The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s two-dose vaccine for people ages 16 and up, making it the first Covid-19 vaccine to pass this final regulatory hurdle.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic,” acting FDA Commissioner Dr. Janet Woodcock said in a statement. “While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The FDA’s approval is not for people under the age of 16. It remains to be seen whether people hesitant to get vaccinated will now change their minds with full FDA approval.
“Full approval could not come at a more important time, as the highly contagious delta variant continues to drive up caseloads and deaths across the U.S.,” Dr. Richard Besser said in a statement. Besser is the Robert Wood Johnson Foundation president and CEO and a former acting director of the Centers for Disease Control and Prevention. “I am hopeful that full approval will address any remaining concerns and will move many people to a ‘yes’ on vaccination.”
Parents may still be questioning and wondering what this approval means for their kids under the age of 16.
While Mondays approval does not cover young people ages 12 to 15, they can still get the Pfizer vaccine through emergency use authorization.
No Covid vaccines have been authorized or approved for use in children under 12. That emergency use authorization for younger children is expected to come sometime in the fall or winter. Before that can happen, however, several steps need to be taken first, including the completion of clinical trials.
Meanwhile, Governor Phil Murphy made a major announcement earlier today. All state employees, all teachers and all school employees MUST be fully vaccinated by October 18 or face weekly, at a minimum, testing schedule of once or twice.