White House Chief Medical Adviser Dr. Anthony Fauci on Wednesday said the Food and Drug Administration (FDA) could approve Pfizer and BioNTech’s vaccine for children under 5 years of age within the next month.
“I hope it happens within the next month or so and not much later, but I can’t guarantee it because I can’t outsmart the FDA,” Fauci said during a virtual town hall meeting with Blue Star Families. non-profit group that supports military families.
Young children are likely to need three doses of the vaccine, Fauci said, as a two-dose course does not provide a high level of protection in trials.
The Centers for Disease Control (CDC) recommends that everyone age 5 and older get the COVID-19 vaccine to help protect against the virus, but children under 5 are the only age group who do not need the COVID-19 vaccine. . 19, CCP (Chinese Communist Party) virus disease,
However, in December, Pfizer announced that it plans to submit data to the FDA in the first half of 2022 if its three-dose trial proves successful.
The company previously trialed two vaccines for children aged 2 to 5 years, but found that the vaccine did not elicit a significant immune response in children in that age group. Pfizer and BioNTech have said they will change their plans and test three doses of their COVID-19 vaccine in children in this age group instead of the usual two doses.
“After routine review by an external independent data monitoring committee (DMC), the companies will amend a clinical study evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months to 5 years. “The pharmaceutical giant said. “The study will now include an evaluation of a third dose of 3mcg at least two months after the second dose in a two-dose series to provide a high level of protection in this young age group.”
Fauci said Wednesday that Pfizer revised the study to include three doses instead of two, delaying the company in submitting data to the FDA and getting approval for a vaccine for young children.
The Epoch Times has contacted a Pfizer representative for comment.
Pfizer says it considers it a “civic duty” to develop a vaccine for young children due to rising numbers of COVID-19 hospitalizations in the population.
According to the Centers for Disease Control (CDC), approximately 909 children were hospitalized with COVID-19 between January 11 and 17, up from 140 at the end of November. A total of 93,552 children were hospitalized with Covid from August 2020 to January 2022, according to the CDC.
However, Fauci has previously said that hospitals are inflating the number of COVID-19 cases in children because they are automatically tested upon admission, echoing a notion that some skeptics have been promoting for some time.
On Wednesday, Fauci reaffirmed that children are much less likely to get severe symptoms from the virus, resulting in the need for hospitalization.
He told Blue Star Families: “It’s true, if you want to be completely frank and candid about the data, that an infected child is much less likely to get serious manifestations of COVID.” However, Fauci noted that the risk of exposure to the virus in young children is “not zero”, adding that “we have a lot of children, if you look at children’s hospitals around the country, who are seriously ill with COVID-19, require hospitalization, some even die.” “.