Pfizer Inc. - PFE STOCK NEWS

The European Commission has granted conditional marketing authorization (CMA) for Pfizer and BioNTech's COVID-19 vaccine, COMIRNATY, for individuals aged 16 and older. This follows a positive opinion from the EMA's Committee for Medicinal Products. The CMA is valid across all 27 EU member states, aiming to combat the COVID-19 pandemic. Notably, the vaccine demonstrated a 95% efficacy rate in a pivotal Phase 3 trial involving over 44,000 participants. The rollout of 200 million doses is set to begin immediately, with production at sites in Germany and Belgium.

Pfizer and BioNTech announced a positive opinion from the EMA's CHMP recommending conditional marketing authorization for their COVID-19 vaccine (BNT162b2) for individuals 16 and older. This CMA allows for expedited approval in response to serious public health threats. The positive recommendation is based on Phase 3 clinical study data, which supports the vaccine's efficacy against COVID-19. If authorized by the European Commission, the vaccine will be available across all EU member states. The vaccine is already authorized for emergency use in over 15 countries.

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) announced that the CDC's Advisory Committee on Immunization Practices recommended the use of their COVID-19 vaccine for individuals 16 and older under an Emergency Use Authorization (EUA). This follows a previous recommendation for high-priority healthcare workers and long-term care residents. With the FDA's authorization on December 11, 2020, the first vaccine shipments from Pfizer's Kalamazoo, MI site are set to be distributed nationwide. Pfizer aims to vaccinate millions by the end of 2021.

EMD Serono and Pfizer (NYSE: PFE) announced that the CHMP of the EMA adopted a positive opinion recommending BAVENCIO® (avelumab) for first-line maintenance treatment of advanced urothelial carcinoma (UC) patients who are progression-free after platinum-based chemotherapy. This decision, based on the Phase III JAVELIN Bladder 100 trial, is expected to be reviewed by the European Commission in early 2021. BAVENCIO is the first immunotherapy showing significant overall survival improvement in this setting. Approximately 200,000 bladder cancer cases are diagnosed yearly in Europe.

Pfizer Inc. (NYSE:PFE) has declared a 39-cent first-quarter 2021 dividend, payable on March 5, 2021, to shareholders on record as of January 29, 2021. This marks a 3% increase from the fourth-quarter 2020 dividend of 38 cents. The upcoming dividend will be the 329th consecutive quarterly dividend paid by Pfizer. The board's decision reflects confidence in Pfizer's business and its scientific pipeline. Following the merger of Upjohn and Mylan to form Viatris Inc., Pfizer's dividend will be adjusted to maintain shareholder value.

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted 17 to 4 in favor of granting Emergency Use Authorization (EUA) for Pfizer's and BioNTech's COVID-19 mRNA vaccine, BNT162b2. The committee's decision was based on robust data from a pivotal Phase 3 clinical trial, showing a vaccine efficacy rate of 95% after the second dose. The FDA will consider this recommendation before making a final decision on the EUA. All trial participants will be monitored for long-term safety. The companies remain ready to distribute the vaccine promptly if authorized.

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) announced the publication of final efficacy results from their Phase 3 trial of the COVID-19 vaccine candidate BNT162b2. Involving 43,448 participants aged 16 and older, the trial demonstrated a 95% efficacy rate against COVID-19 with a favorable safety profile. The trial results showed that the vaccine was well-tolerated across diverse populations, including those with pre-existing conditions. The companies are pursuing regulatory submissions globally, having received emergency use authorizations in several countries.

Pfizer and BioNTech have released pivotal Phase 3 trial results for BNT162b2, their mRNA-based COVID-19 vaccine, published in the New England Journal of Medicine. The trial involved 43,448 participants and showed a remarkable 95% efficacy in preventing COVID-19 after a two-dose regimen. The vaccine was well-tolerated, with common side effects like fatigue and pain at the injection site. The companies are seeking Emergency Use Authorization from the FDA and have already received approvals in other countries. Ongoing monitoring for long-term safety and efficacy will continue for two more years.