Moderna EUA request

News Update

Moderna files for U.S. authorization to use its COVID-19 vaccine in teens

By Gwen Baumgardner (Reporter), Ben Burke (Producer), Mack Pittman (Editor)

(Reuters) – Moderna Inc. said on Thursday it has filed for U.S. authorization to use its COVID-19 vaccine in adolescents aged 12 to 18, the latest company to seek approval to help expand the inoculation drive in the country.

Moderna‘s vaccine is already being used in the United States, the European Union and Canada for anyone over 18. The drugmaker has already submitted applications to the European and Canadian health regulators seeking authorization for the vaccine’s use in adolescents.

Moderna‘s two-shot vaccine last month was shown to be effective in adolescents aged 12-17 and showed no new or major safety problems in a clinical trial which evaluated the vaccine in 3,732 teenagers.

Vaccinating children has been considered key to achieving “herd immunity” and the U.S. has already authorized Pfizer and German partner BioNTech SE’s COVID-19 vaccine for use in children as young as 12.

Earlier this week, Pfizer announced plans to test its vaccine in a larger group of children under the age of 12.

The study will involve up to 4,500 kids in the U.S., Finland, Poland and Spain.

A Pfizer spokesperson said the company expects data from 5-11 year-olds in September.

Pfizer would likely ask regulators for emergency use authorization later that month.

Data for children two to five years old could arrive soon after that.

And, data from the six months to 2 year-olds is expected to arrive sometime in October or November.

NEW INFO ON THE COVID VACCINE FRONT!
MODERNA JUST FILED FOR EMERGENCY USE AUTHORIZATION OF ITS VACCINE…THIS TIME FOR KIDS AGED 12 TO 17.
THE VACCINE IS ALREADY USED ON ADULTS IN THE U-S — CANADA — AND EUROPE.
LAST MONTH — A CLINICAL TRIAL OF OVER 37-HUNDRED TEENS FOUND THE MODERNA VACCINE *WAS EFFECTIVE — AND SHOWED NO NEW OR MAJOR SAFETY ISSUES.
IF APPROVED — MODERNA WOULD JOIN PFIZER AS THE ONLY VACCINES VACCINATING U-S TEENS.
EARLIER THIS WEEK — PFIZER ANNOUNCED PLANS TO EXPAND VACCINE TRIALS IN CHILDREN…SOME AS YOUNG AS 6 MONTHS.

 

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(Reuters) – Moderna Inc. said on Thursday it has filed for U.S. authorization to use its COVID-19 vaccine in adolescents aged 12 to 18, the latest company to seek approval to help expand the inoculation drive in the country.

Moderna‘s vaccine is already being used in the United States, the European Union and Canada for anyone over 18. The drugmaker has already submitted applications to the European and Canadian health regulators seeking authorization for the vaccine’s use in adolescents.

Moderna‘s two-shot vaccine last month was shown to be effective in adolescents aged 12-17 and showed no new or major safety problems in a clinical trial which evaluated the vaccine in 3,732 teenagers.

Vaccinating children has been considered key to achieving “herd immunity” and the U.S. has already authorized Pfizer and German partner BioNTech SE’s COVID-19 vaccine for use in children as young as 12.

Earlier this week, Pfizer announced plans to test its vaccine in a larger group of children under the age of 12.

The study will involve up to 4,500 kids in the U.S., Finland, Poland and Spain.

A Pfizer spokesperson said the company expects data from 5-11 year-olds in September.

Pfizer would likely ask regulators for emergency use authorization later that month.

Data for children two to five years old could arrive soon after that.

And, data from the six months to 2 year-olds is expected to arrive sometime in October or November.