FDA COVID booster pullback drives slight vaccine stock gains

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The FDA is scaling back COVID-19 booster approvals to high-risk groups. New rules demand randomized trials for healthy under-65s while preserving annual shots for seniors and people with chronic conditions.

Dr. Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), and FDA Commissioner Dr. Martin A. Makary, called for a more evidenced-based approach to COVID vaccination in an editorial in NEJM.

In their NEJM editorial, Drs. Prasad and Makary underscored the ongoing uncertainty regarding repeated vaccinations for many, stating, “We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose.” Further clinical testing, especially through randomized controlled trials in the 50-64 year-old age group focusing on symptomatic Covid-19 as a primary endpoint, would “compel much-needed evidence generation,” they wrote.

They outlined the FDA’s new direction to address this: “The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.” This strategic shift also acknowledges that “uptake of the annual Covid-19 booster has been poor,” with “less than 25% of Americans received boosters each year.”

Following the news, COVID-19 vaccine makers saw stock gains with an initial pop and later fade. Moderna (MRNA) spiked nearly 8% after the FDA said future COVID-19 boosters will be reserved for seniors and high-risk patients, then settled to a 2.5% advance by mid-afternoon. BioNTech (BNTX) followed a similar arc, up 5% intraday and roughly 1.6% late. Pfizer (PFE) rose about 2%, while Novavax (NVAX) gained significant momentum, jumping 15% following its long-awaited FDA approval on May 18 for its COVID-19 vaccine, albeit with new restrictions limiting its use to seniors and high-risk individuals. Its stock was up less than 1% toward the end of the afternoon.

The NEJM op-ed estimates that “100 million to 200 million Americans will have access to vaccines in this manner.”

This chart illustrates the relative stock performance of major COVID-19 vaccine makers over the past six months, a period that has seen shifts in vaccine demand and investor sentiment. [Data from Yfinance]