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Pfizer Covid-19 Vaccine Approved for 12-15 year-old’s

The US Food and Drug Administration approved the emergency use for Pfizer’s Covid-19 vaccine on Monday to people ages 12 to 15. This means everyone ages 12 and up are now eligible for the vaccine.

This is the first vaccine authorized for people under the age of 18. It was previously approved for people ages 16 and up. Covid-19 vaccines from Moderna and Johnson and Johnson are still authorized for people 18 and older.

Pfizer held a clinical trial that involved 2,260 12-to-15-year old’s which was then reviewed and approved by the FDA. The trial showed that the vaccine has 100% efficiency.

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“It was a relatively straightforward decision,” Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research, the arm of the FDA that regulates vaccines, told reporters Monday evening.

The FDA looked at the Pfizer safety and efficacy data. The agency also looked at the immune responses of some of the children who were vaccinated, and compared them to the immune responses of older teens and adults who got the shot.

“The response to the vaccine was excellent and in fact it was even better, really, in the younger age group than it was in the 16-25 age group,” Marks said.”The safety profile was very similar in 12-15-year-olds as in 16-25-year-olds.”

Expanding authorization to people 12 to 15 opens Covid-19 vaccination to another 5% of the US population, nearly 17 million more people. The expanded authorization means 85% of the US population is eligible to receive a Covid-19 vaccine.

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Pfizer said last week it expects to submit for emergency use authorization for its Covid-19 vaccine for children ages 2 to 11 years old in September. Its vaccine safety and efficacy study in children ages 6 months to 11 years old is ongoing.

The vaccine is expected to be available to the new age group as early as this week.

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