NEW YORK - Pfizer Inc. (NYSE: NYSE:PFE) has received U.S. Food and Drug Administration (FDA) approval for the expanded use of its respiratory syncytial virus (RSV) vaccine, ABRYSVO®, to include adults aged 18 through 59 who are at increased risk of lower respiratory tract disease (LRTD) caused by RSV. This decision, announced today, broadens the vaccine's indication, which already covers individuals 60 years and older and pregnant individuals during their third trimester.
The approval is grounded on outcomes from the Phase 3 trial, MONeT, which evaluated ABRYSVO's safety, tolerability, and immunogenicity in adults at risk due to certain chronic medical conditions. Pfizer plans to publish the results from this study and present them at a future scientific conference.
RSV poses a significant health risk, particularly to younger adults with chronic conditions such as obesity, diabetes, and heart failure. With this new approval, ABRYSVO becomes the sole RSV vaccine indicated for adults under 50 at increased risk, complementing its existing authorizations.
ABRYSVO is a bivalent vaccine, designed to protect against both major subgroups of RSV, without the need for adjuvants. In May 2023, the FDA initially approved the vaccine for use in individuals aged 60 and above. Subsequent approvals for maternal immunization were granted in August 2023, which aimed to protect infants up to 6 months old through vaccination of pregnant individuals between 32 and 36 weeks of gestation.
In addition to its U.S. approvals, ABRYSVO has received marketing authorization in the European Union and several other countries for older adults and maternal immunization. Pfizer emphasizes that ABRYSVO should not be administered to those with a history of severe allergic reactions to any component of the vaccine and that it may not protect all vaccinated individuals.
The company also cautions against potential side effects such as fatigue, headaches, and injection site pain, which were the most common adverse reactions observed in clinical trials.
This announcement is based on a press release statement from Pfizer Inc. detailing the FDA's approval of ABRYSVO for a new patient population and its continued global authorization efforts.
In other recent news, Pfizer has been in the spotlight due to several noteworthy developments. The pharmaceutical giant has received approval from the U.S. Food and Drug Administration for its new hemophilia drug, HYMPAVZI, marking a significant advancement in the treatment of the disease. Pfizer has also welcomed Mortimer (Tim) J. Buckley to its Board of Directors, further strengthening its leadership team.
However, the company has also faced criticism from Starboard Value, a significant shareholder. Starboard's CEO, Jeffrey Smith, expressed dissatisfaction with Pfizer's performance, particularly in the development of profitable new drugs. Consequently, the investment firm has requested a special committee to investigate claims of coercive actions against former Pfizer executives.
In financial news, Pfizer declared a Q4 cash dividend of $0.42 per share, marking their 344th consecutive quarterly payment. This consistent return to shareholders underscores Pfizer's financial stability. Meanwhile, financial research firm CFRA has revised upwards the earnings forecasts for Pfizer, indicating a positive outlook for the company's financial future.
These are the recent developments at Pfizer, providing investors with insights into the company's performance, leadership changes, and potential challenges ahead.
InvestingPro Insights
As Pfizer expands its market reach with the FDA's approval of ABRYSVO for a broader patient population, investors may want to consider some key financial metrics and insights from InvestingPro.
Pfizer's market capitalization stands at $163.71 billion, reflecting its position as a major player in the pharmaceutical industry. This aligns with the InvestingPro Tip that Pfizer is a "prominent player in the Pharmaceuticals industry," which is particularly relevant given the recent FDA approval of ABRYSVO for expanded use.
The company's revenue for the last twelve months as of Q2 2024 was $55.17 billion, with a gross profit of $33.19 billion. While these figures are substantial, it's worth noting that Pfizer has experienced a revenue decline of 29.65% over the same period. This context makes the expanded approval of ABRYSVO potentially significant for future revenue growth.
An InvestingPro Tip highlights that Pfizer "pays a significant dividend to shareholders," which is supported by the current dividend yield of 5.81%. This could be attractive to investors looking for income in addition to potential growth from new product approvals like ABRYSVO.
Another relevant InvestingPro Tip indicates that "net income is expected to grow this year." This expectation could be bolstered by the expanded market for ABRYSVO, potentially contributing to improved financial performance.
For investors interested in a more comprehensive analysis, InvestingPro offers 11 additional tips for Pfizer, providing a deeper understanding of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.