Federal regulators authorize Pfizer COVID-19 vaccine for emergency use in kids 12 to 15


The U.S. Food and Drug Administration on Monday authorized the Pfizer COVID-19 vaccine for emergency use in kids 12 to 15 years old, paving a path for the country to move closer to vaccinating the majority of the population.

That opens up vaccine eligibility to 17 million adolescents, or 5.7 percent of the U.S. With schools across the country planning to return to hybrid or in-person learning by the fall, public health officials have pushed for immunizing youth to prevent further spread of the virus.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” said Dr. Janet Woodcock, acting FDA commissioner. “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.”

Researchers found that youth 12 to 15 experienced similar side effects to adults, including sore arms, fatigue, headache, chills and fever. Side effects were reported more often after the second Pfizer dose, according to the data.

Pfizer is now seeking full FDA approval for its COVID-19 vaccine, which would allow clinicians to administer the two-dose series even after the federal emergency is over.

Emergency use authorization can help vaccine sites use up their existing supply, too. As vaccine demand ebbs across the country, public health officials and hospitals are resorting to walk-in clinics and incentives to convince people to get the vaccine.

In Texas, where more than a quarter of the population is under 18, it could go a long way in boosting vaccination numbers. The vaccine manufacturer started a clinical trial for kids under 12 last month at Baylor College of Medicine.

More than 1.5 million adolescents between 11 and 17 years old have caught COVID-19 since the pandemic began in March 2020.

Pfizer officials said teen trial participants produced strong antibody responses.

Manufacturers developing drugs and vaccines first test their products on the general adult population. Researchers start separate trials on other parts of the population, such as teens, because of the higher chance of different immune responses compared to adults.

Moderna and Johnson & Johnson’s vaccines are not authorized for emergency use in teens yet. However, Moderna said its vaccine is 96 percent effective in teens so far.

gwendolyn.wu@chron.com

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