for COVID-19 Vaccine for Children Ages Six Months to Four Years to Gather More Data on Impact of Second and Third Doses

  • The Pfizer-BioNTech vaccine for children aged six months to four years has been delayed.
  • The company notified the FDA of the additional data, the agency said on Friday, spurring the decision.

On Friday, the Food and Drug Administration announced that the application for the Pfizer-BioNTech vaccine for children aged six months to four years has been shelved.

The company applied for an emergency use permit on February 1. It included data on the first two doses of a three-dose vaccine kit for young children. An FDA advisory committee meeting to discuss the merits of the approval was scheduled for Feb. 15.

The data for the third shot was due later, and the New York company planned to apply for a third shot permit at another time.

The FDA said Friday that Pfizer has notified it that the company has new vaccine data that merit inclusion in its decision-making process.

As a result, the February 15 meeting was rescheduled to an unknown date.

Despite regulators pushing to expand vaccination eligibility to include young children, the controversial move would make the US the only country to vaccinate children under one year of age against Covid.

Despite regulators pushing to expand vaccination eligibility to include young children, the controversial move would make the US the only country to vaccinate children under one year of age against Covid.

Pfizer DELAYS FDA Application for COVID-19 Vaccine for Children Ages Six Months to Four Years

‘ [FDA] Pfizer is advised that new information has recently emerged regarding its request for an emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine in children 6 months to 4 years of age,” the agency said in a statement.

“Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of the third dose should be considered as part of our decision on a possible authorization.”

A new time for the Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting has not yet been scheduled.

Unlike the two-dose vaccine used for people five years of age and older, the Pfizer vaccine for children six months to five years of age consists of three shots.

The shot is also significantly smaller, at just three micrograms, compared to a ten microgram injection for children 5 to 12 years old and a 30 microgram injection for people 12 and older.

Pfizer originally planned to make only two smaller doses for younger children, although plans had to be changed in December after children aged three and four showed poor antibody responses to the first two smaller doses.

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