Pfizer Stock Price, News & Analysis

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.

ViiV Healthcare launched a report in collaboration with Economist Impact, outlining actions to eliminate health disparities related to HIV, STIs, mental health, and COVID-19 in the US and UK over the next 20 years. The study highlights that current healthcare inequities are both avoidable and costly, urging stakeholders to adopt a cohesive approach towards health equity. Key recommendations include restructuring healthcare systems for prevention, reimagining investments, enhancing collaboration, and better targeting of interventions aimed at vulnerable populations.

Pfizer Inc. (NYSE: PFE) announces that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued positive recommendations for abrocitinib, a JAK1 inhibitor, for treating moderate to severe atopic dermatitis in adults. Another recommendation supports the approval of XELJANZ^® (tofacitinib) for adults with active ankylosing spondylitis. If approved by the European Commission, both medications could provide new treatment options for patients with limited alternatives.

Pfizer Inc. (NYSE: PFE) announced the Japanese Ministry of Health's approval of CIBINQO® (abrocitinib), a JAK1 inhibitor, for treating moderate to severe atopic dermatitis in patients aged 12 and older. CIBINQO will be available in Japan at 100mg and 200mg doses. This approval is based on data from over 1,500 patients in Phase 3 studies. Pfizer aims to ensure widespread accessibility of CIBINQO in Japan, with regulatory applications submitted globally, including the US and EU. This marks a significant step in addressing treatment gaps for atopic dermatitis.

Pfizer Inc. (NYSE:PFE) announced positive top-line results from a Phase 3 study (B7471004) of PREVNAR 20™, a 20-valent pneumococcal vaccine, in adults aged 65 and older. The study demonstrated noninferior immune responses when PREVNAR 20 was administered alongside the seasonal influenza vaccine, Fluad, compared to separate administration. The safety profiles were comparable in both scenarios. The trial, involving 1,796 participants, supports CDC guidance on coadministration, aiming to improve vaccination rates against respiratory diseases.

ViiV Healthcare presented three-year findings from the Phase III TANGO study, demonstrating that the 2-drug regimen Dovato (dolutegravir/lamivudine) is non-inferior to the three-drug TAF-based regimens for HIV-1 patients. No virologic failures occurred in the Dovato group (0% vs <1% with TAF), reinforcing its viability as a treatment option. Notably, patients on Dovato displayed better management of fasting lipids. Overall adverse event rates were similar, with Dovato showing marginally higher drug-related AEs. This study was crucial in establishing Dovato's long-term effectiveness.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have submitted data to the U.S. FDA for their COVID-19 vaccine aimed at children aged 5 to <12 years. The Phase 2/3 trial included 2,268 participants and showed a favorable safety profile with robust neutralizing antibody responses from a 10 μg two-dose regimen. A formal request for Emergency Use Authorization (EUA) is expected in the coming weeks, with plans for submissions to other regulatory authorities, including the European Medicines Agency (EMA).

Topline results for younger cohorts (ages 2-5 and 6 months-2 years) are anticipated in Q4 2021.

ViiV Healthcare announced that the FDA has accepted and granted Priority Review for its New Drug Application (NDA) for cabotegravir long-acting, intended for HIV pre-exposure prophylaxis (PrEP). If approved by the target date of 24 January 2022, cabotegravir will be the first long-acting therapy for preventing HIV infection. The NDA is supported by positive results from studies HPTN 083 and HPTN 084, which demonstrated cabotegravir's superiority over daily oral medications. ViiV will also submit to other regulatory authorities by the end of 2021.