Pfizer Shares Fall as FDA Widens Covid Vaccine Safety Probe
FDA & Biotech

Pfizer Shares Fall as FDA Widens Covid Vaccine Safety Probe

Regulators are now investigating deaths potentially linked to vaccines across all adult age groups, increasing pressure on the pharmaceutical giant.

Pfizer Inc. (PFE) shares fell in Tuesday trading after the U.S. Food and Drug Administration expanded its safety investigation into deaths with a potential link to COVID-19 vaccines to include all adult age groups.

The pharmaceutical giant’s stock was down 1.71%, or $0.44, to trade at $25.33 by early afternoon, reflecting investor unease over the heightened regulatory scrutiny. The probe, which initially focused on pediatric cases, now casts a wider net, creating fresh uncertainty for one of the most widely administered vaccines in history.

An FDA spokesperson confirmed the expanded scope of the investigation, stating the agency is conducting a "thorough investigation, across multiple age groups, of deaths potentially related to Covid vaccines." This development follows a period of waning investor enthusiasm for vaccine manufacturers as the global pandemic has receded, shifting focus to new growth drivers.

Pfizer's COVID-19 vaccine, developed in partnership with BioNTech, was a cornerstone of its revenue during the pandemic, catapulting the company's earnings to record highs. However, with demand for vaccines and treatments like Paxlovid declining sharply, the company has been navigating a challenging transition. The expanded FDA probe introduces a new headwind, potentially impacting public perception and future vaccine uptake, even as the company works on next-generation combination shots for flu and Covid.

Shares of other major vaccine makers, including Moderna and BioNTech, also experienced brief dips following the news, according to reports from Investing.com. The regulatory action signals that authorities remain vigilant about post-market surveillance of the vaccines, which were developed and authorized under unprecedented timelines.

For Pfizer, the investigation adds another layer of complexity to its post-pandemic strategy. The company has a market capitalization of over $146 billion but has seen its stock trade down from its pandemic-era peaks. While Pfizer maintains a diversified portfolio of treatments in oncology, immunology, and cardiology, the immense success of its COVID franchise has made for difficult year-over-year comparisons.

Analysts have a mixed but generally cautious outlook on the stock, with a consensus target price of $29.04. The company's forward price-to-earnings ratio stands at a modest 8.67, suggesting that much of the concern over declining COVID-related revenues is already priced in. However, unexpected regulatory actions like the expanded FDA probe can still rattle investor confidence.

The financial impact of the probe remains unclear, but it could lead to labeling changes or, in a more severe scenario, restrictions on use if a definitive link is established. Bloomberg first reported that the investigation was being broadened, leading to the immediate stock reaction.

Investors will be closely watching for further updates from the FDA. Any definitive findings from the probe could have long-lasting implications not just for Pfizer, but for the public's trust in mRNA vaccine technology. In the meantime, the company continues to focus on its pipeline and integrating its $43 billion acquisition of Seagen, a move designed to bolster its cancer-fighting drug portfolio and secure a path to growth beyond the COVID-19 windfall.