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    BNTX   US09075V1026

BIONTECH SE

(BNTX)
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Press Release: Pfizer and BioNTech Receive First Authorization in European Union for COVID-19 Vaccine in Adolescents

05/28/2021 | 03:45pm EDT
 
   NEW YORK and MAINZ, GERMANY, May 28, 2021 -- 
https://www.globenewswire.com/Tracker?data=Sxgmu401CGBB8iDQgUbB0e-nbifByzPJJ_kHxvnMkzhdwrvN09yrJbHZJqoisiZK5qMnloR2iGj8qn87pRe2eQ== 
Pfizer Inc. (NYSE: PFE) and 
https://www.globenewswire.com/Tracker?data=TfwfyH9_E5H_wB1L-c1FkpowQS6zQdXhD58NvQ-2hJqbGMoR8x1FH4qH_zOZ66LHx0ZxhVIoF2RykmOR5dei2Q== 
BioNTech SE (Nasdaq: BNTX) today announced that the Conditional 
Marketing Authorization (CMA) for COMIRNATY(R) in the European Union 
(EU) has been expanded to include individuals 12 to 15 years of age. 
This follows the European Medicines Agency's (EMA) Committee for 
Medicinal Products for Human Use (CHMP) positive opinion to authorize 
the vaccine in this age group. The extended indication for the CMA for 
COMIRNATY(R) is valid in all 27 EU member states. 
 
   COMIRNATY(R) was the first COVID-19 vaccine to receive authorization in 
the EU and is the first to have its CMA extended to adolescents. 
Distribution and administration of COMIRNATY(R) by the EU member states 
will continue to be determined according to the populations identified 
in the EU and per national guidance. 
 
   "Today's extension of our COVID-19 vaccine authorization in the European 
Union is another critical milestone in our collective effort to broaden 
vaccination programs to as many people as possible," said Ugur Sahin, 
M.D., CEO and Co-founder of BioNTech. "Making vaccines available to 
adolescents will help re-open schools and support the return to a normal 
day-to-day life." 
 
   "This is a meaningful moment for adolescents, parents and entire 
families who are seeking protection from this virus and a return to 
normalcy," said Albert Bourla, Chairman and Chief Executive Officer, 
Pfizer. "We appreciate the agency's thorough and efficient review of the 
data from our clinical trial, and look forward to seeing more people 
across Europe immunized as a result of today's decision." 
 
   The EU decision is based on data from a pivotal Phase 3 clinical trial, 
which enrolled 2,260 participants aged 12 to 15 years. Participants 
received two 30 <MU>g doses of the COVID-19 vaccine. Results from this 
trial, which were published in 
https://www.globenewswire.com/Tracker?data=8XBQ9_lISenE-e1IU5GIaXY9gV_7RuvjnIzJe-JA0tEzjo16Oz2qAvyIck7RysJDkcN1HmCRaAwLKVICVL49pULGE-EXpH00Bt5hRRKGDXt_1p780gbfIO19gqxzdldNZuGGE1nkq9JFJaytdSCIBw== 
The New England Journal of Medicine on May 27, 2021, showed a vaccine 
efficacy of 100% in participants with or without prior SARS-CoV-2 
infection and robust antibody responses. In the trial, the vaccine was 
also generally well tolerated. Participants will continue to be 
monitored for long-term protection and safety for an additional two 
years after their second dose. 
 
   In addition, the pediatric study evaluating the safety and efficacy of 
the COVID-19 vaccine in children 6 months to 11 years of age is ongoing. 
Pfizer and BioNTech expect to have definitive readouts and, subject to 
the data generated, submit for an Emergency Use Authorization (e.g., in 
the U.S.) or a variation to Conditional Marketing Authorizations (e.g., 
in the EU) for two cohorts, including children 2-5 years of age and 5-11 
years of age, in September. The readout and submission for the cohort of 
children 6 months to 2 years of age are expected in the fourth quarter. 
 
   The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech 
proprietary mRNA technology, was developed by both BioNTech and Pfizer. 
BioNTech is the Marketing Authorization Holder in the European Union, 
and the holder of emergency use authorizations or equivalents in the 
United States (jointly with Pfizer), United Kingdom, Canada and other 
countries in advance of a planned application for full marketing 
authorizations in these countries. 
 
   AUTHORIZED USE IN THE EU: 
 
   COMIRNATY(R)    (the Pfizer-BioNTech COVID-19 vaccine) has been granted 
conditional marketing authorisation by the by the European Commission to 
prevent coronavirus disease 2019 (COVID-19) in people from 12 years of 
age. The European Medicines Agency's (EMA's) human medicines committee 
(CHMP) has completed its rigorous evaluation of COMIRNATY(R) , 
concluding by consensus that sufficiently robust data on the quality, 
safety and efficacy of the vaccine are now available. 
 
   IMPORTANT SAFETY INFORMATION: 
 
 
   -- Events of anaphylaxis have been reported. Appropriate medical treatment 
      and supervision should always be readily available in case of an 
      anaphylactic reaction following the administration of the vaccine. 
 
   -- Syncope (fainting) may occur in association with administration of 
      injectable vaccines, in particular in adolescents. Procedures should be 
      in place to avoid injury from fainting. 
 
   -- The efficacy, safety and immunogenicity of the vaccine has not been 
      assessed in immunocompromised individuals, including those receiving 
      immunosuppressant therapy. The efficacy of COMIRNATY(R) may be lower in 
      immunosuppressed individuals. 
 
   -- As with any vaccine, vaccination with COMIRNATY(R) may not protect all 
      vaccine recipients. Individuals may not be fully protected until 7 days 
      after their second dose of vaccine. 
 
   -- In clinical studies, adverse reactions in participants 16 years of age 
      and older were injection site pain (> 80%), fatigue (> 60%), headache (> 
      50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and 
      injection site swelling (> 10%) and were usually mild or moderate in 
      intensity and resolved within a few days after vaccination. A slightly 
      lower frequency of reactogenicity events was associated with greater age. 
 
   -- The overall safety profile of COMIRNATY(R) in adolescents 12 to 15 years 
      of age was similar to that seen in participants 16 years of age and 
      older. The most frequent adverse reactions in clinical trial participants 
      12 to 15 years of age were injection site pain (> 90%), fatigue and 
      headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia 
      (> 20%). 
 
 
   -- There is limited experience with use of COMIRNATY(R) in pregnant women. 
      Administration of COMIRNATY(R) in pregnancy should only be considered 
      when the potential benefits outweigh any potential risks for the mother 
      and fetus. 
 
   -- It is unknown whether COMIRNATY(R) is excreted in human milk. 
 
   -- Interactions with other medicinal products or concomitant administration 
      of COMIRNATY(R) with other vaccines has not been studied. 
 
   -- For complete information on the safety of COMIRNATY(R) always make 
      reference to the approved Summary of Product Characteristics and Package 
      Leaflet available in all the languages of the European Union on the EMA 
      website. 
 
 
   The black equilateral triangle denotes that additional monitoring is 
required to capture any adverse reactions. This will allow quick 
identification of new safety information. Individuals can help by 
reporting any side effects they may get. Side effects can be reported to 
https://www.globenewswire.com/Tracker?data=SFulcTwihiJ1-aY2gbhQfhISrZwM1E0eBRtHMAA142gHniYkDHhChCXn0MsxuMiDuWehujfpKgSRRdyeN3zT1V1CSDuTjE9M4ONFVrkpT70gzZmT8Dc2M-hAG5GvO-KPLA9p1ODQ1ei3o9tUr74xJ5HvBnvheA5kiaifHcG9H2SO_XcC9MnGTlnPx76dMKZPnTrU9boUDrN0JC5P4dCIJ7C12-CxQ-7-dqMGgfKMqjc= 
EudraVigilance or directly to BioNTech using email 
https://www.globenewswire.com/Tracker?data=6vK14kiQQw5rpDDHPKQTxRuZ6eAKEuq8k-iv7NxrXBYnoMSQK5nANfE3krjBOpcEKmsiZ85hr7HYF_dQ0a0iQ-X99dI6Yut82Ye1DWUg7phDsp1iFngAvDDAf9XskOAPGkNjoyAFu54eV93sGBpnH207XdLxAYAY0Jm2TQkchcdFb5ZBFirvmecoIBv0EG5Rps4SvjxiqYQYtKomlnLeQRSX0yV7TiSa8aDLNspkE5N1P9EVDey1pm07EKSVrizrZFVMPws05pODkEP0SmJ1_A== 
medinfo@biontech.de, telephone +49 6131 9084 0, or via the website 
https://www.globenewswire.com/Tracker?data=Xgt8kffFUIppvC_7A2IC3YGZCh1PnkrjjwEeyR0XMr3KqvxGsImaQyuyeilc7xSwWa_g9YJeRD8Ak5mdn4kKUoTkYp5pUR_WGpGCakIQ8kdqw5hSvZHq_Ke1Ye1SZ0h8yYm9uJq7IWBUHWBcE5a7kQYDdfqva6PpDSztX89CwJrP3o9CIs1hq5vNQWDd60BB0f0mfd-viSLxsLyRXQv-R4s3feTBhj3ReLCMA0CJFtw= 
www.biontech.de 
 
   The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed 
by the U.S. Food and Drug Administration (FDA), but has been authorized 
for emergency use by FDA under an Emergency Use Authorization (EUA) to 
prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute 
respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 
12 years of age and older. The emergency use of this product is 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 Emergency Use 
Authorization (EUA) Fact Sheet for Healthcare Providers Administering 
Vaccine (Vaccination Providers) and Full EUA Prescribing Information 
available at 
https://www.globenewswire.com/Tracker?data=Xgt8kffFUIppvC_7A2IC3RfbjHLR4gkqcKKUimtqOkrtV8SCnAcobNJ4jvaPMod636lfKdcnd9d50Gu1lRc9zznHOG15tEd9vZ4wQ-T-7ROZ88hR-Clee3HhjN8-Wr-wylzRpgXJwW9GmsWxxx_M06b653Eif0RCOQgzW4YirBydE8CZyhCj_Li3BMMryY-7NXQKCD7uNN6-34X1KHXLUVPxv4bGUlSYOT971uTSeiUvJqIjGUatczJOtKW5j2ld3zRr10DfeWAg-tgWMTcJ2w== 
www.cvdvaccine-us.com. 
 
   About Pfizer: Breakthroughs That Change Patients' Lives 
 
   At Pfizer, we apply science and our global resources to bring therapies 
to people that extend and significantly improve their lives. We strive 
to set the standard for quality, safety and value in the discovery, 
development and manufacture of health care products, including 
innovative medicines and vaccines. Every day, Pfizer colleagues work 
across developed and emerging markets to advance wellness, prevention, 
treatments and cures that challenge the most feared diseases of our 
time. Consistent with our responsibility as one of the world's premier 
innovative biopharmaceutical companies, we collaborate with health care 
providers, governments and local communities to support and expand 

(MORE TO FOLLOW) Dow Jones Newswires

May 28, 2021 15:45 ET (19:45 GMT)

Stocks mentioned in the article
ChangeLast1st jan.
BIONTECH SE 3.41% 351.81 Delayed Quote.331.56%
CLASS III MILK FUTURES (DC) - CMG (ELECTRONIC)/C1 0.00% 16.44 End-of-day quote.4.18%
CLASS IV MILK?FUTURES (GDK) - CMG (ELECTRONIC)/C1 0.13% 16.01 End-of-day quote.16.10%
DJ INDUSTRIAL 0.80% 35116.4 Delayed Quote.14.14%
DRY WHEY?FUTURES (DY) - CMG (ELECTRONIC)/C1 0.00% 59.675 End-of-day quote.35.01%
NASDAQ COMP. 0.55% 14761.294551 Real-time Quote.13.85%
NONFAT DRY MILK FUTURES (GNF) - CMG (ELECTRONIC)/C1 0.06% 125.775 End-of-day quote.11.40%
PFIZER, INC. 3.91% 45.68 Delayed Quote.24.10%
S&P GSCI CLASS III MILK (USD) -1.36% 120.9567 Delayed Quote.-7.66%
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Financials
Sales 2021 13 071 M 15 518 M 15 518 M
Net income 2021 7 590 M 9 011 M 9 011 M
Net cash 2021 8 581 M 10 188 M 10 188 M
P/E ratio 2021 9,79x
Yield 2021 -
Capitalization 71 595 M 84 970 M 84 998 M
EV / Sales 2021 4,82x
EV / Sales 2022 5,32x
Nbr of Employees 2 200
Free-Float 87,3%
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Mean consensus HOLD
Number of Analysts 12
Last Close Price 296,44 €
Average target price 165,41 €
Spread / Average Target -44,2%
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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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