Pfizer Stock Price, News & Analysis

The FDA has granted Emergency Use Authorization (EUA) for a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 and older, as well as those aged 18-64 at high risk. The booster, to be administered at least six months after the primary series, is backed by clinical data demonstrating strong immune response against COVID-19 variants. The reactogenicity profile post-booster is mild to moderate, similar to the primary series. The vaccine continues to be supplied under existing agreements, with a commitment to provide two billion doses to lower-income countries by 2022.

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) expanded their agreement with the U.S. government to supply an additional 500 million COVID-19 vaccine doses for donation to low-income countries. This increases the total pledged doses to one billion, supporting the commitment to deliver two billion doses to low- and middle-income countries by the end of 2022. The doses are expected to be delivered by September 2022, with production at Pfizer facilities in the U.S.

Pfizer Inc. (NYSE: PFE) invites investors and the public to a webcast with CEO Albert Bourla at the Cantor Global Healthcare Conference on September 27, 2021, at 12:10 p.m. EDT. The webcast can be accessed on the Pfizer Investors website. A transcript and replay will be available within 24 hours and accessible for 90 days. Pfizer is committed to extending patient lives through innovative therapies and maintaining transparency with investors regarding its performance and strategies.

Pfizer (PFE) and BioNTech (BNTX) released results from a pivotal Phase 2/3 trial of their COVID-19 vaccine for children 5 to 11 years old. The study demonstrated a good safety profile and robust antibody responses after administering a 10 µg dose in a two-dose regimen. The vaccine's immune response was comparable to that seen in older populations. The companies plan to submit these data to the FDA and EMA for Emergency Use Authorization soon, with results for children under 5 expected later this year.

The FDA's Vaccines Advisory Committee has unanimously recommended the Emergency Use Authorization (EUA) for a COMIRNATY booster dose for individuals 65 and older and those at high risk for severe COVID-19. Data presented showed high neutralization titers against SARS-CoV-2 variants post-booster with a mild to moderate reactogenicity profile. Real-world evidence from Israel indicates that booster doses significantly enhance protection, comparable to initial vaccine effectiveness. The FDA is anticipated to make its decision soon, potentially marking COMIRNATY as the first COVID-19 booster authorized in the U.S.

Astellas Pharma and Pfizer announced that XTANDI (enzalutamide) improved overall survival in the Phase 3 ARCHES trial for men with metastatic hormone-sensitive prostate cancer (mHSPC). The study involved 1,150 patients and showed a 34% reduction in the risk of death (HR=0.66; p<0.0001) compared to placebo. Median OS was not reached in either group. Results are set to be presented at the ESMO Congress. This marks the third stage where enzalutamide has shown survival benefits in advanced prostate cancer, enhancing its clinical profile in earlier disease settings.

Pfizer has received marketing authorization from the UK MHRA for CIBINQO (abrocitinib), a once-daily oral JAK1 inhibitor. This drug is approved for treating moderate to severe atopic dermatitis in patients aged 12 and older who require systemic therapy. The authorized doses are 100mg and 200mg. This marks the first marketing authorization globally for abrocitinib, following its PIM designation last year. Pfizer aims to collaborate with NICE and the Scottish Medicines Consortium to ensure patient access to this treatment.

Pfizer Inc. (NYSE: PFE) invites the public to join two webcasts featuring company executives at healthcare conferences. Frank D’Amelio, CFO, will discuss at the Morgan Stanley 19th Annual Global Healthcare Conference on September 14, 2021, at 10:15 a.m. EDT. Angela Hwang, Group President, will speak at the BofA Global Healthcare Conference on September 15, 2021, at 11:45 a.m. EDT. Webcast access and registration details can be found on Pfizer's website, with transcripts available within 24 hours post-event.

Pfizer has initiated the RENOIR Phase 3 clinical trial for its RSV bivalent prefusion F subunit vaccine candidate in adults aged 60 and older. This trial aims to enroll approximately 30,000 participants and assess the vaccine's safety and efficacy against severe respiratory illness caused by RSV, which poses significant risks to older adults. With no current vaccine available, the trial addresses an urgent medical need, particularly as RSV leads to over 14,000 deaths annually in the U.S. among older adults.