Moderna asks FDA for emergency approval to allow people as young as 12 to get vaccine
FILE – In this Jan. 9, 2021, file photo, vials of the Moderna COVID-19 vaccine are placed next to a loaded syringe in Throop, Pa. On Sunday, Jan. 17, 2021, California’s state epidemiologist Dr. Erica S. Pan recommended providers stop using lot 41L20A of the Moderna vaccine pending completion of an investigation by state officials, Moderna, the U.S. Centers for Disease Control and the federal Food and Drug Administration, because some people received medical treatment for possible severe allergic reactions. (Christopher Dolan/The Times-Tribune via AP, File)
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(NewsNation Now) — Vaccine producer Moderna on Thursday asked U.S. regulators to allow the emergency use of their vaccine in adolescents aged 12 to 17.
Moderna announced last month the results of its internal study saying its COVID-19 vaccine strongly protects kids as young as 12 from coronavirus.
Moderna studied more than 3,700 12- to 17-year-olds. The main goal was to produce an immune response on par with that seen in the company’s large, Phase 3 trial in adults, which was 94.1% effective at preventing COVID-19.
There were no COVID-19 diagnoses in those given two doses of the Moderna vaccine compared with four cases among kids given dummy shots. In a press release, the company also said the vaccine appeared 93% effective two weeks after the first dose.
Preliminary findings showed the vaccine triggered the same signs of immune protection in kids as it does in adults, and the same kind of temporary side effects such as sore arms, headache and fatigue.
“We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger age population. We remain committed to helping to end the COVID-19 pandemic.”
The Moderna vaccine was the second vaccine approved for adults in the U.S. and use a double-dose of messenger RNA technology to produce antibodies.
Most children with COVID-19 develop only mild symptoms or no symptoms. Yet children remain at risk of becoming seriously ill, and they can spread the virus. Widely vaccinating 12- to 18-year olds could allow schools and summer camps to relax masking and social distancing measures suggested by the Centers for Disease Control and Prevention.
Just last month, a CDC advisory panel voted to back the use of Pfizer’s COVID-19 vaccine for children aged 12 to 15.
Both Pfizer and Moderna have begun testing in even younger children, from age 11 down to 6-month-old babies. This testing is more complex: Teens receive the same dose as adults, but researchers are testing smaller doses in younger children. Experts hope to see some results in the fall.
Moderna has an agreement with the government to supply 300 million doses of its COVID-19 vaccine.
