US Stands To Lose Its Scientific Edge, Vaccine Maker Warns
Moderna claims the Food and Drug Administration moved the goalposts when it rejected the company's application for a new flu vaccine. Citing the uncertainty of innovation under the Trump administration, the CEO says the FDA's move “threatens U.S. leadership in innovative medicines.” Meanwhile, vaccine makers are readjusting their plans.
Bloomberg:
Moderna Blames FDA For Threatening US Leadership In Medicine
Moderna Inc. lashed out at the US Food and Drug Administration for making it harder for companies to create new medicines, escalating a dispute between the vaccine maker and the regulator. In a call with analysts on Friday, Chief Executive Officer Stephane Bancel said the agency had become unpredictable. If the FDA keeps it up, it “threatens US leadership in innovative medicines.” (Smith, 2/13)
The New York Times:
Vaccine Makers Curtail Research And Cut Jobs
In Massachusetts, Moderna is pulling back on vaccine studies. In Texas, a small company canceled plans to build a factory that would have created new jobs manufacturing a technology used in vaccines. In San Diego, another manufacturing company laid off workers. When Robert F. Kennedy Jr. was picked in November 2024 to become the next health secretary, public health experts worried that the longtime vaccine skeptic would wreak havoc on the fragile business of vaccine development. (Robbins, 2/16)
The New York Times:
RFK Jr. Allies Target States To Overturn Vaccine Mandates For Schools
Longtime allies of Robert F. Kennedy Jr., the nation’s health secretary, have launched a new effort to repeal laws that for decades have required children to be vaccinated against measles, polio and other diseases before they enter day care or kindergarten. A newly formed coalition of vaccine activists is targeting laws that are considered the linchpin of protection from deadly diseases. States have long mandated childhood immunizations before children can start day care or school, though some exemptions are available. (Jewett, 2/13)
Politico:
RFK Jr.’s Allies Are Trying To Free Anti-Vaccine Doctors To Speak Their Minds
Doctors who give health advice to their patients or community that runs counter to the medical establishment face a rare but very real risk of state sanctions, including losing their license to practice. That could soon change if anti-vaccine activists succeed in getting the Supreme Court to weigh in on how broadly the First Amendment protects doctors’ rights to free speech — an issue that is central to Health Secretary Robert F. Kennedy Jr.’s Make America Healthy Again movement. (Gardner, 2/15)
Also —
CIDRAP:
WHO Criticizes CDC-Funded Vaccine Study In Africa As Unethical
The World Health Organization (WHO) issued a statement Friday criticizing a Centers for Disease Control and Prevention (CDC)-funded study of the hepatitis B vaccine in Guinea-Bissau. CIDRAP News broke the news of the study in December, shortly after the single-blinded clinical trial was announced in the Federal Register. Since then, the trial has been widely criticized for proposing to provide a life-saving birth dose of the hepatitis B vaccine—as endorsed by the WHO— to only half of the 14,000 babies to be studied, while allowing the other half to be vaccinated at six weeks of age, the current policy in Guinea-Bissau. (Szabo, 2/16)
