FDA approves Moderna's new lower-dose COVID-19 vaccine
The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company's existing shot, but a second option.
The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose — a fifth of the dose of its current COVID-19 vaccine, Spikevax — by refining its immune target.
The approval 'adds an important new tool to help protect people at high risk of severe disease from COVID-19,' Stephane Bancel, Moderna's CEO, said in a statement Saturday.
The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus.
That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax.
Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials.
Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall.
The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as effective — and more by some measures — than the original shot, the company said.
The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Axios
an hour ago
- Axios
Exclusive: HHS watchdog finds more than $16B in health savings
The Department of Health and Human Services' watchdog identified more than $16 billion in overpayments, fraudulent billings and possible cost savings in health programs over a half year spanning the Biden and Trump administrations, including more than $3.5 billion to be returned to the government. Why it matters: The semiannual summary, first shared publicly to Axios, comes as the Trump administration says it's prioritizing government efficiency and rooting out waste, fraud and abuse. It reflects growing concern over federal payments to Medicare Advantage plans, along with enforcement actions like McKinsey agreeing to pay $650 million to settle charges that its advice caused Purdue Pharma to submit fraudulent claims stemming from the opioid crisis. The report was sent to Congress late Friday. By the numbers: The HHS Office of Inspector General identified $16.6 billion in real and potential savings from October 2024 through March of this year. The office's investigations identified $3.5 billion in funds due back to the federal government, and its audits found another $451 million that the government will recoup. More than $12 billion in potential cost savings were identified if HHS makes recommended policy changes. The office issued 165 recommendations over the six months. In one example, OIG found that Medicare could have saved $7.7 billion if it lowered payments for swing beds at critical access hospitals so that they match skilled nursing facilities. The change would require action from Congress, and the Centers for Medicare and Medicaid Services said it didn't agree with the recommendation. Nearly 400 civil actions, including settlements, resulted from OIG's work during the period. OIG says its work returned $11 to the federal government for each $1 invested in its office. "Whether it's us, whether it's [the Government Accountability Office], whether it's DOGE, whether it's state auditors, there's always a need for program integrity and oversight," said John Hagg, assistant inspector general in the IG's office of audit services. Zoom in: OIG over the six months covered in the report continued its investigations that raise concerns over improper payments in Medicare Advantage. OIG found that many patient diagnoses reported by privately run Medicare plans were supported only through health risk assessments. That allowed plans to be paid more to care for sicker, more expensive patients without enough supporting documentation, raising questions about their validity, per OIG. OIG recommended that Medicare further restrict plans' abilities to get higher payments based on diagnoses reported only on in-home health risk assessments in order to save an estimated $4.2 billion for Medicare. The office plans to do more work on Medicare Advantage in the near future, Melicia Seay, assistant inspector general in the office of evaluation and inspection, told Axios. "There's a lot of areas in terms of Medicare Advantage that we're exploring, whether it is the payment policy related to the program, the service delivery, quality of care," she said. Catch up quick: President Trump in January abruptly fired several agency inspectors general, including longtime HHS watchdog Christi Grimm. He claimed that"some were not doing their job."
Business Insider
3 hours ago
- Business Insider
Teva announces results from a study of treatment patterns of tardive dyskinesia
Teva (TEVA) Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced results from a study of treatment patterns among patients with tardive dyskinesia residing in long-term care facilities, highlighting a critical gap in TD diagnosis and treatment. Key results from the study revealed: Of the residents being treated with antipsychotic drugs, 5.6% had a diagnosis of extrapyramidal syndrome, – a broad term used to describe any drug-induced movement disorder with no wide-treating therapeutic option – while 1.1% had a specific diagnosis of TD. The most common comorbidities observed in residents on APDs at risk for TD included dementia, chronic pulmonary disease and congestive heart failure. Moderate or severe liver disease was observed in less than1% of residents on APDs. Less than half of patients diagnosed with TD residing in LTC settings received the standard of care treatment recommended by the American Psychiatric Association – a vesicular monoamine transporter 2 inhibitor. The majority were treated with a non-FDA approved treatment, primarily benztropine, and a quarter were not treated at all. Confident Investing Starts Here:
Yahoo
3 hours ago
- Yahoo
NY Times columnist compares Elon Musk to history's worst murderers over USAID cuts
New York Times columnist David Brooks suggested Elon Musk belongs on a list of history's greatest mass murderers, including Pol Pot, Mao and Stalin due to DOGE'S cuts to USAID. "So far, 55,000 adults have died of AIDS in the four months since Trump was elected; 6,000 children are dead because of what Doge did. That's just PEPFAR, the HIV. You add them all up, that's 300,000 dead, and we're four months in. You add that all up and accumulate that over four years the number of dead grows very high," Brooks said on PBS News Hour Saturday. "There are mass murderers in the world, Pol Pot, Mao Tse Tung, Stalin. We don't have anybody on the list from America," Brooks added. Trump 'Agreed' On Shutting Down Usaid, Elon Musk Says The New York Times columnist conceded the so-called deaths that he claims Musk is responsible for are not "the same kind of genocide" perpetrated by the despots he cited, but maintained that Musk's closure of USAID made him partially responsible for mass deaths. The casualty counts Brooks cited were provided by a Boston University digital tracker that monitors deaths that it claims occur from changes in U.S. foreign aid created by Global Health Professor Brooke Nichols. When filtered for USAID cuts, the tracker states that 99,528 adults and 207,680 children have died this year from "funding discontinuation." Read On The Fox News App The communist regime Khmer Rouge killed between 1.5-3 million people between 1975 and 1979 in the Cambodian Genocide when the group plunged the country into mass violence targeting intellectuals and religious minorities following their overthrow of the Cambodian Monarchy and installation of Pol Pot as dictator in 1975. Thirty-eight million people died of starvation during Mao's Great Leap Forward and the ensuing famine it produced. Mao biographers Jung Chang and Jon Halliday estimate that Mao was responsible for over 70 million peacetime deaths. Stalin killed over six million of his own citizens in the gulags, the Great Terror and other actions. Click Here For More Coverage Of Media And Culture Brooks is purpotedly one of the few conservative voices at the New York Times. However, the columnist has espoused liberal views on a host of topics and has praised Biden's presidency. He has also positioned himself as a fierce critic of President Donald Trump. "Trumpism can be seen as a giant attempt to amputate the highest aspirations of the human spirit and to reduce us to our most primitive, atavistic tendencies," Brooks wrote in a recent column. USAID was set up in the early 1960s to act on behalf of the U.S. to deliver aid across the globe, particularly in impoverished and underdeveloped regions. The agency now operates in 60 nations and employs some 10,000 people, two-thirds of whom work overseas — though most of the on-the-ground work is contracted out to third-party organizations funded by USAID, according to a BBC report. The Trump administration, however, has argued that USAID is a corrupt organization that is mishandling U.S. taxpayer dollars. DOGE froze USAID funds and sent much of its staff home shortly after Trump took office. Musk, who was spearheading the DOGE effort to root out "waste, fraud and abuse" in government, has said the agency is beyond repair. The Trump administration announced that it would be cutting 90% of all USAID contracts in April. U2 frontman Bono recently made a similar claim as Brooks on Joe Rogan's podcast, saying 300,000 people have died due to USAID cuts. Musk swiftly shot back on social media, calling the Irish rocker a "liar/idiot" and claiming that there have not been any deaths from USAID cuts. "He's such a liar/idiot Zero people have died!" The Tesla CEO posted. Musk and Brooks did not respond to Fox News Digital's request to comment. Michael Dorgan contributed to this report. Original article source: NY Times columnist compares Elon Musk to history's worst murderers over USAID cuts
