BIONTECH Stock Price, News & Analysis

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.

BioNTech SE (BNTX) announced plans to assess the establishment of sustainable vaccine manufacturing in Rwanda and Senegal. This decision, made during a meeting in Berlin with African leaders and the European Commission, aims to enhance vaccine supply for the African Union member states. BioNTech intends to produce mRNA vaccines targeting Malaria and Tuberculosis on the continent. The company is already evaluating production capabilities to align with WHO’s upcoming Vaccine Hubs, amid a wider initiative supported by European partners to increase access to vaccines in Africa.

Pfizer and BioNTech have signed a letter of intent with Eurofarma to manufacture and distribute the COMIRNATY COVID-19 vaccine in Latin America. Eurofarma will engage in manufacturing activities within Pfizer’s global supply chain, with production expected to exceed 100 million doses annually starting in 2022. This collaboration aims to enhance vaccine access across the region, complementing the companies' goal to supply over 3 billion doses globally by the end of 2021. The partnership is part of ongoing efforts to ensure equitable vaccine distribution amid the pandemic.

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.