“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer wrote on Twitter. The two drugmakers are also testing the vaccine in children ages 2 to 5 years old and children ages 6 months to 2 years, with data expected in the fourth quarter. he FDA has been completed. November pending approval from federal regulatory health
The first results from the highly anticipated trial studying the effectiveness and safety of the Pfizer and BioNTech COVID-19 vaccine for children ages 5 to 11 showed promising results.
The pharmaceutical companies said early results of their trial indicate the vaccine is safe for children and establishes a strong antibody response against the virus.
Giving a two-dose regimen of 10 μg (micrograms) administered 21 days apart for children between 5 and 11 years old was well tolerated, according to Pfizer and BioNTech. Side effects were also generally comparable to those of people between the ages of 16 and 25 years old who received the vaccine.
This trial used a smaller vaccine dosage, 10 micrograms, rather than the 30 microgram dose used for people 12 and older. The dosage was selected as the preferred dose for safety and effectiveness in young children.
News of the results come as pediatric cases of COVID-19 are increasing amid a nationwide surge of infections.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” said Albert Bourla, the chairman and CEO for Pfizer.
Pfizer Inc (PFE.N) and BioNTech SE have asked U.S. regulators to authorize emergency use of their COVID-19 vaccine for children ages 5 to 11, a group for whom no shot is currently allowed, Pfizer said on Thursday.
The U.S. Food and Drug Administration has set a date of Oct. 26 for its panel of outside advisers to meet and discuss the application, making it possible for children in this age group – numbering around 28 million – to begin receiving the two-dose Pfizer/BioNTech vaccine shortly afterward.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer wrote on Twitter.
The vaccine already has won U.S. emergency use authorization in teens ages 12 to 15 and is fully approved by regulators for people ages 16 and up.
The Pfizer/BioNTech vaccine is one of three in use in the United States, along with the two-dose Moderna (MRNA.O) vaccine and the single-dose Johnson & Johnson (JNJ.N) version, neither of which has won full regulatory approval for any age group.
A rapid authorization of the Pfizer/BioNTech vaccine in young kids could help mitigate a potential surge of cases in the coming weeks and months, with schools open nationwide and colder weather driving activities indoors. If given regulatory authorization, the two-dose Pfizer/BioNTech vaccine would become the first COVID-19 shot made available to children 5 to 11 in the United States.
The Pfizer/BioNTech vaccine has been shown to induce a strong immune response in 5 to 11-year-olds in a 2,268-participant clinical trial, the companies said on Sept. 20
The two drugmakers are also testing the vaccine in children ages 2 to 5 years old and children ages 6 months to 2 years, with data expected in the fourth quarter.
The vaccine could be ready for roll out as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on CNN.
Once the authorization is granted, Zients said: “We are ready. We have the supply. We’re working with states to set up convenient locations for parents and kids to get vaccinated including pediatricians’ offices and community sites.”
The United States leads the world in COVID-19 cases and deaths.
Children currently make up about 27% of all U.S. coronavirus cases and an increasing percentage of hospitalizations, according to the American Academy of Pediatrics. That reflects the high contagiousness of the coronavirus Delta variant among unvaccinated people.
While children are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations more at risk of severe illness.
A Pfizer spokesperson said the application to the FDA has been completed.