Pfizer Stock Price, News & Analysis

Pfizer Inc. (NYSE:PFE) announced that its investigational GBS vaccine, GBS6, has received Breakthrough Therapy Designation from the FDA. This designation aims to expedite the development of GBS6, aimed at preventing invasive Group B Streptococcus disease in newborns. The decision is based on interim analysis from an ongoing Phase 2 trial in pregnant women. If approved, GBS6 could significantly reduce neonatal diseases, addressing a critical public health need. GBS6 targets the six main GBS serotypes, accounting for 98% of global cases.

Pfizer Inc. (NYSE: PFE) will present at two upcoming healthcare conferences. Chief Scientific Officer Mikael Dolsten will speak at Citi's 17th Annual BioPharma Conference on September 7, 2022, at 10:30 a.m. EDT, while Chief Financial Officer David Denton will present at the Wells Fargo 2022 Healthcare Conference on September 8, 2022, at 9:10 a.m. EDT. Investors can access the live webcasts and subsequent replays on Pfizer's investor relations website. Forward-looking statements discussed may involve risks that could materially impact actual results.

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.