BIONTECH - BNTX STOCK NEWS

The U.S. FDA has expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine booster, now available for individuals aged 16 and older. Administered at least six months post-primary series, the booster has shown a 95% efficacy in combating symptomatic COVID-19 compared to non-booster recipients. Pfizer and BioNTech plan to submit a supplemental Biologics License Application to formalize this authorization. The companies will continue supplying vaccines under existing agreements with the U.S. government through April 2022.

BioNTech SE (Nasdaq: BNTX) has scheduled a digital press conference for December 8, 2021, at 3:00 PM CET to discuss initial laboratory study results regarding the impact of the Omicron variant on COVID-19 vaccine-induced immune responses. The conference will be conducted in English and streamed online, with no on-site attendance for journalists. Recordings and presentations will be available later on their website.

BioNTech is known for its development of mRNA-based therapies for cancer and infectious diseases, collaborating with various global pharmaceutical partners.

Recent preliminary laboratory studies have shown that three doses of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) effectively neutralize the Omicron variant, while two doses result in a significant reduction in neutralization titers. A third dose increases neutralizing antibodies by 25-fold, achieving comparable levels to those against the wild-type virus. The companies are also advancing a variant-specific vaccine for Omicron, expected to be ready by March 2022, without affecting their projected capacity of four billion doses for the year.

Pfizer and BioNTech announced that three doses of their COVID-19 vaccine effectively neutralize the Omicron variant, while two doses show significantly reduced effectiveness. A booster dose increases neutralizing antibody titers by 25-fold against Omicron, similar to the response against the wild-type virus. Despite two doses providing some protection against severe disease, a third dose is recommended for optimal protection. The companies are developing a variant-specific vaccine for Omicron, expected by March 2022, without impacting their production capacity of four billion doses in 2022.

BioNTech (Nasdaq: BNTX) and Pfizer announced a positive opinion from the European Medicines Agency's CHMP, recommending the use of their COVID-19 vaccine, COMIRNATY, for children aged 5 to under 12. This marks a significant step as it could be the first vaccine authorized in the EU for this age group. The recommendation is based on a Phase 2/3 trial involving approximately 4,500 children, showing a 90.7% efficacy rate in those without prior infection. A final decision from the European Commission is expected soon, impacting all EU member states.

The Pfizer-BioNTech COVID-19 vaccine has shown a remarkable 100% efficacy against COVID-19 in a longer-term analysis involving adolescents aged 12 to 15. The pivotal Phase 3 trial data indicated no serious safety concerns, reinforcing confidence in the vaccine's effectiveness and safety profile. The companies plan to utilize these findings to support full regulatory approval in the U.S. and globally, moving towards a supplemental Biologics License Application to expand approval for this age group. This analysis contributes substantially to the existing data supporting the continued use of the vaccine.

The Pfizer-BioNTech COVID-19 vaccine showed 100% efficacy in a longer-term analysis for adolescents aged 12-15, with no serious safety issues reported. This data supports submissions for full regulatory approval in the U.S. and globally. The analysis, part of a pivotal Phase 3 trial, indicated that 0 symptomatic COVID-19 cases occurred in vaccinated participants compared to 30 in the placebo group. The companies plan to submit this data for regulatory review to expand the vaccine's approval.

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) have received expanded FDA emergency use authorization for the COVID-19 booster dose for individuals 18 and older. The booster, to be administered at least six months post-primary series, aims to sustain high protection against COVID-19 variants, including Delta. Clinical trials indicated a vaccine efficacy of 95% for booster recipients. The companies expect no impact on existing supply agreements. The FDA's decision is crucial as the pandemic continues to evolve.

BioNTech (BNTX) and Pfizer announced an expanded emergency use authorization (EUA) for their COVID-19 vaccine booster shot in the U.S. for individuals 18 and older. Administered at least six months after the primary series, the booster shows a 95% efficacy based on recent trials. Both companies continue to supply the vaccine under existing agreements with the U.S. government, expected to last through April 2022. This authorization follows positive clinical data demonstrating robust immune responses post-booster, which may help maintain protection against variants like Delta.