The FDA’s Vaccines & Related Biological Products Advisory Committee (VRBPAC) is meeting today to discuss emergency use authorization for the mRNA COVID-19 shots for children ages 6 months to 5 years.
🚨LIVE NOW: FDA Panel on EUA products for infants and toddlers ages 6 mo.-4 years old happening now. https://t.co/D7S1SwJ8UE
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In the meeting, the FDA discussed the case of a 17-month-old female infant who suffered multiple seizures in the clinical trials.
Dr. Jacqueline Miller, Moderna’s Senior Vice President, Therapeutic Area Head, Infectious Diseases, described the case.
She experienced a seizure two days after the 1st dose, and her maximum temperature was 103.1 degrees.
After the initial fever, she developed a rash across her body, and her temperature rose to 104 degrees on day two.
At the time of the seizure, she was noted to be limp with no purposeful movements.
And the seizure was not observed by medical professionals.
She had a second seizure approximately six weeks later, with other symptoms of fever and respiratory infection.
Despite these adverse reactions to the first dose, the infant remained in the clinical trial and received a 2nd dose of the experimental mRNA COVID-19 shot.
WATCH:
🚨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
— Te𝕏asLindsay™ (@TexasLindsay_) June 15, 2022
Dr. Jacqueline Miller expressed this view moments later:
— Te𝕏asLindsay™ (@TexasLindsay_) June 15, 2022
“At this moment, our view is it’s just critically important to start vaccinating babies so that they can start benefitting from the same protection as other age cohorts,” she said.
Watch the livestream for the VRBPAC meeting HERE:
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