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Pfizer Inc.: Real-World Evidence Confirms High Effectiveness of Pfizer-BioNTech COVID-19 Vaccine and Profound Public Health Impact of Vaccination One Year After Pandemic Declared

Pfizer Inc.: Real-World Evidence Confirms High Effectiveness of Pfizer-BioNTech COVID-19 Vaccine and Profound Public Health Impact of Vaccination One Year After Pandemic Declared
Data suggest Pfizer-BioNTech vaccine prevents asymptomatic SARS-CoV-2 infection
Latest data analysis finds unvaccinated individuals were 44 times more likely to develop symptomatic COVID-19 and 29 times more likely to die from COVID-19
Findings represent the most comprehensive real-world evidence to date demonstrating the effectiveness of a COVID-19 vaccine
Data are of global importance to other countries as vaccination campaigns continue worldwide
The Israel Ministry of Health (MoH), Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact ....

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Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants

Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants
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Pfizer Inc.: Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants

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The evaluation is part of the Phase 1/2/3 trial and will study a third dose of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, at 30 µg that will be given to Phase 1 participants to evaluate the safety and tolerability of a booster vaccine
Discussions with regulatory authorities are ongoing regarding an additional registration-enabling study using an mRNA vaccine with a variant sequence; this would provide a flexible solution for rapidly adapting the vaccine for use against the B.1.351 lineage or other new strains that may emerge as possible immune escape virus variants
Based on in-vitro studies conducted to date and observations from real world evidence, the Companies have not observed changes to neutralizing antibody levels that would predict a significant reduction in protection provided by two doses of BNT162b2 ....

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BioNTech SE: Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants

The evaluation is part of the Phase 1/2/3 trial and will study a third dose of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, at 30 µg that will be given to Phase 1 participants to evaluate the safety ....

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Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA

German
Proposed U.S. EUA label update would enable the vaccine to be stored at -25°C to -15°C (-13°F to 5°F) for a total of two weeks
If approved, new storage option could offer pharmacies and vaccination centers greater flexibility in managing and maintaining vaccine distribution and supply
NEW YORK and MAINZ, GERMANY, February 19, 2021 (GLOBE NEWSWIRE)
BioNTech SE (Nasdaq: BNTX) today announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in pharmaceutical freezers and refrigerators. The data have been submitted to the FDA to support a proposed update to the U.S. Emergency Use Authorization (EUA) Prescribing Information, which would allow for vaccine vials to be stored at these temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer ....

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