The FDA approved Moderna’s new Covid-19 vaccine late Friday, though it placed restrictions on its use that the company’s existing Covid shot, Spikevax, does not currently face.
Just as it did earlier this month with Novavax’s Covid vaccine, the agency said the new Moderna shot, called mNexspike, is licensed for use only in people aged 65 and older and people aged 12 to 64 who have at least one medical condition that puts them at increased risk of becoming seriously ill if they contract the SARS-CoV-2 virus. (Such conditions include diabetes, chronic obstructive pulmonary disorder or COPD, and obesity.) Spikevax’s license simply allows its use in people aged 12 years and older.
Read more from STAT’s Helen Branswell on what it means. And if the administration’s strategy on Covid vaccines is confusing to you, check out a story Lizzy wrote Sunday about a television interview with FDA commissioner Marty Makary. But a warning: you may find more contradictions than answers. On CBS News’ “Face the Nation,” Makary called the CDC’s independent vaccine advisory panel a “kangaroo court” that “rubber-stamps” every vaccine. Later, he cited the panel’s proposed risk-based approach as justification for the administration’s policy changes the past few weeks.
Vera Therapeutics reports positive results from trial of kidney disease drug
An experimental medicine from Vera Therapeutics significantly reduced levels of toxic protein in the urine of patients with an autoimmune kidney disease. The Phase 3 study results reported Monday met an intermittent treatment goal and laid down a marker ahead of a competing study readout later this week.
The Vera drug called atacicept lowered proteinuria levels by 46% after nine months compared to 7% lowering in patients given a placebo. The improvement — 42% as calculated using a prespecified statistical model that takes into account baseline factors — will support a regulatory submission to the Food and Drug Administration before the end of the year, Vera said.
The result was in the range of a “best-case” scenario for atacicept laid out by Cowen biotech analyst Ritu Baral in a note previewing the study. How Vera’s stock price reacts, however, might also depend on the readout expected Friday from a similarly designed Phase 3 study involving a competing IgAN medicine made by Otsuka, the Japanese drugmaker.
Read more.
from AXIOS:
| RFK Jr.’s on-the-fly policymaking |
| By Maya Goldman |
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| Photo illustration: Aïda Amer/Axios. Photo: Roy Rochlin/Getty Images |
| Robert F. Kennedy Jr.’s tenure as the nation’s top health official is becoming increasingly known for abrupt policy pronouncements based on limited or sketchy evidence that perplex health care providers, industries and patients.
Why it matters: While Kennedy has branded himself as a change agent bringing “radical transparency” to a bloated federal bureaucracy and promoting “gold standard” science, the results have at times been chaotic, even exposing rifts between President Trump’s circle and Kennedy’s own base. State of play: The Kennedy-led Make America Healthy Again Commission report on causes of childhood illness became a focus last week for a series of erroneous and fabricated references, first reported by NOTUS. The White House had to quickly correct those errors.
What they’re saying: HHS spokesperson Andrew Nixon said Kennedy is “doing what previous administrations would not” in going against the policymaking status quo.
Yes, but: Health industry players have been left wondering what the actual rules of the road are, and how to implement policies that could change day by day.
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