The FDA’s Vaccines and Related Biological Products Advisory Committee is planning to meet on Thursday
Members will debate the parameters for authorizing COVID-19 vaccines in children later this year
This includes how many months of safety data is needed, how many children should be enrolled in trials, and the level of efficacy needed
Parents and doctors have been debating about whether or not to inoculate children because they make up just 0.1% of all COVID deaths
By Mary Kekatos Acting U.S. Health Editor For Dailymail.Com
Published: 12:32 EDT, 9 June 2021 | Updated: 18:28 EDT, 9 June 2021
The vaccine advisory committee of the U.S. Food and Drug Administration (FDA) will meet this week to discuss rules for authorizing coronavirus vaccines in kids under age 12.
Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will not be asked to discuss specific immunizations or cast any votes.
However, the meeting on Thursday will debate how many children should be enrolled in clinical trials, how many months of follow-up safety data is needed and how much efficacy the vaccines should have.
It comes as several vaccine makers get clinical trials in children underway, with the hopes of having a jab approved by the end of the year.
Parents and doctors have been debating about whether or not to inoculate youngsters because they make up just 0.1 percent of all COVID deaths.
The FDA’s Vaccines and Related Biological Products Advisory Committee is planning to meet on Thursday to debate the parameters for authorizing COVID-19 vaccines in children later this year. Pictured: FDA headquarters in White Oak, Maryland, August 2020
Paramaters include how many months of safety data is needed, how many children should be enrolled in trials, and the level of efficacy needed. Pictured: Eloise LaCour, three, gets either a Pfizer COVID-19 vaccine or a 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 – either through emergency use authorization or for licensure — for much younger age groups,’ committee member Dr Paul Offit, director of the Vaccine Education Center at the 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 efficacy are we looking for. it’s those sort of parameters we’ll be discussing.’
Children are often the last group to be tested during clinical trials because they are not merely little adults.
Their bodies and immune systems behave differently, meaning they might have different treatment needs.
What’s more, 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 published online ahead of 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 trials and kid trials to determine immunity.
For COVID-19 vaccines, the FDA said researchers will not need to wait and see if children become infected as was done in adult and teen trials.
Instead, the agency will accept data based on blood draws that show high levels of neutralizing antibodies post-vaccination.
The FDA said manufacturers will have to make strong cases of authorizing shots in children due to low rates of serious illness and death from COVID-19 in youngsters.
Currently, just Pfizer-BioNTech’s COVID-19 vaccine is approved for Americans aged 12 or older.
On Tuesday, the companies announced they had entered late-stage clinical trials of their vaccine in children between ages five and 11.
Smaller doses will be tested at 4,500 participants will be enrolled at nearly 100 clinical trial sites in 26 states, Finland, Poland, Spain and the U.S.
Meanwhile, Moderna Inc’s CEO said the company plans to apply for emergency use authorization this month for children above age 12 and expects data on kids ages five to 11 by September or October.
Post source: Daily mail
No related posts.