CDC Backs FDA's Decision to Reduce Time Between Primary Series and Booster Dose of Pfizer's Covid-19 Vaccine

CNN

The US Food and Drug Administration on Monday expanded the emergency use authorization for Pfizer's Covid-19 vaccine boosters to children ages 12 to 15.

The agency also shortened the time needed before receiving a booster shot from at least six months after completion of the initial series to at least five months, for everyone 12 and older.

"Throughout the pandemic, as the virus that causes Covid-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind," FDA Acting Commissioner Dr. Janet Woodcock said in a statement. "With the current wave of the omicron variant, it's critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight Covid-19."

The US Centers for Disease Control and Prevention on Tuesday backed the FDA's decision to shorten the interval between an initial series of Pfizer's vaccine and a booster shot, but plans to meet with their vaccine advisory board on Wednesday to discuss the issue of expanding booster eligibility to adolescents.

The FDA updated the emergency use authorization after review of real-world data from Israel that showed there were "no new safety concerns" in expanding boosters to adolescents or shortening the timeframe between the initial series and a booster dose.

Specifically, the data showed there were no new cases of myocarditis or pericarditis reported among adolescents who received a booster, according to a statement from the FDA.

The rapid rise in cases across the country made it clear that the benefits of expanding booster eligibility clearly outweighed the risks, FDA leaders said on a call with reporters Monday...

...The FDA on Monday also authorized a third dose as part of the primary series for certain immunocompromised children ages 5 to 11, including those who have received an organ transplant

The CDC agreed with the FDA on this, consistent with their recommendation for adults who are moderately or severely immunocompromised...

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