Baker urges speedy FDA review of Moderna COVID vaccine for kids
Governor says parents deserve ‘peace of mind’
GOV. CHARLIE BAKER wrote a letter to President Biden urging the US Food and Drug Administration to quickly consider approving Moderna’s application for a COVID-19 vaccine for children.
The state’s Republican governor joined Democratic Colorado Gov. Jared Polis in writing the letter, which was sent Thursday.
“Parents have been told, over and over again, that COVID-19 vaccines are on the horizon for their children,” the governors wrote. “They deserve the peace of mind that comes with being able to choose to protect their children through vaccination.”
Moderna submitted an application to the FDA on April 28 seeking emergency use authorization for a version of its vaccine for children aged five and under. Today, there is no approved COVID vaccine for that age group.
The agency has not yet reviewed Moderna’s submission. There has been some suggestion that the agency is waiting for a similar application from Pfizer. Pfizer tested a two-dose vaccine, but the dose did not provoke a sufficient immune response in children, so it is now testing a third dose.
Baker and Polis said the FDA should consider Moderna’s application now, without waiting for Pfizer’s. “Waiting to combine applications from Moderna and Pfizer in an effort to ‘prevent confusion’ with staggered approvals would be ill advised and ultimately prevent our nation’s progress in fighting this virus,” they wrote.
“Ensuring the vaccine is accessible to families with children under 5 will help keep our kids in the classroom and daycare, give parents more peace of mind, and help put the pandemic behind us,” the governors wrote, adding that many parents of young children “feel left behind, and are angry and dismayed” as life returns to normal with their children still unprotected.COVID-19 is generally less severe in children, but there are cases of serious illness.
The governors wrote that the FDA approved Pfizer’s application for a COVID vaccine for children ages five to 11 just three weeks after Pfizer made that request. “We urge the FDA to not delay in reviewing Moderna’s application and give the review of a lifesaving COVID-19 vaccine for our youngest children the attention, urgency and action it deserves,” they wrote.