The FDA’s Vaccine Advisory Committee is meeting this week to discuss what criteria they will ask for before authorizing COVID shots for children under 12
- The FDA’s Advisory Committee on Vaccines and Related Biologics Plans to Meet Thursday
- Members will debate the parameters for authorizing COVID-19 vaccines in children later this year
- This includes how many months of safety data are needed, how many children to enroll in studies and the level of efficacy required
- Parents and doctors have debated whether or not to vaccinate children as they account for only 0.1% of all COVID deaths
The US Food and Drug Administration’s (FDA) vaccine advisory committee is meeting this week to discuss rules for authorizing coronavirus vaccines in children under 12.
Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will not be asked to discuss or vote on specific immunizations.
However, Thursday’s meeting will discuss how many children should be enrolled in clinical trials, how many months of follow-up safety data are needed, and how much efficacy the vaccines should have.
It comes as several vaccine makers get clinical trials underway in children, hoping to have an injection approved by the end of the year.
Parents and doctors have debated whether or not to vaccinate young people as they account for only 0.1 percent of all COVID deaths.
The FDA’s Advisory Committee on Vaccines and Related Biologics plans to meet on Thursday to discuss the parameters for authorizing COVID-19 vaccines in children later this year. Pictured: FDA headquarters in White Oak, Maryland, August 2020
Parameters include how many months of safety data are needed, how many children to enroll in studies, and the level of efficacy required. Pictured: Eloise LaCour, three, will receive either a Pfizer COVID-19 vaccine or booster as part of Phase 1 clinical trials
“What I think we’re going to do with that meeting is we’re going to decide what the parameters are for approval — whether through emergency use authorization or licensing — for much younger age groups,” committee member Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said: CNN last week.
‘Do we want a two-month follow-up? Do we want a six-month follow-up? What level of efficacy are we looking for? we’re going to talk about those kinds of parameters.’
Children are often the last group tested in clinical trials because they are not just small adults.
Their bodies and immune systems behave differently, meaning they may have different treatment needs.
In addition, children may require different doses or needle sizes depending on their height, weight and age. Therefore, most children are not vaccinated until safety in the adult population is well documented.
according to briefing documents Published online ahead of the meeting, the FDA said it is usually acceptable to justify the approval of vaccines in children using so-called immunobridging studies.
These use data from both adult and pediatric studies to determine immunity.
For COVID-19 vaccines, the FDA said researchers don’t have to wait to see if children become infected, as has been done in studies of adults and teens.
Instead, the agency accepts data based on blood draws showing high levels of neutralizing antibodies after vaccination.
The FDA said manufacturers will have to make strong arguments to allow shots in children because of the low rate of serious illness and death from COVID-19 among young people.
Currently, only Pfizer-BioNTech’s COVID-19 vaccine is approved for Americans 12 years of age or older.
On Tuesday, the companies announced that they had begun late-stage clinical trials of their vaccine in children between the ages of five and 11.
Smaller doses will be tested on 4,500 participants will be enrolled at nearly 100 clinical trial sites in 26 states, Finland, Poland, Spain and the US
Meanwhile, Moderna Inc.’s CEO said the company plans to apply for emergency use authorization for children over 12 this month and expects data on children ages five to 11 by September or October.