Pfizer Submits Initial Covid-19 Vaccine Data for Children Ages 5-11 to FDA, But Has Not Yet Request Authorization for Emergency Use

(CNN) – Pfizer and BioNTech said Tuesday they submitted data from the COVID-19 vaccine in children ages 5 to 11 to the US Food and Drug Administration for an initial review.

A formal filing requesting the emergency use authorization (US) for the vaccine is expected to take place in the coming weeks, the companies said in a statement Tuesday.

Submissions to the European Medicines Agency and other regulatory authorities are also planned, they said in a press release.

This is the first time data for a COVID-19 vaccine for younger children has been submitted to the FDA. The Pfizer / BioNTech vaccine is approved for people 16 years of age and older and has an EUA for people 12 to 15 years of age.

Last week, Pfizer released details of a phase 2/3 trial that showed its COVID-19 vaccine was safe and elicited a “robust” antibody response in children ages 5 to 11. The trial included 2,268 participants aged 5 to 11 years and used a two-dose regimen of the vaccine given 21 days apart. This trial used a 10-microgram dose, lower than the 30-microgram dose that has been used for those over 12 years of age.

Participants’ immune responses were measured by looking at levels of neutralizing antibodies in the blood and comparing those levels with a control group of people aged 16 to 25 who received a two-dose regimen with the largest dose of 30 micrograms. Pfizer said the levels compare well to those of older people who received the higher dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”

FDA officials have said that once the vaccine data for younger children is submitted, the agency could authorize a vaccine for younger children in a matter of weeks, not months, but it would depend on timing and quality. of the data provided. The FDA is expected to convene its vaccine advisers to make a recommendation on the vaccine prior to authorization. If approved by the FDA, a CDC vaccine advisory panel will meet to consider whether to recommend its use.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told MSNBC last week that there is a “reasonably good chance” that the vaccine will be available by the end of October.