BIONTECH Stock Price, News & Analysis

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have signed a letter of intent with Eurofarma Laboratórios SA to manufacture their COVID-19 vaccine, COMIRNATY^®, for distribution in Latin America. Eurofarma will initiate technical transfer and on-site development immediately, with finished dose production expected to exceed 100 million doses annually, beginning in 2022. This collaboration aims to enhance equitable access to vaccines in the region, contributing to a total of 3 billion doses planned for global distribution by year-end 2021.

BioNTech (BNTX) announced the submission of a supplemental Biologics License Application (sBLA) for a booster dose of COMIRNATY. Phase 3 trial results show a third dose generates 3.3 times higher neutralizing antibody titers against the SARS-CoV-2 wild-type strain compared to the second dose. The safety profile is favorable, with mild to moderate side effects typical of previous doses. The companies aim to file this data with the EMA and other authorities soon. Notably, the third dose is not yet authorized for general use in the U.S., pending regulatory assessments.

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) announced the initiation of a supplemental Biologics License Application for a third dose of COMIRNATY. New Phase 3 trial data show the booster dose significantly increases SARS-CoV-2 neutralizing antibody titers, achieving levels 3.3 times higher than the second dose. The companies plan to submit these findings to the European Medicines Agency and other regulatory bodies shortly. Adverse events observed were mild to moderate, with a low incidence of severe reactions, consistent with previous clinical data.

Pfizer and BioNTech received FDA approval for COMIRNATY^®, making it the first FDA-approved COVID-19 vaccine for individuals aged 16 and older. This vaccine has been available under Emergency Use Authorization since December 2020. The approval validates the vaccine's efficacy and safety, supported by long-term Phase 3 trial data. Approximately 60% of eligible Americans are fully vaccinated, and the companies aim to enhance vaccine confidence. COMIRNATY is also authorized for individuals aged 12-15 under EUA and will seek further approvals for booster doses and younger age groups.

COMIRNATY, the first FDA-approved COVID-19 vaccine, has been licensed for individuals aged 16 and older. The approval follows a comprehensive review of six-month efficacy and safety data post-second dose. Over 1.2 billion doses have been delivered globally since December 2020. Pfizer and BioNTech anticipate the approval will enhance public confidence in vaccinations as the U.S. grapples with rising COVID-19 rates, especially among unvaccinated populations. Moreover, plans for a third dose and expansion for younger populations are underway.

Pfizer (PFE) and BioNTech (BNTX) have submitted Phase 1 data to the FDA for a booster dose of their COVID-19 vaccine (BNT162b2). This submission follows successful Phase 1 trials showing significantly higher neutralizing antibodies after a third dose compared to the two-dose schedule. The companies plan to also submit this data to the EMA and other authorities soon. Although the booster is not yet widely authorized in the U.S., it was recently approved for immunocompromised individuals. Further Phase 3 results are expected shortly.

Pfizer and BioNTech have submitted Phase 1 data to the FDA supporting a third booster dose of their COVID-19 vaccine, BNT162b2. The data reveal a favorable safety profile and robust immune responses, showing significantly higher neutralizing antibody levels against the original virus and variants like Delta and Beta. This booster dose may maintain protection against COVID-19, particularly in light of evolving variants. The companies expect Phase 3 results soon and plan to seek regulatory licensure for the booster in individuals aged 16 and above.

BioNTech SE (BNTX) provided a corporate update and financial results for Q2 2021, highlighting the delivery of over one billion doses of its COVID-19 vaccine, BNT162b2, to over 100 countries as of July 21, 2021. The company signed agreements for approximately 2.2 billion doses in 2021. Financially, total revenues reached €5.3 billion, up from €41.7 million in Q2 2020, with a net profit of €2.8 billion. BioNTech is expanding its oncology pipeline with 15 candidates in trials and plans to ramp up manufacturing capacity to 3 billion doses by year-end 2021.

BioNTech has successfully acquired Kite's solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, MD, enhancing its capabilities in individualized cancer therapies. This transaction, announced on July 19, 2021, marks a pivotal move in BioNTech's strategy to complement its growth through targeted acquisitions, following the acquisition of Neon Therapeutics in 2020. The integration of Kite's assets is expected to accelerate BioNTech's cell therapy pipeline and expand its North American operations.