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Moderna Stock Falls, Pfizer Dips on COVID Vaccine Ban Speculation
Moderna Inc stock fell 5.5% and Pfizer Inc shares dropped 2.6% following reports from Newsweek and The Daily Beast that the Trump administration may be planning to ban COVID-19 vaccines in the coming months.
The potential move was reported by British cardiologist Dr. Aseem Malhotra, who told the Daily Beast that Health and Human Services Secretary Robert F. Kennedy Jr. and President Donald Trump are allegedly planning to phase out the COVID-19 vaccine “within months.” Malhotra, a vaccine skeptic and Kennedy associate, claimed the decision is supported by “influential” members of Trump’s family.
Malhotra, who advises the lobby group MAHA (Make America Healthy Again) Action, suggested the ban could be implemented gradually or through “one clean decision,” despite potential legal ramifications and public concern.
Pfizer Says It Couldn’t Have Warned About Tumor Risk in Depo-Provera Lawsuits
Pfizer has urged a Florida federal judge to dismiss lawsuits claiming its birth control shot Depo-Provera can cause users to develop a type of brain tumor, saying regulators barred the company from including a warning about the tumors on the drug’s label.
The New York-based pharmaceutical company told U.S. District Judge M. Casey Rodgers in Pensacola in a Friday filing that claims the company failed to warn consumers and physicians about the risk of meningiomas associated with the drug were preempted by the U.S. Food and Drug Administration’s rejection of that warning before the litigation began. The tumors are often benign but can compress brain tissue and require surgery, the plantiffs said in the court filing.
Instead of following a more typical bellwether process to have both sides select cases to test the claims, the judge selected five so-called “pilot” cases to prepare for trial. Pfizer asked the judge to enter judgment for the company in the five cases. If Rodgers sides with the company, Pfizer said it will move for a similar ruling in all of the remaining cases in the litigation, which was centralized in February and currently includes more than 500 cases, court records show.
In a statement, Chris Seeger, Bryan Aylstock and Ellen Relkin, lawyers for the plaintiffs, said Pfizer had “substantial scientific evidence” since the 1980s that Depo-Provera could cause meningiomas but ignored it. “The law makes clear drug manufacturers like Pfizer are responsible for providing proper warnings to patients and doctors,” they said.
FDA Suspends License for Chikungunya Vaccine Ixchiq Over Serious Safety Concerns
The U.S. Food and Drug Administration (FDA) announced late last week that it has suspended the license for French drugmaker Valneva’s chikungunya vaccine, saying that continued administration of the vaccine to the public would pose a danger to health.
The FDA’s Center for Biologics Evaluation and Research, or CBER, said the decision was based on serious safety concerns related to Ixchiq, a live-attenuated vaccine that was approved by the FDA in 2023. The move comes after the agency recommended a pause in the use of Ixchiq in people ages 60 and older on May 9 while officials investigated severe events in vaccine recipients.
On August 6, the FDA lifted the pause but recommended the vaccine only for people at high risk of exposure to chikungunya virus, which is spread by Aedes mosquitoes.
Ixchiq contains a weakened form of the virus, which may cause symptoms of chikungunya disease. Before the suspension of the license, it was recommended for Americans traveling to areas where active chikungunya outbreaks are occurring.
Most US Neurologists Prescribing MS Drugs Have Received Pharma Industry Cash
Nearly 80% of U.S. neurologists prescribing drugs for multiple sclerosis received at least one pharma industry payment, with higher volume prescribers more likely to be beneficiaries, finds a five year analysis of Medicare database payments, published in the open access journal BMJ Open.
And those in receipt of these payments were more likely to prescribe that company’s drugs, especially if the sums involved were larger, sustained, and recent, the findings indicate.
Payments are classified as: research payments; ownership and investment interests; and general payments. The researchers focused on general payments to neurologists, linking these to Medicare Part D data, which covers prescription drugs, using National Provider Identification numbers and drug names.
Getting a Covid Shot This Fall Could Be a Lot More Complicated
The millions of Americans who are used to getting their COVID-19 vaccines at a local pharmacy may face new hurdles this fall depending on where they live and whether federal health officials have decided they qualify.
Pharmacists’ authority to vaccinate individuals varies across state lines. In some places, it’s dependent upon a federal advisory process that U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. has upended.
At the same time, the U.S. Food and Drug Administration has signaled that it will only approve updated COVID-19 vaccines for individuals 65 and older and for younger people considered to be at high risk for severe disease. People, regardless of where they live, may need to prove that they need the shot.
Major U.S. Drug Manufacturing Plant Did Not Properly Investigate Cat Hair, Pests, and Other Problems, FDA Finds
Cat hair, pests, bacteria, and equipment failures. These were among the concerns of a recent regulatory inspection of a key, but historically troubled, manufacturing plant that Novo Nordisk bought last year as part of its parent company’s acquisition of Catalent, one of the largest contract manufacturers serving the pharmaceutical industry.
A copy of a U.S. Food and Drug Administration (FDA) inspection report was obtained by STAT.
The extensive problems seen by the FDA, some of which were noted in previous inspections over the past three years, are raising concerns for drugmakers such as Regeneron Pharmaceuticals and Scholar Rock. And Wall Street analysts are keeping close watch for signs that the issues may also affect other drug companies that rely on the facility.
Trump Pushes 1,500% Drop in Drug Prices as Pharma Firms Face Sept 29 Deadline and Tariffs
U.S. President Donald Trump on Aug. 25 said he would slash drug prices between 1,400% and 1,500%, reaffirming his administration’s aggressive stance on pharmaceutical pricing and plans to impose higher tariffs on imported medicines. “Going to do a number on costs of drugs in US,” he said during a briefing.
This announcement comes nearly a month after Trump sent letters to leading pharmaceutical companies — including Johnson & Johnson, Pfizer, AstraZeneca, Bristol Myers, GSK, Merck, Novartis, Roche, and Sanofi — setting a Sept. 29 deadline to lower drug prices. He demanded that these companies extend “most-favored-nation” (MFN) pricing to all Medicaid patients.
“Provide your full portfolio of existing drugs at MFN rates for every single Medicaid patient,” Trump directed in the letters. He warned that failure to comply would prompt his administration to “deploy every tool in our arsenal to protect American families from continued abusive drug pricing practices.”
