The FDA Vaccine Advisory Committee Will Meet This Week To Discuss What Criteria They Will Ask Before Authorizing COVID Shots For Children Under 12
- The FDA’s Advisory Committee on Vaccines and Related Biological Products is scheduled to meet on Thursday
- Members will discuss the parameters for authorizing COVID-19 vaccines in children by the end of the year
- This includes how many months of safety data are needed, how many children should be enrolled in the studies, and the level of efficacy needed
- Parents and doctors have debated whether or not to inoculate children because they represent only 0.1% of all deaths from COVID
The U.S. Food and Drug Administration (FDA) Vaccine Advisory Committee will meet this week to discuss the rules for authorizing coronavirus vaccines in children under the age of 12.
Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will not be asked to discuss specific vaccinations or cast any votes.
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 effective vaccines should be.
It comes as several vaccine manufacturers start clinical trials on children, hoping to get a vaccine approved by the end of the year.
Parents and doctors have debated whether or not to inoculate young people because they account for only 0.1 percent of all COVID deaths.
The FDA’s Advisory Committee on Vaccines and Related Biological Products is scheduled to meet Thursday to discuss parameters for authorizing COVID-19 vaccines in children later this year. Pictured: FDA headquarters in White Oak, Maryland, August 2020
The parameters include how many months of safety data are needed, how many children should be enrolled in the studies and the level of efficacy needed. Pictured: Eloise LaCour, three, receives 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 decide what the parameters are for approval – through emergency use authorization or licensing – for much younger age groups,” the committee member Dr Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNN last week.
‘Do we want a two-month follow-up? Do we want a six-month follow-up? What level of effectiveness are we looking for. it’s about the kind of parameters we’re going to talk about. ‘
Children are often the last group to be tested in clinical trials because they are not just little adults.
Their bodies and their immune systems behave differently, which means they may have different treatment needs.
Additionally, children may need different doses or needle sizes depending on their height, weight and age, which is why most children are only vaccinated after safety has been well documented in the adult population.
According to briefing documents posted online prior to the meeting, the FDA said it is usually acceptable to justify vaccine approval in children using so-called immunobridging studies.
These use data from both adult and child studies to determine immunity.
For COVID-19 vaccines, the FDA said researchers won’t have to wait and see if children get infected as has been done in adult and adolescent studies.
Instead, the agency will accept data based on blood draws showing high levels of post-vaccination neutralizing antibodies.
The FDA said manufacturers will need to file strong cases of authorization of strokes in children due to the low rates of serious illness and death from COVID-19 in young people.
Currently, only Pfizer-BioNTech’s COVID-19 vaccine is approved for Americans 12 years of age and older.
On Tuesday, the companies announced they had initiated late-stage clinical trials of their vaccine in children between the ages of five and 11.
Smaller doses will be tested at 4,500 participants will be enrolled in nearly 100 clinical trial centers in 26 states, Finland, Poland, Spain and the United States
Meanwhile, the managing director of Moderna Inc said the company plans to apply for emergency use authorization this month for children over the age of 12 and expects data on children between the ages of five and 11 years by September or October.