Pittsburgh, Pennsylvania 2021-06-10 05:36:58 –
Washington (KDKA) – Today, Vaccine Advisors will meet with the Food and Drug Administration to discuss the next steps for immunizing children under the age of 12 against COVID-19.
The meeting is not about approving or voting for anything, nor is it talking about vaccines from a particular pharmaceutical company.
Instead, the goal is to understand how much information a company needs to provide when trying to give a child approval to vaccinate.
This conversation will focus on children under the age of 11 as children between the ages of 12 and 15 have already been vaccinated.
Members of the Food and Drug Administration committee are expected to discuss what is needed for both emergency use and full approval.
For Pfizer, enrollment for the 5-11 year old exam has just begun, and the FDA states that the sample size suitable for approval for children will be around 3,000.
The committee also talks about the potential and theoretical circumstances of children getting sick from the vaccine.
Here in Pittsburgh, UPMC says that having these conversations is a step in the right direction.
Dr. Richina Set, Associate Medical Director at Baylor College of Medicine, said: ..
Moderna has announced that it will have data for children up to the age of 5 by September or October. This is because COVID-19 does not cause as many problems in children as adults.
The FDA says that if these companies want to license the vaccine to their children, they must make a strong claim.
“What we’re trying to do at the conference is to determine the parameters for approval of a much younger age group, either through an emergency use authorization or a license,” said Dr. Paul Offit. It was. Director of the Vaccine Education Center at Philadelphia Children’s Hospital.
In Pennsylvania, health leaders say this is a good start for children to be vaccinated, but parents are still encouraged to pay attention to their children as the school is closed. I am.
So far, Pfizer is the only company seeking full approval for its vaccine.
Moderna says they plan to seek full approval soon.
Pfizer’s exam gives children two dozen for just one-third of the money given to teens and adults.
Again, there is no reason to believe that the FDA will approve a vaccine for children yet, but the meeting will discuss and decide on the answers still needed and the amount of information the company needs to provide for consideration. I will.
Vaccine Advisors To Meet With The FDA Regarding COVID-19 Vaccinations For Children Under 12 – CBS Pittsburgh Source link Vaccine Advisors To Meet With The FDA Regarding COVID-19 Vaccinations For Children Under 12 – CBS Pittsburgh