The Food and Drug Administration's vaccine advisers gave a thumbs-up to vaccines from Moderna and Pfizer for children under 5 years of age. The outside experts voted unanimously that the benefits of the shots outweigh any risks for children under 5. That's roughly 18 million youngsters. The Centers for Disease Control and Prevention will decide on a formal recommendation after its own advisers meet Saturday. If the CDC signs off, shots could be available as soon as next week.
Christina Vert, US FDA Designated Federal Officer: “And we have here 21 yes votes. This is a unanimous vote and there are zero no votes and zero abstain.”
An expert panel convened by the U.S. Food and Drug Administration voted unanimously on June 15 to authorize the use of the Moderna and Pfizer-BNT COVID-19 vaccines on children under the age of five. A representative from Pfizer said that a 3-microgram dosage offered 80 percent protection for children aged six months to five years. Fever and fatigue were the most common side effects. Meanwhile, the Moderna vaccine is one-fourth the dosage of the adult vaccine.
Dr. Jacqueline Miller, Moderna Executive: “As children under four have had the greatest increase in their risk of hospitalization due to COVID-19 during the Omicron surge, initiating this vaccination series now is vital to start protecting children this summer.”
The U.S. has around 18 million children under the age of five. The U.S.' Centers for Disease Control and Prevention will make the final decision. The vaccination of this age group at pharmacies or medical institutions may begin as early as June 21. However, experts warn that two doses of the Moderna vaccine only provide about 40 percent protection, so both vaccine producers are studying the effectiveness of a third dose.
Dr. Doran Fink, US FDA Expert Panel Member: “We do feel very confident that the evidentiary standard for benefit for EUA has been met here. But I think, you know, in terms of what the efficacy is after a third dose and whether an additional dose beyond that would be needed is going to require a little bit more data.”
On June 15, Chief Medical Advisor to the President of the United States Anthony Fauci tested positive for COVID-19. A statement issued by the National Institutes of Health said the 81-year-old Fauci, who is fully vaccinated and has been boosted twice, tested positive in a rapid test and has mild symptoms. He has not been in contact with U.S. President Joe Biden or other senior officials recently.