Pfizer Inc. - PFE STOCK NEWS

Pfizer and BioNTech announced that the CHMP has recommended conditional marketing authorization for their Omicron BA.1-adapted bivalent COVID-19 vaccine for individuals 12 years and older. This 30-µg booster dose combines mRNA from the original vaccine and mRNA for the Omicron BA.1 variant. The vaccine demonstrated improved immunogenicity, showing a 9-fold increase in neutralizing titers against the Omicron strain compared to the original vaccine. If approved, doses will be available to EU member states within days, supporting upcoming vaccination campaigns.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) received FDA Emergency Use Authorization for a 30-µg booster dose of their Omicron BA.4/BA.5 Bivalent Vaccine, combining mRNA for the original virus and Omicron BA.4/BA.5 subvariants. This booster is authorized for individuals aged 12 and older. The companies are also preparing applications for younger age groups. Clinical data showcase a strong immune response against multiple subvariants, reinforcing the vaccine's efficacy. Shipping will begin immediately under existing agreements with the U.S. government.

Pfizer and BioNTech announced the submission of a booster dose application for an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine to the European Medicines Agency (EMA). This submission follows their earlier application for the Omicron BA.1-adapted vaccine. The booster targets individuals 12 years and older, generating a strong neutralizing antibody response per pre-clinical data. Regulatory approvals are expected shortly, with availability as early as September, pending authorization. The companies also submitted a request for Emergency Use Authorization to the FDA on August 22.

Pfizer (NYSE:PFE) announced positive interim results from its Phase 3 RENOIR trial for the bivalent RSV vaccine candidate, RSVpreF. The vaccine showed an efficacy of 85.7% against severe lower respiratory tract illness (LRTI-RSV) in adults aged 60 and older. The findings were considered significant enough for Pfizer to plan a Biologics License Application (BLA) submission to the FDA in fall 2022. The vaccine was reported to be well-tolerated, with no safety concerns noted during the trial.

Pfizer and BioNTech have updated the efficacy results of their COVID-19 vaccine for children aged 6 months to 4 years, reporting a vaccine efficacy of 73.2% based on 34 cases observed more than seven days post-vaccination. Efficacy was confirmed across variants, primarily Omicron BA.2, with favorable safety profiles. The data supports the ongoing review for Emergency Use Authorization by the FDA and a conditional Marketing Authorization by the EMA, alongside plans for an adapted vaccine targeting emerging Omicron strains.

Pfizer and BioNTech announced their submission to the FDA for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals aged 12 and older. The companies have rapidly scaled production and are prepared to begin shipping doses immediately upon authorization. A similar application has been submitted to the European Medicines Agency. The bivalent vaccine is designed to generate a robust immune response against multiple variants, with pre-clinical data showing strong neutralizing antibody responses against Omicron variants and the original strain.

Pfizer Inc. (NYSE: PFE) will host a webcast featuring Mikael Dolsten, Chief Scientific Officer, at the Handelsbanken Life Science Innovation Day on August 24, 2022, at 4:30 p.m. CEST (10:30 a.m. EDT). Interested parties can access the live discussion or register via Pfizer's investor website. Following the event, a transcript and replay will be available within 24 hours for 90 days. Pfizer emphasizes its commitment to improving global health through innovative therapies and vaccines.

Pfizer announced positive top-line results from its pivotal Phase 3 study of the 20-valent pneumococcal conjugate vaccine candidate (20vPnC) aimed at preventing invasive pneumococcal disease in infants. The vaccine candidate achieved statistical non-inferiority for all 20 serotypes after the fourth dose. It also demonstrated a favorable safety profile similar to Prevnar 13. Pfizer intends to submit a supplemental Biologics License Application by year-end 2022, pending discussions with the U.S. FDA, to potentially address the significant burden of infant pneumococcal disease.

NextRNA Therapeutics announces the appointment of Dominique Verhelle, PhD, MBA, as CEO, effective immediately. Verhelle, a co-founder of the company, has spearheaded its scientific and corporate strategy since its inception. Under her leadership, NextRNA secured $56M in financing to advance its unique platform aimed at developing small molecule drugs targeting non-coding RNA interactions. Additionally, Jason Katz has been appointed as VP and Head of Drug Discovery, bringing extensive drug discovery experience from IFM Therapeutics and Merck.