FDA works ’around the clock’ on child vax
Parents anxiously wait for updates
Many parents are anxiously awaiting the moment they can vaccinate their young children against coronavirus, placing mounting pressure on the Food and Drug Administration, which said it is working “around the clock” on the process.
“Just like you, we are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible. We have to let the science and data guide us. The FDA is working around the clock to support the process for making
COVID-19 vaccines available for children,” Dr. Janet Woodcock, acting FDA commissioner, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement on Friday.
Children under age 12 are not currently eligible for vaccination, but clinical trials are well underway.
“It’s important that the public recognize that, because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response to a COVID-19 vaccine in this population,” Woodcock and Marks wrote.
Clinical trials in young kids will include a twomonth follow-up period before vaccine manufacturers do a complete analysis of the data from the studies to understand safety and efficacy.
After that, companies can request emergency use authorization from the FDA, which the agency would review over a a matter of weeks.
Dr. Alysse Wurcel, infectious disease physician at Tufts Medical Center, has two daughters, ages 5 and 7.
She said, “I’m anxiously awaiting. I will get on that list as soon as possible.”
She added that getting her children vaccinated is “an absolute necessity for the safety of our family and for the safety of our community.”
Wurcel said it’s important that parents are patient and wait for the FDA to clear the vaccines in kids.
“There’s a process in place for a reason. I have faith there are very smart people looking over this,” Wurcel told the Herald, adding, “The last thing we want is for someone to rush through approval and for something to come out,” such as an adverse effect or new side effect.
Woodcock and Marks advised parents against asking their doctor to just go ahead and vaccinate their children with the current shots.
“Children are not small adults — issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults,” read the statement.
In the meantime, adults who interact closely with kids under 12 should get vaccinated and wear a mask, according to the FDA officials.