JUST IN: FDA Advisors Recommend Emergency Authorization for…

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.

🚨BREAKING: FDA Discusses one of the confirmed cases linked to side effects of mRNA products from clinical trials for babies + kids: a 1 yr old suffered multiple seizures but continued in the trial to receive a 2nd dose despite an investigator confirming it caused seizures. 🚩 pic.twitter.com/oCoVnKjCYN

— Lindsay (@TexasLindsay) June 15, 2022

Below is the data about the febrile seizure based on the presentation today. The child had a subsequent seizure associated with another fever approximately six weeks later. The child has remained in the study and received another dose of the vaccine. The other three events occurred 10 to 66 days after vaccination and were not considered related by the investigators, according to Rituparna Das, the Vice President of the Clinical Development COVID-19 Vaccines Moderna.

The clinical trials enrolled 6,607 individuals from 6 months to 5 years. 5,011 participants received one dose of Moderna vaccine (mRNA1273), 1,911 participants (6-23 months) and 3,100 (2-5 years).

Safety endpoints included solicited, local and systemic adverse reactions, which were collected seven days post-vaccination. All unsolicited events were captured for 28 days after each vaccination, a serious adverse events (SAE),Medically Attended AEs (MAAEs),and adverse events of special interests were followed throughout the entire study.

Below are the data for Solicited Local Reactions within 7 Days After Dose 1 and 2 for infants and toddlers (6-23 months) and young children (2-5 years). The figure below showed that pain was the most common event, with similar rates and severity following dose one and dose two. Looking at infants and toddlers, pain was again the most common local adverse reaction.

Reactions were evaluated according to age. Young children’s events (37 months to 5 years) included fever, headache, fatigue, myalgia, arthralgia, nausea, vomiting, and chills.

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