Children ages 12-15 years old can now be vaccinated after the U.S. Food and Drug Administration amended the Pfizer-BioNTech COVID-19 vaccine’s emergency use authorization. Vaccinations of youths could begin this week, officials said Monday, May 10.
In a recent study, researchers determined the Pfizer vaccine is 100 percent effective in protecting this age group against the disease.
The authorization “is a significant step in the fight against the COVID-19 pandemic,” said Dr. Jane Woodcock, acting FDA commissioner.
“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” she said during a Monday news conference. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all our COVID-19 vaccine emergency use authorizations.”
Dr. Jack Franklin, the Llano County local health authority, expressed in confidence in the safety of the vaccine.
“As far as safety is concerned, these vaccines have caused very few issues in the adults that have received them,” he said in an emailed statement to DailyTrib.com. “I do not anticipate any issues in the younger children.”
The Pfizer-BioNTech vaccine was previously authorized for use in ages 16 and older. The Moderna and Johnson & Johnson vaccines are cleared for use in ages 18 and older.
A study involving 1,005 youths ages 12-15 was done to determine the Pfizer vaccine’s effectiveness. A placebo was given to 978 young study subjects.
According to the study, no child who received both doses of the vaccine developed COVID-19. In the placebo group, 16 developed COVID-19 after contracting the virus that causes it. Reported side effects mirrored those felt by people 16 years and older who received the Pfizer vaccine: soreness at the injection site, tiredness, headache, fever, chills, muscle pain, and joint pain. These symptoms typically lasted 1-3 days.
According to the American Academy of Pediatrics, one out of every five new COVID-19 case in the United States is age 18 and younger.
On May 7, the Texas Department of State Health Services sent letters to 3,000 state pediatricians to encourage them to enroll in the state’s COVID-19 Vaccines for Children Program in anticipation of the FDA’s ruling.
“Vaccinating adolescents will bring us closer to ending the pandemic and getting back to normal,” said DSHS Commissioner Dr. John Hellerstedt in a news release. “Starting the enrollment process now will enable pediatric providers to start vaccinating their patients soon after the FDA expands the Pfizer vaccine’s (emergency use authorization).”
COVID-19 vaccinations are voluntary in Texas.
Franklin said he is considering a Llano County vaccine clinic for 12- to 15-year-olds in the coming weeks, similar to one recently held for 16- to 18-year-olds. The plan, however, involves a lot of moving parts, including waiting until afterschool activities have ended.
“We will need to either coordinate with Baylor Scott & White (Health), as they have the Pfizer vaccine, or the Texas (Military Department), which ran our previous vaccine clinic,” he added.