BIONTECH - BNTX STOCK NEWS

Pfizer and BioNTech have secured a new agreement with the European Commission to deliver an additional 200 million doses of the COMIRNATY vaccine, bringing the total supply to 500 million doses by the end of 2021. The agreement allows for an option of 100 million more doses. With this arrangement, at least 250 million Europeans could be vaccinated. Both companies are ramping up manufacturing capacity to meet global demand, aiming for around two billion doses by the end of 2021.

The U.S. government has exercised its option to purchase an additional 100 million doses of the Pfizer-BioNTech COVID-19 vaccine, bringing the total to 300 million. The government will pay $1.95 billion for these doses, aimed at vaccinating 150 million people. Pfizer and BioNTech are committed to increasing vaccine supply to combat COVID-19. The vaccine has been authorized for emergency use in individuals aged 16 and older. Manufacturing primarily occurs at Pfizer's Kalamazoo facility, utilizing BioNTech's proprietary mRNA technology.

BioNTech commenced mRNA production for the COVID-19 vaccine at its Marburg facility in Germany, aiming for an annual capacity of up to 750 million doses once fully operational. The initial batch can produce around eight million doses, with the first vaccines expected to be distributed in early April 2021. The facility has Good Manufacturing Practice (GMP) certification, ensuring high-quality standards. BioNTech plans to produce 250 million doses in the first half of 2021 and is undergoing a validation process with the European Medicines Agency (EMA) to confirm manufacturing quality.

Pfizer and BioNTech announced significant preclinical findings for their mRNA vaccine candidates, BNT162b1 and BNT162b2, targeting COVID-19. Results demonstrated that vaccinated rhesus macaques produced neutralizing antibodies up to 18.2 times higher than convalescent human serum. The vaccines also protected macaques from SARS-CoV-2 challenge without enhancing disease. These outcomes prompted the initiation of the pivotal Phase 3 trial for BNT162b2, which is currently authorized for emergency use in individuals aged 16 and older in the U.S.

BioNTech (BNTX) and Fosun Pharma announced that their COVID-19 vaccine, COMIRNATY®, has received emergency use authorization in Hong Kong. This significant milestone allows the vaccine to be manufactured in BioNTech's German facilities and supplied for the Hong Kong SAR Government's vaccination program. The vaccine demonstrated a 95% efficacy rate in adults during clinical trials and is already authorized in over 50 countries. The collaboration aims to enhance global vaccine accessibility, with plans for rapid rollout across Asia.

Pfizer and BioNTech have secured an advance purchase agreement with COVAX to supply up to 40 million doses of their COVID-19 vaccine in 2021. The initial doses are expected in Q1 2021, subject to supply agreements. This collaboration is part of COVAX's initiative to ensure equitable vaccine access for 92 low- and lower-middle-income countries at a not-for-profit price. The agreement underscores the companies' commitment to global health, as both aim to enhance vaccine accessibility worldwide.

Pfizer and BioNTech SE have secured an advance purchase agreement with COVAX for up to 40 million doses of their COVID-19 vaccine, aimed at equitable distribution. The doses will be supplied throughout 2021, with the first expected in Q1, 2021. This initiative supports 92 low-income countries, ensuring access at a not-for-profit price. Both companies emphasize their commitment to providing affordable vaccines globally, aimed at combating the pandemic. The financial specifics of the agreement remain undisclosed.

The in vitro study conducted by Pfizer and BioNTech demonstrates that sera from individuals immunized with their COVID-19 vaccine (BNT162b2) can neutralize the U.K. variant of SARS-CoV-2 (B.1.1.7). The study published on bioRxiv indicates that sera inhibited the pseudovirus featuring the U.K. strain spike protein, suggesting that the vaccine may remain effective against this variant. The companies emphasize the need for continuous monitoring and the flexibility of their mRNA platform to adapt to potential future virus strain changes.

Pfizer and BioNTech announced new study results from the University of Texas Medical Branch showing that antibodies from recipients of the Pfizer-BioNTech COVID-19 vaccine effectively neutralize a variant of the virus with a key mutation (N501Y) linked to increased transmissibility. The study suggests the vaccine remains effective against this mutation, indicating that its immune response is preserved against emerging strains. Further monitoring is required for ongoing evaluation of the vaccine's effectiveness against new variants. The vaccine is authorized for emergency use but not yet fully licensed by the FDA.