When can children under 12 get vaccinated against COVID-19? CDC Director Walensky has an answer

“We are waiting for companies to submit the data to the FDA,” said Walensky, referring to vaccine makers Pfizer / BioNTech
PFE,
-2.23%

and Moderna
MRNA,
-6.67%.
“We expect this to happen in the fall. We’ll be looking at this data from the FDA, CDC, with the urgency we all feel to get our kids vaccinated, and hopefully by the end of the year.

Walensky’s comments came as one million children in public schools in New York City, the country’s largest school system, were returning to school full-time in person for the first time in 18 months. The question of when young children can be vaccinated has been a priority for many parents, especially as the delta variant has fueled an increase in COVID-19 cases over the summer that seems to show signs of spiking in some states, but not the others.

Currently, the only vaccine available for children is the Pfizer and BioNTech vaccine, which the United States Food and Drug Administration cleared for emergency use on children ages 12 to 15 in May. Moderna is studying the effects of its vaccine on young children and said in July that he hopes he has enough data seek FDA clearance by the end of this year or early 2022.

here is a timeline when clinical data and emergency use authorizations are expected from various vaccine manufacturers.

‘Today’ co-host Savannah Guthrie asked Walensky why it took longer for a vaccine for young children to become available, given that vaccines for adults were available nine months after the day. widespread onset of the pandemic in the United States

“We want to go fast, we plan to go fast, but we also want to have the efficacy data and the safety data that the FDA will need so that we know… this is the right thing for children,” Walensky said.

Others have been more optimistic about when vaccines will be available for children under 12. Former FDA Director Scott Gottlieb, who sits on Pfizer’s board of directors, recently said he expects the FDA to spend around four to six weeks reviewing Pfizer’s clinical data on the youth. children, which the company says should be available by the end of September.

In the “best scenario”, Gottlieb told CBS “Face the Nation” Sunday, “you could potentially have a vaccine available for children between the ages of five and eleven by Halloween.”

Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and senior medical adviser to President Joe Biden, also said he expects young children to be able to get vaccinated. in October or early November.

Fauci also recently stated that a vaccine mandate for schoolchildren is a “good idea”. Some public school systems, including New York City, require vaccines for teachers and other staff.

The FDA said on September 10 that it would “follow the science” when evaluating vaccines for young children.

“It is important for the public to recognize that as young children grow and develop further, it is essential that extensive and robust clinical trials of adequate size be conducted to assess the safety and immune response to a COVID vaccine.” 19 in this population, ”Acting FDA Commissioner Janet Woodcock MD and Peter Marks, MD, Ph.D., director of the Center for Biologics Research and Evaluation, FDA, said in a joint statement.

They added: “Children are not little adults – and issues that can be addressed in pediatric vaccine trials may include whether there is a need for different doses or different strength formulations of vaccines already in use for them. adults. “