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Pfizer Inc and BioNTech SE Receives First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine Booster

09/22/2021 | 09:44pm EDT

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19. The booster dose is to be administered at least six months after completion of the primary series, and is the same formulation and dosage strength as the doses in the primary series. The FDA based this EUA on the totality of scientific evidence shared by the companies and reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC),including data from the Pfizer-BioNTech clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of the COVID-19 vaccine. A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for the vaccine. As a next step, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for the use and rollout of boosters to Americans. Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies do not expect the introduction of booster doses in the U.S. to impact the existing supply agreements in place with governments and international health organizations around the world. Pfizer and BioNTech have pledged to provide two billion doses to low- and middle-income countries in 2021 and 2022 – at least one billion doses each year. 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.

ę S&P Capital IQ 2021
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Financials (USD)
Sales 2021 81 557 M - -
Net income 2021 18 627 M - -
Net Debt 2021 29 307 M - -
P/E ratio 2021 12,8x
Yield 2021 3,62%
Capitalization 244 B 244 B -
EV / Sales 2021 3,35x
EV / Sales 2022 3,82x
Nbr of Employees 78 500
Free-Float 59,3%
Duration : Period :
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Technical analysis trends PFIZER, INC.
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Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 20
Last Close Price 43,56 $
Average target price 45,72 $
Spread / Average Target 4,96%
EPS Revisions
Managers and Directors
Albert Bourla Chairman, Chief Executive & Operating Officer
Frank A. D'Amelio Chief Financial Officer & EVP-Global Supply
Mikael Dolsten Chief Scientific Officer & Research President
Lidia L. Fonseca Executive VP, Chief Digital & Technology Officer
Aida Habtezion Chief Medical Officer
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