23 November 2021 - - US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) and German biotechnology company BioNTech SE (NASDAQ: BNTX) have posted topline results from a longer-term analysis of the safety and efficacy of their COVID-19 vaccine in individuals 12 through 15 years of age, the companies said.

The updated findings from the companies' pivotal Phase 3 trial show that a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose.

The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no serious safety concerns observed in individuals with at least 6 months of safety follow-up after the second dose.

These longer-term follow-up data will form the basis for a planned supplemental Biologics License Application to be submitted to the FDA to expand approval of the vaccine for use in individuals 12 years and older.

The vaccine is currently available for individuals 12 through 15 years of age under Emergency Use Authorization, granted by the FDA in May 2021.

The companies also plan to submit these data to pursue regulatory approvals for this age group in other countries where emergency use authorizations or equivalents were initially granted.

The updated analysis of the Phase 3 clinical trial in individuals ages 12 through 15 years was conducted in accordance with guidance from the FDA for all companies investigating COVID-19 vaccines to review safety and efficacy at key milestones. Data through up to six months after the primary vaccination series are required for licensure.

These data were collected from November 2020 to September 2021.

Results from this analysis of 2,228 trial participants build upon and confirm previously released data and demonstrate strong protection against COVID-19.

From the 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection with SARS-CoV-2, 30 cases of COVID-19 were in the placebo group and 0 cases were in the Pfizer-BioNTech vaccine group, corresponding to vaccine efficacy of 100% (95% confidence interval [CI, 87.5, 100.0]).

Efficacy was consistently high across gender, race and ethnicity demographics, obesity and comorbidity status.

Pfizer and BioNTech plan to submit these data for scientific peer review for potential publication.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older.

The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b) (1) of the FD and C Act unless the declaration is terminated or authorization revoked sooner.