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Moderna says its Covid-19 vaccine was well-tolerated and generated robust immune response in children ages 6 to 11

<i>Jacob King/WPA Pool/Getty Images</i><br/>Interim results of a Phase 2/3 trial showed Moderna's Covid-19 vaccine was well-tolerated and generated a robust immune response in children ages 6 to 11.
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Jacob King/WPA Pool/Getty Images
Interim results of a Phase 2/3 trial showed Moderna's Covid-19 vaccine was well-tolerated and generated a robust immune response in children ages 6 to 11.

By Jamie Gumbrecht, CNN

Interim results of a Phase 2/3 trial showed Moderna’s Covid-19 vaccine was well-tolerated and generated a robust immune response in children ages 6 to 11, the company said Monday.

The trial included more than 4,700 participants between the ages of 6 and 11, and looked at two 50-microgram doses of Moderna’s vaccine given 28 days apart. This is smaller than the 100-microgram dose given to adults. The company compared the antibody response in younger children to the response in young adults in the company’s Phase 3 trial, and found a “strong immune response in this cohort of children one month after the second dose.”

The data have not yet been peer-reviewed or published.

The vaccine’s safety and tolerability were generally consistent with the Phase 3 study of the vaccine in adolescents and adults, the company said. “The majority of adverse events were mild or moderate in severity,” the company said in a news release. “The most common solicited adverse events were fatigue, headache, fever, and injection site pain.”

Moderna said it will submit these data to the US Food and Drug Administration, European Medicines Agency and other global regulators “in the near term.”

Moderna’s vaccine is currently authorized for people age 18 and older. The company requested emergency use authorization for its vaccine for people ages 12 to 17 in June, but FDA authorization has not yet been extended to that age group.

The company said it is continuing to monitor study participants, and to study younger age groups that are a part of the trial.

What’s next for vaccine for younger children

Younger children may be eligible to be vaccinated against Covid-19 within a couple weeks. Another vaccine company, Pfizer, has already sought emergency use authorization for its vaccine for people ages 5 to 11.

FDA’s independent vaccine advisory board will meet Tuesday to discuss whether Pfizer and BioNTech’s Covid-19 vaccine should be authorized for younger children. If authorized, it would become the first vaccine available for younger children.

Pfizer’s vaccine is already authorized for children 12 to 15 and is approved for people age 16 and older.

If the FDA committee votes in its favor, the FDA will then make the final decision about whether to authorize it.

Then, the US Centers for Disease Control and Prevention’s independent advisory committee meets November 2 and 3, and will vote on whether to recommend it. Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or modify the committee’s recommendation.

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Comments

6 Comments

  1. Yet children have not and are not dying of Covid…
    Despite that, we have thousands of cases of 12-25-year-olds who have permanent heart damage due to vaccinations from Covid. But their risk of dying from covid is less than .01%
    Let’s keep pushing the $$$$ for those vaccines.
    Let’s keep vaccinating with poison to cull the world.

    It’s time for the WORLD to wake up and see the writing in blood…there is an end game and its NOT for the “greater good”.

      1. Other than copy/pasting what you seem to think is a “reputable link”, what proof do YOU actually have that these negative effects are rare? You just blindly believe the lies and feed them to the public.. Gimme a break Barn.. BTW why do you keep blocking my other comments that basically said the same thing Im sayn here?

  2. Moderna says it is safe. Pfizer says it is safe. How about someone who doesn’t have a financial interest? Maybe on of your reporters could ask Central Oregon Pediatric Associates what the think about the shot for 5 -11 year olds.

    1. That sounds like a challenge Barney LOL! We dare you! If KTVZ actually did that they might be a tiny bit closer to being a non-biased news source… Dont hold your breath, they have an agenda that leans hard to the left

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