FDA Authorizes Pfizer-BioNTech Vaccine for Adolescents Aged 12-15 Years

Strategic Insights -

The Food and Drug Administration has granted emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years, marking a significant milestone in the country's vaccination efforts. This expansion of vaccine eligibility offers protection against COVID-19 for millions of children during summer activities and raises hopes of a return to normalcy in schools in the fall. As part of this development, the Centers for Disease Control and Prevention (CDC) is expected to review the clinical trial data and provide the final go-ahead. Preparations are underway for some providers to begin vaccinating adolescents immediately, with President Joe Biden announcing that 20,000 pharmacy sites around the country will be ready to administer COVID-19 vaccines to adolescents.

The FDA's clearance comes as an amendment to the existing emergency use authorization for the Pfizer-BioNTech vaccine granted for adults late last year and expanded in late March to those as young as 16. However, a technical problem has emerged, with few pediatricians possessing ultra-cold freezers needed for long-term storage of the Pfizer-BioNTech vaccine. The Georgia Department of Public Health may be able to help split up the vaccine trays and distribute them between practices.

Local pediatricians, such as Dr. Hugo Scornik and Dr. Jane Wilkov, are preparing to vaccinate 12- to 15-year-olds. Decatur schools have announced plans to partner with a local pediatrician to vaccinate over 1,200 students, and parents have been signing up at a rapid rate. However, not all schools are seeing the same level of enthusiasm. In Early County, school Superintendent Bronwyn Ragan-Martin has reported that many high school students remain unvaccinated, and she expects similar disinterest in vaccinating 12- to 15-year-olds.

Key Takeaways

  • The FDA has authorized the use of the Pfizer-BioNTech vaccine in adolescents aged 12-15 years, expanding vaccine eligibility and raising hopes of a return to normalcy in schools in the fall.
  • The CDC is expected to review the clinical trial data and provide the final go-ahead for the vaccine's use in adolescents.
  • Preparations are underway for some providers to begin vaccinating adolescents immediately, with 20,000 pharmacy sites around the country ready to administer COVID-19 vaccines.
  • However, a technical problem has emerged, with few pediatricians possessing ultra-cold freezers needed for long-term storage of the Pfizer-BioNTech vaccine.
  • Decatur schools have announced plans to partner with a local pediatrician to vaccinate over 1,200 students, with parents signing up at a rapid rate.
  • However, not all schools are seeing the same level of enthusiasm, with some students and parents expressing concerns and hesitancy about vaccination.
  • President Joe Biden has announced plans to ship doses of the vaccine to pediatricians, allowing parents and their children to get vaccinated from a trusted provider.
  • The vaccine has been shown to be 100% effective in protecting children and has no serious side effects, according to clinical trials.

Statistics

  • 585,882 youths in Georgia fall within the 12- to 15-year-old age group, making up 6% of the population.
  • People 17 and under in Georgia make up 11% of confirmed cases, 2% of hospitalizations, and 0.05% of confirmed COVID-19 deaths.
  • The Pfizer-BioNTech vaccine has been granted emergency use authorization for use in people 16 and up, making it the first vaccine in the U.S. to be assessed for full regulatory approval.
  • Pfizer-BioNTech plans to file for full FDA approval of its vaccine for people age 16 and up in the coming months.
  • The company also plans to file in September for emergency use authorization for its COVID-19 vaccine in ages 2 to 11.

Sources

  • Axios-Ipsos poll, April 2021
  • Pfizer-BioNTech press release
  • FDA press release
  • CDC press release
  • Georgia Department of Public Health press release
  • Conyers pediatrician Dr. Hugo Scornik
  • Decatur schools interim Superintendent Maggie Fehrman
  • Early County school Superintendent Bronwyn Ragan-Martin
  • East Cobb mother of three Beth Warren
  • Database specialist John Perry