BIONTECH Stock Price, News & Analysis

BioNTech has initiated a randomized Phase 2 trial of its individualized mRNA cancer vaccine BNT122 for high-risk colorectal cancer patients, targeting around 200 individuals with circulating tumor DNA post-treatment. Conducted in the US, Germany, Spain, and Belgium, the trial aims to assess autogene cevumeran against standard watchful waiting. Primary endpoint is disease-free survival, with secondary goals including overall survival. This effort builds on prior positive Phase 1 results, indicating potential for significant clinical impact in colorectal cancer treatment.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have submitted data to the U.S. FDA for their COVID-19 vaccine aimed at children aged 5 to <12 years. The Phase 2/3 trial included 2,268 participants and showed a favorable safety profile with robust neutralizing antibody responses from a 10 μg two-dose regimen. A formal request for Emergency Use Authorization (EUA) is expected in the coming weeks, with plans for submissions to other regulatory authorities, including the European Medicines Agency (EMA).

Topline results for younger cohorts (ages 2-5 and 6 months-2 years) are anticipated in Q4 2021.

The FDA has granted Emergency Use Authorization (EUA) for a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 and older, as well as those aged 18-64 at high risk. The booster, to be administered at least six months after the primary series, is backed by clinical data demonstrating strong immune response against COVID-19 variants. The reactogenicity profile post-booster is mild to moderate, similar to the primary series. The vaccine continues to be supplied under existing agreements, with a commitment to provide two billion doses to lower-income countries by 2022.

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) expanded their agreement with the U.S. government to supply an additional 500 million COVID-19 vaccine doses for donation to low-income countries. This increases the total pledged doses to one billion, supporting the commitment to deliver two billion doses to low- and middle-income countries by the end of 2022. The doses are expected to be delivered by September 2022, with production at Pfizer facilities in the U.S.

BioNTech has expanded its agreement with the U.S. government to supply an additional 500 million doses of its COVID-19 vaccine, bringing the total to one billion doses for donation to low- and middle-income countries. This effort aligns with the companies' commitment to provide two billion doses globally by the end of 2022. Deliveries are anticipated to complete by September 2022, with production occurring at U.S. facilities. This strategic collaboration aims to ensure equitable vaccine access worldwide amidst the ongoing pandemic.

On September 20, 2021, Pfizer and BioNTech announced pivotal Phase 2/3 trial results of their COVID-19 vaccine in children aged 5 to 11 years. The vaccine demonstrated a favorable safety profile and robust neutralizing antibody responses with a 10 µg dose, which is lower than the 30 µg dose for older populations. Data from 2,268 participants showed a geometric mean titer of 1,197.6, indicating strong immune responses. The companies plan to submit these results to regulatory agencies, including the FDA and EMA, for Emergency Use Authorization.

Pfizer (PFE) and BioNTech (BNTX) released results from a pivotal Phase 2/3 trial of their COVID-19 vaccine for children 5 to 11 years old. The study demonstrated a good safety profile and robust antibody responses after administering a 10 µg dose in a two-dose regimen. The vaccine's immune response was comparable to that seen in older populations. The companies plan to submit these data to the FDA and EMA for Emergency Use Authorization soon, with results for children under 5 expected later this year.

On September 17, 2021, Pfizer and BioNTech announced that the FDA's VRBPAC unanimously recommended Emergency Use Authorization for a COMIRNATY booster dose for individuals 65 and older, and those at high risk of severe COVID-19. The booster, six months post the two-dose series, shows robust neutralization against SARS-CoV-2 and variants. Real-world data from Israel indicates significant protection levels comparable to early vaccine rollout. The FDA decision is pending, which could make COMIRNATY the first authorized COVID-19 vaccine booster in the U.S.

The FDA's Vaccines Advisory Committee has unanimously recommended the Emergency Use Authorization (EUA) for a COMIRNATY booster dose for individuals 65 and older and those at high risk for severe COVID-19. Data presented showed high neutralization titers against SARS-CoV-2 variants post-booster with a mild to moderate reactogenicity profile. Real-world evidence from Israel indicates that booster doses significantly enhance protection, comparable to initial vaccine effectiveness. The FDA is anticipated to make its decision soon, potentially marking COMIRNATY as the first COVID-19 booster authorized in the U.S.