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    BNTX   US09075V1026

BIONTECH SE

(BNTX)
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Pfizer Canada ULC and BioNTech SE Announce Health Canada Grants Full Approval for COMIRNATY« to Prevent COVID-19 in Individuals 12 Years of Age and Older

09/16/2021 | 11:46am EDT

Pfizer Canada ULC and BioNTech SE announced that Health Canada has granted full approval (Notice of Compliance or NOC) for COMIRNATY® to prevent COVID-19 in individuals 12 years of age and older. The vaccine was initially authorized for use in Canada under an interim order authorization on December 9, 2020 and has been referred to as the Pfizer-BioNTech COVID-19 Vaccine. The authorization permitted essential rollout of vaccine doses across Canada to help provide protection during the COVID-19 pandemic, based on preclinical and clinical data, including initial data from the phase 3 clinical trial. Although the vaccine's brand name will be COMIRNATY following this approval, Canada will continue to receive vials of the vaccine labeled as Pfizer-BioNTech COVID-19 Vaccine. The formulation for Pfizer-BioNTech COVID-19 Vaccine is the same formulation as COMIRNATY and they are considered interchangeable by Health Canada to provide the COVID-19 vaccination series. Given the current ongoing pandemic, a gradual transition to new labeling with the COMIRNATY brand name will occur at a later date. For this full approval (Notice of Compliance; NOC) of the new drug submission (NDS), Pfizer and BioNTech submitted a comprehensive data package that included longer-term follow-up data from the phase 3 trial, where the vaccine's efficacy and safety profile were observed up to six months after the second dose. The NDS package also included the manufacturing and facilities data required for licensure.


ę S&P Capital IQ 2021
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Analyst Recommendations on BIONTECH SE
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Financials
Sales 2021 16 703 M 19 377 M 19 377 M
Net income 2021 8 797 M 10 205 M 10 205 M
Net cash 2021 8 661 M 10 048 M 10 048 M
P/E ratio 2021 7,23x
Yield 2021 -
Capitalization 61 368 M 71 229 M 71 192 M
EV / Sales 2021 3,16x
EV / Sales 2022 2,54x
Nbr of Employees 2 500
Free-Float 87,3%
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Technical analysis trends BIONTECH SE
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Mean consensus HOLD
Number of Analysts 15
Last Close Price 254,09 €
Average target price 254,59 €
Spread / Average Target 0,20%
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Managers and Directors
Ugur Sahin Chief Executive Officer
Jens Holstein Chief Financial Officer
Helmut Jeggle Chairman-Supervisory Board
Ízlem TŘreci Chief Medical Officer
Sierk P÷tting Chief Operating Officer
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