Fauci: Children aged 4 and younger will likely need three-dose COVID vaccine regimen

White House chief medical adviser Dr. Anthony Fauci said Wednesday that children 4-years-old and younger will likely need three shots of a COVID-19 vaccine to complete their regimen once the government grants approval for toddlers to be vaccinated.

Fauci informed reporters at the daily White House press briefing that clinical trials for Pfizer-BioNTech's vaccine are currently underway in children from 6 months to 2 years old and from 2 to 4 years old. But so far, these vaccine doses have not been shown to meet the same standards for effectiveness that the shots approved for adults have met.

"With regard to the clinical trials that are being done in children from 6 months to 24 months and from 24 months through 4 years: As you probably know, the original data that was done was determine if the doses that were given to those children reached what we call 'non-inferiority' with a more adult or adolescent population," Fauci said.

He continued: "And in the original data that was put forth, it looked like the dose and the regimen for the children who were 6 months to 24 months worked well, but it turned out that the other dose — namely the other group, from 24 months to 4 years — did not yet reach the level of non-inferiority. So, the studies are continued."

"It looks like it will be a three-dose regimen," Fauci said. "I don’t think we can predict when we will see an [emergency use authorization] with that, because the company is still putting the data before the FDA."

Fauci did not want to speak for the Food and Drug Administration as to when the vaccines would be approved for children aged 4 and younger.

"I think we just need to be patient and know one thing for sure that that’s why the system works," Fauci said. "Because the FDA is very scrupulous in their ability and in their effort to make sure that before something gets approved for people at any age — including and especially children, because of the special vulnerability of the children — that when these vaccines become available for children at those ages, we can be certain that they will be safe and that they will be effective."

Reporters also asked Fauci when the U.S. would be able to lift coronavirus restrictions and treat COVID-19 as an endemic virus, rather than a pandemic, similar to what the United Kingdom and other European countries are doing.

"We are not there right now," Fauci said, citing the latest number of COVID-19 cases, deaths, and hospitalizations provided by the Centers for Disease Control and Prevention. "As [CDC Director] Dr. Walensky said, when you have over 2,000 deaths, 150,000 hospitalizations, and you have people who are now getting infected to the tune of somewhere around 700,000 a day, we’re not there yet."

The CDC reported Wednesday that the current seven-day daily average of cases is about 692,400 cases per day, a decrease of about 6% over the previous week. The seven-day average of hospital admissions for COVID-19 is about 19,800 per day, a decline of 8% over last week.

The seven-day average daily deaths reported was about 2,200 per day, which is an increase of 21% over the previous week.

Fauci said that before the U.S. could consider COVID-19 endemic, there would needto be "sufficient control" over infections, cases, and deaths. He clarified he does not mean COVID-19 needs to be eradicated like smallpox, which he said was "unreasonable," nor does it need to be eliminated like polio or measles, "but a level of control that does not disrupt us in society, does not dominate our lives, does not prevent us to do the things that we generally do under normal existence."

"That would be a level of infection, but more importantly, concentrating on the severity of disease, hospitalizations, and deaths that fall within the category of what we generally accept — we don’t like it, but we accept it — with other respiratory viruses: RSV, para flu, and even influenza," Fauci said.

To get to that point, Fauci said the community needs to be immunized "either through infection plus boosting, either vaccine plus boosting, or just vaccine alone."

"Those are the things that will hopefully get us to the point when we have antivirals to be able to treat people who are at high risk — that we no longer are in a situation of threat — threat to our equanimity, threat to our economy, the threat to allow us to live a normal life," he said.

"We believe we can get there because we have the tools with vaccines, with boosts, with masks, with tests, and with antivirals. That’s what we talk about when we get to the point where we can, quote, 'live with the virus.' But, as Dr. Walensky emphasized, that is not where we are at this point. So, we still have a way to go."