Emergency use approval for COVID vaccines by age group explained


Middle school student Elise Robinson receives her first coronavirus vaccination on Wednesday, May 12, 2021, in Decatur, Ga. Hundreds of children, ages 12 to 15, received the Pfizer vaccine at the DeKalb Pediatric Center, just days after it was approved for use within their age group. (AP Photo/Ron Harris)

(NEWS10)- The COVID-19 pandemic has set a new standard for how the U.S. responds to health crises with the quick approval of vaccines to drive new infections down. The move made some people question the safety of the vaccines.

The development of Messenger RNA (mRNA) technology to create the Pfizer and Moderna COVID vaccines has not been without controversy. Johnson & Johnson has also come under fire for the potential to cause a certain type of blood clot.

In a relatively short time, by Food and Drug Administration (FDA) standards, Pfizer’s COVID-19 vaccine was approved for emergency use in people 16 years or older followed by Moderna and Johnson & Johnson for use in adults older than 18.

Pfizer’s vaccine is now approved for emergency use among adolescents ages 12-15. Pfizer, Moderna, and Johnson & Johnson are all conducting clinical trials to expand the emergency use authorization to kids six months to 12 years old.

While the vaccine approval process is usually not front and center in the news, emergency approval of the COVID-19 vaccines was, whether it be from curiosity about the mRNA technology or the quickness of its emergency approval.

Those unfamiliar with the vaccine approval process or emergency use approval process may be questioning why the vaccines were approved for adults first before children.

The answer is simple.

When contacted for comment, the FDA told NEWS10 this is a normal procedure for vaccine approval.

“Vaccines intended for children are generally tested first in adults, with a step-down clinical development program to children and infants,” said Abby Capobianco, a press officer for the FDA.

Further explanation of clinical trial protocol for vaccines is on the FDA’s website. There are three phases with specific testing requirements. Pfizer included kids ages 12-15 in phase two and phase three of its clinical trials.

The FDA reaffirmed the safety of Pfizer’s vaccine for use in adolescents in a press release on May 10.

“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” said Acting FDA Commissioner, Dr. Janet Woodcock.

More information about the FDA’s vaccine development protocols can be found on its website.

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