Pfizer-BioNTech submitted data from its vaccine trials among children ages 5 to 11 to the Food and Drug Administration for review on Tuesday.
Pfizer-BioNTech submitted vaccine data for children ages 5 to 11 to the Food and Drug Administration on Tuesday, spurring hope that a vaccine could be available for younger children by the end of October.
The data encompasses results from a clinical trial that included more than 2,000 children. The FDA is expected to review this data over the next few weeks before considering an Emergency Use Authorization (EUA).
In a joint statement, Pfizer and BioNTech said a formal submission request for an EUA is expected to follow in the coming weeks, and the organizations also plan to submit to the European Medicines Agency.
Dr. Anthony Fauci, the nation’s leading infectious disease expert, told MSNBC on Tuesday he expects FDA emergency approval to come in the next couple of weeks after scientists take time to examine the submitted data.
“The FDA takes very seriously the importance of getting vaccines, shown to be safe and effective in children,” Dr. Fauci said. “I would imagine in the next few weeks they will examine that data and hopefully give the O.K. so we can start vaccinating children hopefully by the end of October.”
In a statement, Pfizer said this latest vaccine trial demonstrated a “favorable safety profile and elicited robust neutralizing antibody responses” among children who received a two-dose regimen of the Pfizer vaccine. The latest clinical trial included 2,268 participants between the ages of 5 and 11.
At this point in time, the Pfizer vaccine is the only vaccine available for Americans under the age of 18. Moderna submitted data to the FDA in June to use its COVID-19 vaccine among 12 to 17-year-olds, and Johnson & Johnson is continuing clinical trials in younger individuals.
According to national reports, several FDA officials have said they expect the agency to grant an EUA in a matter of weeks — not months — following a review of the submitted data.
email: mhirneisen@newspress.com
