White House chief medical advisor Dr. Antrhony Fauci on Wednesday said the Food and Drug Administration (FDA) could approve Pfizer and BioNTech’s vaccine for children under 5-years-old within the next month.
“My hope is that it’s going to be within the next month or so and not much later than that, but I can’t guarantee that because I cant outguess the FDA,” Fauci said during a virtual town hall meeting with Blue Star Families, a nonprofit group that supports military families.
Younger children will likely require three doses of the vaccine, Fauci said, as a two-dose course did not produce high levels of protection in trials.
The Center for Disease Control (CDC) recommends everyone ages 5 years and older get a COVID-19 vaccine to help protect against the virus but children under 5-years-old are the only age group that does not need to be vaccinated against COVID-19, the disease caused by the CCP (Chinese Communist Party) virus,
However, Pfizer announced in December that it plans to submit data to the FDA in the first half of 2022 if its three-dose study proves successful.
The company had previously trialed two shots in children between the ages of 2 and 5 but found that the vaccine didn’t produce a significant immune response among children within that age group. Pfizer and BioNTech said they would change their plans and test three doses of their COVID-19 vaccine on children in that age group rather than the usual two doses.
“Following a routine review by the external independent Data Monitoring Committee (DMC), the companies will amend the clinical study evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age,” the pharmaceutical giant said. “The study will now include evaluating a third dose of 3 microggams at least two months after the second dose of the two-dose series to provide high levels of protection in this young age group.”
Fauci said Wednesday that Pfizer revising the study to include three doses instead of two had delayed the company from submitting its data to the FDA and getting approval for the vaccine in young children.
The Epoch Times has contacted a Pfizer spokesperson for comment.
Pfizer says they see it as their “civic duty” to develop a vaccine for younger children due to the rise in hospitalizations with COVID-19 among the population.
According to data from the Center for Disease Control (CDC), roughly 909 children were hospitalized for COVID-19 between Jan. 11 and Jan. 17, an increase from 140 in late November. In total, from August 2020 to January 2022, 93,552 children have been hospitalized with Covid, according to the CDC.
However, Fauci has previously said that hospitals are overcounting COVID-19 cases in children because they are automatically tested when they are admitted, echoing a narrative some skeptics have been pushing for some time.
On Wednesday, Fauci again reiterated that children are much less likely to get severe symptoms from the virus which results in the need for hospitalization.
He told Blue Star Families, “It is true if you want to be perfectly frank and candid about the data, that a child who gets infected is much less likely to get a severe manifestation of COVID.” However, Fauci noted that the risk of young children contracting the virus is “not zero”, adding “we have plenty of children when you look at children’s hospitals throughout the country, who are severely ill with COVID-19 requiring hospitalization, some even dying.”
From The Epoch Times