Virginia Vaccine Use In Ages 12-15 Needs Final Federal Approval

VIRGINIA — Virginia is awaiting final federal approval for COVID-19 vaccine use in children 12 to 15 after the U.S. Food and Drug Administration granted emergency use authorization to the Pfizer vaccine for this age group Monday.

"While this is an exciting first step toward offering this vaccine and its protection to more than 400,000 Virginians, we must await additional federal approval before doing so," said Dr. Danny Avula, Virginia's state vaccination coordinator.

Before the Pfizer vaccine can be made available to children ages 12 to 15, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices must approve the vaccine for use in adolescents. Avula said the committee is expected to meet Wednesday.

"We are encouraged by the FDA’s action and its support of the vaccine’s use in those 12 and older," said Avula. "Virginia already has begun planning for the expansion of vaccine availability to this age group, including having discussions with local health districts, school systems, pediatricians and other physicians, and our pharmacy partners."

The FDA amended its emergency use authorization to the Pfizer vaccine first granted on Dec. 11, 2020 for ages 16 and older to add ages 12 to 15. The authorization followed a clinical trial of 2,260 participants aged 12 to 15 in the U.S. Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo and over half were followed for safety two months after the second dose. The vaccine was found to be 100 percent effective in preventing COVID-19, but there is limited data on whether the vaccine can prevent transmission of the virus and how long the vaccine offers protection. The FDA concluded the benefits of the vaccine outweigh the risks for the 12 to 15 age group.

Side effects during the clinical trial were consistent with those in clinical trials for people 16 and older. The most common side effects were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. These were more often reported after the second dose of the vaccine.

Gov. Ralph Northam urged families to talk to their health provider ahead of the CDC's likely approval for the ages 12 to 15 this week.