Pfizer/BioNTech to Seek Authorization for Vaccine in Young Teens After Positive Trial Results

With Pfizer/BioNTech’s COVID-19 vaccine demonstrating 100 percent efficacy in patients aged 12 to 15 years in their phase 3 trial, the companies will seek an amendment to their Emergency Use Authorization (EUA) and other regulatory authorizations to allow its use in that age group.

The companies said Wednesday that topline results from their phase 3 trial of adolescents, which encompassed 2,260 participants ages 12 to 15, showed their vaccine was 100 percent effective, elicited strong antibody responses and was well-tolerated in the age bracket. Specifically, while 18 COVID-19 cases were seen in the trial’s placebo group, none were observed in participants who received the vaccine.

The vaccine prompted more robust responses than those seen in an earlier analysis of participants aged 16 to 25 years, the drugmakers noted.

The positive data will be included in requests in the coming weeks to the FDA and other regulators for amended authorizations, according to Pfizer CEO Albert Bourla, who said the companies hope to obtain clearance for vaccinating 12- to 15-year-olds before the next school year begins.

“We share the urgency to expand the authorization of our vaccine to use in younger populations,” Bourla said.

According to Ugur Sahin, CEO and co-founder of BioNTech, the initial adolescent study results “suggest that children are particularly well-protected by vaccination,” a finding he called “very encouraging,” considering the increased spread of the UK viral variant in recent weeks.

Pfizer and BioNTech, who are also conducting a global phase 1/2/3 study of six-month to 11-year-old children, began vaccinating the five- to 11-year-old cohort last week and intend to begin dosing the two- to five-year-old participants next week.

The companies will also soon begin assessing a lyophilized, or freeze-dried, version of its COVID-19 vaccine in a 1,100-participant phase 3 trial of patients aged 18 to 55 years, according to the ClinicalTrials.gov website. The site lists the U.S. trial’s estimated start date as today and its estimated completion date as May 30. A freeze-dried vaccine would offer advantages over the one currently authorized, which requires ultra-cold shipping and storage temperatures, in that it could be stored at refrigerator temperatures, simplifying distribution and making storage easier.

Pfizer confirmed the trial and said it would share more details once it begins. — James Miessler