JUST-IN: FDA Recommended Emergency Authorization For Moderna’s C-19 Vaccine In Kids 6 Months To 5 Years!

THIS WEDNESDAY, the US FDA advisory committee recommended authorization of Moderna experimental shot for children six months to 5 years.

They held a meeting of the VRBPAC to talk about the Moderna EUA request for a C-19 vaccine for children from six months to five years and Pfizer BioNTech EUA request for six months to 4 years.

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“All 21 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” in response to the question: Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine when administered as a 2-dose series (25 micrograms each dose) outweigh its risks for use in infants and children six months through 5 years of age?” CNN reported.

“The FDA, which typically follows the committee’s decisions, will now decide whether to authorize the vaccine for emergency use in this young age group,” the news site added.

FDA advisors voted 21-0 to authorize Moderna’s show for children from six months to five years of age. The Nordic countries (Germany, France, Denmark, Norway, Sweden, and Finland) paused the Moderna use for people under 30 because of the cardiovascular side effects.

The VAERS data showed 49,283 side effects were reported for aged 5-17 after getting the Moderna shot.

Below you can see the data about the febrile seizure based on the presentation today. The kid had a seizure linked with a fever six weeks later. It remained in the study and got another dose of the shot. The next three events happened from 10 to 66 days after the vaccination, and the investigators stated that they weren’t linked to the vaccination.

The clinical trials included 6,607 children from 6 months to 5 years. 5,011 took one dose of the shot, 1,911 participants were from 6 to 23 months, and 3,100 from 2 to 5 years.

The adverse reactions were collected seven days after the vaccination. All unsolicited events were captured for 28 days after each vaccination.

Below you can see the data for Solicited Local Reactions Within 7 Days After the first and the second dose of the shot.

Reactions were evaluated regarding age. Young kids’ side effects were fever, headache, fatigue, myalgia, arthralgia, nausea, vomiting, and chills.

For infants and toddlers, fever, irritability, crying, sleepiness, and loss of appetite.

Headache and fatigue- are the most common.

Source

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