All 17 experts ousted from the federal vaccine advisory committee have spoken out about the drastic changes that anti-vaccine advocate and current US health secretary Robert F. Kennedy Jr. has made since taking office. Those changes include unilaterally restricting access to COVID-19 vaccines and summarily firing the entire Advisory Committee on Immunization Practices (ACIP), which had guided federal vaccine policies for more than 60 years.
"We are deeply concerned that these destabilizing decisions, made without clear rationale, may roll back the achievements of US immunization policy, impact people’s access to lifesaving vaccines, and ultimately put US families at risk of dangerous and preventable illnesses," the fired experts write in an editorial published in JAMA.
Kennedy dismissed the entire committee on June 9, accusing the former members of lacking public trust and being "plagued with persistent conflicts of interest," despite the committee's transparent disclosure and conflict of interest policies.
© Getty | Ute Grabowsky
Under the Trump administration, the Food and Drug Administration is eagerly embracing artificial intelligence tools that staff members are reportedly calling rushed, buggy, overhyped, and inaccurate.
On Monday, the FDA publicly announced the agency-wide rollout of a large language model (LLM) called Elsa, which is intended to help FDA employees—"from scientific reviewers to investigators." The FDA said the generative AI is already being used to "accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets."
"It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications," the announcement promised.
© Getty | Congressional Quarterly
News broke yesterday that researchers in Philadelphia appear to have successfully treated a 6-month-old baby boy, called KJ, with a personalized CRISPR gene-editing therapy. The treatment corrects an ultra-rare mutation in KJ that breaks a liver enzyme. That enzyme is required to convert ammonia, a byproduct of metabolism, to urea, a waste product released in urine. Without treatment, ammonia would build up to dangerous levels in KJ—and he would have a 50 percent chance of dying in infancy.
While the gene-editing treatment isn't a complete cure, and long-term success is still uncertain, KJ's condition has improved and stabilized. And the treatment's positive results appear to be a first for personalizing gene editing.
Now, who doesn't love a good story about a seemingly miraculous medical treatment saving a cute, chubby-cheeked baby? But, this story delivers more than an adorable bundle of joy; the big triumph is the striking timeline of the treatment's development—and the fact that it provides a template for how to treat other babies with ultra-rare mutations.
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Oncologist Vinay Prasad, a divisive critic of COVID-19 responses, will be the next top vaccine regulator at the Food and Drug Administration, agency Commissioner Martin Makary announced on social media Tuesday.
Prasad will head the FDA's Center for Biologics Evaluation and Research (CBER), which is in charge of approving and regulating vaccines and other biologics products, such as gene therapies and blood products.
"Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER—a significant step forward," Makary wrote on social media.
© Getty | Marvin Joseph
Under President Trump, the Food and Drug Administration may no longer approve seasonal COVID-19 vaccines updated for the virus variants circulating that year, according to recent statements by Trump administration officials.
Since the acute phase of the pandemic, vaccine manufacturers have been subtly updating COVID-19 shots annually to precisely target the molecular signatures of the newest virus variants, which continually evolve to evade our immune responses. So far, the FDA has treated these tweaked vaccines the same way it treats seasonal flu shots, which have long been updated annually to match currently circulating strains of flu viruses.
The FDA does not consider seasonal flu shots brand-new vaccines. Rather, they're just slightly altered versions of the approved vaccines. As such, the regulator does not require companies to conduct lengthy, expensive vaccine trials to prove that each slightly changed version is safe and effective. If they did, generating annual vaccines would be virtually impossible. Each year, from late February to early March, the FDA, the Centers for Disease Control and Prevention, and the World Health Organization direct flu shot makers on what tweaks they should make to shots for the upcoming flu season. That gives manufacturers just enough time to develop tweaks and start manufacturing massive supplies of doses in time for the start of the flu season.
It's been a wild ride for investors in Rivian Automotive (NASDAQ: RIVN) and Nio (NYSE: NIO), filled with ups and downs. Both companies have previously had solid momentum behind them, and faced headwinds, setbacks, or disruptions. Both also still have much to prove to investors.
One analyst recently cast doubt on Rivian's gross profit, and Nio will need to show that it can offset the effects of China's brutal price war. Let's dive into both electric vehicle (EV) makers below and see what may lay ahead for them.
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One of the biggest takeaways from Rivian's fourth quarter was that it achieved $170 million in gross profit, which is simply total revenue minus the cost of revenue. It was a sizable win compared to analysts' estimates of $49 million in gross profit and was the company's first quarterly gross profit in its short history.
While the company certainly made progress -- Rivian's cost of revenue dropped 18.6% while revenue spiked 31.9% higher -- there was a small drawback. That came in the form of sharply higher sales of regulatory credits, which added $299 million in revenue during the fourth quarter. Regulatory credits are awarded to automakers that produce and sell electric vehicles, and the excess can be sold to other automakers that need the credits to meet emissions standards.
Rivian expects sales of regulatory credits to be similar for 2025 and guided for a positive gross profit for the full-year. Doing so would be a big step toward proving to investors that it has a path to profitability.
At least one analyst disagrees with Rivian's management. Bernstein's Daniel Roeska warned that the company may fail to reach that goal until 2027.
It's true that Rivian will face challenges. Its delivery growth has stalled, so much of the automaker's gross profit improvement will come from a reduction in revenue costs. The company lacks a revenue catalyst, with the R2 not set to hit the roads until the first half of 2026.
Gross profit will be something that analysts and investors both focus on throughout 2025, and it would go a long way if Rivian could achieve its full-year positive gross profit.
Meanwhile, Nio is expected to see strong momentum throughout 2025, driven by two new brands, Onvo and Firefly. In fact, during Q4, the company's deliveries broke down to 52,760 from its premium Nio brand and 19,929 from its Onvo brand. As deliveries of both Onvo and Firefly accelerate it is expected to drive strong revenue and delivery growth, but that didn't materialize quite as expected during Q4 with Firefly only having just launched.
Nio's Q4 deliveries were up 45% compared to the prior year, but its total revenue jumped a much lesser 15.2%, suggesting that the exhaustingly brutal price war in China is having a large effect on its pricing power.
Nio's first-quarter deliveries were in line with management's guidance at 42,094. But investors must remember the disappointment from that guidance, as it fell far short of analysts' original expectation of 65,000 in deliveries.
Information source: Nio delivery press releases. Graphic source: Author.
Over the past three years, Rivian and Nio have shed 70% and 82% of their value, respectively, and both certainly have much to prove to investors on their way toward profitability. It won't happen overnight, but if Rivian can achieve full-year 2025 gross profit, perhaps even with less reliance on regulatory credit sales, and Nio can offset the weight of China's price war, both will set themselves up for a much brighter future.
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Last week, Health Secretary and anti-vaccine advocate Robert F. Kennedy Jr. announced the Trump administration would hack off nearly a quarter of employees at the Department of Health and Human Services, which oversees critical agencies including the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Centers for Medicare and Medicaid Services (CMS).
The downsizing includes pushing out about 10,000 full-time employees through early retirements, deferred resignations, and other efforts. Another 10,000 will be laid off in a brutal restructuring, bringing the total HHS workforce from 82,000 to 62,000.
"This will be a painful period," Kennedy said in a video announcement last week. Early yesterday morning, the pain began.
© Getty | J. David Ake
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