FDA Advisors Recommend Emergency Authorization for Moderna’s Covid-19 Shot in Young Kids 6 Months to 5 Years of Age
The U.S. Food and Drug advisory committee on Wednesday voted in favor of authorizing the use of Moderna’s experimental Covid-19 vaccine for children 6 months through 5 years of age.
The U.S. Food and Drug Administration (FDA) conducted a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the Moderna EUA request for a COVID-19 vaccine for 6 months through 5 years of age and Pfizer-BioNTech EUA request for 6 months through 4 years of age.
The recommendation was the first of two votes called by the FDA vaccine advisors. Later this afternoon, the same committee will also evaluate the experimental Pfizer Covid-19 vaccine for children ages 6 months to 4 years.
“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 6 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 vaccine for children 6 months old to 5 years old. The Nordic countries (Germany, France, Denmark, Norway, Sweden, and Finland) all paused the use of Moderna for people under 30 due to concerns around rare cardiovascular side effects. But in the US, the FDA advisors believed the benefits of experimental shot outweigh its risks for use in infants and children 6 months through 5 years.
According to the Vaccine Adverse Events Reporting System (VAERS) data, 49,283 adverse events were reported for ages 5-17 through June 3, 2022, after receiving the Moderna vaccine.
The FDA discussed one of the confirmed cases linked to the side effects of mRNA products from clinical trials for babies. A one-year-old baby suffered multiple seizures but continued in the trial to receive the 2nd dose.
https://www.thegatewaypundit.com/2022/06/just-fda-advisors-recommend-emergency-authorization-modernas-covid-19-shot-young-kids-6-months-5-years-age/
https://www.fda.gov/media/159257/download