Pfizer asks FDA for emergency clearance for its Covid vaccine for children aged 5 to 11

Pfizer and BioNTech announced Thursday that they have submitted an emergency request to the United States Food and Drug Administration for authorization of the companies’ two-dose Covid-19 vaccine in children aged 5 to 11.

“With new cases in children in the United States continuing to be at a high level, this submission is an important step in our continued efforts against # COVID19,” Pfizer tweeted. “We are committed to working with the FDA with the ultimate goal of helping protect children from this serious public health threat.”

An FDA advisory committee plans to meet to discuss the authorization on October 26.

The companies said last month that the vaccine was safe for children aged 5 to 11 and showed a “robust” antibody response based on data collected in a trial involving more than 2,000 children.

During the trial, children received two lower doses than those given to people 12 years of age and older. Pfizer and BioNTech said the injections produced antibody responses and side effects comparable to those seen in a similar study of people aged 16 to 25 who received the full dose of the vaccine.

Pfizer first applied for emergency use authorization for its adult vaccine in November. The FDA in August granted full vaccine approval for people aged 16 and older, becoming the first coronavirus vaccine to pass this final regulatory hurdle.

The vaccine is currently being given to children 12 to 15 years of age under the Emergency Use Clearance from the FDA.

According to data from the Centers for Disease Control and Prevention, more than 186 million Americans have been fully immunized.

Pfizer’s injections are one of three that are used in the United States, along with Moderna’s two-dose vaccine and Johnson & Johnson’s single-shot vaccine. Moderna and Johnson & Johnson are still in the research phase of the images used for children aged 5 to 11.

It is a story of rupture; come back for updates.