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    BNTX   US09075V1026

BIONTECH SE

(BNTX)
  Report
Delayed Quote. Delayed Nasdaq - 12/03 04:00:00 pm
344.06 USD   +3.17%
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Press Release : FDA Advisory Committee Votes in Favor of Granting Emergency Use Authorization for the Pfizer-BioNTech Covid-19 Vaccine in Children 5 to <12 Years

10/26/2021 | 04:19pm EST
   -- Committee reviewed clinical data showing a favorable safety profile and 
      high vaccine efficacy of 90.7% in children 5 to <12 years of age during a 
      period when Delta was the prevalent strain 
 
   -- 10-ug dose level used in the trial for children 5 to <12 years of age was 
      carefully selected based on safety, tolerability and immunogenicity data 
 
   -- If Emergency Use Authorization is granted, the Pfizer-BioNTech COVID-19 
      Vaccine will be the first COVID-19 vaccine authorized in the U.S. for use 
      in this age group 

NEW YORK and MAINZ, GERMANY, OCTOBER 26, 2021 -- https://www.globenewswire.com/Tracker?data=DxqlTOxVHLM8uAn0U9bMbayv51jXkU1v0lB4M9enTZ7yHI5i0J3BtocoxnjkqHooqDL0SY_a5-FBvZww1INAZQ== Pfizer Inc. (NYSE: PFE) and https://www.globenewswire.com/Tracker?data=ko1z1Gx2y4E4CIQuOzVvOjaC5rs-jSipg5bRNfYLH-lb91HYeJuBtbc7rvbHvSrUktK7E4M5PYOVaTYdBGc2uA== BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 0, with 1 abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the companies' COVID-19 vaccine in children 5 to <12 years of age. VRBPAC is made up of independent experts who advise the FDA on scientific and regulatory matters, including the evaluation of vaccine safety and efficacy.

The committee reviewed the totality of scientific evidence shared by the companies, including results from a https://www.globenewswire.com/Tracker?data=sIO0_Cx6Ed20DcdIxtemRHzwVCbKogDdqnKm75PVsfejRJj6yVG_nwvhB6dv3WlZzier5JlN1UpTGOJ6wbvZDGRRq4DZ_igTbPqqtFpLgpDYGnUYR-pOY_wPNrRtz0aUyb6Kw_ugVl3lbuIb0evCIAJpsZ2xO0DGACsVKbrmGm3t40QVz8USkZRkeLfZS4K6rUvuy-rJZlLOQXqueM5PaXVCf5FWtgA75tRGZNe5-Fy4j8x8bIio6n0i4jFtFgm3 Phase 2/3 randomized, controlled trial that included 4,500 children 5 to <12 years of age (2,268 from the original group and 2,379 from the supplemental safety group). Participants in this age group received a two-dose regimen of 10-ug doses administered 21 days apart, one-third of the 30-ug dose used for people 12 years and older. This dose level was carefully selected for use in the trial based on safety, tolerability and immunogenicity data evaluated as part of a dose-ranging study. The Phase 2/3 trial showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine.

"We appreciated the opportunity to present our clinical data demonstrating the safety and high efficacy of our COVID-19 vaccine in children 5 to under 12 years of age," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "COVID-19 is an ongoing threat for the more than 28 million young children in this age group in the U.S., as they remain at risk for this infection. About 10% of all weekly U.S. cases occur in children 5 to under 12 years of age with a potential risk of complications. In addition, immunizing children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner. We thank the FDA advisory committee for their review and positive recommendation in support of Emergency Use Authorization to help protect this young population."

"We are committed to support the ongoing efforts to reduce infections and COVID-19 cases around the world by expanding the population of people protected against COVID-19," said Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech. "The clinical data reviewed underline that our vaccine induces a strong immune response in children when Delta was the prevalent strain and thus may contribute to help address this public health crisis."

The FDA is expected to make its decision in the coming days. If authorized and subsequently recommended by the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), the Pfizer-BioNTech COVID-19 Vaccine will be the first COVID-19 vaccine available for use in children 5 to <12 years of age in the U.S. The companies expect to then begin shipping pediatric vaccine doses immediately, as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government's commitment to free access to COVID-19 vaccines.

Pfizer and BioNTech have submitted requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world, including the European Medicines Agency. Initial data from the other two age cohorts in the ongoing Pfizer-BioNTech clinical trial in children -- those 2 to <5 years of age and those 6 months to <2 years of age -- are expected as soon as fourth quarter 2021 or early first quarter 2022.

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 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 or ongoing.

U.S. INDICATION & AUTHORIZED USE

HOW IS THE VACCINE GIVEN?

The vaccine will be given as an injection into the muscle.

Primary Series: The vaccine is administered as a 2-dose series, 3 weeks apart. A third dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.

Booster Dose:

   -- A single booster dose of the vaccine may be administered at least 6 
      months after completion of a primary series to individuals: 
 
          -- 65 years of age and older 
 
          -- 18 through 64 years of age at high risk of severe COVID-19 
 
          -- 18 through 64 years of age with frequent institutional or 
             occupational exposure to SARS-CoV-2 
 
   -- A single booster dose of the vaccine may be administered to certain 
      individuals who have completed primary vaccination with a different 
      authorized COVID-19 vaccine. Individuals should check with their 
      healthcare provider regarding eligibility for, and timing of, the booster 
      dose. 

WHAT IS THE INDICATION AND AUTHORIZED USE?

The FDA-approved COMIRNATY(R) (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 primary vaccination series or a booster dose.

COMIRNATY(R) (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

   -- It is approved as a 2-dose series for prevention of COVID-19 in 
      individuals 16 years of age and older. 
 
   -- It is also authorized under EUA to provide: 
   -- 
 
          -- a two-dose primary series in individuals 12 through 15 years 
 
          -- a third primary series dose in individuals 12 years of age and 
             older who have been determined to have certain kinds of 
             immunocompromise 
 
          -- a single booster dose to the following individuals who have 
             completed a primary series with Pfizer-BioNTech COVID-19 Vaccine 
             or COMIRNATY(R): 
 
                 -- 65 years of age and older 
 
                 -- 18 through 64 years of age at high risk of severe COVID-19 
 
                 -- 18 through 64 years of age with frequent institutional or 
                    occupational exposure to SARS-CoV-2 
 
          -- a single booster dose to eligible individuals who have completed 
             primary vaccination with a different authorized COVID-19 vaccine. 
             Booster eligibility and schedule are based on the labeling 
             information of the vaccine used for the primary series. 

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:

   -- a two-dose primary series in individuals 12 years of age and older 
 
   -- a third primary series dose for individuals 12 years of age and older who 
      have been determined to have certain kinds of immunocompromise 
 
   -- a single booster dose to the following individuals who have completed a 
      primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY(R): 
 
          -- 65 years of age and older 
 
          -- 18 through 64 years of age at high risk of severe COVID-19 
 
          -- 18 through 64 years of age with frequent institutional or 
             occupational exposure to SARS-CoV-2 
 
   -- a single booster dose to eligible individuals who have completed primary 
      vaccination with a different authorized COVID-19 vaccine. Booster 
      eligibility and schedule are based on the labeling information of the 
      vaccine used for the primary series. 

EUA Statement

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 12 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&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet at https://www.globenewswire.com/Tracker?data=44l0ydtkJMHQcrSfbY0EFyZSH-zZHgzHkhQaqrCFPaE4E7Xr2LWjaNcWRsxjGrI6sbEHyoYsFJzSSwn-dvlerzfzXpUmA76oNsQfDou681o= www.cvdvaccine-us.com.

IMPORTANT SAFETY INFORMATION

(MORE TO FOLLOW) Dow Jones Newswires

October 26, 2021 18:19 ET (22:19 GMT)

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Financials
Sales 2021 17 474 M 19 769 M 19 769 M
Net income 2021 9 220 M 10 430 M 10 430 M
Net cash 2021 9 793 M 11 079 M 11 079 M
P/E ratio 2021 8,28x
Yield 2021 -
Capitalization 73 453 M 83 098 M 83 098 M
EV / Sales 2021 3,64x
EV / Sales 2022 3,14x
Nbr of Employees 2 800
Free-Float 87,3%
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Number of Analysts 15
Last Close Price 304,13 €
Average target price 260,16 €
Spread / Average Target -14,5%
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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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