Today Pfizer-BioNTech released results from the first phase 2/3 trial of its COVID-19 mRNA vaccine on children ages 5 to 11, and said the vaccine was both safe and produced neutralizing antibodies to the novel coronavirus.
The trail considered a two-dose regimen of 10 micrograms (µg) administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older, Pfizer said in a press release. The study included 2,268 participants. The trial is also studying that dose in children ages 6 months to 11 years.
"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children," said Pfizer CEO Albert Bourla.
Pfizer said it would be submitting applications for use to regulatory bodies as soon as possible, and ideally would see vaccination begin in this age group by the beginning of winter.
Pediatric infection with COVID-19, though rarely serious, is on the rise in the United States as the age-group remains one of the last eligible to receive COVID-19 vaccine, schools have resumed in-person instruction, and the Delta (B1617.2) variant continues to spread in communities with low vaccination rates.
Currently, roughly one in five new COVID-19 cases are confirmed in children in the United States.
FDA likely to OK Pfizer booster this week
The Pfizer vaccine is currently the only vaccine approved by the Food and Drug Administration (FDA) for use in those 16 and older, and under emergency use authorization for those 12 through 15 years of age.
On Sep 17, a committee of advisers to the FDA unanimously said booster shots, or third doses of the vaccine, should be made available to Americans 65 and older and those at risk for severe disease from COVID-19.
The FDA is likely to authorize booster shots of the Pfizer COVID-19 vaccine this week for people ages 65 and older and those at high risk of getting severe COVID-19, the New York Times reports.
The likely outcome is different than the one touted by the Biden administration just last month, when it promised all Americans could be eligible for a booster dose of vaccine by today, Sep 20, if it had been at least 6 months from their second dose of vaccine.
In separate interviews on Fox News and CNN, National Institutes of Health Director Francis Collins, MD, and White House chief medical adviser Anthony Fauci, MD, said they expect to see broader approval of COVID-19 vaccine boosters in the coming weeks and months as the FDA and the Centers for Disease Control and Prevention (CDC) get more data on waning immunity.
Fauci told NBC's Meet the Press yesterday that data on booster shots for those who received the Moderna or Johnson & Johnson vaccines is a few weeks away from being reviewed by the FDA.
The CDC COVID Data Tracker shows 54.6% of Americans are fully vaccinated, and 63.8% have received at least one dose of COVID-19 vaccine.
Yesterday the United States reported 36,794 COVID-19 cases, and 291 deaths, according to the Johns Hopkins COVID-19 tracker.
The 7-day average of new daily cases is 147,355, with 2,012 daily deaths, according to the Washington Post tracker. COVID-19 deaths rose by 22% in the past week.