The Food and Drug Administration announced Wednesday that it has granted emergency use authorization for updated COVID-19 vaccine boosters for Americans up to age 5, and the Centers for Disease Control and Prevention officially approved its use. Boosters can be given at least two months after the last shot of the vaccine.
“The FDA’s authorization of updated COVID-19 (bivalent) vaccines for this younger age group, and CDC’s advice for use, are critical next steps in our nation’s vaccination program, one that has helped provide greater coverage rather than severe, killed illness from COVID-19,” the CDC director said. Dr. Rochelle Walensky, in a statement.
“Since children have returned to school in use and others are resuming their pre-pandemic behaviors and activities, there is an increased risk of exposure to the virus that causes COVID-19,” said Dr. Peter Marks, the FDA’s chief vaccine officer. official. He said in a statement.
The FDA said it knew about the immune response and protection of injections in children, so it received a reminder of previous formulas to make its decision.
These new bivalent injections are manufactured using almost the same procedure as Pfizer-BioNTech and Moderna, to add a component designed for the BA. 4 and BA. 5 variants.
“As families across the country participate in the fall festivities and plan for the upcoming holiday season, our goal is to provide school-age youth with greater coverage as opposed to the Omicron BA. 4/BA. 5 subvariants, which continue to account for more than 80% of instances in the United States,” said Pfizer’s CEO, Albert Bourla. in one sentence.
Pre-orders closed last week for new Pfizer and BioNTech vaccines formulated for this younger age group. A Pfizer spokesman said it has the capacity to ship up to 6 million doses for young people in the next week, after its latest quality checks.
A spokesman for the Department of Health and Human Services responded to a request for comment on the number of vaccines requested for Pfizer’s new vaccines for younger people.
Moderna’s recall for kids is just a smaller dose of the same formulas that’s already being distributed to older age groups and doesn’t want to be ordered in advance.
Compared to adults, a smaller proportion of young people will be eligible for the updated booster because, to begin with, fewer have received the vaccine.
Only about 60. 8% of teens 12 and older and 31. 5% of children five and older have gained even their first two doses of COVID vaccine, according to CDC data.
Marks said the virus “tends to be less severe in young people than in adults,” but cautioned that young people were still at risk of hospitalization or the long-term effects of the virus and would benefit from the shots.
The CDC recently estimated that about 86. 3% of young people in the U. S. are in the U. S. U. S. citizens have survived at least one COVID-19 infection, in an antibody survey on blood samples.
“We inspire parents to get vaccinated number one in the formative years and stay current with an updated booster dose when they are eligible,” Marks said.
Wednesday’s resolution leaves only children under five ineligible for the updated COVID booster.
Federal fitness officials have said in the past that they expect those vaccines to be available to the next youngest age group, up to 6 months, during the winter.
Moderna said in a Wednesday that it plans to complete its application for emergency use authorization at this younger age organization “later this year. “