Pfizer Stock Price, News & Analysis

Pfizer reported third-quarter 2021 revenues of $24.1 billion, a 134% increase year-over-year, driven by the success of the Comirnaty vaccine, which contributed $13 billion. Excluding Comirnaty, revenues still grew 7% to $11.1 billion. The reported diluted EPS was $1.42, with adjusted EPS at $1.34. Pfizer raised its full-year revenue guidance to $81-82 billion and adjusted EPS to $4.13-4.18. The company anticipates around $36 billion in revenue from Comirnaty for 2021, with plans to deliver 2.3 billion doses globally.

The U.S. FDA has granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for children aged 5 to 11 years. This milestone is supported by clinical data indicating a 90.7% vaccine efficacy among participants when Delta was the prevalent strain. The vaccine demonstrates a favorable safety profile and will be administered in two 10-µg doses. With this authorization, Pfizer-BioNTech's vaccine is now the only option for this age group in the U.S., aiming to protect millions of school-aged children from COVID-19.

Pfizer and BioNTech announced the U.S. government's purchase of an additional 50 million COVID-19 vaccine doses, bringing the total to 600 million under the existing supply agreement. This move supports pediatric vaccination efforts, particularly for children under 5, pending regulatory authorization. Deliveries are anticipated by April 30, 2022. Furthermore, the companies aim to manufacture 4 billion doses worldwide in 2022, with a commitment to provide vaccines to low-income countries. The FDA has been approached for Emergency Use Authorization for children aged 5 to under 12 years.

ViiV Healthcare, majority-owned by GSK and partnered with Pfizer, has received approval from the European Commission to update product guidelines for Vocabria and Rekambys. This allows HIV patients the option to start treatment directly with injections, bypassing the oral lead-in phase. The change aims to simplify the treatment initiation process, as both methods have shown similar efficacy and safety. This decision is based on positive phase III clinical trial results that support the new regimen.

ViiV Healthcare announced positive interim results from the CARISEL study evaluating a long-acting HIV treatment regimen of Vocabria (cabotegravir) and Rekambys (rilpivirine). Conducted during the COVID-19 pandemic, the study showed 97% of participants found the bi-monthly injection visits acceptable. Healthcare teams across five European countries largely agreed on the regimen's feasibility, with mean scores of 4.6 for acceptability. Additionally, implementation concerns among healthcare teams decreased significantly over time, indicating strong potential for this innovative treatment in diverse settings.

Pfizer and BioNTech announced FDA's Vaccines Advisory Committee voted 17-0, with 1 abstention, to recommend Emergency Use Authorization (EUA) for their COVID-19 vaccine for children aged 5 to <12 years. This vaccine demonstrated a 90.7% efficacy rate in clinical trials conducted during the Delta variant surge, using a 10-µg dosage. If authorized, this will be the first COVID-19 vaccine approved for this age group in the U.S. The companies anticipate starting vaccine distribution immediately upon authorization, ensuring free access for eligible children.

The Next Practices Group has appointed Ray Kerins as the new CEO of The Next Security Group (NextSec) starting November 1, enhancing its focus on public affairs and security, including cybersecurity and physical protection.

Kerins, who previously served in senior roles at Bayer, Pfizer (NYSE: PFE), and Merck (NYSE: MRK), aims to bolster the company’s offerings to protect and promote client reputations.

Pfizer and BioNTech have announced the first results from a Phase 3 trial for a COVID-19 vaccine booster, revealing a relative efficacy of 95.6% against disease during Delta's prevalence. The trial included over 10,000 participants aged 16 and older, showing the booster restored vaccine protection to levels seen after the initial two doses and had a favorable safety profile. The companies plan to submit these results to regulatory agencies for licensure in the U.S. and globally.

Pfizer (NYSE:PFE) announced that the CDC's Advisory Committee on Immunization Practices (ACIP) has recommended the use of PREVNAR 20 for adults age 65 and older and those aged 19 to 64 with certain risk factors. This marks the first time a pneumococcal conjugate vaccine has been routinely recommended for younger adults with specific health conditions. The simplified one-dose recommendation aims to improve immunization rates and public health outcomes. PREVNAR 20 targets 20 serotypes of pneumococcus, which are responsible for significant disease burden in the U.S., leading to over 180,000 hospital admissions annually.