FDA Expands Use of Pfizer-BioNTech Vaccine Amid Surge of COVID Cases

Washington, DC–Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to:

  • Expand the use of a single booster dose to include use in individuals 12 through 15 years of age.
  • Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.
  • Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.

According to FDA, the most commonly reported side effects by individuals who received a booster dose or an additional dose as part of a primary series were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills.

Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the second dose of a two-dose primary series.

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