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Pfizer requests FDA clearance for vaccine in kids ages 12 to 15

By / Published on Friday, 09 Apr 2021 22:03 PM / Comments Off on Pfizer requests FDA clearance for vaccine in kids ages 12 to 15 / 31 views


Pfizer on Friday requested to expand use of its Covid-19 vaccine to adolescents ages 12 to 15.

The request asks the Food and Drug Administration to amend the emergency use authorization, which the FDA originally granted late last year for people ages 16 and up.

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Last week, Pfizer-BioNTech said its Phase 3 clinical trials showed its vaccine was safe and 100 percent effective in 12- to 15-year-olds, though the findings have not been peer-reviewed.

“The hope of starting to vaccinate this age group before the start of the next school year,” CEO Albert Bourla said in a statement when those results were released.

“Vaccinating our teenagers is the next step in seeing our way through the pandemic,” said Dr. Buddy Creech, a pediatric infectious disease expert at the Vanderbilt University Medical Center in Nashville, Tennessee.

“By extending the age groups that can receive vaccine, we can continue our efforts to protect those that are most vulnerable: older adults as well as adults and teenagers with underlying medical conditions,” said Creech, who was not involved in the Pfizer research.

The FDA’s review process will probably take several weeks, provided the data look good and are consistent with what was seen in adults, said Dr. Jesse Goodman, director of the Center on Medical Product Access, Safety and Stewardship at Georgetown University and former FDA chief scientist.

Norman Baylor, president and chief executive of Biologics Consulting and former director of the FDA’s Office of Vaccine Research and Review, agreed.

The FDA does not need to consult with its independent advisory panel before amending the Pfizer EUA, though they may decide to do so in the interest of full transparency, Baylor said.

One-third of Americans have received at least one dose of a Covid-19 vaccine, according to an NBC News database. In order to vaccinate the entire population, however, vaccines will have to be authorized for children.

Pfizer is also studying how well the vaccine works in children ages 6 months to 11 years old. The first doses in that trial were administered in March.

The Pfizer vaccine is the only one currently authorized for teens ages 16 and over; the other vaccines available in the U.S., from Moderna and Johnson & Johnson, are for people ages 18 and up. In December, Moderna began testing its mRNA vaccine in adolescents between 12 and 18 years old. It is also studying its vaccine in children ages six months to 11 years old.

Pfizer’s request comes as Covid-19 infections among younger teens and kids are driving outbreaks in some states. In Michigan, for example, case rates for children ages 10 to 19 are at an all-time high, according to the Michigan Department of Health and Human Services.

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